[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sanofi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":565},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,43,69,90,112,134,155,176,199,222,250,273,295,318,341,360,380,399,422,442,467,485,505,526,545],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100652932","phase-1-study-to-assess-safety-and-immunogenicity-of-an-egg-based-h5n8-influenza-vaccine-at-multiple-dose-levels-adjuvanted-with-matrix-m-in-healthy-participants-18-years-of-age-and-above-100652932",false,"NCT07779408","Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.","A Phase 1\u002F2, Parallel, Observer-blind Study to Assess the Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.","Inclusion Criteria:\n\n* Aged 18 years or above on the day of inclusion\n* Participants who are healthy as determined by medical evaluation including medical history\n* Not pregnant\u002Fbreastfeeding; non-childbearing potential or uses effective contraception\u002Fabstinence from ≥4 weeks before the first study intervention dose to ≥8 weeks after the last dose\n* Informed consent form has been signed and dated\n* Able to attend all scheduled visits and to comply with all study procedures\n* Covered by health insurance, if required by local regulations\n\nExclusion Criteria:\n\n* Known or suspected immunodeficiency; immunosuppressive therapy in past 6 months; or long-term systemic corticosteroid (eg, prednisone for more than 2 weeks in the past 3 months)\n* Known hepatitis B or hepatitis C infection (based on medical history)\n* Known personal or family history of previous episodes of Guillan-Barré syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis\n* Known systemic hypersensitivity to any of the study intervention components or history of life-threatening reaction to the study interventions or products with same substances\n* Self-reported thrombocytopenia contraindicating intramuscular (IM) injection based on investigator's judgment\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection based on investigator's judgment\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n* History of A\u002FH5 infection prior to the study participation\n* Moderate or severe acute illness\u002Finfection (per investigator judgment)\u002Ffever (≥ 38.0°C \\[≥ 100.4°F\\]) on study intervention day. Include participant only after the condition or fever has resolved\n* Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion\n* Any vaccine given 4 weeks before first study intervention or any planned vaccination to be given prior to Day 43 (ie, approximately 21 days after the second study intervention)\n* Previous vaccination against A(H5) with an investigational or marketed vaccine. This includes, but is not limited to, influenza subtypes A(H5N1), A(H5N8), and A(H5N6)\n* Has received a blood transfusion or blood-derived products, including immunoglobulins in the past 3 months\n* Participation in another clinical study for a vaccine, drug, medical device, or medical procedure within 4 weeks before enrollment or planned participation during the present study period\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily\n* Is an investigator, investigator\u002Fstudy center employee, or immediate family member (parent, spouse, natural\u002Fadopted child) of the investigator\u002Femployee with direct involvement in the study\n* Any screening safety laboratory parameters out of normal ranges and assessed as \\> Grade 2\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",true,"ALL","18 Years",{"count":21,"type":22},640,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness.\n\nThe study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose).\n\nStudy duration per participant: approximately 14 months (including screening visit).",[29,30],"Healthy Volunteers","Influenza","NOT_YET_RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":22},"2026-08-10",{"date":39,"type":22},"2028-02-22",{"name":41,"class":42},"Sanofi","INDUSTRY",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100607164","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100607164","NCT07184996","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis.","SUNSCAPE-1","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \\\u003C18 years of age who meet the definition of Tanner Stage 5 for development\n* Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline\n* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies\n\nExclusion Criteria:\n\n* Participants with Crohn's Disease (CD), indeterminate colitis\n* Current diagnosis of Ulcerative Proctitis\n* Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \\>3 bowel resections\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapies prior to baseline\n* Participants with prohibited medications or therapies prior to baseline\n* Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","16 Years","80 Years",{"count":54,"type":22},980,[56],"PHASE3","This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* Screening period\n* 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction)\n* 12-week Sub-Study 3 (Extended Induction for non-responders)\n* 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)\n\nThe treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.",[59],"Ulcerative Colitis","RECRUITING",{"date":62,"type":35},"2026-08-20",{"date":64,"type":35},"2025-10-08",{"date":66,"type":22},"2028-05-09",{"name":41,"class":42},219,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100599629","phase-3-a-study-to-investigate-the-efficacy-safety-and-pharmacokinetics-of-oral-rilzabrutinib-compared-with-placebo-in-participants-18-years-of-age-and-older-with-warm-autoimmune-hemolytic-anemia-100599629","NCT07086976","A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Period and Long-term Extension to Assess the Efficacy and Safety of Rilzabrutinib in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)","LUMINA 3","Inclusion Criteria:\n\n* Male and female participants with a documented (confirmed) diagnosis of primary wAIHA for at least 6 months.