[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GlaxoSmithKline\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":661},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,105,0,25,[9,48,70,85,117,143,169,193,220,247,277,306,328,356,373,398,426,457,487,513,536,560,582,607,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100652864","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-gsk5784283-felcorekibart-compared-with-placebo-in-participants-with-moderate-to-very-severe-copd-persist-copd-1-100652864",false,"NCT07780669","A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)","A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-1)","Inclusion Criteria:\n\n* Male or eligible female participants\n* Participants with \\>=40 to less than or equal to (\\\u003C=) 80 years of age.\n* An eosinophilic phenotype with elevated BEC.\n* Moderate to very severe COPD with frequent exacerbations.\n* Participants with elevated COPD assessment test (CAT) score.\n* Current or former cigarette smokers.\n* On triple (Inhaled corticosteroid \\[ICS\\]+ Long-acting muscarinic antagonist \\[LAMA\\]+ Long-acting beta-agonist \\[LABA\\]) or dual inhaled COPD therapy, if ICS is considered not appropriate.\n\nExclusion Criteria:\n\n* Current or prior physician diagnosis of asthma\n* Other clinically significant lung disease.\n* Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.\n* Participants with a history of, or plan for lung volume reduction surgery \u002F endobronchial valve procedure.\n* Continuous oxygen therapy (more than 16 hours\u002F day).\n* Cor pulmonale resulting in right heart failure and severe pulmonary hypertension.\n* A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).\n* Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.\n* New York Heart Association class III or IV heart failure.\n* Other significant medical conditions that could impact participants' safety or study outcomes.","ALL","40 Years","80 Years",{"count":21,"type":22},624,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.",[28],"Pulmonary Disease, Chronic Obstructive",[30,31,32,33,34,35],"Chronic obstructive pulmonary disease","GSK5784283","Eosinophilic phenotype","Felcorekibart","Monoclonal antibody","Thymic Stromal Lymphopoietin","NOT_YET_RECRUITING","2026-08-19",{"date":39,"type":40},"2026-08-21","ACTUAL",{"date":42,"type":22},"2026-08-31",{"date":44,"type":22},"2030-03-15",{"name":46,"class":47},"GlaxoSmithKline","INDUSTRY",{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100652858","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-gsk5784283-compared-with-placebo-in-participants-with-uncontrolled-asthma-persist-asthma-1-100652858","NCT07780643","A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK5784283 (Felcorekibart) as an Add-On Therapy in Adults and Adolescents With Uncontrolled Asthma (PERSIST ASTHMA-1)","Inclusion Criteria:\n\n* Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).\n* Participants aged 12 to 80 years at the time of signing the informed consent.\n* Male or eligible female participants:\n\n  * Female participants:\n\n    * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n      i. Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.\n* A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.\n* If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials.\n* A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines.\n* Evidence of variable airflow obstruction consistent with asthma.\n* Documented history of asthma exacerbation within 12 months prior to Visit 1.\n* A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS).\n* At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist \\[LABA\\], Leukotriene receptor antagonists \\[LTRA\\], theophylline, Long-acting muscarinic agonists \\[LAMA\\], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening.\n* Uncontrolled asthma based on ACQ-5 score.\n\nExclusion Criteria:\n\n* Any concomitant respiratory disease that in the opinion of the investigator and\u002For medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.\n* History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).\n* Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.\n* New York Heart Association (NYHA) class III or IV heart failure.\n* Other significant medical conditions that could impact participants' safety or study outcomes.\n* History of an unresolved clinically significant infection within 30 days prior to Visit 1.\n* A known immunodeficiency, other than that explained by the use of corticosteroids taken as therapy for asthma.\n* Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit 1.\n* Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma).\n* Current smokers (tobacco and\u002For marijuana), current users of vaping products\u002Felectronic-cigarettes or participants with a smoking history \\>=10 pack-years.","12 Years",{"count":57,"type":22},514,[25],"The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.",[61],"Asthma",[61,33,31,63,64],"Placebo","Standard of care",{"date":39,"type":40},{"date":42,"type":22},{"date":68,"type":22},"2029-10-11",{"name":46,"class":47},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":26,"conditions":79,"keywords":80,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":84,"locationsCount":4},"100652835","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-gsk5784283-felcorekibart-compared-with-placebo-in-participants-with-moderate-to-very-severe-copd-persist-copd-2-100652835","NCT07780656","A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)","A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-2)","Inclusion Criteria:\n\n* Male or eligible female participants.\n* Participants with \\>=40 to less than or equal to (\\\u003C=) 80 years of age.\n* An eosinophilic phenotype with elevated BEC.\n* Moderate to very severe COPD with frequent exacerbations.\n* Participants with elevated COPD assessment test (CAT) score.\n* Current or former cigarette smokers.\n* On triple (Inhaled corticosteroid \\[ICS\\]+ Long-acting muscarinic antagonist \\[LAMA\\]+ Long-acting beta-agonist \\[LABA\\]) or dual inhaled COPD therapy, if ICS is considered not appropriate.\n\nExclusion Criteria:\n\n* Current or prior physician diagnosis of asthma.\n* Other clinically significant lung disease.\n* Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.\n* Participants with a history of, or plan for lung volume reduction surgery \u002F endobronchial valve procedure.\n* Continuous oxygen therapy (more than 16 hours\u002F day).\n* Cor pulmonale resulting in right heart failure and severe pulmonary hypertension.\n* A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).\n* Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.\n* New York Heart Association class III or IV heart failure.\n* Other significant medical conditions that could impact participants' safety or study outcomes.",{"count":21,"type":22},[25],[28],[30,31,32,33,34,35],{"date":39,"type":40},{"date":42,"type":22},{"date":44,"type":22},{"name":46,"class":47},{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":17,"minAge":93,"maxAge":19,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100639043","phase-1-a-study-of-investigational-rsvhmpv-combination-and-investigational-hmpv-vaccines-in-younger-and-older-adults-100639043","NCT07628049","A Study of Investigational RSV\u002FhMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults","A Phase 1\u002F2, Randomized, Controlled, Observer-blind, Multicentre Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of GSK Biologicals' Investigational Respiratory Syncytial Virus (RSV)\u002FHuman Metapneumovirus (hMPV) Combination and Investigational hMPV Vaccines When Administered Intramuscularly According to a Single Dose Schedule in Younger Adults ≥18 to ≤49 Years and Older Adults Aged ≥60 to ≤80 Years","Inclusion criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Written informed consent obtained from the participant prior to performance of any study-specific procedure.\n* Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications).\n* Body Mass Index (BMI) between 18 kg\u002Fm\\^2 and 33 kg\u002Fm\\^2, inclusive.\n\nSpecific inclusion criteria for OA\n\n* A male or female between and including, 60 to 80 YOA at the time of the study intervention administration.\n* Healthy participants or medically stable patients as established by medical history and physical examination.\n\nSpecific inclusion criteria for YA\n\n* A male or female participant between and including 18 to 49 YOA at the time of the study intervention administration.\n* Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.\n* Participants of non-childbearing potential may be enrolled in the clinical study.\n* Participant of childbearing potential may be enrolled in the study if the participant:\n\n  * has used two methods of contraception, at-least one of which must be a highly effective method, and the other being male condom for male sexual partners of POCBP to be used during sexual intercourse (with the exception of sexual abstinence, vasectomized partner and male partner who has been sterilized, in which case contraception is not required), at-least 30 days prior to study intervention administration, and has agreed to continue using above contraception requirements for 8 weeks after study intervention administration.\n  * has a negative serum pregnancy test at screening and negative urine pregnancy test prior to study intervention administration on Day 1.\n\nExclusion criteria:\n\nParticipants are excluded from participating in the study if any of the following criteria apply:\n\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).\n* Any medical condition that in the judgment of the investigator would make IM injection unsafe.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) or immunosuppressive\u002Fcytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).\n* Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.\n* Documented history of HIV, HBV, HCV infection.\n* History of RSV and \u002For hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months.\n* Recurrent history or uncontrolled neurological disorders or seizures, or history of demyelinating conditions (including GBS).\n* Any history of dementia or any medical condition that moderately or severely impairs cognition.\n* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.\n* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).\n* Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before study intervention administration (Day -29 to Day 1), or within 5 half-lives, whichever is longer, or their planned use during the study period.\n* Has previously received an investigational or approved vaccine or antibody for prevention of hMPV and\u002For RSV-associated diseases.\n* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and\u002For planned use of long-acting immune-modifying treatments at any time up to the end of the study.\n\n  * Up to 3 months prior to the study intervention administration:\n\n    * For corticosteroids, this will mean prednisone equivalent \\>=20 mg\u002Fday for adult participants. Inhaled, topical and intra-articular steroids are allowed.\n    * Administration of immunoglobulins and\u002For any blood products or plasma derivatives.\n  * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.\n* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.\n* History of chronic alcohol consumption and\u002For drug abuse as deemed by the investigator to render the potential participant unable\u002Funlikely to provide accurate safety reports or comply with study procedures.\n* Participation of any study personnel or their immediate dependents, family, or household members.\n* Planned move during the study period that will prohibit participating in the study until study end.\n* Bedridden participants.\n\nSpecific exclusion criteria for OA population\n\n* Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.\n* At screening (Phase 1 only), participants with:\n\n  * \\>=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded:\n\n    * Hematologic: hemoglobin (Hb), white blood cells (WBC), platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils,\n    * Biochemical: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, creatinine, blood urea nitrogen (BUN).\n  * Grade 1\u002Fmild hematologic and\u002F or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included.\n\nSpecific exclusion criteria for YA population\n\n* Pregnant or lactating participant.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions for 8 weeks after study intervention administration.\n* Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration.\n* At screening, participants with:\n\n  * \\>=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded:\n\n    * Hematologic: Hb, WBC, platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils,\n    * Biochemical: ALT, AST, ALP, bilirubin, creatinine, BUN.\n  * Grade 1\u002Fmild hematologic and\u002F or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included.\n* Use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's wort) beginning 14 days (or 5 half-lives) prior to study intervention administration and\u002For planned administration during the study period. Certain medications may be permitted (Eg: contraceptives for POCBP).",true,"18 Years",{"count":95,"type":22},1456,[97,98],"PHASE1","PHASE2","The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV\u002FhMPV combination vaccine and investigational hMPV vaccine in younger and older adults.",[101],"Respiratory Syncytial Virus Infections+Metapneumovirus",[103,104,105,106,107],"Safety","Reactogenicity","Immunogenicity","Respiratory syncytial virus (RSV)","Human metapneumovirus (hMPV)","RECRUITING",{"date":110,"type":40},"2026-08-20",{"date":112,"type":40},"2026-06-05",{"date":114,"type":22},"2029-04-05",{"name":46,"class":47},4,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100494181","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-belantamab-for-the-treatment-of-multiple-myeloma-when-used-as-monotherapy-and-in-combination-treatments-100494181","NCT05714839","A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments","A Phase 1\u002F2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma","DynaMMic-1","Inclusion criteria\n\n* Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.\n* Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG) and have progressed on or following the last line of treatment\n\n  * Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, including any immunomodulatory drug (IMiDs lenalidomide, pomalidomide or thalidomide), a proteasome inhibitor, and an anti-CD38 monoclonal antibodies (mAb) (either in combination or separately).\n  * Part 3: Have received at least 1 prior line of treatment anti-myeloma treatments, including lenalidomide. Prior anti-CD38-containing regimen is not mandated, however no more than 70% of participants recruited may be anti-CD38 naïve.