[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Janssen Research & Development, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":556},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,78,0,25,[9,55,85,104,124,146,168,189,210,231,251,271,292,313,333,353,374,394,415,435,456,476,496,514,536],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100577593","phase-1-study-of-hld-0915-in-patients-with-metastatic-prostate-cancer-100577593",false,"NCT06800313","Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer","Phase 1\u002F2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer","Patients must meet the following criteria to be eligible study participation:\n\nKey Inclusion Criteria:\n\nAll Study Arms (Phase 1 Part 1 \\& 2, Phase 2 Part 1, Part 2A, 2B, 2C \\& 2D):\n\nMales ≥ 18 years old Histological, pathological, and\u002For cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication\n\nmCRPC Arms: (Phase 1 Part 1 \\& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen\n\nSOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng\u002FmL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of radiographic or PSA progression while receiving ARPI\n\nmHSPC arms (Phase 2 Part 2B, 2C \\& 2D) serum testosterone \\>150ng\u002Fml mHSPC with distant metastatic disease based on conventional imaging and PSA \\>2.0 ng\u002FmL\n\nKey Exclusion Criteria:\n\nAll arms (Phase 1 Part 1 \\& 2, Phase 2 Part 1, Part 2A, 2B, 2C \\& 2D):\n\nHas experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of \\>10 mg\u002Fday Prior or ongoing significant medical condition\n\nmCRPC arms: (Phase 1 Part 1 \\& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods\n\nSOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer\n\nmHSPC arms (Phase 2 Part 2B, 2C \\& 2D) regional pelvic lymph node disease only","MALE","18 Years",{"count":20,"type":21},190,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.",[28],"Metastatic Prostate Cancer",[30,31,32,33,34,35,36,37,38,39,40,41],"Prostate Cancer","RIPTAC","HLD-0915","Genital Neoplasms, Male","Urogenital Neoplasms, Male","Genital Diseases, Male","Urogenital Diseases, Male","Neoplasms, Glandular and Epithelial","Prostatic Neoplasms","Prostate Adenocarcinoma","Hormone Sensitive, Castrate Resistant","Metastatic Castrate Resistant Prostate Cancer","RECRUITING","2026-08-19",{"date":45,"type":46},"2026-08-20","ACTUAL",{"date":48,"type":46},"2025-02-06",{"date":50,"type":21},"2028-07-11",{"name":52,"class":53},"Janssen Research & Development, LLC","INDUSTRY",18,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":63,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100633297","phase-1-a-study-of-hld-0117-in-patients-with-metastatic-breast-cancer-100633297","NCT07524855","A Study of HLD-0117 in Patients With Metastatic Breast Cancer","A Phase 1a\u002F1b Study of HLD-0117 in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)","HLD-0117","Inclusion Criteria:\n\n* Female (assigned at birth), ≥18 years old, and able to provide informed consent\n* Histologically confirmed metastatic or locally advanced breast cancer\n* Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist\n* Prior treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4\u002F6 inhibitor (in the adjuvant and\u002For metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting\n* Radiologic disease progression on the most recent therapy\n* Measurable disease per RECIST v1.1\n* Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate\n* ER-positive and HER2-negative status documented within 2 years\n* ECOG performance status 0-1 and life expectancy of at least 3 months\n* Adequate organ function Recovery from prior therapy-related toxicities to Grade ≤1 (except alopecia; neuropathy and endocrinopathies ≤Grade 2)\n* Ability to swallow oral medication and comply with study procedures\n* Stable dose (≥30 days) of bisphosphonates or denosumab, if applicable\n\nExclusion Criteria:\n\n* Inflammatory breast cancer or known brain metastases\n* Recent major bleeding or uncontrolled bleeding disorder\n* Ongoing corticosteroid use \\>10 mg\u002Fday (prednisone equivalent)\n* Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant)\n* Untreated or unstable spinal cord compression\n* Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions\n* Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed)\n* Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases)\n* Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers)\n* Major surgery within 28 days\n* Any condition that may interfere with safety or study compliance\n* Pregnancy or breastfeeding","FEMALE",{"count":65,"type":21},170,[24],"Assessment of the safety and efficacy of HLD-0117 as monotherapy in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally advanced breast cancer that have progressed on prior systemic therapies.",[69],"Metastatic Breast Cancer",[71,31,72,73,74,75],"breast cancer","breast carcinoma","locally advanced breast cancer","breast tumor","malignant Tumor of the breast","2026-08-13",{"date":78,"type":46},"2026-08-17",{"date":80,"type":46},"2026-04-09",{"date":82,"type":21},"2029-10-10",{"name":52,"class":53},6,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":84},"100599317","phase-1-a-study-of-jnj-78278343-in-combination-with-jnj-95298177-for-treatment-of-prostate-cancer-100599317","NCT07082920","A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer","A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example \\[e.g.\\], immunohistochemistry \\[IHC\\] with both androgen receptor \\[AR\\]- and NE-marker positivity) are allowed\n* Must have metastatic castration-resistant prostate cancer (mCRPC)\n* PSA must measure at least 2 nanograms per milliliters (ng\u002FmL) at screening\n* Measurable or evaluable disease\n* Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of study drug and must continue this therapy throughout the treatment phase\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion criteria:\n\n* Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (\\\u003C=) 1 or baseline levels (except for alopecia and vitiligo)\n* Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343, JNJ-95298177, or JNJ-87189401\n* Participants with leptomeningeal disease or brain metastases, with the exception of participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic greater than (\\>) 2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment\n* Treatment with any anti-cancer or investigational agents within 14 days prior to the first dose of study treatment; specific requirements for certain anti-cancer therapies are as follows:\n\n  1. Any T-cell redirecting treatment (e.g., CD3-directed bispecific or Chimeric Antigen Receptor T-cell \\[CAR-T\\] therapy) within 90 days prior to the first dose of study treatment\n  2. Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment\n  3. Radium (Ra) 223 dichloride within 28 days prior to the first dose of study treatment\n  4. Any prior treatment with kallikrein-related peptidase 2 (KLK2)-targeted therapy\n  5. Any prior prostate-specific membrane antigen (PSMA)-targeting therapy (that is \\[i.e.\\], participants who received PSMA-targeting radioconjugates are excluded) \\[Parts 2A and 2B only\\]. Prior PSMA RLT is allowed in Part 1 and required for Part 2C and Part 2D but last dose must be \\>3 months prior to the first dose of study treatment\n  6. Any prior antibody drug conjugates (ADCs) with microtubule inhibitor payloads (e.g., auristatins, maytansinoids, tubulysins)\n* Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments",{"count":93,"type":21},140,[24],"The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD of JNJ-7827834 and JNJ-95298177 with or without JNJ-87189401 is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) in Part 2 (Dose expansion) of study.",[38],"2026-08-11",{"date":76,"type":46},{"date":100,"type":46},"2025-07-07",{"date":102,"type":21},"2027-03-01",{"name":52,"class":53},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100650465","phase-1-a-study-of-jnj-98768111-in-participants-with-advanced-prostate-cancer-100650465","NCT07746713","A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer","A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer","Inclusion criteria:\n\n* a. Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine features is permitted. b. Measurable or evaluable disease (metastatic prostate cancer) based on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan. Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy. c. Serum prostate-specific antigen (PSA) value greater than or equal to (\\>=) 2 nanograms per milliliters (ng\u002FmL). d. Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of trial drug and must continue this therapy throughout the treatment phase\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n* Agree to all of the following during the trial and for 6 months after the last dose of trial drug: a. Use a highly effective method of contraception; b. Wear a condom when engaging in any activity that allows for passage of ejaculate to another person; c. Not to donate sperm or freeze for future use for the purpose of reproduction; d. Not plan to father a child. In addition, the participant should be advised of the benefit for a female partner to use a highly effective method of contraception\n* Sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the trial and is willing to participate in the trial\n\nExclusion criteria:\n\n* Active central nervous system (CNS) involvement\n* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (\\\u003C=) 1 or baseline levels\n* External beam radiation therapy to soft tissue lesions within 14 days prior to start of trial intervention\n* History of clinically significant cardiovascular disease within 6 months prior to signing informed consent\n* History of solid organ or bone marrow transplantation",{"count":112,"type":21},100,[24],"The purpose of Part 1 of this study is to find out how safe JNJ-98768111 is and the most suitable dose (recommended phase 2 dose \\[RP2D\\]) regimen(s) of JNJ-98768111. The purpose of Part 2 of this study is to find out how safe JNJ-98768111 is at the RP2D regimen(s) in participants with advanced prostate cancer (cancer of the prostate, a male reproductive gland found below the bladder, which has spread extensively to other parts of the body).",[38],"NOT_YET_RECRUITING","2026-07-31",{"date":119,"type":46},"2026-08-05",{"date":78,"type":21},{"date":122,"type":21},"2029-03-16",{"name":52,"class":53},{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100650339","phase-2-a-study-of-jnj-95597528-in-participants-with-inadequately-controlled-moderate-to-severe-asthma-100650339","NCT07746687","A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma","A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Inadequately Controlled Moderate to Severe Asthma","READY-BREATHE","Inclusion criteria:\n\n* Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline\n* Confirmed variable expiratory flow (1 or more of the following) per global initiative for asthma (GINA) 2025 at the baseline visit: a. Evidence of bronchodilator responsiveness at screening and baseline: Post-bronchodilator forced expiratory volume in 1 second (FEV1) increases by greater than or equal to (\\>=) 200 milliliter (mL) and \\>=12 percent (%) of pre- bronchodilator value, or increase in peak expiratory flow (PEF) \\>=20%, if spirometry is not available; b. Demonstrated increase in lung function within the past 3 years after \\>=4 weeks of daily inhaled corticosteroids (ICS)-containing treatment, shown by: increase from baseline FEV1 by \\>=12% and \\>=200 mL, or increase in PEF by \\>=20%; c. Positive bronchial provocation test within the past 3 years, as defined by: \\>=20% decrease from baseline in FEV1 with standard doses of methacholine, or \\>=15% decrease from baseline in FEV1 with standardized hyperventilation, hypertonic saline or mannitol challenge, or decrease from baseline in FEV1 of \\>10% and \\>200 mL with standardized exercise challenge\n* Inhaled corticosteroid: Prescribed medium- or high-dose ICS for at least 1 year and a stable dose of medium- or high-dose ICS for at least 3 months prior to the screening visit per GINA 2025: • High-dose ICS is defined as a total daily dose \\>=500 microgram (mcg) fluticasone propionate or equivalent, • Medium-dose ICS is defined as a total daily dose \\>=250 to 500 mcg fluticasone propionate or equivalent\n* Additional controller medication: Must be on a stable dose of at least 1 additional maintenance asthma controller, in addition to ICS, per GINA 2025, for at least 3 months prior to screening (for example, long-acting beta-agonist \\[LABA\\], long-acting muscarinic antagonist \\[LAMA\\] \\[can be combined with ICS in 1 inhaler or can be separate inhalers\\], leukotriene receptor antagonist \\[LTRA\\])\n* Asthma control questionnaire, 5-item (ACQ-5) score \\>=1.5 at the screening visit and the baseline visit\n\nExclusion criteria:\n\n* History of