\n* Participants who have previously failed to maintain a sustained response after treatment with CS (CS-resistance \\[defined as failure to obtain hemoglobin response within 3 weeks on at least 1 mg\u002Fkg or 60 mg prednisone or equivalent per day\\], CS-dependent wAIHA \\[defined as need to continue on prednisone or equivalent at a dose of \\>10 mg\u002Fday to maintain a response\\]), or are intolerant or ineligible to CS (defined as with contraindications, pre-existing medical conditions or CS-related complications that may render CS intolerant or ineligible per the best clinical judgement of the investigators).\n* Participants with Eastern Cooperative Oncology Group (ECOG) performance status Grade 2 or lower.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Participants with clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator.\n* Participants with medical 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 with no evidence of metastatic disease for the past 3 years.\n* Participants with symptomatic herpes zoster within 3 months prior to screening.\n* Participants with mixed wAIHA, or secondary wAIHA from any cause including drugs, Evans Syndrome, lymphoproliferative disorders (low count monoclonal B-cell lymphocytosis is allowed), infectious or autoimmune disease, or active hematologic malignancies. Participants with positive antinuclear antibodies but without a definitive diagnosis of an autoimmune disease are allowed.\n* Participants with history of myelodysplastic syndrome.\n* Participants with uncontrolled or active HBV infection or Active HCV infection.\n* HIV infection.\n* Participants with history of solid organ transplant.\n* Participants with a history of active or latent tuberculosis (TB).\n* Splenectomy within 12 weeks before screening and planned surgery during the PAP.\n* Concurrent treatment with other experimental\u002Finvestigational drugs within 30 days or 5 half-lives, whichever is longer, prior to treatment start. Participants who previously received treatment with BTK inhibitors for wAIHA before Day 1 (randomization) are not eligible.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":78,"type":22},90,[56],"This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female participants ≥ 18 years of age with a confirmed diagnosis of primary wAIHA.\n\nFollowing a 4-week screening period, eligible participants will be randomized in a 2:1 ratio to receive rilzabrutinib or placebo in primary analysis period (PAP) for a duration of up to 24 weeks. All participants who completed PAP will then continue in open-label period (OLP) to receive rilzabrutinib for a duration of 28 weeks. Upon the completion of OLP, only participants who demonstrate Hb increase during the last 8 weeks of OLP per specified criteria in the protocol will be eligible to continue in long-term extension (LTE) of the study. The duration of the LTE period will be from the first-participant-in (FPI)-LTE until the last participant completes 52 weeks in LTE. The safety follow-up period of this study following treatment completion or discontinuation will be 2 weeks.",[82],"Autoimmune Haemolytic Anaemia",{"date":34,"type":35},{"date":85,"type":35},"2025-08-18",{"date":87,"type":22},"2029-12-26",{"name":41,"class":42},95,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100606082","phase-2-brivekimig-for-the-treatment-of-moderate-to-severe-hidradenitis-suppurativa-100606082","NCT07170917","Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa","A Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study of Brivekimig Followed by a Maintenance Period in Participants With Moderate to Severe Hidradenitis Suppurativa","BRIGHTEN","Inclusion Criteria:\n\n* Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline\n* Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.\n* Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.\n* Participants must be either biologic-naive or biologic-experienced.\n* Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit.\n* Participant must have a draining tunnel count of ≤20 at the Baseline visit.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS\n* History of recurrent or recent serious infection\n* Known history of significant immunosuppression\n* History of solid organ transplant or stem cell transplant\n* History of splenectomy\n* History of moderate to severe congestive heart failure.\n* History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease\n* Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured\n* History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol\n* Active suicidality and therefore significant suicide risk, as judged by the Investigator\n* A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study\n* History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":99,"type":22},208,[26],"This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa.\n\nThe purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS.\n\nStudy details include:\n\nThe study duration (per participant) will be up to approximately 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period.