\n* Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:\n\n  * transplant was greater than (\\>)100 days prior to screening.\n  * No active bacterial, viral, or fungal infection(s) present\n* Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.\n* Measurable disease defined as at least ONE of the following:\n\n  * Serum M-protein concentration greater than or equal to (\\>=) 0.5 gram (g)\u002F deciliter (dL) (\\>=5 gram\u002Fliter \\[g\u002FL\\])\n  * Urine M-protein excretion \\>=200 milligram (mg)\u002F24 hours (\\>=0.2 g\u002F24 hours)\n  * Serum free light chain (FLC) assay: involved FLC level \\>=10 mg\u002FdL (\\>=100 milligrams per liter \\[mg\u002FL\\]) and an abnormal serum FLC ratio (less than \\[\\\u003C\\]0.26 or \\>1.65)\n* Have adequate organ system function as defined by the laboratory assessments\n* All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events \\[NCI-CTCAE\\], v5.0, 2017) must be Grade less than or equal to (\\\u003C=)1 at the time of screening except for alopecia (any grade), neuropathy (Grade \\\u003C=2), or endocrinopathy managed with replacement therapy (any grade).\n* Participants or legally authorized representative (LAR) (if applicable per local regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Male Participants (for parts 1b, 2 and 3):\n* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male Participants enrolled in part 1 (and expansion) cohort receiving belantamab monotherapy are not required to use contraception\n* Male participants are eligible to participate in parts 2 and 3 if they agree to the following during the intervention period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm:\n\n  * Refrain from donating fresh unwashed semen PLUS either:\n\n    * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n    * Must agree to use contraception\u002Fbarrier as detailed below\n    * Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1 percent (%) per year when having sexual intercourse with POCBP who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is NOT a Participant of child-bearing potential (POCBP) or\n  * Is a POCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency, 30 days prior to treatment start, during the intervention period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n* Part 3: Due to pomalidomide being a thalidomide analogue with a risk for embryofetal toxicity and prescribed under a pregnancy prevention\u002Fcontrolled distribution program, POCBP will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or use two methods of reliable birth control (one method that is highly effective plus an additional barrier method), beginning at least 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for at least 4 weeks following discontinuation of pomalidomide treatment. Thereafter, POCBP must use one contraceptive method that is highly effective (with a failure rate of less than (\\\u003C)1% per year) for a further 3 months (total 4 months).\n* The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention\n* All POCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.\n\nExclusion criteria\n\n* Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.\n* Part 3: Active or history of venous or arterial thromboembolism within the past 3 months. Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis\n* Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.\n* Participant is exhibiting signs of meningeal or central nervous system involvement with MM.\n* Part 2: Current corneal epithelial disease except nonconfluent Superficial punctate keratitis (SPK).\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Presence of malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the Principal investigator (PI) and GlaxoSmithKline (GSK) Medical Director, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM). Participants on active surveillance or hormone treatment for non-metastatic prostate cancer are not excluded. Participants on hormone therapy for non-metastatic breast cancer are not excluded\n* Evidence of cardiovascular risk including any of the following:\n\n  * Evidence of current clinically significant untreated arrhythmias, including, but not limited to, clinically significant Electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree Atrioventricular (AV) block.\n  * Part 1 dose escalation and Part 2 only: QT interval corrected using Fridericia's formula (QTcF) interval \\>480 millisecond (msec) (QT interval corrected for heart rate according to Fridericia's formula), and\u002For hypokalemia, and\u002For family history of long QT syndrome.\n  * Part 1 dose expansion and Part 3: Not applicable.\n  * History of MI, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within three months of screening.\n  * Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n  * Uncontrolled hypertension\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab \u002F belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other Monoclonal antibodies (mAbs).\n* Active infection requiring antibiotic, antiviral, or antifungal treatment.\n* For serology of Hepatitis B surface antigen (HBsAg)+ at screen or within 3 months prior to first dose Japan only: must test Hepatitis B e antigen (HBeAg) and Hepatitis B e antibody (HBeAb). Eligibility verification should be evaluated and agreed with a hepatologist (after they record the approval in the participant medical record).\n* Known Human immunodeficiency virus (HIV) infection, unless the participant can meet specific criteria.\n* Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.\n* Participants with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) will be excluded unless specific criteria can be met.\n* Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible.\n* Part 1: Refractory to belantamab mafodotin (confirmed PD as per IMWG criteria while on belantamab mafodotin therapy or within 60 days of completing that treatment). Prior belantamab mafodotin is allowed if it was discontinued due to toxicity which subsequently resolved. Note: Prior treatment with other anti- B-cell maturation antigen (BCMA) directed agents is allowed. Provided there is at least 6-month washout after the last dose of prior anti-BCMA therapy.\n* Part 2: Prior belantamab mafodotin therapy is not allowed. Prior treatment with other anti-BCMA directed agents is allowed provided there is at least a 6-month washout after the last dose of prior anti-BCMA therapy .\n* Prior radiotherapy within 2 weeks of start of study therapy.\n* Plasmapheresis within 7 days prior to the first dose of study drug.\n* Prior allogeneic stem cells transplant.\n* Participants who have received prior Chimeric Antigen Receptor T-cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.\n* Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first dose or has not recovered fully from surgery.\n* Prior treatment with a mAb within 30 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is longer.\n* Part 1 dose escalation only: Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including Granulocyte colony stimulating factor \\[G-CSF\\], Granulocyte-macrophage colony-stimulating factor \\[GMCSF\\], recombinant erythropoietin) or any thrombopoietin receptor agonists within 2 weeks before the first dose of study drug. This does not apply for Part 1 Expansion Cohort.\n* Part 3: Prior belantamab, belantamab mafodotin, and pomalidomide therapy are not allowed. Prior treatment with other anti- BCMA directed agents is allowed provided there is at least 6-month washout after the last dose of prior anti-BCMA therapy.\n* Participants must not receive live\u002Flive attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab for at least 70 days following last study treatment.\n* Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board (IRB) approval (by chair or designee) is allowing exception to this criterion for a specific participant.\n* The use of other anti-cancer therapy not specified in this protocol, and any investigational agents other than belantamab and belantamab mafodotin, or any other MM Standard of Care (SoC) agents other than pomalidomide or dexamethasone are explicitly prohibited for the duration of the study.",{"count":126,"type":22},123,[97,98],"The study consists of three parts:\n\n* Part 1: The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+).\n* Part 2: The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different doses of belantamab in combination with a fixed dose of Belantamab mafodotin (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).\n* Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the belantamab in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.",[130],"Multiple Myeloma",[132,133,134],"Belantamab","Belantamab Mafodotin","Relapsed or Refractory Multiple Myeloma","2026-08-18",{"date":37,"type":40},{"date":138,"type":40},"2023-06-14",{"date":140,"type":22},"2028-08-03",{"name":46,"class":47},44,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100639691","phase-3-a-study-to-investigate-velzatinib-compared-with-imatinib-in-adult-participants-with-previously-untreated-metastatic-andor-unresectable-gastrointestinal-stromal-tumors-strategist-frontline-100639691","NCT07585266","A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and\u002For Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)","A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) Versus Imatinib in Participants With Previously Untreated Metastatic and\u002For Unresectable Gastrointestinal Stromal Tumors (GIST)","Inclusion Criteria:\n\n* Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).\n* Has histologically or cytologically confirmed GIST that is metastatic and\u002For surgically unresectable.\n* Has not received prior systemic therapy for their metastatic and\u002For surgically unresectable GIST.\n* Tumor tissue must be provided to the central laboratory. Tumor tissues may be archival (preferred) or obtained from a fresh biopsy acquired for standard of care (biopsies must be collected before randomization).\n* Participants must have ≥1 target lesion (TL).\n* All participants must use adequate contraception according to local regulations throughout the study and for a specified period after the last dose of study medication (at least 30 days for velzatinib\u002Fimatinib, or 15 days for imatinib only, as applicable, or longer if local regulations specify).\n* Male participants must either be abstinent or use a male condom (with a recommendation for their female partner to use highly effective contraception). They must also refrain from donating semen.\n* Female participants must not be pregnant or breastfeeding.\n\n  1. Those of non-childbearing potential are eligible without additional contraception.\n  2. Those of childbearing potential must use an acceptable, highly effective contraceptive method and have a negative pregnancy test before starting the study. The investigator will assess their pregnancy risk.\n* Is capable of giving signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Has adequate organ function.\n\nExclusion Criteria:\n\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of metastatic disease.\n* Has any clinically significant gastrointestinal abnormalities that may alter absorption, e.g., malabsorption syndrome or major resection of the stomach and\u002For bowels.\n* Has had any major surgery (minor surgical procedures such as central venous catheter placement and tumor needle biopsy are not considered major surgical procedures) within 14 days of the first dose of study treatment or participants who have not fully recovered from surgery.\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant. Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: a) transplant was \\[\\>100 days\\] prior to screening, and b) the participant has no active infection(s) at the time of screening.\n* Has known allergy or hypersensitivity to velzatinib or imatinib, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has a history within 6 months prior of clinically significant or uncontrolled cardiac disease, unstable angina, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure \\[New York Heart Association,1994\\], or clinically significant arrhythmia not controlled by standard of care therapy, ventricular arrhythmia, cerebrovascular accident or transient ischemic attack and uncontrolled hypertension.\n* Has untreated brain or Central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed \\[e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain\u002FCNS metastases\\]. Participants with previously treated and clinically stable brain\u002FCNS metastases and who have completed all corticosteroid therapy for ≥2 weeks before randomization are not excluded from participation\n* Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, (excluding e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy) or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.\n* Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).\n* Has any serious and\u002For unstable medical or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.\n* Has received radiotherapy within 14 days prior to first dose of study treatment.\n* Has received any live vaccine within 30 days of randomization. Vaccination against Coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms (e.g., Emergency Use Authorization, Conditional Marketing Authorization, or Marketing Authorization Application) are not exclusionary.\n* Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony-stimulating factor \\[G-CSF\\], granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before randomization.\n* Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type of medical research before signing ICF.\n* Has a positive drug\u002Falcohol screening assessment.\n* Has a known Human immunodeficiency virus (HIV) infection and meets at least one of the following criteria:\n\n  1. Has documented evidence of plasma HIV-1 ribonucleic acid (RNA) ≥50 c\u002FmL within 3 months prior to or at screening. In the 3 to 12 months prior to screening, plasma HIV 1 RNA levels consistently \\\u003C50 c\u002FmL are required for enrollment; if multiple instances of plasma HIV-1 RNA values ≥50 c\u002FmL occurred in the 3 to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR\n  2. Has not had CD4 cell counts measured in the past 12 months (i.e., at least two separate measurements taken a minimum of 28 days apart, one of which must be conducted at screening); OR\n  3. Has had any CD4 cell count values ≤200 cells\u002Fmm3 in the past 12 months; OR\n  4. Has had one or more changes in their combination antiretroviral therapy regimen (except for switches as allowed per details provided in protocol) or has received an antiretroviral therapy regimen that is inconsistent with locally recommended guidelines during the 3 months prior to screening; OR\n  5. Has a history of HIV-associated non-Hodgkin lymphoma within 5 years prior to screening or a history of HIV-associated invasive cervical cancer; OR\n  6. Has received treatment with an HIV 1 immunotherapeutic vaccine within 90 days of screening.