uncontrolled, significant renal, cardiac, vascular, pulmonary (other than asthma), gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that makes the participant unsuitable for the trial per investigator judgment\n* Any clinically important pulmonary disease other than asthma or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts\n* Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents inhibiting interleukin (IL)-13, IL-4Rα, and IL-4 signaling\n* Participants with either of the following events within the 2 weeks prior to the screening visit: a. Treatment with systemic steroids (oral or parenteral) for worsening asthma, b. Hospitalization or an emergency medical care visit for worsening asthma\n* Current smokers or former smokers with a smoking history \\>=20 pack-years. Former smokers must have stopped smoking within 6 months of the screening visit. This includes participants using vaping products and e-cigarettes","ALL","85 Years",{"count":135,"type":21},440,[25],"The purpose of this study is to assess how well JNJ-95597528 works when compared to placebo in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).",[139],"Asthma",{"date":119,"type":46},{"date":142,"type":21},"2026-09-23",{"date":144,"type":21},"2030-07-04",{"name":52,"class":53},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100648098","phase-3-a-study-of-esketamine-nasal-spray-versus-placebo-spray-in-adult-participants-with-treatment-resistant-depression-100648098","NCT07716098","A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression","A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression","Inclusion Criteria:\n\n* Participant must meet the diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single episode MDD, the duration of the episode must be greater than or equal to \\[\\>=\\] 12 months) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the mini international neuropsychiatric interview (MINI) as the primary diagnosis. Participant must have had the first onset of depression prior to 55 years of age\n* Participant must have had nonresponse (less than or equal to \\[\\\u003C=\\] 25 percent \\[%\\] improvement) to \\>=2 oral antidepressant treatments in the current episode of depression, assessed using the massachusetts general hospital-antidepressant treatment response questionnaire (MGH-ATRQ), and confirmed by documented records (for example, medical\u002Fpharmacy\u002Fprescription records or a letter from a treating physician)\n* The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the state versus trait, assessability, face validity, ecological validity, rule of three P's (SAFER) Interview\n* Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided\n* A female participant of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin \\[β-hCG\\]) at the start of screening and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1, prior to randomization\n\nExclusion Criteria:\n\n* The participant has used ketamine\u002Fesketamine (lifetime)\n* The participant's depressive symptoms have demonstrated nonresponse in the current major depressive episode to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral\u002Fbilateral ECT, or to adequate course of treatment with transcranial magnetic stimulation (TMS), defined as at least 4 weeks of treatment with 5 sessions per week\n* Participant has received vagal nerve stimulation (VNS) or deep brain stimulation (DBS) in the current episode of depression\n* Participant has homicidal ideation\u002Fintent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the columbia suicide severity rating scale (C-SSRS), corresponding to a response of \"Yes\" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past year prior to the start of the screening phase. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the double-blind treatment phase should be excluded\n* Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase. a. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary\n* Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)",{"count":154,"type":21},348,[156],"PHASE3","The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams \\[mg\\] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder \\[MDD\\] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).",[159],"Depressive Disorder, Treatment-Resistant","2026-07-30",{"date":117,"type":46},{"date":163,"type":21},"2026-07-27",{"date":165,"type":21},"2029-09-12",{"name":52,"class":53},4,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":175,"sex":63,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100643964","phase-1-a-study-to-assess-nipocalimab-concentrations-in-breast-milk-of-healthy-lactating-women-100643964","NCT07669077","A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women","A Phase 1, Open-Label, Lactation Study to Assess Concentrations of Nipocalimab in Breast Milk of Healthy Lactating Women","Inclusion criteria:\n\n* Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening\n* Study participant must have good venous accessibility in both arms\n* Study participant must be between 5 weeks and 24 months post-partum, inclusive, on Day -1\n* Study participant must agree, when nipple cream is needed during the assessment phase, to use only lanolin nipple cream\n* Study participant must have well established lactation and must be exclusively breast-feeding her infant (or not providing more than 1 supplemental bottle of formula\u002Fday) when enrolled in the study\n\nExclusion criteria:\n\n* Study participant has history of breast implants, breast augmentation, or breast reduction surgery\n* Study participant currently has active or unresolved mastitis at screening or Day -1\n* Study participant currently has or had an active clinically significant infection within the last 6 weeks\n* Study participant has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol-specified assessments\n* Study participant has suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients",true,{"count":177,"type":21},8,[24],"The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics \\[PK\\]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.",[181],"Healthy",{"date":117,"type":46},{"date":184,"type":46},"2026-06-23",{"date":186,"type":21},"2027-02-16",{"name":52,"class":53},1,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100643826","phase-3-a-study-of-jnj-78934804-in-participants-with-moderately-to-severely-active-crohns-disease-100643826","NCT07577843","A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","DUET