\n\nThe randomized treatment duration will be up to approximately 152 weeks",[103],"Hidradenitis Suppurativa","2026-08-18",{"date":62,"type":35},{"date":107,"type":35},"2025-11-06",{"date":109,"type":22},"2029-11-23",{"name":41,"class":42},79,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":17,"sex":18,"minAge":119,"maxAge":19,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100595901","early-detection-of-type-1-diabetes-in-first-degree-relatives-of-type-1-diabetes-patients-detect-t1d-gulf-100595901","NCT07038473","Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)","Islet Autoantibody Early Detection in At-risk Children\u002FAdolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries","Inclusion Criteria:\n\n* Children and adolescents, age 1.5 years to 18 years\n* First degree relatives of T1D probands\n* Parent or legal guardian signing an informed consent\n\nExclusion Criteria:\n\n* Already developed clinical overt T1D\n* Known diabetes of any kind (type 1, type 2, Maturity Onset Diabetes of the Young - MODY)\n* Have a previous history of being treated with insulin\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","18 Months",{"count":121,"type":22},3500,[123],"NA","The aim of this research is to identify pre-symptomatic Type 1 Diabetes (T1D) in young children and adolescents who have first degree relatives with T1D. This protocol has been developed to address the growing need for standardized T1D screening, monitoring, and data collection in alignment with international recommendations. The study's estimated duration is 13 months and will consist of two visits: Visit 1 (screening visit) and Visit 2 (confirmatory visit).",[126],"Type 1 Diabetes",{"date":32,"type":35},{"date":129,"type":35},"2025-12-17",{"date":131,"type":22},"2026-12-25",{"name":41,"class":42},7,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100607165","phase-3-a-maintenance-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100607165","NCT07185009","A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","SUNSCAPE-2","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \\\u003C18 years of age who meet the definition of Tanner stage 5 for development)\n* Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1\n* OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study\n\nExclusion Criteria:\n\n* Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator\n* Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":143,"type":22},751,[56],"This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).\n\nStudy details include:\n\nThe study duration may be up to 286 weeks including:\n\n* 40-week Pivotal Maintenance Sub-Study\n* 240-week Open-Label Extension (OLE) Sub-Study\n* 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.\n\nThe treatment duration may be up to 280 weeks including:\n\n* 40 weeks in Pivotal Maintenance Sub-Study\n* 240 weeks in OLE Sub-Study\n\nThe total number of on-site visit will be up to 32:\n\n* 21 visits in the Pivotal Maintenance Sub-Study.\n* 11 visits in the OLE Sub-Study.",[59],"2026-08-17",{"date":104,"type":35},{"date":150,"type":35},"2026-01-16",{"date":152,"type":22},"2033-04-28",{"name":41,"class":42},46,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":4},"100652179","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-belumosudil-compared-with-best-available-therapy-in-participants-aged-12-years-or-older-with-chronic-graft-versus-host-disease-100652179","NCT07771439","A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease","A Parallel Group, Phase 3, Randomized, Open-label, 2-arm Study to Demonstrate the Superiority of Belumosudil Versus Best Available Therapy (BAT) in Participants at Least 12 Years of Age With Chronic Graft Versus Host Disease (cGVHD) Refractory to or Recurrent After 2 to 5 Prior Lines of Systemic Therapy","Inclusion Criteria:\n\n* Participant must be at least 12 years of age at the time of signing the informed consent.\n* Participants who have undergone allo-HCT.\n* Participants with active moderate to severe cGVHD at the time of enrollment, defined using the NIH Consensus diagnosis and staging criteria for which the physician believes a new line of systemic therapy is required.\n* Participant receiving systemic CNI and\u002For CS must be on a stable dose\u002Fregimen (prednisone equivalent \\\u003C1 mg\u002Fkg\u002Fday for CS) for at least 2 weeks prior to randomization.\n* cGVHD is refractory to, or has recurred following, at least 2 prior lines of systemic treatment. Participants must have received a minimum of 2 and a maximum of 5 prior systemic therapies for cGVHD.\n* Participant must have received ruxolitinib for the treatment of cGVHD unless the Investigator believes treatment with ruxolitinib for cGVHD was not suitable for the participant.\n* Participants and\u002For their LAR must accept to be treated with 1 of the following BAT options as recommended to them by the Investigator on Cycle 1 Day 1:\n\n  * ECP,\n  * Low-dose MTX,\n  * MMF,\n  * Rituximab,\n  * mTOR inhibitors (sirolimus, everolimus)\n  * Imatinib,\n  * Ibrutinib,\n  * Proteasome inhibitors,\n  * Pentostatin.\n* Body weight ≥ 30 kg I 09. Life expectancy of \\> 6 months.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease or post-transplant lymphoproliferative disease after most recent allo-HCT.\n* Participants who meet any of the following criteria regarding systemic cGVHD treatments:\n\n  * Participants who newly initiated any systemic cGVHD treatment within 14 days prior to the date of randomization.\n  * Participants receiving systemic ruxolitinib treatment who are unable to meet the following requirements:\n* Ruxolitinib must be tapered and discontinued within 14 days following the first dose of belumosudil or BAT (allowing for a maximum overlap period of up to 14 days with belumosudil or BAT treatment).\n* No dose increases of ruxolitinib are permitted from 14 days prior to the date of randomization until permanent discontinuation of ruxolitinib (dose reductions and discontinuations are permitted during this period).\n\n  * Participants receiving other systemic cGVHD treatment (apart from CS and CNI) including investigational treatments who have not completed a washout period of at least 14 days or 5 half-lives (whichever is shorter) prior to the first dose of belumosudil or BAT treatment.\n\nNote: Topical and organ-specific treatment for cGVHD and other supportive agents are allowed.