\n* Is pregnant or breastfeeding.\n* Is unable to adhere to the protocol, including requirements for the Follow-up Period of the study.\n* Has an alanine aminotransferase (ALT) value \\>2.5x upper limit of normal (ULN) or (for participants with documented liver metastases\u002Ftumor infiltration) has an ALT value \\>5x ULN\n* Has a total bilirubin value \\>1.5x ULN.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Evidence of chronic hepatitis B virus (HBV) infection with detectable viral load despite antiviral therapy with high resistance barrier.\n* 12-lead electrocardiogram (ECG) demonstrating mean QT interval corrected (QTc) corrected by Fridericia's formula \\>480msec at screening or history of long QT syndrome.",{"count":151,"type":22},800,[25],"Gastrointestinal Stromal Tumour (GIST) is a soft tissue tumour that develops in the digestive system, most often in the stomach or small intestine. It is caused by changes in certain proteins that cause the cells to grow uncontrollably. Although current treatments may be effective, tumours may stop responding over time, highlighting the need for newer options. This study is evaluating velzatinib (GSK6042981) in participants with newly diagnosed GIST that has spread or cannot be surgically removed. Velzatinib will be compared with imatinib, the standard treatment, to assess whether it can delay disease worsening and is safe and well tolerated.",[155],"Gastrointestinal Stromal Neoplasms",[157,158,159,160],"Velzatinib","Imatinib","GIST","Gastrointestinal stromal tumor","2026-08-17",{"date":37,"type":40},{"date":164,"type":40},"2026-07-27",{"date":166,"type":22},"2032-09-28",{"name":46,"class":47},17,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":168},"100628007","phase-3-a-study-of-efficacy-and-safety-of-depemokimab-compared-with-placebo-in-adults-and-adolescents-with-at-risk-type-2-asthma-100628007","NCT07456033","A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma","The MODIFY Study: A Phase 3b\u002F4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks","MODIFY","Inclusion Criteria:\n\n* Adults and adolescents \\>=12 years of age, at the time of signing the informed consent\u002Fassent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be \\>=18 years of age.\n* Participants must have a documented physician diagnosis of asthma for \\>=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines\n* Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.\n\n  * Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)\u002F Long-acting beta2-adrenergic receptor agonist (LABA).\n* A well-documented requirement for treatment with low to medium dose ICS\u002FLABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy\u002FSingle Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS.\n\n  * Study will limit enrolment to a maximum of 40 percent (%) of participants on low dose ICS\u002FLABA.\n* Sex and Contraceptive\u002FBarrier Requirements Male or eligible female Participants:\n\n  * Male Participants: Contraception for male participants with female partners is not required.\n  * Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n  * Is a participant of nonchildbearing potential (PONCBP) OR\n  * Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C)1%, from at least 14 days prior to the first dose of study intervention until at least 35 weeks after the last administered dose of study intervention.\n  * A POCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1, Exit Visit 11 or Withdrawn from study visit, and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention.\n  * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n  * The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Capable of giving signed informed consent\u002Fassent as which includes compliance with the requirements Randomization inclusion criteria-\n* Type 2 high disease at risk of asthma exacerbations as defined by either:\n\n  * An elevated peripheral blood eosinophils (EOS) count of \\>=500 cells\u002Fmicroliter (μL) at screening or \\>=500 cells\u002FμL in the last 3 months prior to the screening visit.\n\nOR\n\n* An elevated peripheral blood EOS count of \\>=300 cells\u002FμL at screening OR \\>=300 cells\u002FμL in the last 3 months prior to the screening visit AND\n\n  * Fractional exhaled nitric oxide \\>=35 parts per billion (ppb) at screening. OR\n  * Documented current Chronic Rhinosinusitis with Nasal Polyps.\n\nExclusion Criteria:\n\n* Participants have had 3 or more exacerbations in the last year prior to Visit 1.\n* Participants on maintenance OCS or high dose ICS\u002FLABA for asthma.\n* Participants with a duration of asthma greater than (\\>)20 years.\n* Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.\n* Participants with other conditions that could lead to elevated EOS such as hypereosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis.\n* Participants who developed an exacerbation within 4 weeks before screening.\n* Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved.\n* A known immunodeficiency (e.g. human immunodeficiency virus), other than that explained by the use of CS taken as therapy for asthma.\n* A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.\n* Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic or any other system abnormalities that are uncontrolled with standard treatment.\n* Participants with current diagnosis of vasculitis.\n* Participants who have received treatment with any approved or investigational biologic monoclonal antibody (mAb).\n* A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention.\n* Current smokers or former smokers with a smoking history of \\>=20 pack years (number of pack years = \\[number of cigarettes per day\u002F20\\] \\* number of years smoked) and vapers.\n* Participants with allergy\u002Fintolerance to a mAb or biologic or any of the excipients of depemokimab.\n* Participants who are pregnant or breastfeeding.\n* Participants who have known evidence of lack of adherence to controller medications and\u002For ability to follow physician's recommendations.\n* Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator.\n\nLiver safety exclusion criteria:\n\n* Alanine aminotransferase (ALT) \\>2\\* Upper limit of normal (ULN).\n* Total bilirubin \\>1.5\\*ULN; For participants with Gilbert's syndrome: can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is less than or equal to (\\\u003C=)1.5\\*ULN.\n* Cirrhosis or current unstable liver or biliary disease as per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.\n\nCardiac safety exclusion criteria:\n\n* Electrocardiogram (ECG) Assessment: QTc corrected by Fridericia's formula (QTcF) \\>=450 millisecond (msec) or QTcF \\>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12-lead ECG machine read at Visit 1.\n* Participants are excluded if an abnormal ECG finding from central over read of the 12 lead ECG conducted at Screening Visit is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the investigator.\n\nRandomization exclusion criteria:\n\n* ECG Assessment: QTcF \\>=450 msec or QTcF \\>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12 lead ECG machine read at Visit 1.\n* ALT \\>2\\*ULN.\n* Total bilirubin \\>1.5\\*ULN; For participants with Gilbert's syndrome can be included with total bilirubin \\>1.5\\*ULN as long as direct bilirubin is \\\u003C=1.5\\*ULN.\n* Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable.\n* Maintenance Asthma Therapy: Any changes in the dose or regimen of baseline ICS and\u002For additional controller medication (except for treatment of an exacerbation) during the run-in period.",{"count":178,"type":22},456,[25],"The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).",[61],[183,184,175,185],"GSK3511294","Depemokimab","Type 2 asthma","2026-08-13",{"date":161,"type":40},{"date":189,"type":40},"2026-03-13",{"date":191,"type":22},"2030-09-23",{"name":46,"class":47},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},"100608399","phase-2-a-study-to-assess-the-effectiveness-and-safety-of-gsk3862995b-in-adults-with-bronchiectasis-100608399","NCT07201051","A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis","A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants With Bronchiectasis","Inclusion Criteria:\n\n* Body mass index (BMI) between 18-35 kilograms per square meters (kg\u002Fm\\^2)\n* Clinical history consistent with bronchiectasis (cough, chronic sputum production, and\u002For recurrent respiratory infections) that is confirmed on chest computed tomography (CT)\n* Meet one of the two criteria:\n\n  * In the 12 months prior to screening, have had 2 or more documented pulmonary exacerbations that required a new antibiotic prescription by a physician or 1 pulmonary exacerbation that required hospitalization; or\n  * In the 12 months prior to screening, have had 0 or 1 pulmonary exacerbation and a QOL-B RSS of less than (\\\u003C)50 at screening\n* Current sputum producers\n* Post-bronchodilator FEV1 greater than or equal to (\\>=) 30 percent (%) or greater of predicted normal value\n* Non-smokers or former cigarette smokers\n* Males and females of childbearing and non-childbearing potential\n* A female participant is eligible to participate if she is not pregnant or breastfeeding\n* Is a Woman of non-childbearing potential (WONCBP) or is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1\n* A WOCBP must have a negative highly sensitive serum pregnancy test within 28 days before the first dose of study intervention\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol\n\nExclusion Criteria:\n\n* Participants with a primary diagnosis of asthma or Chronic Obstructive Pulmonary Disorder (COPD) as judged by the investigator\n* Bronchiectasis due to cystic fibrosis, alpha-1-antitrypsin deficiency, common variable immunodeficiency, hypogammaglobinemia, or traction bronchiectasis due to fibrotic lung disease\n* Active non-tuberculosis mycobacterial (NTM) lung infection on treatment or meeting ATS\u002FInfectious Diseases Society of America (IDSA) criteria for active lung infection\n* Active tuberculosis, untreated latent Tuberculosis (TB), invasive fungal lung infections or allergic bronchopulmonary aspergillosis needing treatment\n* Participant uses long-term oxygen therapy for more than 12 hours per day\n* Participants with an acute lower respiratory tract pulmonary infection needing treatment or pulmonary exacerbation within 4 weeks of the screening visit.\n* Participant has a past or current medical condition(s) or disease(s) that is\u002Fare not well controlled and, which in the judgment of the Investigator, may affect participant safety or affect study endpoints\n* Participants with an unstable cardiac disease, myocardial infarction, Cerebrovascular Accident (CVA), stroke or New York Heart Association Class III or IV heart failure within 12 months prior to screening\n* Participants with clinically significant abnormal Electrocardiogram (ECG) at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints\n* Significant allergies to humanized monoclonal antibodies\n* Participants with a history of lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected for cure with no evidence of recurrence or metastatic disease for 1-year\n* A known or suspected immunodeficiency that has led to opportunistic infections, recurrent invasive infections, or prolonged infections that suggest an underlying immunocompromised state by the judgement of the investigator. Positive HIV antibody test\n* Alanine aminotransferase (ALT) \\>2x Upper limit of normal (ULN)\n* Total bilirubin \\>1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin \\>1.5xULN as long as direct bilirubin is less than or equal to (\\\u003C=)1.5xULN\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n* Presence of hepatitis B surface antigen (Hepatitis B surface antigen \\[HBsAg\\]) and\u002For hepatitis B core antibody (Hepatitis B core antibody \\[HBcAb\\]) at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention\n* Positive hepatitis C Hepatitis B core antibody (RNA) test result at screening or within 3 months prior to first dose of study intervention\n* Corrected QT interval (QTc) \\>450 milliseconds (msec) at screening visit based on the average of triplicate ECGs The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","85 Years",{"count":202,"type":22},363,[98],"This study is designed to find out how effective and safe a new drug, GSK3862995B, is for adult participants with bronchiectasis, a chronic lung disease. The study will also test how the body processes the drug and to check for any immune reactions. Participants will be divided into groups randomly to receive either one of two different doses of the study drug or a placebo. The main goal of the study is to see how well the drug works compared to the placebo in helping those with bronchiectasis.",[206],"Bronchiectasis",[208,206,209,103,105,210],"GSK3862995B","Efficacy","Pharmacokinetics","2026-08-11",{"date":213,"type":40},"2026-08-12",{"date":215,"type":40},"2025-10-30",{"date":217,"type":22},"2027-12-10",{"name":46,"class":47},134,{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":92,"sex":17,"minAge":93,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100599531","phase-1-a-study-to-evaluate-safety-reactogenicity-and-immunogenicity-of-the-gsk-4-component-strep-a-vaccine-with-aluminum-hydroxide-alum-or-as37-in-healthy-young-adults-100599531","NCT07085702","A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Young Adults","A Phase 1 Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Vaccine Against Group A Streptococcus Pyogenes (Strep A) With Alum or AS37 in Healthy Adults 18 to 25 Years of Age in Australia","Inclusion Criteria:\n\n* Participants, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries \\[eDiaries\\], return for follow-up visits).\n* Written or witnessed\u002Fthumb-printed informed consent obtained from the participant prior to performance of any study-specific procedure.\n* Healthy participants as established by medical history, clinical examination, and laboratory assessments.\n* Satisfies all screening requirements.\n* Male and female participants between and including 18 and 25 years of age at the time of informed consent.\n* Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche, postmenopause, or had current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy.\n* Female participants who are of childbearing potential may be enrolled in the study if the participant:\n\n  * has practiced adequate contraception for 1 month prior to study intervention administration, and\n  * has a negative pregnancy test on the day of study intervention administration, and\n  * has agreed to continue adequate contraception during the entire study intervention administration period and for 1 month after completion of the study intervention administration series.