ENCORE-CD","Inclusion criteria:\n\n* Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD\n* Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \\>= 220 but less than or equal to (\\\u003C=) 450 and either: a. Mean daily stool frequency (SF) count \\>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \\>= 2.0, based on the unweighted CDAI component of abdominal pain (AP)\n* Have moderately to severely active ileal and\u002For colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria\n* Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies\n\nExclusion criteria:\n\n* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC\n* Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study\n* Presence of draining (that is, functioning) stoma or ostomy\n* Has a history of short bowel syndrome, is missing greater than (\\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention\n* Currently has or is suspected of having an abscess",{"count":198,"type":21},460,[156],"The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \\[worsens with time\\] and life-threatening disease of the intestine).",[202],"Crohn Disease",{"date":117,"type":46},{"date":205,"type":46},"2026-05-22",{"date":207,"type":21},"2030-07-12",{"name":52,"class":53},55,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100643529","phase-3-a-study-of-jnj-78934804-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100643529","NCT07577856","A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis","DUET ENCORE-UC","Inclusion criteria:\n\n* Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.\n* Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy\n* An endoscopy subscore \\>=2 as obtained during central review of the screening video endoscopy\n* Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies\n\nExclusion criteria:\n\n* Isolated proctitis (UC limited to the rectum only or to less than \\[\\\u003C\\] 20 centimeter \\[cm\\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis\n* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD\n* Has a history of or ongoing chronic or recurrent infectious disease\n* Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab\n* Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention",{"count":219,"type":21},644,[156],"The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).",[223],"Colitis, Ulcerative",{"date":117,"type":46},{"date":226,"type":46},"2026-05-23",{"date":228,"type":21},"2030-10-30",{"name":52,"class":53},63,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":177},"100643295","phase-2-a-study-of-neoadjuvant-amivantamab-with-either-lazertinib-or-chemotherapy-in-participants-with-resectable-egfr-mutated-nsclc-100643295","NCT07586202","A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC","A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer","AmiNA","Inclusion Criteria:\n\n* Participant must have histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease\n* Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation\n* Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample\n* Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* History of uncontrolled illness\n* Medical history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis, or has current interstitial lung disease (ILD)\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed\n* Presence of primary driver mutations (anaplastic lymphoma kinase \\[ALK\\], mesenchymal-epithelial transition \\[MET\\], human epidermal growth factor receptor 2 \\[HER2\\], proto-oncogene tyrosine-protein kinase ROS \\[ROS1\\], neurotrophic tyrosine receptor kinase \\[NTRK\\], B-Raf proto-oncogene \\[BRAF\\], REarranged during transfection \\[RET\\], or kirsten rat sarcoma viral oncogene homolog \\[KRAS\\]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing\n* Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug",{"count":240,"type":21},68,[25],"The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.",[244],"Carcinoma, Non-Small-Cell Lung",{"date":117,"type":46},{"date":247,"type":46},"2026-07-28",{"date":249,"type":21},"2028-04-03",{"name":52,"class":53},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":167},"100642847","phase-2-a-study-evaluating-the-prophylactic-use-of-tocilizumab-to-prevent-cytokine-release-syndrome-with-ramantamig-administration-in-participants-with-relapsedrefractory-multiple-myeloma-100642847","NCT07589634","A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed\u002FRefractory Multiple Myeloma","79635322MMY2002: Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed\u002FRefractory Multiple Myeloma","TRI Pro","Inclusion criteria:\n\n* Documented diagnosis of multiple myeloma (MM) as defined by the criteria: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria; b. Measurable disease at screening as assessed by local laboratory as defined in the protocol\n* Received at least 1 prior lines of antimyeloma therapy\n* Relapsed or refractory disease as defined: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by the IMWG response criteria greater than (\\>) 60 days after cessation of treatment.; b. Refractory disease is defined as failure to achieve a response (that is, partial response or better) or confirmed PD by the IMWG response criteria during previous treatment or less than or equal to (\\\u003C=) 60 days after cessation of treatment\n* Have an eastern cooperative oncology group (ECOG) performance status (PS) score of 0 to 2 at screening and immediately before the start of study treatment administration. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to MM or associated therapy\n* Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment\n\nExclusion criteria:\n\n* Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent\n* Major surgery, (for example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study\n* Suspected or known allergies, hypersensitivity, or intolerance to ramantamig and tocilizumab or their excipients\n* Presence of any of the following: a. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); b. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; c. Any active malignancy other than MM that is considered at high risk of recurrence requiring systemic therapy\n* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required",{"count":260,"type":21},230,[25],"The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig, compared to participants who receive placebo. CRS is an acute inflammatory reaction that can occur during treatment and may be associated with flu-like or other systemic symptoms, such as fever and tiredness.",[264],"Multiple Myeloma",{"date":117,"type":46},{"date":267,"type":46},"2026-06-30",{"date":269,"type":21},"2030-12-02",{"name":52,"class":53},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":63,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":188},"100642162","phase-4-a-study-to-assess-concentration-of-tremfya-in-breast-milk-of-lactating-women-who-are-receiving-tremfya-therapeutically-100642162","NCT07654751","A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","CNTO1959ISD4001: A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","Inclusion criteria:\n\n* Has an active diagnosis of at least one approved indication for guselkumab (psoriasis, psoriatic arthritis \\[PsA\\], UC and CD) as confirmed by medical records\n* Be medically stable on the basis of medical history review performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator\n* Currently is on established guselkumab maintenance therapy, that is, has received at least 2 guselkumab subcutaneous (SC) maintenance doses before Day 1\n* Has made the decision to be treated with guselkumab and to breastfeed independently prior to the participant consenting to participate in this study\n* Must be at least 5 weeks postpartum on Day 1\n* Have well-established lactation; participant must be exclusively breastfeeding their infant(s) (or not providing more than 1 supplemental bottle of formula\u002Fday) when enrolled in the study\n* Must plan to continue breastfeeding throughout the duration of the study\n\nExclusion criteria\n\n* Has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol specified assessments\n* Has history of drug or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria within 1 year before screening\n* Uses or has used an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before enrolling in the study\n* Has received or plans to receive any live, attenuated vaccine within 12 weeks prior to administration of guselkumab. Non-live vaccines approved or authorized for emergency use (for example, Coronavirus disease-19 \\[COVID-19\\]) by local health authorities are allowed\n* Has a positive urine pregnancy test on Day 1",{"count":279,"type":21},10,[281],"PHASE4","The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.",[284,223,202,285],"Psoriasis","Arthritis, Psoriatic",{"date":117,"type":46},{"date":288,"type":21},"2026-10-01",{"date":290,"type":21},"2027-08-31",{"name":52,"class":53},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100637014","phase-3-a-study-of-seltorexant-as-monotherapy-in-adults-and-elderly-participants-with-major-depressive-disorder-100637014","NCT07573176","A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder","A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant","Inclusion criteria:\n\n* Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment\n* Experienced at least one MDD episode prior to their current episode\n* Current episode of MDD must be a minimum of 2 weeks in duration\n* Must meet one of the following criteria regarding current medication status.\n\n  1. Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record\u002Fsource document).\n\n     OR\n  2. Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.\n* Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg\u002Fm\\^2)\n* Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG)\n\nExclusion criteria:\n\n* Use of ketamine\u002Fesketamine in the current depressive episode (up to 2 doses are allowed prior to screening)\n* Has treatment-resistant depression (TRD)\n* Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years\n* Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia\n* Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders\n* Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder\n* Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months\n* Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months\n* Has any significant sleep disorder, including but not limited to untreated\u002Funcontrolled conditions\n* Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients","74 Years",{"count":301,"type":21},600,[156],"The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\\[MDD\\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.",[305],"Depressive Disorder, Major",{"date":117,"type":46},{"date":308,"type":46},"2026-04-30",{"date":310,"type":21},"2029-05-03",{"name":52,"class":53},30,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100632784","phase-3-a-study-comparing-jnj-79635322-and-teclistamab-in-participants-with-relapsed-or-refractory-multiple-myeloma-100632784","NCT07518186","A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide","TRIlogy-5","Inclusion criteria:\n\n* Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory\n* Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication\n* Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment\n\nExclusion criteria:\n\n* Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study\n* Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients\n* Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM\n* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required",{"count":322,"type":21},700,[156],"The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.",[264],{"date":117,"type":46},{"date":328,"type":46},"2026-05-31",{"date":330,"type":21},"2032-12-08",{"name":52,"class":53},88,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},"100631327","phase-3-a-study-of-guselkumab-versus-risankizumab-in-participants-with-moderately-to-severely-active-crohns-disease-100631327","NCT07499232","A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease","A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease","CHARGE","Inclusion criteria:\n\n* Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and\u002For endoscopy\n* Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\\>=) 220 but less than or equal to (\\\u003C=) 450\n* Baseline endoscopic evidence of active ileal and\u002For colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \\>= 4 (for participants with isolated ileal disease) or \\>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:\n\n  1. a minimum score of 1 for the component of \"size of ulcers\" AND\n  2. a minimum score of 1 for the component of \"ulcerated surface\"\n* In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study\n* Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol\n\nExclusion criteria\n\n* Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab\n* Currently