\n\n* Participant has had previous exposure to belumosudil.\n* Participants with a Karnofsky Performance Scale (KPS) score \\\u003C60 (if aged ≥16 years) or Lansky Performance Score of \\\u003C60 (if aged \\\u003C16 years).\n* Clinically uncontrolled chronic or ongoing infectious disease requiring antibiotic, antiviral, or antifungal treatment within 14 days prior to the date of randomization.\n* Impairment of GI function (unrelated to cGVHD) or GI disease (unrelated to cGVHD) that may significantly alter the absorption of belumosudil (such as ulcerative disease, malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or small bowel resection).\n* Administration of live or live-attenuated vaccines is prohibited within 28 days or 5 elimination half-lives of the respective vaccine, whichever is longer, prior to study treatment administration and until study intervention discontinuation.\n* Has a forced expiratory volume in the first second (FEV1) ≤39% or has lung score of 3 according to 2014 NIH consensus diagnostic and staging criteria.\n* Has any of the following lab results:\n\n  * Absolute neutrophil count \\\u003C1.0 × 109\u002FL. The use of G-CSF is not allowed within 7 days before the screening hematological test.\n  * Platelet count \\\u003C25 × 109\u002FL. Platelet transfusions are not allowed within 72 hours before the screening hematological test.\n  * ALT and\u002For AST \\>3 × ULN (\\>5 × ULN if abnormalities are due to cGVHD).\n  * Total bilirubin \\>1.5 × ULN (\\>3 × ULN if Gilbert's syndrome or due to cGVHD).\n  * eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged \\\u003C18 years).\n* Participants with active viral diseases\n* Diagnosed or treated for another malignancy other than the underlying disease allo-HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","12 Years",{"count":164,"type":22},356,[56],"Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and\u002For CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation. The study will target patients post-ruxolitinib treatment, except where Investigators deemed ruxolitinib treatment for cGVHD not suitable. In the BAT arm, the study doctor will select one BAT based on clinical judgement, local availability etc. prior to randomization.\n\nParticipants randomized to the BAT arm will have the option to cross-over to open-label belumosudil treatment upon meeting predefined criteria.\n\nStudy details include:\n\n* The study duration will be defined as 3 years from LPI.\n* Individual participant duration on study will consist of:\n\n  * Up to 28 days for screening.\n  * Treatment until clinically significant progression of cGVHD, relapse\u002Frecurrence of the underlying disease, start of a new systemic treatment for cGVHD (except change from BAT to belumosudil during the cross-over), experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first.\n  * Thirty days of post treatment safety follow-up.\n  * Follow-up for cGVHD status as applicable.\n  * Long-term follow-up until death or end of study, whichever occurs first.",[168],"Chronic Graft Versus Host Disease","2026-08-14",{"date":104,"type":35},{"date":172,"type":22},"2026-09-07",{"date":174,"type":22},"2032-03-02",{"name":41,"class":42},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":184,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100614889","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-fitusiran-prophylaxis-in-male-participants-aged-1-to-less-than-12-years-with-hemophilia-a-or-b-100614889","NCT07285460","A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B","An Open-label, Parallel, Phase 3, Two-arm Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B With or Without Inhibitory Antibodies to Factors VIII or IX","ATLAS-KIDS","Inclusion Criteria:\n\nParticipants not previously exposed to fitusiran are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must be 1 to \\\u003C12 years of age at the time of enrollment.\n* Participants must have severe hemophilia A or B (FVIII \\\u003C1% or FIX ≤2%) as evidenced by a central laboratory measurement at screening or documented medical record evidence.\n* Participants must meet inhibitor or non-inhibitor status as defined below:\n\nInhibitor:\n\nRequiring use of BPA for prophylaxis or BPA as on-demand therapy for any bleeding episodes for at least the last 3 months prior to screening, and meet one of the following Nijmegen-modified Bethesda assay results criteria:\n\n* Inhibitor titer of ≥0.6 BU\u002FmL at screening, OR\n* Inhibitor titer of \\\u003C0.6 BU\u002FmL at screening with medical record evidence of 2 consecutive titers ≥0.6 BU\u002FmL, OR\n* Inhibitor titer of \\\u003C0.6 BU\u002FmL at screening with medical record evidence of 1 inhibitor titer ≥0.6 BU\u002FmL and a history of anamnestic response, or severe allergic reaction (eg, anaphylaxis) or nephrotic syndrome\n\nNon-inhibitor:\n\nRequiring use of clotting factor concentrates (CFCs) for prophylaxis or CFCs as on-demand therapy for any bleeding episodes for at least the last 3 months prior to screening, and meet each of the following criterion:\n\n* Nijmegen-modified Bethesda assay inhibitor titer of \\\u003C0.6 BU\u002FmL at screening, AND\n* No use of BPA to treat bleeding episodes for at least the last 3 months prior to screening\n\n  * Participants must have adequate peripheral venous access, as determined by the Investigator, to allow the blood draws required by the study protocol.\n  * Male: There are no contraceptive requirements for this study except where required by local regulations.\n  * Capable of giving signed informed consent\u002Fassent. A signed written informed consent must be obtained from parent(s)\u002Flegal guardian (hereafter referred to as the \"parent\"), as well as a written or oral assent obtained from participant, per local and national requirements.