\n* Male participants who are sexually active with a female partner of childbearing potential are eligible to participate if they agree to have their partner use a highly effective method of contraception for 1 month prior to the first study intervention administration until 1 month after completion of the study intervention administration series.\n* Male participants must refrain from donating sperm for 1 month prior to the first study intervention administration until 1 month after completion of the study intervention administration series.\n* Participants seronegative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C at Screening.\n\nExclusion Criteria:\n\n* History of rheumatic fever or rheumatic heart disease during the lifetime of the participant as confirmed during interview with the participant or as documented in medical records.\n* Recent history of pharyngitis in the last four (4) weeks will be excluded. These participants can be rescreened once the recent pharyngitis passes the 4-weeks period. Participants with symptoms of acute pharyngitis at Screening will be tested with a Strep A rapid antigen test. Those with positive results will be excluded.\n* Progressive, unstable, or uncontrolled clinical conditions.\n* History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Hypersensitivity (e.g., allergy) to medicinal products or medical equipment anticipated to be used in this study.\n* Clinical conditions that represents a contraindication for IM vaccination or blood draws.\n* Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.\n* Acute disease and\u002For fever (defined as temperature \\>=38.0°C) at the time of enrollment.\n* Any Grade \\>=2 and\u002For clinically significant hematological and\u002For biochemical laboratory abnormality.\n* Any echocardiographic\u002FDoppler Echo findings consistent with carditis at Screening.\n* Recurrent history or uncontrolled neurological disorders or seizures.\n* Medical history or family history of autoimmune disease and other pIMDs.\n* Family history of acute rheumatic fever.\n* Acute or chronic illness, or clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality.\n* Any other clinical condition that might pose additional risk to the participant due to participation in the study.\n* Administration of long-acting immune-modifying drugs (e.g., infliximab) at any time prior to the administration of the first dose of study intervention(s) or planned administration during the study period.\n* Prior receipt of an experimental Strep A vaccine.\n* Use of any investigational or nonregistered product (drug, vaccine, or medical device) other than the study interventions during the period starting 30 days before the first dose of study intervention (Day -30 to Day 1), or their planned use during the study period.\n* Receipt of a vaccine not foreseen by the study protocol administered during the period starting at 21 days before the first dose of study intervention (28 days before the first dose, in case of live vaccines) and ending after the last dose of study intervention administration.\n* Administration of immunoglobulins and\u002For any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before administration of the first dose of study intervention(s) or planned administration during the study period.\n* Chronic administration (defined as \\>14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first dose of study intervention. For corticosteroids, this means prednisone equivalent \\>=20 mg\u002Fday for adult participants. Inhaled, topical, intra-articular, and intranasal steroids are allowed.\n* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug, vaccine, or invasive medical device).\n* Pregnant or lactating female participant.\n* Participant who is planning to become pregnant or planning to discontinue contraceptive precautions.\n* History of or current chronic alcohol consumption and\u002For drug abuse.\n* Any study personnel or their immediate dependents, family, or household members.","25 Years",{"count":229,"type":22},108,[97],"The purpose of this study is to assess the safety of 3 doses of 2 new Strep A vaccine formulations, one with an Alum adjuvant, and the other with AS37 adjuvant. The Strep A vaccine will be tested for the first time in humans, in healthy young adults 18 to 25 years of age. The study will also assess if the vaccines have any immediate reactions and if they induce an immune response. A low, medium, and high dose of each formulation of the vaccine will be assessed in sequence.",[233],"Streptococcal Infections",[235,236,103,104,105,237,238],"Strep A","Streptococcus pyogenes","Healthy Adults","Australia","2026-08-07",{"date":211,"type":40},{"date":242,"type":40},"2025-07-29",{"date":244,"type":22},"2027-06-29",{"name":46,"class":47},2,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":254,"minAge":93,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":4},"100646135","phase-3-mo-rez-in-first--line-1l-maintenance-treatment-of-non-homologous-recombination-deficient-ovarian-cancer-non-hrd-oc-behold-ovarian03-100646135","NCT07694427","Mo-Rez in First- Line (1L) Maintenance Treatment of Non-Homologous Recombination Deficient Ovarian Cancer (Non-HRd OC) [BEHOLD-Ovarian03]","A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan With or Without Bevacizumab in Comparison to Active Observation With or Without Bevacizumab as Maintenance Treatment in Participants With Newly Diagnosed FIGO Stage III\u002FIV Non-Homologous Recombination Deficient Ovarian Cancer","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF).\n* Has newly diagnosed Stage III\u002FIV (2014 FIGO staging) \\[Berek, 2021\\] epithelial ovarian, primary peritoneal or fallopian tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, clear cell carcinoma, carcinosarcoma or mixed histology.\n* Has completed first-line platinum-based chemotherapy cycles. Inclusion of IV regimens at Q3W cycles, consolidation regimens and Intravenous (IV)\u002F Intraperitoneal (IP) and Hyperthermic intraperitoneal chemotherapy (HIPEC) regimens are acceptable. In the event of history of platinum or paclitaxel allergy, alternative agents are allowed (in consultation with the sponsor). At least cycles of first-line chemotherapy must be completed with or without bevacizumab.\n* Has Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) response determined by investigator after the completion of first-line treatment must be Complete response (CR), Partial response (PR), No evidence of disease (NED), or Stable disease (SD).\n* Is able to commence C1D1 of study treatment within 9 weeks of the final dose of front-line therapy. Final dose of front-line therapy is defined as the last day that platinum-based chemotherapy with\u002Fwithout bevacizumab was given. Participants may continue bevacizumab dosing if specified cycles of bevacizumab post-chemotherapy are administered prior to randomization.\n* If planning to receive bevacizumab: Has received at least specified number of cycles of bevacizumab per label and local approval in combination front-line chemotherapy\n* Has provided a sample sufficient for Homologous repair deficiency (HRD) testing (if local testing is not available), and the results available prior to date of randomization.\n* Tumor specimen should be obtained from the most recent procedure and from a site not previously irradiated. If a suitable archival sample is not available, a fresh tumor tissue sample must be obtained during Screening. Fine needle aspirates, bone marrow samples, bone specimens, or cell blocks are not acceptable. Additional details regarding acceptable biopsy collections and processing can be found in the Laboratory Manual and other laboratory documentation. Tumor sample may also be used for other biomarker testing.\n* Is willing to use adequate contraception. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:\n* Is a Participant of non-childbearing potential (PONCBP) OR\n* Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency, as described in Protocol, 30 days prior to C1D1 and during the study intervention period and for at least 8 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.\n* A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n* If a urine test cannot be confirmed as negative (e.g., a positive result or an indeterminate result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Additional requirements for pregnancy testing during and after study intervention are provided in Protocol\n* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy.\n* Is capable of giving signed informed consent as described, including compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.\n* Has adequate organ function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Has Ovarian cancer (OC) with germline or somatic pathogenic\u002Flikely pathogenic Breast cancer gene (BRCA)1\u002F2 mutation or evidence of homologous repair deficiency as per local or central test.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.\n* First-line Poly adenosine diphosphate-ribosylation (ADP) ribose polymerase inhibitor(s) (PARPi) for maintenance is a treatment option for participants, as determined by the Principal Investigator.\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has untreated brain or Central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain\u002FCNS metastases). Participants with previously treated and clinically stable brain\u002FCNS metastases and who have completed all corticosteroid therapy for ≥14 days prior to the date of C1D1 are not excluded from participation.\n* Has any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.\n* Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, excluding alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, Grade 2 neuropathy, or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.\n* Has any serious and\u002For unstable medical condition (including infection) or any serious and\u002For unstable psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.\n* Has clinically significant wound healing complications or incompletely healed wounds.\n* Has a history or evidence of Gastrointestinal (GI) perforation, tracheoesophageal fistula, or any Grade 4 fistula; participants with GI fistula, visceral fistula, or abdominal abscess within 6 months prior to the date of C1D1; has osteonecrosis of the jaw.\n* Has evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on Computed tomography (CT) scan or clinical symptoms of bowel obstruction.\n* Has clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 30 days prior to the date of C1D1.\n* Has congenital bleeding diathesis, acquired coagulopathy, recent pulmonary hemorrhage\u002Fhemoptysis (\\>2.5 mL of red blood or a half teaspoon) within the last 3 months prior to the date of C1D1.\n* Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1.\n* Has received treatment with any cytotoxic chemotherapy drugs or other antitumor drugs within 30 days or 5 half-lives, whichever is shorter, prior to date of C1D1 (or need to continue these drugs during study participation) other than maintenance bevacizumab. Cytotoxic chemotherapy drugs or other antitumor drugs include endocrine therapy, molecular targeted therapy, immunotherapy, or biotherapy.\n* Has received treatment with an investigational agent within 30 days of the date of C1D1.\n* Has ever received prior therapy\n* Has received treatment with inhibitors of P-glycoprotein (P-gp), Breast cancer gene (BCRP), or Organic anion transporting polypeptides (OATP) 1B1\u002F1B3 transporters within 7 days prior to the date of C1D1. Has received treatment with inducers of P-gp within 14 days prior to date of C1D1.\n* Has received any live vaccine within 30 days of C1D1. mRNA and adenoviral based Coronavirus disease 2019 (COVID-19) vaccines are considered non-live.\n* Has received any transfusion of blood products (including platelets or RBCs) or administration of colony-stimulating factors (including Granulocyte colony stimulating factor (G-CSF), Granulocyte macrophage colony-stimulating factor (GM-CSF), or recombinant Erythropoietin (EPO)s) within 14 days prior to date of C1D1.\n* Has a known Human immunodeficiency virus (HIV) infection AND meets at least 1 of the following criteria:\n\n  * Has documented evidence of plasma HIV-1 Ribonucleic acid (RNA) ≥50 c\u002FmL within 3 months prior to or at screening. In the 3 months to 12 months prior to screening, plasma HIV-1 RNA levels consistently \\\u003C50 c\u002FmL are required for enrollment; if multiple instances of plasma HIV-1 RNA values ≥50 c\u002FmL occurred in the 3 months to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR\n  * Has not had Cluster of differentiation (CD)4 cell counts measured in the past 12 months (i.e., at least 2 separate measurements taken a minimum of 28 days apart, 1 of which must be conducted at screening); OR\n  * Has had any CD4 cell count values ≤350 cells\u002Fmm3 in the past 12 months; OR\n  * Has had 1 or more changes in their combination antiretroviral therapy regimen (except for switches as allowed per details provided in the protocol) or has received an antiretroviral therapy regimen that is inconsistent with locally recommended guidelines during the 3 months prior to screening; OR\n  * Has a history of HIV-associated non-Hodgkin lymphoma within 5 years prior to screening; OR\n  * Has received treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.\n\nParticipants with history of Centers for Disease Control and Prevention (CDC) Stage III disease (also known as AIDS defining disease \\[CDC, 2014\\] are eligible (provided all other applicable criteria are met) if the Acquired immunodeficiency syndrome (AIDS)-defining disease has been treated and cured or is stable for at least 3 months prior to screening. Cutaneous Kaposi's Sarcoma not requiring systemic therapy is not exclusionary.\n\n* Has an Alanine aminotransferase (ALT) value \\>2.5 × Upper limit of normal (ULN) and\u002For, for participants with documented liver metastases\u002Ftumor infiltration, has an ALT value \\>5 × ULN.\n* Has a total bilirubin value \\>1.5 × ULN. Participants with Gilbert's syndrome can be included with a total bilirubin value \\>1.5 × ULN, provided direct bilirubin is ≤1.5 × ULN and participant otherwise meets entry criteria.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice. Participants who exhibit these signs or symptoms as a result of the malignancy under investigation and whose conditions are deemed adequately controlled by the investigator may be eligible for inclusion. Stable noncirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones), hepatobiliary involvement of malignancy, or chronic stable Hepatitis B virus (HBV) infection (in a participant for whom Hepatitis D virus (HDV) infection has been excluded) or chronic Hepatitis C virus (HCV) infection is acceptable if the participant otherwise meets entry criteria.