has or is suspected to have an abscess\n* Has an active fistula during screening or at Week 0 with an anticipated need for surgery\n* Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention\n* Currently has a malignancy or has a history of malignancy within 5 years before screening",{"count":342,"type":21},530,[156],"The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).",[202],{"date":117,"type":46},{"date":348,"type":46},"2026-04-21",{"date":350,"type":21},"2030-12-11",{"name":52,"class":53},144,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100626658","phase-3-a-study-of-nipocalimab-in-adults-with-moderate-to-severe-systemic-lupus-erythematosus-100626658","NCT07438496","A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus","A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus","GARDENIA-SLE","Inclusion Criteria:-\n\n* Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening\n* Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\\>=) 24 weeks prior to screening and meeting european league against rheumatism\u002Famerican college of rheumatology (EULAR\u002FACR) classification criteria\n* Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \\>= 6 and a clinical SLEDAI-2K \\>= 4 at screening, AND a clinical SLEDAI-2K score \\>= 4 points at Week 0. For eligibility, points attributed to \"lupus headache,\" \"alopecia,\" and \"organic brain syndrome\" are excluded\n* Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization\n* Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening\n\nExclusion Criteria:\n\n* History of severe, progressive and\u002For uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and\u002For any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory\n* Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications\n* Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins\n* Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation","75 Years",{"count":301,"type":21},[156],"The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).",[366],"Lupus Erythematosus, Systemic",{"date":117,"type":46},{"date":369,"type":46},"2026-03-05",{"date":371,"type":21},"2031-11-07",{"name":52,"class":53},231,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},"100617688","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-jnj-88545223-for-the-treatment-of-participants-with-active-psoriatic-arthritis-100617688","NCT07321873","A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis","A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 For the Treatment of Participants With Active Psoriatic Arthritis","VELOTA","Inclusion Criteria:\n\n* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening\n* Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (Week 0\u002FDay 1) based on the 66\u002F68 joint assessment; AND (b) C-reactive protein (CRP) greater than or equal to (\\>=) 0.1 milligrams per deciliter (mg\u002FdL) at screening from the central laboratory\n* Have \\>= 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis\n* Have active plaque psoriasis with at least one psoriatic plaque of \\>= 2 centimeter (cm) diameter or nail changes consistent with psoriasis\n* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention\n\nExclusion Criteria:\n\n* Has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)\n* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, or metabolic disturbances\n* Has suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223 or excipients used in the investigational medicinal product (IMP), including placebo (JNJ-88545223 investigator's brochure); or has a history of severe allergic reaction, angioedema, or anaphylaxis to drugs or food\n* Has fibromyalgia or osteoarthritis symptoms that, in the opinion of the investigator, would have potential to interfere with efficacy assessments\n* Currently has a malignancy or has a history of malignancy within 5 years prior to screening",{"count":383,"type":21},240,[25],"The purpose of this study is to evaluate how well the study drug JNJ-88545223 works compared with a placebo (an inactive substance) in adults with active psoriatic arthritis (PsA). The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.",[285],{"date":117,"type":46},{"date":389,"type":46},"2026-01-15",{"date":391,"type":21},"2027-08-02",{"name":52,"class":53},73,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":404,"phases":4,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":414},"100616733","a-study-to-assess-real-world-use-and-outcomes-of-tar-200-for-participants-with-non-muscle-invasive-bladder-cancer-nmibc-in-the-united-states-100616733","NCT07309445","A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States","A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US","Nova-sTAR","Inclusion criteria:\n\n* Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy\n* Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit\u002FStudy visit 1\n* Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice\n* Must provide informed consent as described in the protocol\n\nExclusion criteria:\n\n* Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment\n* Had previous treatment with TAR-200 discontinued prior to baseline visit\u002FStudy visit 1\n* Previously received TAR-200 intravesically as part of a clinical trial(s)\n* Previously received greater than (\\>) 2 doses\u002Fcycles of TAR-200 in the real-world setting\n* Currently participating in an interventional bladder cancer clinical trial",{"count":403,"type":21},150,"OBSERVATIONAL","The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).",[407],"Non-Muscle Invasive Bladder Neoplasms",{"date":117,"type":46},{"date":410,"type":46},"2026-06-12",{"date":412,"type":21},"2029-10-09",{"name":52,"class":53},16,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":188},"100615695","phase-1-a-study-of-14c-bleximenib-radiolabeled-in-participants-with-acute-leukemia-100615695","NCT07295951","A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia","An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia","Inclusion criteria:\n\n* Body weight greater than or equal to (\\>=) 40 kilograms (kg)\n* Relapsed or refractory (R\u002FR) acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 (NPM1), nucleoporin 98 (NUP98) or nucleoporin 214 (NUP214) gene alterations, and has exhausted, or is ineligible for available therapeutic options\n* Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1\n* Regular bowel movements (that is \\[i.e.