\n\nExclusion Criteria:\n\nParticipants not previously exposed to fitusiran are excluded from the study if any of the following criteria apply:\n\n* Known co-existing bleeding disorders other than hemophilia A or B.\n* Presence of clinically significant liver disease.\n* History of antiphospholipid antibody syndrome.\n* History of arterial or venous thromboembolism, unrelated to an indwelling venous access\n* Any condition (eg, medical concern), which in the opinion of the Investigator, would make the participant unsuitable for dosing or which could interfere with the study compliance, the participant's safety and\u002For the participant's participation in the completion of the treatment period of the study.\n* History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.\n* Subjects with a central or peripheral indwelling catheter, with a history of venous access complications (such as infections, thrombosis) leading to hospitalization and\u002For systemic anticoagulation therapy in the last 12 months.\n* At screening, anticipated need of surgery during the study or planned surgery scheduled to occur during the study.\n* Completion of a surgical procedure within 14 days prior to screening, or currently receiving additional BPA infusion for postoperative hemostasis.\n* History of intolerance to SC injection(s).\n* Current participation in ITI therapy.\n* The use of emicizumab (Hemlibra®) or any non-factor bleed management treatment within 6 months prior to screening\n* Prior gene therapy\n* Current or future participation in another clinical study, scheduled to occur during this study, involving an investigational product other than fitusiran or an investigational device.\n* AT activity \\\u003C60% at screening, as determined by central laboratory analysis.\n* Co-existing thrombophilic disorder.\n* Presence of an active Hepatitis C virus infection\n* Presence of acute hepatitis A or Hepatitis E virus infection.\n* Presence of acute or chronic hepatitis B virus infection.\n* Platelet count ≤100 000\u002FμL.\n* Presence of acute infection at screening.\n* Human immunodeficiency virus (HIV) positive with a CD4 count of \\\u003C400 cells\u002FμL.\n* Estimated glomerular filtration rate ≤45 mL\u002Fmin\u002F1.73 m2 (using the Schwartz formula).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","MALE","1 Year","11 Years",{"count":5,"type":22},[56],"This is a parallel, Phase 3, two-arm, open-label study to evaluate the efficacy and safety of treatment with fitusiran prophylaxis administered to male pediatric participants (aged 1 to \\\u003C12 years) who have severe hemophilia A or B, with or without inhibitory antibodies to FVIII or FIX.\n\nNumber of participants:\n\nApproximately 85 participants will be enrolled into the study:\n\n* Approximately 60 fitusiran-naïve participants with severe hemophilia A or B, with or without inhibitors (fitusiran-naïve arm), and\n* Approximately 25 participants with severe hemophilia A or B with inhibitors rolling over from the EFC15467\\* dose confirmation study (roll-over arm).\n\n  * Fitusiran has been investigated in the pediatric population in study EFC15467, which enrolled male participants aged 1 to \\\u003C12 years with hemophilia A or B with inhibitors to examine the safety and tolerability of fitusiran in the pediatric population.\n\nParticipants will be enrolled into 1 of 2 arms:\n\n* Fitusiran-naïve: these participants have not previously received fitusiran, and they will undergo screening and study eligibility assessments. Once enrolled, they will go through a 24-week standard of care (SOC) period before starting fitusiran prophylaxis.\n* Roll-over participants from the EFC15467 study: only participants who are still on active treatment in study EFC15467 and consenting to study EFC17905 will be eligible to roll over. They will not need to undergo screening or further eligibility assessments. They will directly enroll into the fitusiran treatment period and continue treatment on their current fitusiran dose.\n\nThe duration of fitusiran treatment will be up to 160 weeks for the fitusiran-naïve arm and up to 60 weeks for the roll-over arm.",[191],"Hemophilia",{"date":147,"type":35},{"date":194,"type":35},"2025-12-18",{"date":196,"type":22},"2031-12-30",{"name":41,"class":42},30,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},"100617951","phase-3-non-inferiority-study-of-frexalimab-subcutaneous-administration-compared-to-intravenous-administration-in-adult-participants-with-multiple-sclerosis-100617951","NCT07325292","Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis","A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis","Frexcite","Inclusion Criteria:\n\nThe participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group:\n\nGroup A (RMS)\n\n* The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.\n* The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.\n* The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).\n* The participant must have at least 1 of the following prior to screening:\n\n  * 1 documented relapse within the previous year OR\n  * 2 documented relapses within the previous 2 years, OR\n  * 1 documented Gd enhancing lesion on an MRI scan within the previous year. Group B (nrSPMS)\n* Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria\n* The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.\n* The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.\n* The participant must have documented evidence of disability progression observed during the 12 months before screening.\n* The participant must have an absence of clinical relapses for at least 24 months.\n* The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).\n\nParticipants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply:\n\n\\- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.