\n* Has documented positive Hepatitis B surface antigen (HBsAg) at screening, unless they meet all of the following criteria:\n* Are receiving effective antiviral therapy (i.e., with nucleos(t)ide analogs with a high barrier to viral resistance \\[tenofovir or entecavir\\]) for at least 7 days prior to first dose of study intervention and are willing to continue for at least 6 months after the last dose of study intervention or longer at the discretion of the treating hepatologist;\n* Have undetectable HBV DNA, per institutional or local guidelines, at screening;\n* Have documented negative HDV antibody testing at screening.\n* Has documented positive Hepatitis B surface antibody (HBcAb) at screening unless they meet all of the following criteria:\n* Have undetectable HBV DNA, per institutional or local guidelines, at screening;\n* Have negative HBsAg at screening.\n* Has a positive HCV antibody test result at screening unless HCV RNA is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment. The HCV RNA test is optional, and participants with a negative HCV antibody test are not required to undergo HCV RNA testing as well. Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled if a confirmatory negative HCV RNA test is obtained and the participant otherwise meets entry criteria.\n* Has QTcF \\>470 msec.\n* Has a history within 12 months prior to screening of clinically significant or uncontrolled cardiac disease, acute MI, New York Heart Association Class III or IV congestive heart failure \\], or clinically significant arrhythmia not controlled by standard of care therapy.\n* Has baseline Left ventricular ejection fraction (LVEF) \\\u003C50% or less than institutional Lower limit of normal (LLN)\n* Has clinically significant abnormal BP according to investigator assessment, or inadequately treated and uncontrolled hypertension including history of hypertensive crisis; hypertensive encephalopathy; or adjustment of antihypertensive medications due to poor blood pressure control within 14 days prior to the C1D1.\n* Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety). Successfully managed renal obstruction is permitted.\n* Has a history of nephrotic syndrome or Grade 3 proteinuria.\n* Meets the following criteria for proteinuria during screening assessments: ≥2+ proteinuria on urine dipstick and 24-hour urine collection demonstrating ≥1g of urine in 24 hours. Only participants with ≥2+ proteinuria on dipstick at screening will undergo a 24-hour urine collection. Participants with ≥2+ proteinuria on dipstick but \\\u003C1g of protein in 24 hours are eligible.","FEMALE",{"count":256,"type":22},720,[25],"This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) alone or in combination with bevacizumab works in treating ovarian cancer compared to bevacizumab alone or active observation (AO). The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to bevacizumab alone OR AO and will help provide a better understanding of the main side effects of the drugs.",[260],"Ovarian Neoplasms",[262,263,264,265,266,267,268],"Ovarian Cancer","Mocertatug rezetecan","Mo-Rez","GSK5733584","Bevacizumab","Active Observation","BEHOLD-Ovarian03","2026-08-04",{"date":271,"type":40},"2026-08-06",{"date":273,"type":22},"2026-10-09",{"date":275,"type":22},"2032-11-08",{"name":46,"class":47},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":246},"100647219","phase-3-a-study-to-investigate-safety-and-efficacy-of-efimosfermin-compared-with-placebo-in-adult-participants-with-compensated-cirrhosis-due-to-metabolic-dysfunction-associated-steatohepatitis-mash-100647219","NCT07704892","A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 3, Two-part, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis (Stage F4 Fibrosis) Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-2)","NEBULA-2","Inclusion Criteria:\n\n* Participants aged between 18 and 75 years at enrolment.\n* Participants with history or presence of at least two components of metabolic syndrome.\n* Liver biopsy consistent with cirrhosis (fibrosis stage 4).\n\nExclusion Criteria:\n\n* Participants with other chronic liver diseases.\n* Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.\n* Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications.\n* History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.\n* A recent history or planned surgical procedures or medications intended to produce significant weight loss.\n* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \\>= 5 times upper limit normal (ULN).\n* Current or history of excessive alcohol intake","75 Years",{"count":287,"type":22},380,[25],"This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.",[291],"Metabolic Dysfunction-associated Steatohepatitis",[293,294,295,296,297],"Cirrhosis","Efimosfermin","Fibrosis","Metabolic dysfunction-associated","Steatohepatitis","2026-08-03",{"date":300,"type":40},"2026-08-05",{"date":302,"type":40},"2026-07-22",{"date":304,"type":22},"2033-12-08",{"name":46,"class":47},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":285,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},"100645475","phase-3-a-pivotal-clinical-study-to-investigate-the-safety-and-efficacy-of-efimosfermin-compared-with-placebo-in-adult-participants-with-compensated-cirrhosis-due-to-metabolic-dysfunction-associated-steatohepatitis-mash-100645475","NCT07701993","A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)","NEBULA-1","Inclusion Criteria:\n\n* Participants aged between 18 and 75 years at enrollment.\n* Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.\n* Participants with history or presence of at least two components of metabolic syndrome.\n\nExclusion Criteria:\n\n* Participants with other chronic liver diseases.\n* Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.\n* Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications.\n* Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.\n* Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.\n* Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>=5 times upper limit normal (ULN).\n* Participants with current or history of excessive alcohol intake.",{"count":315,"type":22},1740,[25],"This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.",[291],[320,296,321,295,293],"Efimosfermin alfa","steatohepatitis",{"date":300,"type":40},{"date":302,"type":40},{"date":325,"type":22},"2033-08-24",{"name":46,"class":47},1,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":285,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":4},"100650420","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-multiple-study-interventions-in-participants-with-moderate-to-severe-ulcerative-colitis-100650420","NCT07747467","A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis","A Phase 1b, Non-Randomized, Open-Label, Repeat-Dose, Single Center Study Utilizing a Master Protocol to Investigate the Safety and Tolerability of Multiple Study Interventions in Advanced Therapy Naïve Participants With Moderate to Severe Ulcerative Colitis","PEGASUS","Inclusion Criteria:\n\n* Diagnosis of UC for greater than or equal (\\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC, in the assessment of the investigator, must be available.\n* Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection.\n* Active disease beyond the rectum (greater than \\[\\>\\]15 centimeter \\[cm\\] of active disease from the anal verge at the screening colonoscopy).\n* Documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before screening (may be performed during screening) for participants with pancolitis of \\>8 years duration or left-sided colitis of \\>12 years duration, or primary sclerosing cholangitis\n* Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \\[5-ASA\\] compounds, corticosteroids, thiopurines).\n* May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy\n\nExclusion Criteria:\n\n* Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis.\n* Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture\u002Fstenosis within the small bowel or colon.\n* Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy.\n* Have a history of malignant neoplasm within the last 5 years.\n* Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease\n* Have any active, chronic, or recurrent infections based on the investigator's assessment.\n* Have history of opportunistic infections within 1 year of screening (\n* Have history or presence of significant medical illness including but not limited to cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurological, and psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of the data.\n* Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening.\n* Have significant allergies to humanized monoclonal antibodies.\n* Have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions .\n* Have had previous colectomy (total or subtotal), or any other manifestation that might require surgery while enrolled in the trial.\n* Have ostomy or ileoanal pouch.\n* Have received any of the following for treatments of UC:\n\n  * Immunomodulatory medications, including cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, within 4 weeks before screening endoscopy.\n  * Topical (rectal) treatment of 5-ASA or corticosteroid enemas\u002Fsuppositories within 2 weeks of screening endoscopy.\n  * Have received approved or investigational advanced therapy (ATs) (i.e., biologics or small molecules including biosimilars).\n  * Interferon therapy within 8 weeks before screening endoscopy.\n  * Agents that deplete B- or T-cells (e.g., rituximab) within 12 months of baseline. Participants remain excluded if there is evidence of persistent targeted lymphocyte depletion at the time of screening endoscopy.\n* Had Clostridium difficile infection within 30 days of screening endoscopy or have a positive test result at screening, or other intestinal pathogen within 30 days before screening endoscopy.\n* Participant must not have signs of an ongoing infection related to an intestinal pathogen.\n* In the investigator's opinion, any clinically significant abnormalities of laboratory results from chemistry, hematology or urinalysis tests obtained at the screening visit that cannot be attributed to the underlying moderate-to-severe UC.\n* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n* History of a significant allergic reaction (anaphylaxis, urticaria) or significant sensitivity to study intervention or any constituents of the study interventions (including excipients).\n* Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site.",{"count":337,"type":22},16,[97],"This study will look at how safe and tolerable different treatments are for adults who have moderate to severe ulcerative colitis (UC). The platform design uses one single master protocol that explains how the overall study is organized, whereas each treatment, as sub-study will be tested to see how well the study drug works and how it affects participants.",[341],"Colitis, Ulcerative",[343,344,345,346,347,348],"Ulcerative Colitis","Anti-Interleukin-18 (anti-IL-18)","Inflammatory bowel disease","aletekitug","GSK1070806","Gastrointestinal Diseases","2026-07-31",{"date":300,"type":40},{"date":352,"type":22},"2026-08-10",{"date":354,"type":22},"2028-12-04",{"name":46,"class":47},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":285,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":371,"leadSponsor":372,"locationsCount":4},"100650416","phase-1-a-sub-study-to-investigate-the-safety-and-tolerability-of-aletekitug-in-participants-with-moderate-to-severe-ulcerative-colitis-100650416","NCT07747480","A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis","A Phase 1b, Non-Randomized, Open-Label, Repeat-Dose, Single Center Study to Investigate the Safety and Tolerability of Aletekitug in Advanced Therapy Naïve Participants With Moderate to Severe Ulcerative Colitis","Inclusion Criteria:\n\n* Diagnosis of UC for greater than or equal (\\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC must be available.\n* Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection.\n* Active disease beyond the rectum (greater than \\[\\>\\]15 centimeter \\[cm\\] of active disease from the anal verge at the screening colonoscopy).\n* Documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before screening (may be performed during screening) for participants with pancolitis of \\>8 years duration or left-sided colitis of \\>12 years duration, or primary sclerosing cholangitis\n* Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \\[5-ASA\\] compounds, corticosteroids, thiopurines).\n* May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy.\n* Must meet contraception requirements if a female participant is a woman of childbearing potential (WOCBP)\n\nExclusion Criteria:\n\n* Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis. Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture\u002Fstenosis within the small bowel or colon.\n* Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy.\n* Have a history of malignant neoplasm within the last 5 years.\n* Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease\n* Have any active, chronic, or recurrent infections based on the investigator's assessment.\n* Have history of opportunistic infections within 1 year of screening\n* Have history or presence of significant medical illness including but not limited to cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurological, and psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of the data.\n* Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening:\n* Have significant allergies to humanized monoclonal antibodies.\n* Have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions\n* Have had previous colectomy (total or subtotal), or any other manifestation that might require surgery while enrolled in the trial.\n* Have ostomy or ileoanal pouch.\n* Have received any of the following for treatments of UC:\n\n  * Immunomodulatory medications, including cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, within 4 weeks before screening endoscopy.\n  * Topical (rectal) treatment of 5-ASA or corticosteroid enemas\u002Fsuppositories within 2 weeks of screening endoscopy.\n  * Have received approved or investigational advanced therapy (Ats) (i.e., biologics or small molecules including biosimilars).\n  * Interferon therapy within 8 weeks before screening endoscopy.\n  * Agents that deplete B- or T-cells (e.g., rituximab) within 12 months of baseline. Participants remain excluded if there is evidence of persistent targeted lymphocyte depletion at the time of screening endoscopy.