\\], average production of at least one stool every 2 days)\n* A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment\n\nExclusion criteria:\n\n* Acute promyelocytic leukemia or diagnosis of Down syndrome associated leukemia, according to world health organization (WHO) 2016 criteria\n* Active central nervous system (CNS) disease\n* Recipient of solid organ transplant\n* Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to Grade 1 or less\n* Major surgery (e.g., requiring general anesthesia) within 2 weeks prior to first dose of study treatment or has not recovered from surgery or has major surgery planned during the time the participant is receiving study treatment",{"count":279,"type":21},[24],"The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).",[426,427,428],"Acute Lymphoblastic Leukemia","Acute Leukemias","Acute Myeloid Leukemia",{"date":117,"type":46},{"date":431,"type":46},"2025-11-18",{"date":433,"type":21},"2026-09-29",{"name":52,"class":53},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":455},"100614192","phase-3-a-study-of-amivantamab-in-addition-to-standard-of-care-agents-soc-compared-with-soc-alone-in-participants-with-recurrentmetastatic-head-and-neck-cancer-100614192","NCT07276399","A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent\u002FMetastatic Head and Neck Cancer","A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma","OrigAMI-5","Inclusion criteria:\n\n* Be more than or equal to (\\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater)\n* Have histologically or cytologically confirmed recurrent\u002Fmetastatic (R\u002FM) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative\n* Be treatment-naive for systemic therapy in the R\u002FM setting\n* Have an ECOG performance status of 0 or 1\n* Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1\n\nExclusion criteria:\n\n* Have an uncontrolled illness\n* Have untreated brain metastases or history of known presence of leptomeningeal disease\n* Have a history of clinically significant cardiovascular disease\n* Inadequate organ or bone marrow function\n* Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase",{"count":444,"type":21},500,[156],"The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory\u002Fmetastatic (R\u002FM) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R\u002FM setting.",[448],"Squamous Cell Carcinoma of Head and Neck",{"date":117,"type":46},{"date":451,"type":46},"2025-12-03",{"date":453,"type":21},"2029-06-18",{"name":52,"class":53},198,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":475},"100613426","phase-2-a-study-of-jnj-79635322-in-participants-with-relapsed-or-refractory-multiple-myeloma-100613426","NCT07266441","A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma","A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody","TRIlogy-3","Inclusion:\n\n* Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:\n\n  1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria\n  2. Measurable disease at screening as assessed by central laboratory\n* Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD) 38 monoclonal antibody (mAb)\n* Documented evidence of progressive disease(PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by the IMWG criteria\n* Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent\n* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 to 2 at screening and immediately before the start of study treatment administration\n\nExclusion:\n\n* Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322\n* Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase\n* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM\n* Participant has leptomeningeal disease\n* Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment",{"count":465,"type":21},157,[25],"The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.",[264],{"date":117,"type":46},{"date":471,"type":46},"2026-02-08",{"date":473,"type":21},"2028-12-12",{"name":52,"class":53},71,{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":495},"100612817","phase-3-a-study-comparing-jnj-79635322-and-an-anti-b-cell-maturation-antigen-bcmaxcd3-bispecific-antibody-in-participants-with-relapsed-or-refractory-multiple-myeloma-100612817","NCT07258511","A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma","A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody","TRIlogy-4","Inclusion:\n\n* Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:\n\n  1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria\n  2. Measurable disease at screening as assessed by central laboratory\n* Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody\n* Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by IMWG criteria\n* Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration\n\nExclusion:\n\n* Active hepatitis of infectious origin\n* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM\n* Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab\n* Major surgery, (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study\n* Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, or during study treatment",{"count":485,"type":21},400,[156],"The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.",[264],{"date":117,"type":46},{"date":491,"type":46},"2026-02-04",{"date":493,"type":21},"2031-09-30",{"name":52,"class":53},124,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":404,"phases":4,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":510,"leadSponsor":512,"locationsCount":513},"100610677","a-study-of-clinical-outcomes-in-participants-with-egfr-mutated-advanced-non-small-cell-lung-cancer-nsclc-in-a-real-world-setting-100610677","NCT07230691","A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting","Prospective, Multi Country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Approved Amivantamab-containing Regimens Under Standard Clinical Practice","LEPIDOPTERA","Inclusion Criteria:\n\n* Participant has a confirmed diagnosis of common epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) (EGFR exon 19 deletions or exon 21 L858R substitution) and is eligible for an amivantamab-containing regimen per the judgment of the treating physician and in alignment with the approved amivantamab indications and recommended prophylactic and reactive medication as described in the local specific summary of product characteristics (SmPC) for amivantamab\n* Participants or their legally acceptable representative, where applicable, must sign a participation agreement\u002FInformed consent form (ICF) allowing source data verification in accordance with