\n* The participant has a history of infection or may be at risk for infection:\n* Fever within 28 days of the Screening Visit\n* Presence of psychiatric disturbance or substance abuse\n* History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and\u002For antiphospholipid syndrome and any participants requiring antithrombotic treatment.\n* Current hypogammaglobulinemia defined by Ig levels (IgG and\u002For IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.\n* A history or presence of disease that can mimic MS symptoms.\n* The participant has a contraindication for MRI.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","60 Years",{"count":209,"type":22},160,[56],"This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment.\n\nThe purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.\n\nStudy details include:\n\nThe study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months.\n\nThe number of scheduled visits (Parts A and B) will be 17 for participants receiving frexalimab SC or IV, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.",[213],"Multiple Sclerosis","2026-08-13",{"date":169,"type":35},{"date":217,"type":35},"2026-01-14",{"date":219,"type":22},"2028-11-30",{"name":41,"class":42},38,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":230,"maxAge":4,"enrollmentInfo":231,"targetDuration":233,"studyType":234,"phases":4,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},"100635705","a-study-evaluating-disease-characteristics-and-outcomes-in-participants-with-asthma-in-routine-clinical-practice-100635705","NCT07556159","A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice","A Hybrid Cross-sectional and Prospective Study to Assess Patient Characteristics, Disease Burden, Disease Control, Phenotypes, Endotypes, and Outcomes in a Real-world Setting in Patients With Asthma","AIRITY","Inclusion Criteria:\n\nApplicable for Part 1 participants:\n\n* Age 6 years and older, at the time of signing the informed consent\n* Physician diagnosis of asthma for at least 12 months\n* Existing treatment with low, medium, or high dose ICS and other asthma therapies as reflected in GINA 2-5 steps\n* Participant or legally authorized representative (where applicable) has consented to participate\n\nApplicable for Part 2 participants:\n\n* Age 18 years and older, at the time of signing the informed consent.\n* Physician diagnosis of asthma for at least 12 months\n* Existing treatment with low or medium ICS and other asthma therapies as reflected in GINA 2-4 steps\n* Participant or legally authorized representative (where applicable) has consented to participate\n* Participants must meet the criteria for at least one of the cohorts below:\n\nA) Asthma control cohorts\n\n1. ACQ-5 \\>= 1.5\n2. ACQ-5 \\\u003C 1.5 (B) Type-2 biomarker cohorts\n3. Elevated T2 biomarkers (B1: Type-2-high cohort)\n4. Low T2 biomarkers (B2: Type-2-low cohort)\n\nParticipants are excluded from the study if any of the following criteria apply (applicable for both Part 1 and Part 2 participants):\n\n* Current diagnosis of chronic obstructive pulmonary disease (COPD) or congestive heart failure\n* Participants with moderate\u002Fsevere cognitive impairment.\n* Participants with moderate\u002Fsevere cardiac disease.\n* Participants on immunosuppressive medication for a chronic condition.\n* Participation in other interventional and noninterventional clinical study (currently or in the past 3 months)\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","6 Years",{"count":232,"type":22},2500,"24 Months","OBSERVATIONAL","The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life.\n\nThe study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.",[237],"Asthma",[239,240,241],"Cross-Sectional","Multicenter","Inhaled Corticosteroids","2026-08-12",{"date":214,"type":35},{"date":245,"type":35},"2026-04-01",{"date":247,"type":22},"2029-04-04",{"name":41,"class":42},59,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":18,"minAge":258,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},"100530882","a-study-to-observe-how-adolescent-patients-with-severe-atopic-dermatitis-despite-less-extensive-skin-lesions-eczema-area-and-severity-index-score--16-respond-to-dupilumab-treatment-100530882","NCT06192563","A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment","A Prospective Observational Study of Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score \u003C 16 for Adolescents and \u003C 21 for Children) Receiving Dupilumab","AD-BEASCUITS","Inclusion Criteria:\n\n* Male or female, aged between 6 months and 17 years at the baseline visit.\n* Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:\n\n  \\-- Adolescents (12 to 17 years old) with EASI \\\u003C 16 and children (6 months to 11 years of age) with EASI \\\u003C 21 and.\n  1. Children's Dermatology Life Quality Index (cDLQI)\\* ≥ 10 and \u002F or\n  2. Itch NRS ≥ 7 and \u002F or\n  3. Localization in visible or sensitive areas (head\u002Fneck\u002Fhands or genitals)\n* Participants\u002F caregivers able to understand and complete study-related questionnaires.\n* Provided signed informed consent or parental\u002Flegally acceptable representative consent and participant assent where applicable.\n\n  * Only for adolescents and children 6-11 years of age.\n\nExclusion Criteria:\n\n* Use of dupilumab within 6 months prior to study entry.\n* Participants currently participating in any interventional clinical trial that modifies patient care.\n* Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse).\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","6 Months","17 Years",{"count":261,"type":22},230,"In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive\u002Fvisible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent and children participants with moderate to mild EASI score and severe itching and\u002For localized AD to better understand the potential clinical benefits of dupilumab in these populations.