\n* Had Clostridium difficile infection within 30 days of screening endoscopy or have a positive test result at screening, or other intestinal pathogen within 30 days before screening endoscopy.\n* Participant must not have signs of an ongoing infection related to an intestinal pathogen.\n* In the investigator's opinion, any clinically significant abnormalities of laboratory results from chemistry, hematology or urinalysis tests obtained at the screening visit that cannot be attributed to the underlying moderate-to-severe UC.\n* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n* Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site;\n* Uncontrolled hypertension (i.e., blood pressure consistently measures \\>=140\u002F90 millimeters of mercury (mmHg) while actively taking 1 or more antihypertensive medications).",{"count":337,"type":22},[97],"This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC). This study is the sub-study of the platform trial.",[341],[343,344,345,368,347,348],"Aletekitug",{"date":300,"type":40},{"date":352,"type":22},{"date":354,"type":22},{"name":46,"class":47},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},"100563248","phase-2-a-study-to-investigate-the-safety-and-efficacy-of-gsk4532990-compared-with-placebo-in-adult-participants-aged-18-to-70-years-with-alcohol-related-liver-disease-100563248","NCT06613698","A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease","A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)","STARLIGHT","Inclusion Criteria:\n\n* Capable of giving signed informed consent prior to the performance of any study-specific procedures.\n* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.\n* In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.\n* A female participant is eligible to participate after meeting additional pre-defined criteria.\n* Participants must meet predefined stable use requirements of concomitant medications based on study criteria.\n* Participant has advanced chronic liver disease\n\nExclusion Criteria:\n\n* Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)\n* Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.\n* Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.\n* Prior organ transplant or current listing or active consideration for organ transplant during the screening period (except for corneal transplants).\n* Chronic or acute, including partial, known portal vein thrombosis.\n* Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.\n* Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.\n* Poorly controlled hypertension\n* Clinical suspicion of rhabdomyolysis during the screening period\n* Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and\u002For low blood fibrinogen level.\n* Body Mass Index (BMI) \\>35 kg\u002Fm2 at screening\n* Any liver-related clinical event that started (onset) \\\u003C8 weeks prior to Baseline (D1).","70 Years",{"count":383,"type":22},393,[98],"The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.",[387],"Liver Diseases, Alcoholic",[389,390,297],"GSK4532990","Alcohol-related liver disease",{"date":298,"type":40},{"date":393,"type":40},"2024-09-27",{"date":395,"type":22},"2028-03-07",{"name":46,"class":47},140,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":425},"100584107","phase-1-a-study-to-test-the-safety-and-effectiveness-of-gsk5764227-alone-or-with-other-treatments-in-participants-with-advanced-gastrointestinal-cancers-that-cannot-be-surgically-removed-embold-pangi-201-100584107","NCT06885034","A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)","A Phase1 b\u002F2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors","Inclusion criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF).\n\nCRC Cohort\n\n* Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).\n\nPDAC Cohort\n\n* Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).\n\nAll Cohorts\n\n* Is willing to use adequate contraception.\n* Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Has an ECOG performance status of 0 or 1.\n* Has adequate organ function.\n\nExclusion criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of disease.\n* Has had any major surgery within 28 days prior to randomization or first dose of study intervention, depending on sub-cohort\u002Fcohort assignment\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has severe, uncontrolled or active cardiovascular disorders.\n* Has serious or poorly controlled hypertension.\n* Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.\n* Has untreated brain or Central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed.\n* Has evidence of current ILD\u002Fnon-infectious pneumonitis or a prior history of ILD\u002Fnon-infectious pneumonitis requiring high-dose glucocorticoids Or suspected ILD\u002Fnon-infectious pneumonitis that cannot be ruled out by imaging.\n* Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy.\n* Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.\n* Is pregnant or breastfeeding.",{"count":406,"type":22},451,[97,98],"This study will check how well a new medicine, Risvutatug rezetecan, (Ris-Rez, also known as GSK5764227) works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.",[410],"Gastrointestinal Neoplasms",[412,413,414,415,416,417],"GSK5764227","Risvutatug Rezetecan","Ris-Rez","Solid Tumors","Colorectal Cancer","Pancreatic ductal adenocarcinoma","2026-07-30",{"date":298,"type":40},{"date":421,"type":40},"2025-06-11",{"date":423,"type":22},"2029-01-09",{"name":46,"class":47},85,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":4},"100650101","phase-1-a-study-to-evaluate-the-subcutaneous-belantamab-bcmab-formulation-versus-intravenous-belantamab-in-participants-with-multiple-myeloma-while-treated-with-standard-of-care-100650101","NCT07742527","A Study to Evaluate the Subcutaneous Belantamab (BCMAb) Formulation Versus Intravenous Belantamab in Participants With Multiple Myeloma While Treated With Standard of Care","A Randomized, Open-label, Phase 1b, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Subcutaneous Belantamab (BCMAb) Formulation With rHuPH20 Versus Intravenous Belantamab in Participants With Multiple Myeloma While Treated With Standard of Care","DynaMMic-2","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participants at the time of signing the Informed Consent Form (ICF) must be aged 18 years old or greater or are of the legal age of consent in the jurisdiction in which the study is taking place.\n* Histologically or cytologically confirmed diagnosis of multiple myeloma (MM), as defined by the International Myeloma Working Group (IMWG).\n* Currently receiving maintenance therapy with either anti- cluster of differentiation 38 (anti-CD38) directed therapy, or lenalidomide, or both, following autologous stem cell transplantation (ASCT) in either first or second line.\n* No change in current myeloma treatment for at least 2 months prior to during screening, or during the trial.\n* Partial response (PR) or better per IMWG per Investigator's assessment for at least 2 months prior to screening.\n* All current treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version (v) 6.0, 2025) must be Grade less than or equal to (\\\u003C=) 2 at the time of screening except for alopecia (any grade), or endocrinopathy managed with replacement therapy (any grade).\n* ASCT must be greater than (\\>) 100 days prior to screening, and participants are transfusion independent and not receiving granulocyte colony-stimulating factor (G-CSF) or thrombopoietin analogies.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have organ system functions as defined by the laboratory assessments.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, and skin changes (POEMS) syndrome, primary plasma cell leukemia, or non-secretory myeloma.\n* Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab, or hyaluronidase, or any of the components of the study treatment. History of severe hypersensitivity to other monoclonal antibodies (mAbs).\n* Active infection requiring antibiotic, antiviral, or antifungal treatment.\n* Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety).\n* Prior B cell maturation antigen (BCMA) directed therapy.\n* Plasmapheresis within 7 days prior to the first dose of study drug.\n* Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first dose or has not recovered fully from surgery.\n* Participants must not receive live\u002Flive attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab for at least 70 days following last study treatment.\n* Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type within 60 days of an investigational medicinal product before randomization.\n* Known human immunodeficiency virus (HIV) infection, unless the participant can meet all the following criteria:\n\n  * Established antiretroviral therapy (ART) for at least 4 weeks and HIV viral load \\\u003C400 copies\u002Fmilliliter (mL)\n  * CD4+ T-cell (CD4+) counts greater than or equal to (\\>=) 350 cells\u002Fmicroliter (uL)\n  * No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months\n* Participants with hepatitis B virus (HBV) infection will be excluded\n* Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria:\n\n  * RNA test negative\n  * Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C virus (HCV) RNA test after a washout period of at least 4 weeks.\n* Is pregnant or breastfeeding.\n* Evidence of cardiovascular risk including any of the following:\n\n  * Evidence of current clinically significant untreated arrhythmias, including, but not limited to, clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.\n  * History of myocardial infarction (MI), acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within three months of screening.\n  * Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n  * Uncontrolled hypertension.",{"count":435,"type":22},22,[97],"This study aims to compare how belantamab behaves in the body when given as an injection under the skin (SC) versus into a vein (IV) in participants with multiple myeloma who are receiving standard of care treatment, to enable eventual development of SC formulation. It will assess how much belantamab is absorbed and how long it stays in the blood as well as assess whether it is safe and tolerated well by participants.",[130],[132,34,440,441,442,443,444,64,445,446,447,448,449,432],"B cell Maturation Antigen (BCMA)","Subcutaneous belantamab (BCMAb)","Intravenous","Subcutaneous","Multiple myeloma","First Line","Second Line","Maintenance","Autologous Stem Cell Transplant (ASCT) Maintenance treatment","DynaMMic","2026-07-29",{"date":298,"type":40},{"date":453,"type":22},"2026-10-16",{"date":455,"type":22},"2030-03-18",{"name":46,"class":47},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":92,"sex":17,"minAge":465,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":477,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":483,"leadSponsor":485,"locationsCount":486},"100649909","phase-3-a-study-on-the-immune-response-and-safety-of-an-investigational-combined-measles-mumps-rubella-and-varicella-vaccine-when-given-to-healthy-children-4-to-6-years-of-age-100649909","NCT07742644","A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age","A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine Compared With ProQuad, Administered as a Second Dose in Healthy Children 4-6 Years of Age","MMRVNS 20-002","Inclusion Criteria (INC):\n\n* INC#1 Participant's parent(s)\u002FLAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).\n* INC#2 Written or witnessed\u002Fthumb printed or digital informed consent obtained from the participant's parent(s)\u002FLAR(s) prior to performance of any study specific procedure.\n* INC#3 Informed assent obtained from the participants in line with local rules and regulations.\n* INC#4 Healthy participants as established by medical history and clinical examination at screening.\n* INC#5 A male or female participant between and including 4 and 6 years of age (i.e., from fourth birthday until the day before the seventh birthday) at the time of the study interventions administration, and in accordance with local regulations.\n* INC#6 Participant who previously received a first dose of varicella-containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).\n* INC#7 Participant who previously received a first dose of measles, mumps, rubella containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).\n* INC#8 Participant who previously received 3 or 4 doses of any combined DTP (DTaP\u002FDTwP) vaccine (diphtheria and tetanus toxoids and pertussis antigens whether or not combined with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b antigens) according to the local recommendations.\n\nExclusion Criteria (EXC):\n\n* EXC#1 History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or gelatin.\n* EXC#2 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* EXC#3 Hypersensitivity to latex.\n* EXC#4 Unstable chronic conditions as determined by medical history and physical examination.\n* EXC#5 Major congenital defects, as assessed by the investigator.\n* EXC#6 History of measles, mumps, rubella or varicella\u002Fzoster disease as evaluated by the investigator.\n* EXC#7 History of diphtheria, tetanus, pertussis, and\u002For poliomyelitis disease.\n* EXC#8 Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures (including all subtypes, such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures).\n* EXC#9 Active untreated tuberculosis.\n* EXC#10 Condition that, in the judgment of the investigator, would make intramuscular injection unsafe.\n* EXC#11 Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.\n* EXC#12 Use of any investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or their planned use during the study period.\n* EXC#13 Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.\n* EXC#14 Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and\u002For planned use of long-acting immune modifying treatments at any time up to the end of the study.\n\n  * Up to 90 days prior to the study interventions administration.\n\n    * For corticosteroids, this will mean prednisone equivalent ≥0.5 mg\u002Fkg\u002Fday with maximum of 20 mg\u002Fday for pediatric participants. Inhaled, intra-articular\u002Fintra-bursal and topical steroids are allowed.\n  * Up to 180 days prior to study interventions administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study interventions, e.g., nirsevimab), antitumoral medication.\n* EXC#15 Previous vaccination with a second dose of varicella-containing vaccine or measles, mumps, rubella containing vaccine.\n* EXC#16 Vaccination against diphtheria, tetanus, pertussis, and\u002For poliomyelitis given after the second year of life (i.e., after the second birthday at 24 months of age).\n* EXC#17 Occurrence of any of the following events after a previous administration of DTP vaccine:\n\n  * Encephalopathy of unknown etiology occurring during the period starting within 7 days of vaccination of a previous administration of DTP vaccine.