local requirements\n* Participant is being planned to be initiated with an amivantamab-containing regimen for the first time within 4 weeks following the visit for start of data collection\n* Decision to administer an amivantamab-containing regimen has been made prior to participant's enrollment in the study and is separate from the physician's decision to include the participant in the current study\n\nExclusion criteria:\n\n* At the time of the initiation of the amivantamab-containing regimen, the participant is receiving an active systemic anticancer treatment for advanced NSCLC that is not included in the locally approved combination regimen with amivantamab (regardless of whether it is part of an interventional study). One cycle of platinum-based chemotherapy (for example, carboplatin-pemetrexed) is permitted prior to the first dose of amivantamab in a 1L while awaiting biopsy results\n* Participant has received prior treatment with amivantamab in a clinical trial or for compassionate use\n* Participants who are not receiving amivantamab but are being treated with a biosimilar or a non-original biologic agent\n* Participants with conditions listed in the contraindications of the SmPC for amivantamab or other agents essential for the applicable amivantamab-containing treatment regimen (lazertinib\u002F platinum\u002F pemetrexed)",{"count":505,"type":21},380,"The purpose of this study is to describe the clinical and health-related outcomes of amivantamab-containing regimens for the treatment of common epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC; most common type of lung cancer) in a real-world setting. Metastatic NSCLC is when this disease spreads to other parts of body. NSCLC may occur due to mutations (changes) in many genes including epidermal growth factor receptor (EGFR).",[244],{"date":117,"type":46},{"date":451,"type":46},{"date":511,"type":21},"2030-12-17",{"name":52,"class":53},80,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":132,"minAge":522,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":535},"100610428","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-esketamine-for-reduction-of-symptoms-of-major-depressive-disorder-100610428","NCT07227454","A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder","A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior","AVENUE","Inclusion Criteria:\n\n* Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID)\n* Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of \"Markedly\" or greater (that is, greater than or equal to \\[\\>=\\] 4) at both screening and baseline (predose) visits\n* Must have a children's depression rating scale - revised (CDRS-R) total score \\>= 58 at baseline (predose)\n* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality\n* Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening\n\nExclusion Criteria:\n\n* Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder\n* Participant currently meets DSM-5 criteria for borderline personality disorder\n* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis\n* Participant has a history of seizure disorder\n* Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients","12 Years","17 Years",{"count":525,"type":21},258,[156],"The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.",[305],{"date":117,"type":46},{"date":531,"type":46},"2026-01-08",{"date":533,"type":21},"2031-09-15",{"name":52,"class":53},35,{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":555},"100610395","phase-1-a-study-of-amivantamab-and-olomorasib-combination-therapy-in-participants-with-metastatic-non-small-cell-lung-cancer-100610395","NCT07227025","A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer","A Phase 1\u002F2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer","KaRAnaSa","Inclusion criteria:\n\n* Participant must have histologically or cytologically confirmed metastatic NSCLC characterized by a KRAS G12C mutation at the time of enrollment. For Phase 1: Participant must have progressed on or after, or have intolerance to, platinum-based chemotherapy and Programmed Death-Ligand 1 (PD-L1)-targeted immunotherapy given in combination or sequentially. Receipt of additional lines of prior therapy is permitted. Progression must have occurred on or after the most recent line of systemic anticancer therapy. For Phase 2: Participant must have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy given in combination or sequentially. Progression must have occurred on or after the most recent line of systemic anticancer therapy. Receipt of additional lines of prior therapy is not permitted\n* Participant must have at least 1 measurable lesion, according to RECIST version.1.1, that has not been previously irradiated\n* May have brain metastases only if previously definitively, locally treated, and participant is clinically stable and asymptomatic for greater than (\\>) 2 weeks and is off or receiving low-dose corticosteroid treatment for at least 2 weeks prior to start of study treatment\n* Can have a prior or concurrent second malignancy (other than the disease under study) with natural history or treatment course that is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion criteria:\n\n* Participant has history of uncontrolled illness\n* Suspected or known allergies, hypersensitivity, or intolerance to amivantamab excipients or olomorasib excipients\n* Medical history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis, or has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Presence of primary driver mutations (epidermal growth factor receptor \\[EGFR\\], anaplastic lymphoma kinase \\[ALK\\], mesenchymal-epithelial transition \\[MET\\], human epidermal growth factor receptor 2 \\[HER2\\], ROS1, neurotrophic tyrosine receptor kinase \\[NTRK\\], B-Raf proto-oncogene \\[BRAF\\], rearranged during Transfection \\[RET\\], neuroblastoma RAS viral oncogene homolog \\[NRAS\\], and other KRAS mutations besides G12C) as determined by local genomic testing\n* Prior treatment with any KRAS inhibitor",{"count":545,"type":21},60,[24,25],"The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose \\[RP2CD\\]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation \\[change\\] in the kirsten rat sarcoma viral oncogene homolog \\[KRAS\\] gene in tumor cells in which glycine \\[G\\] at position 12 is replaced with cystine \\[C\\]).",[244],{"date":117,"type":46},{"date":551,"type":46},"2026-03-03",{"date":553,"type":21},"2029-04-30",{"name":52,"class":53},13,""]