\n\nThe main objective of the study us to assess the real-word effectiveness and safety of dupilumab in pediatric patients (age 6 months-17 years) who suffer from severe AD with EASI score \\\u003C 16 for adolescents (age 12-17 years) and \\\u003C 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.",[264],"Atopic Dermatitis","2026-08-11",{"date":214,"type":35},{"date":268,"type":35},"2023-11-30",{"date":270,"type":22},"2028-03-31",{"name":41,"class":42},9,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":294},"100647072","phase-1-phase-1b2-study-of-iv-sarilumab-in-adult-with-ra-100647072","NCT07704580","Phase 1b\u002F2 Study of IV Sarilumab in Adult With RA","A Randomized Open Label, Phase 1b\u002F2 Study to Evaluate Intravenous Administration With Long Dosing Interval Regimens of Sarilumab in Adult Participants With Rheumatoid Arthritis","OPALS","Inclusion Criteria:\n\n* Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.\n* Diagnosis of RA, according to the American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) 2010 RA Classification Criteria with ≥3 months disease duration.\n* ACR Class I to III functional status, based on the 1991 revised criteria\n* Moderate-to-severely active RA, defined as: DAS28-ESR\\>3.2.\n* Inability to continue treatment with a RA DMARD approved for first line use because of intolerance or inadequate response.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Any prior (within the defined periods below) or concurrent use of immunosuppressive:\n\n  * Janus kinase (JAK) inhibitor (eg, tofacitinib) within 4 weeks of baseline.\n  * Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.\n  * Anakinra within 1 week of baseline.\n  * Abatacept within 8 weeks of baseline.\n  * Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks.\n  * Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline.\n  * Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.\n* Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist (prior IL-6 antagonist treatment that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).\n* Unstable methotrexate (MTX) dose (if participant is on concomitant MTX).\n* Concurrent use of systemic corticosteroids (CS) of more than 10 mg\u002Fday.\n* Pregnant or breastfeeding woman.\n* Exclusion related to tuberculosis (TB): active TB or a history of incompletely treated TB regardless of screening Quantiferon® result.\n* History of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).\n* Uncontrolled diabetes mellitus.\n* History of prior articular or prosthetic joint infection.\n* Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the baseline visit.\n* History of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.\n* History of juvenile idiopathic arthritis or arthritis onset prior to age 16.\n* Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and\u002For Felty's syndrome.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":282,"type":22},140,[25,26],"This is a Phase 1\u002FPhase 2 study with:\n\n* 5-arms design for Part A;\n* and a single arm for Part B.\n\nThe purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older.\n\nStudy details include:\n\n* The study duration will be up to 64 weeks.\n* The treatment duration will be up to 6 months for each study phase.\n* Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit.\n\n  * For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits.\n  * For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit.\n* Part B has 13 visits, including a post-treatment EOS follow-up visit.",[286],"Rheumatoid Arthritis","2026-08-07",{"date":265,"type":35},{"date":290,"type":35},"2026-07-02",{"date":292,"type":22},"2028-10-26",{"name":41,"class":42},4,{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":303,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":317},"100646618","a-study-to-investigate-the-safety-and-effectiveness-of-sar448851-in-participants-with-early-alzheimers-disease-100646618","NCT07688213","A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 48-week SAR448851 Treatment Followed by Open-label Extension in Participants With Early Alzheimer's Disease","TREMHANCE","Inclusion Criteria:\n\n* Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent.\n* Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association \\[NIA-AA\\] Stage 3) or mild AD dementia (NIA-AA Stage 4).\n* Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening.\n* Have a study partner who must provide separate written informed consent at screening. Study partner should be \\>18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant.\n* The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening.\n\nExclusion Criteria:\n\n* The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures).\n* The participant has evidence of more than 4 microhemorrhages (\\\u003C10 mm in diameter) or superficial siderosis.\n* The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4\u002F4).\n* The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy.\n* The participant is currently receiving anticoagulant therapies.\n* The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","55 Years","85 Years",{"count":209,"type":22},[26],"This is a randomized, placebo-controlled Phase 2 study to evaluate the efficacy and safety of SAR448851 in early Alzheimer's disease (AD) participants. The purpose of this study is to measure efficacy and safety with once daily oral SAR448851 compared to placebo in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.\n\nThis Phase 2 study has 2 parts: Part A is a randomized, double-blind, parallel-group, placebo-controlled study with SAR448851 oral once daily. Part B is an open-label extension. All participants who complete Part A may continue to Part B. An optional dose 2 cohort will be considered to evaluate the efficacy and safety of SAR448851 dose 2 oral once daily.