\n  * A temperature (≥40.6°C \\[≥105°F\\]) during the period starting 48 hours after vaccination not due to another identifiable cause.\n* EXC#18 Use of salicylates (aspirin) or salicylate-containing products or its planned use, during the period of 6 weeks following study interventions administration.\n* EXC#19 Planned administration\u002Fadministration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration\\* (Visit 2), with the exception of\n\nInfluenza vaccines:\n\n* Inactivated influenza vaccine must not be administered in the period starting 28 days before the dose and ending 28 days after the dose of study intervention administration. If administered outside this prohibited period, it should be administered at a different location than the study intervention.\n* Live attenuated influenza vaccine must not be administered during the period starting 30 days before the dose and ending 43 days after the dose of study intervention administration (Visit 2).\n\n  * If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and\u002For organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and sponsor is notified.\n\n    * EXC#20 Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug\u002Fvaccine\u002Finvasive medical device).\n    * EXC#21 Any study personnel's immediate dependents, family, or household members.\n    * EXC#22 Child in care.\n    * EXC#23 Participants with the following high-risk individuals in their household:\n\n      * Immunocompromised individuals.\n      * Pregnant women without documented history of varicella.\n      * Newborn infants of mothers without documented history of varicella.\n      * Newborn infants born \\\u003C28 weeks of gestation.","4 Years","6 Years",{"count":468,"type":22},1860,[25],"The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine.\n\nThe vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).\n\nThe study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.",[472,473,474,475,476],"Measles","Mumps","Rubella","Varicella (Chickenpox)","Measles-Mumps-Rubella+Chickenpox Vaccine",[472,473,474,475,478,105,479,480],"Combined vaccine","Vaccine safety","Children aged 4 to 6 years",{"date":298,"type":40},{"date":211,"type":22},{"date":484,"type":22},"2028-11-21",{"name":46,"class":47},62,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":92,"sex":17,"minAge":494,"maxAge":495,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":246},"100624184","phase-1-a-trial-to-evaluate-the-safety-and-reactogenicity-of-an-investigational-pneumococcal-vaccine-in-toddlers-12-to-15-months-of-age-receiving-a-single-booster-dose-100624184","NCT07406334","A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose","A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 To 15 Months of Age Receiving a Single Booster Dose","Inclusion Criteria:\n\n1. Participants' parent(s)\u002FLegally acceptable representative \\[LAR(s)\\] who, in the opinion of the investigator, can and will comply with all protocol requirements.\n2. Written or witnessed\u002Fthumb printed informed consent obtained from the participants' parent(s)\u002FLAR(s) prior any study-specific procedure is performed.\n3. A male or female between, and including, 12 to15 Months of age at the time of the study intervention administration.\n4. Healthy participants or medically stable patients as established by medical history and clinical examination before entering the study.\n5. To the best knowledge of the participant's parent(s)\u002FLAR(s), the child has been eligible for pneumococcal vaccination and has completed a 2-dose primary series with PCV10.\n\nExclusion Criteria:\n\n1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).\n2. Hypersensitivity to latex.\n3. History of microbiologically proven Invasive pneumococcal Disease (IPD).\n4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n5. Major congenital defects, as assessed by the investigator.\n6. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures.\n7. Condition that in the judgment of the investigator would make intramuscular injection unsafe.\n8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n9. Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the trial period.\n10. Previous vaccination with any pneumococcal vaccine other than PCV10.\n11. Previous receipt of more than 2 pneumococcal vaccine doses (primary series or booster).\n12. Planned administration\u002Fadministration of any inactivated or otherwise non-live vaccine in the period starting 14 days before and ending 14 days after the dose of study intervention administration or planned administration\u002Fadministration of any live vaccine in the period starting 28 days before and ending 28 days after the dose of study intervention administration, with the exception of inactivated influenza vaccine which may be administered but must be given at least 7 days before or 15 days after receipt of any study intervention.\n13. Receipt of blood or plasma products or immunoglobulins, from 90 days before study intervention administration, or planned receipt up to 30 days of study intervention administration.\n14. Chronic administration of immune-modifying drugs and\u002For planned use of long-acting immune-modifying treatments at any time up to the end of the study.\n\n    * For corticosteroids: prednisone equivalent ≥0.5 mg\u002Fkg\u002Fday (maximum 20 mg\u002Fday) within 90 days prior for pediatric participants.\n    * Inhaled and topical steroids are allowed.\n15. Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention.\n16. Any child of trial personnel or their immediate dependents, family, or household members.\n17. Child in care.","12 Months","15 Months",{"count":497,"type":22},45,[97],"The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. PCV20 will be used as a comparator for this study.",[501],"Pneumonia, Bacterial",[503,504,505,506],"Pneumococcal Vaccine","Phase 1","Pediatric","Booster dose",{"date":418,"type":40},{"date":509,"type":40},"2026-05-15",{"date":511,"type":22},"2027-02-22",{"name":46,"class":47},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":92,"sex":17,"minAge":93,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":526,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":327},"100647541","phase-1-a-comparative-study-to-investigate-the-difference-in-blood-levels-of-two-different-formulations-of-gsk5784283-100647541","NCT07712393","A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283","Open-Label, Randomized, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Two Formulations of GSK5784283 Administered by Subcutaneous Injection","Inclusion Criteria:\n\n* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.\n* Body weight greater than or equal (\\>=) 50 kilogram (kg) (110 pounds \\[lbs\\]) and body mass index within the range 19 to 30 kilogram per meter square (kg\u002Fm\\^2) (inclusive).\n* A female participant is eligible to participate if she is a participant of non-childbearing potential (PONCBP) as specified in the protocol.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n* Hypersensitivity- Participants with allergy\u002Fintolerance to any biologic therapy or any of the known excipients used in products administered subcutaneously\n* History or presence of any clinically significant medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n* Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs during screening period which in the opinion of the investigator, may put the subject at risk because of his\u002Fher participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.\n* Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the clinical study.\n* Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to study intervention administration.\n* Current smokers (tobacco and\u002For marijuana) or former smokers with a smoking history \\>10 pack-years and participants using vaping products, including electronic cigarettes.\n* Regular alcohol consumption that exceeds the limits specified in the protocol\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.\n* The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine-read or manually over-read \\>450 millisecond (msec).","60 Years",{"count":522,"type":22},24,[97],"The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic \\[PK\\] study) in healthy adults. The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way.",[61],[61,31,210,103,527,528],"Tolerability","Healthy volunteers","2026-07-28",{"date":450,"type":40},{"date":532,"type":40},"2026-07-17",{"date":534,"type":22},"2027-04-26",{"name":46,"class":47},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":559},"100600623","phase-3-a-study-of-gsk5764227-in-participants-with-relapsed-small-cell-lung-cancer-sclc-100600623","NCT07099898","A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)","Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Adults \\>18 or the minimum legal adult age at the time the informed consent form is signed\n* Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n* Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of \\>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible.\n* Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.\n* Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Has adequate organ function and an ECOG performance status of 0 or 1\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Pathological diagnosis of complex SCLC or transformed SCLC.\n* Limited stage small cell lung cancer at diagnosis\n* Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has severe, uncontrolled or active cardiovascular disorders.\n* Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.\n* Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).\n* Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal\u002Fmeningeal\u002Fbrainstem metastasis or evidence of spinal cord metastases.\n* Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids.\n* Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma\u002FCOPD, restrictive lung disease),\n* Has active Hepatitis B or Hepatitis C",{"count":544,"type":22},420,[25],"In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.",[548],"Neoplasms, Lung",[550,413,551,552,414],"Small Cell Lung Cancer (SCLC)","Topotecan","EMBOLD SCLC-301",{"date":450,"type":40},{"date":555,"type":40},"2025-08-11",{"date":557,"type":22},"2029-09-28",{"name":46,"class":47},126,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":581},"100464951","phase-3-depemokimab-in-participants-with-hypereosinophilic-syndrome-efficacy-and-safety-trial-100464951","NCT05334368","Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial","A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)","DESTINY","Inclusion Criteria:\n\n* Participants who are greater than or equal (\\>=) 40 kilogram (kg) at Screening Visit 1.\n* Participants who have a documented diagnosis of HES prior to Visit 2.\n* A history of 2 or more HES flares within the past 12 months prior to Visit 1.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) woman of non-childbearing potential (WONCBP) Or b) woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\\u003C) 1 percentage (%).\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Participants with HES disease manifestations which in the opinion of the investigator may put the participant at unacceptable risk from study participation or confound interpretation of efficacy or safety data.\n* Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to Visit 1.\n* Participants with a known immunodeficiency (e.g., Human Immunodeficiency Virus \\[HIV\\]), other than that explained by the use of OCS or other therapy taken for HES.\n* Participants with a history of or current lymphoma.\n* Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.\n* Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplastic syndrome, chronic eosinophilic leukaemia-not otherwise specified.\n* Cirrhosis or current unstable liver or biliary disease per investigator assessment.\n* Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.\n* Participants with current diagnosis of vasculitis.\n* Hypereosinophila with no clinical symptoms and\u002For proof of organ dysfunction.\n* Clinical diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA).\n* Participants with an allergy\u002F intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product.\n* Participants who have a previous documented failure with anti-interleukin (IL)-5\u002F5R therapy.\n* Participants who have received monoclonal antibodies (mAb) within 30 days or 5 half-lives, whichever is longer, prior to Visit 1.\n* Participants who test positive for the FIP1L1-PDGFRα fusion gene.\n* QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥450 milliseconds (msec) or QTcF ≥480 msec for participants with Bundle Branch Block at Screening Visit 1.\n* Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator.\n* Participants who are pregnant or breastfeeding.",{"count":126,"type":22},[25],"This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy.\n\nThe study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells\u002F microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy.\n\nParticipants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.",[572],"Hypereosinophilic Syndrome",[184,572,566,34,574],"Anti-interleukin -5",{"date":450,"type":40},{"date":577,"type":40},"2022-09-06",{"date":579,"type":22},"2032-07-16",{"name":46,"class":47},92,{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":285,"enrollmentInfo":590,"targetDuration":4,"studyType":23,"phases":592,"briefSummary":593,"conditions":594,"keywords":595,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":606},"100606575","phase-3-evaluating-the-efficacy-and-safety-of-initiating-depemokimab-early-therapy-in-chronic-obstructive-pulmonary-disorder-copd-with-type-2-inflammation-100606575","NCT07177339","eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation","A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation","VIGILANT","Inclusion Criteria:\n\n* Male or eligible female participants\n* Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)\n* Moderate to severe COPD, defined as\n\n  * A clinically documented history of COPD for at least 1 year\n  * A post-salbutamol Forced expiratory volume in one second (FEV1)\u002FForced vital capacity (FVC) ratio of less than (\\\u003C)0.70 and a post-salbutamol FEV1 greater than (\\>)30 percent (%) and \\\u003C80% predicted normal values\n* Elevated risk for exacerbations, defined as\n\n  * A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and\n  * The presence of risk factors for future exacerbations\u002Fdeterioration such as:\n  * Modified Medical Research Council (mMRC) dyspnea score \\>= 2\n  * COPD Assessment Test (CAT) \\>= 15\n  * Post-bronchodilator FEV1 \\\u003C 50% predicted\n  * Chronic bronchitis\n* Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \\>=10 pack-years at Screening.\n* Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist \\[LABA\\] or LABA+ Long-acting muscarinic receptor antagonist \\[LAMA\\]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months\n* Body mass index (BMI) \\>=16 kilograms per square meter (kg\u002Fm\\^2)\n\nExclusion Criteria:\n\n* The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded\n\n  * Participants with a current or prior physician diagnosis of asthma\n  * Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred\n* Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.\n* COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1\n* COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1\n* Lung resection: Participants with a history of, or plan for lung volume reduction surgery\u002Fendobronchial valve procedure\n* Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1\n* Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded\n* Continuous oxygen: Participants requiring oxygen supplementation for COPD",{"count":591,"type":22},1196,[25],"Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.",[28],[184,596,597,598,32,599],"Chronic Obstructive Pulmonary Disorder","COPD","Type 2 inflammation","Exacerbation",{"date":529,"type":40},{"date":602,"type":40},"2025-10-20",{"date":604,"type":22},"2029-06-08",{"name":46,"class":47},121,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":92,"sex":17,"minAge":93,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":23,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":327},"100644373","phase-1-a-study-to-evaluate-the-safety-reactogenicity-and-immune-response-of-the-gsk-vaccines-institute-for-global-health-gvgh-quadrivalent-pan-salmonella-vaccine-with-and-without-alum-in-healthy-young-adults-100644373","NCT07663032","A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults","A Phase 1, Randomized, Controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GVGH Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Adults 18 to 45 Years of Age in Africa","Inclusion Criteria:\n\n1. Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., completion of the Diary cards, return for follow-up visits).\n2. Written informed consent obtained from the participant prior to performance of any study specific procedure.\n3. Healthy participants as established by medical history, clinical examination, and laboratory assessment\\*.\n\n   \\*Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, and human immunodeficiency virus (HIV) antibodies will also be tested at Screening.\n4. A male or female between and including 18 to 45 years of age at the time of the first study intervention administration, and no older than 45 years of age at second dose administration.\n5. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or menopause.\n6. Participants of childbearing potential may be enrolled in the study if the participant:\n\n   * Has practiced adequate contraception (as indicated in Section 10.5) for at least 30 days prior to study intervention administration, and\n   * Has a negative pregnancy test within 24 hours prior to the study intervention administration, and\n   * Has agreed to continue adequate contraception during the entire treatment period and for 8 weeks after completion of the study intervention administration series.\n7. Negative HLA-B27 testing.\n8. Body mass index of 18\\>= to \\\u003C=30 kg\u002Fm2 at Screening.\n9. Living in the study area and plan to remain in the study area for the study duration.\n\nExclusion Criteria:\n\nMedical Conditions:\n\n1. Known exposure to S. Typhi, S. Paratyphi A, and non-typhoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration as confirmed using medical history.\n2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.\n3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n4. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.\n5. Recurrent history or uncontrolled neurological disorders or seizures.\n6. Any clinically significant hematological and\u002For biochemical laboratory abnormality.\n7. Clinical conditions representing a contraindication to intramuscular (IM) injections and\u002For blood draws.\n8. Any behavioral or cognitive impairment or psychiatric disease that in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.\n9. Acute or chronic illness which may be severe enough to preclude participation.\n10. Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.\n\n    Prior\u002FConcomitant Therapy:\n11. History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant's life.\n12. History of receiving any investigational iNTS, S. Paratyphi A, or GMMA vaccines in the participant's life.\n13. Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days (Days -30 to 1) before the first dose of study interventions, or their planned use during the study period.\n\n    Use of herbs and traditional treatments is not considered an exclusion criterion.\n14. A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 30 days after the last dose of study interventions administration, with the exception of flu vaccines or Coronavirus disease 2019 vaccine.\n15. Administration of long-acting immune-modifying drugs (e.g., infliximab) at any time during the study period.\n16. Administration of immunoglobulins and\u002For any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period.\n17. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will be prednisone equivalent \\>=20 mg\u002Fday for adult participants. Inhaled and topical steroids are allowed.\n\n    Prior\u002FConcurrent Clinical Study Experience:\n18. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (vaccine and drug).\n\n    Other Exclusions:\n19. Pregnant or lactating female.\n20. Female planning to become pregnant or planning to discontinue contraceptive precautions.\n21. History of\u002Fcurrent chronic alcohol consumption and\u002For drug abuse. This will be decided at the discretion of the Investigator.\n22. Any study personnel or their immediate dependents, family, or household members.","45 Years",{"count":616,"type":22},196,[97],"The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa. The purpose of the current Phase 1 study is to evaluate the safety, reactogenicity, and the immune response induced by the Pan-Salmonella vaccine.",[620],"Salmonella Infections",[622,623,624,625,626,105,104,103],"GVGH Quadrivalent Pan-Salmonella vaccine","Salmonella (S.) Typhi","S. Paratyphi A","S. Typhimurium (STm)","S. Enteritidis (SEn)","2026-07-26",{"date":529,"type":40},{"date":630,"type":40},"2026-06-24",{"date":632,"type":22},"2027-11-14",{"name":46,"class":47},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":92,"sex":254,"minAge":93,"maxAge":614,"enrollmentInfo":641,"targetDuration":4,"studyType":23,"phases":643,"briefSummary":644,"conditions":645,"keywords":647,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":660},"100641186","phase-3-a-study-on-the-immune-response-and-safety-of-a-combined-vaccine-against-diphtheria-tetanus-and-acellular-pertussis-dtpa-in-japanese-healthy-pregnant-women-100641186","NCT07596199","A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women","A Phase 3, Non-Randomized, Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety and Reactogenicity of a Single Dose of Combined Reduced-Antigen-Content Diphtheria, Tetanus and Acellular Pertussis (dTpa) Vaccine in Japanese Healthy Pregnant Women","Inclusion Criteria:\n\n1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n2. Participants and Legally acceptable representative(s) \\[LAR(s)\\] who give physical or digital informed consent after the study has been explained according to local regulatory requirements, and before any study-specific procedures are performed. The informed consent given at screening should include consent for both the maternal participant's participation and participation of the infant after the infant's birth.\n3. Healthy participants as established by medical history and clinical examination at screening.\n4. Participants between and including 18 and 45 years of age at the time of the study intervention administration (Visit 1\u002FDay 1).\n5. Pre-pregnancy body mass index (BMI) (based on participant's report) between 17.0 and 39.9 kg\u002Fm\\^2, inclusive.\n6. Pregnant female at 27,0\u002F7 to 36,6\u002F7 weeks of gestation (completed week 27 but not week 37) at the time of vaccination (Visit 1\u002FDay 1), as established or confirmed by ultrasound examination.\n7. No significant fetal abnormalities, as observed by the fetal morphological abnormality screening test conducted after 18 weeks of gestation and the most recent ultrasound testing (no more than 6 weeks before enrollment).\n8. Nuchal translucency scan, serum testing and any other prenatal tests, if conducted, should suggest normal pregnancy.\n9. Participants who are willing to provide cord blood and\u002For infant blood.\n10. Participants who are willing to have them and their newborns followed-up until 1 month post-delivery.\n11. Participants who do not plan to give their child for adoption.\n12. Japanese ethnic origin.\n\nExclusion Criteria:\n\nMedical conditions:\n\n1. Participants diagnosed with multiple pregnancies.\n2. Women with co-morbid medical or obstetric conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes such as;\n\n   * Gestational hypertension (defined as systolic blood pressure \\>=140 mmHg and\u002For diastolic blood pressure \\>=90 mmHg) at \\>=20 weeks of gestation in a woman with a previously normal blood pressure. Women with gestational hypertension who maintain blood pressure in the normal range (\\\u003C140 mmHg and \\\u003C90 mmHg) through diet and\u002For on antihypertensive medications would be eligible except for eclampsia\u002Fpre-eclampsia.\n   * Hemodynamically significant cardiac disorders (previously corrected patent ductus arteriosis is allowed).\n   * Gestational diabetes which is not controlled by medication, diet and\u002For exercise as determined by glucose challenge\u002Ftolerance test conducted after 20 weeks of gestation or as per local recommendations of the country (Gestational diabetes is defined as absence of pre-gestational diabetes and hyperglycemia during pregnancy, which is not due to other known causes).\n   * Any other conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes\n3. Acute or unstable chronic conditions, chronic clinically significant abnormality, poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination and\u002For laboratory tests.\n4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n5. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures.\n6. Condition that in the judgment of the investigator would make intramuscular injection unsafe.\n7. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant and\u002For to the unborn infant due to participation in the clinical study.\n8. Prior major congenital anomalies or early onset (\\\u003C34 weeks of gestation) of eclampsia\u002Fpre-eclampsia in previous pregnancy, or stillbirth or neonatal death, or multiple (\\>=2) spontaneous abortions, or pre-term delivery (\\\u003C=34 weeks gestation) or having ongoing intervention (medical\u002Fsurgical) in current pregnancy to prevent pre-term delivery.\n9. Family history (first degree relatives only) of congenital anomalies, recurrent pregnancy losses (two or more consecutive losses) and unexplained neonatal death(s) in the participant.\n10. History of an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine.\n11. History of transient thrombocytopenia or neurological complications (for convulsions or hypotonic-hyporesponsive episodes) following an earlier immunisation against diphtheria and\u002For tetanus.\n12. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines.\n13. History of physician-diagnosed or laboratory-confirmed pertussis within the past 5 years.\n14. Lymphoproliferative disorder or malignancy within 5 years before the study dose administration (excluding effectively treated non melanoma skin cancer).\n\n    Prior\u002FConcomitant therapy:\n15. Previous vaccination containing diphtheria, tetanus or pertussis antigens, or diphtheria and tetanus toxoids at any time during the current pregnancy and within 5 years from study participation.\n16. Use of any investigational or non-registered product other than the study intervention(s) during the current pregnancy or their planned use during the study period.\n17. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and\u002For planned use of long-acting immune-modifying treatments or planned administration through delivery.\n\n    * Up to 6 months prior to the study intervention administration:\n\n    For corticosteroids, this will mean prednisone equivalent \\>=20 mg\u002Fday for adult participants. Inhaled, intra-articular\u002Fintra-bursal and topical steroids are allowed.\n    * Up to 6 months prior to the study intervention administration:\n\n    long-acting immune-modifying drugs including among others immunotherapy monoclonal antibodies, antitumoral medication.\n18. Planned administration\u002Fadministration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and planned administration through delivery (Visit 3\u002FDay of delivery), except:\n\n    * Seasonal influenza vaccines, RSV vaccines, Hepatitis B vaccines, and SARS-CoV-2, all of which may be administered according to standard of care \\>=14 days before or after study vaccination.\n19. Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 3 months before the study intervention or planned administration through delivery with the exception of anti-D (Rh)-immunoglobulin.\n20. Planned administration of any prophylactic medication (e.g., analgesics, antipyretics) in the absence of any symptom and in anticipation of a reaction to the study intervention administration.\n\n    Prior\u002FConcurrent clinical study participation:\n21. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention drug\u002Fvaccine\u002Finvasive medical device.\n\n    Other exclusion criteria:\n22. History of chronic alcohol consumption and\u002For drug abuse, based on investigator's judgment.\n23. Any study personnel or their immediate dependents, family, or household members.",{"count":642,"type":22},100,[25],"The purpose of this Phase 3, non-randomized, single-arm, open-label study is to evaluate the immune response, reactogenicity and safety of GSKs dTpa vaccine in Japanese pregnant women between 27 weeks and less than 37 weeks of pregnancy. Both the pregnant women and their neonates born during the study will be evaluated for specific analyses.",[646],"Diphtheria-Tetanus-acellular Pertussis Vaccines",[648,649,650,651,652,104,103],"Diphtheria","tetanus and acellular pertussis (dTpa) vaccine","Pregnant women","Neonates","Immune response","2026-07-25",{"date":529,"type":40},{"date":656,"type":40},"2026-06-29",{"date":658,"type":22},"2027-01-20",{"name":46,"class":47},18,""]