\n\nThe study duration will be up to 111 weeks for Part A and B, and up to 63 weeks for the dose 2 cohort. The treatment duration will be up to 96 weeks for Part A and B, and up to 48 weeks for the dose 2 cohort.\n\nUp to 160 participants will be included in this study.",[309,310],"Dementia, Alzheimer's Type","Alzheimer's Disease",{"date":37,"type":35},{"date":313,"type":35},"2026-07-28",{"date":315,"type":22},"2029-07-31",{"name":41,"class":42},1,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":185,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":340},"100599713","a-study-to-investigate-efficacy-and-safety-of-teplizumab-compared-with-placebo-in-participants-1-to-25-years-of-age-with-stage-3-type-1-diabetes-100599713","NCT07088068","A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes","A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)","βETA PRESERVE","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n* Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent.\n* Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria\n* Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis\n* Participants must be positive for at least one T1D autoantibody at screening:\n* Glutamic acid decarboxylase (GAD-65),\n* Insulinoma Antigen-2 (IA-2),\n* Zinc-transporter 8 (ZnT8), or\n* Insulin (if obtained not later than 14 days after exogenous insulin therapy initiation).\n* Islet cell cytoplasmic autoantibodies (ICAs)\n* Have random C-peptide level ≥0.2 nmol\u002FL obtained at screening\n* Enter Inclusion Criteria Sex\n* Both male and female participants are eligible.\n* Contraceptive use by women 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, and one of the following conditions applies:\n* Is a woman of nonchildbearing potential (WONCBP) OR\n* Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of \\\u003C1% during the study intervention period (to be effective before starting the intervention) and for at least 30 days after the last administration of study intervention.\n* A WOCBP must have a negative highly sensitive pregnancy test at screening (serum) and within 24 hours (urine or serum as required by local regulations) before the first administration of study intervention.\n* Lactating woman must interrupt breastfeeding and pump and discard breast milk during and for 20 days after last administration of study intervention.\n* Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.\n\nNote: For minor participants, a specific ICF must also be signed by the participant's legally authorized representative (LAR).\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.\n* Participant has an active serious infection and\u002For fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.\n* At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).\n* At screening, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).\n* Participant has evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and\u002For TB testing. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n* Has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease (at discretion of Investigator).\n* Any clinically significant abnormality identified either in medical\u002Fsurgical history or during screening evaluation (eg, physical examination, laboratory tests, vital signs), or any adverse event (AE) during screening period which, in the judgment of the investigator, would preclude safe completion of the study or constrains efficacy assessment.\n* Participant has recent or planned vaccinations as follows:\n* Live-attenuated (live) vaccines (eg, varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) within the 8 weeks before first dose of the investigational medicinal product (IMP) or planned\u002Frequired administration during treatment or up to 26 weeks after last IMP administration in any treatment course\n* Inactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.\n* Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin\n* Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including but not limited to systemic corticosteroids (ie, oral, high doses of inhaled or injectable) with duration \\>14 days, adrenocorticotropic hormone, verapamil).\n* Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.\n* Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).\n* Participant has previously received teplizumab or other anti-CD3 treatment.\n* Other medications not compatible or interfering with IMP at discretion of Investigator.\n* Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 8 weeks or 5 half-lifes, whichever is longer, prior to screening.\n* Participant has any of the following laboratory parameters, at screening prior to first dose:\n* Lymphocyte count: \\\u003C1000\u002FµL,\n* Neutrophil count: \\\u003C1500\u002FµL (\\\u003C 1000 \u002FµL in participants with documented Duffy-null genotype),\n* Platelet count: \\\u003C150,000 platelets\u002FµL,\n* Hemoglobin: \\\u003C10 g\u002FdL,\n* Aspartate aminotransferase (AST) \\>2.0 × upper limit of normal (ULN),\n* Alanine aminotransferase (ALT) \\>2.0 × ULN,\n* Total bilirubin \\>1.5 × ULN with the exception of participants with the diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to hyperbilirubinemia\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","25 Years",{"count":328,"type":22},723,[56],"This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment.\n\nThe purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.",[332],"Type 1 Diabetes Mellitus","2026-08-06",{"date":37,"type":35},{"date":336,"type":35},"2025-08-06",{"date":338,"type":22},"2028-12-12",{"name":41,"class":42},162,{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":111},"100615299","this-study-is-a-non-interventional-disease-registry-of-adolescent-and-adult-patients-with-atopic-dermatitis-who-initiate-or-switch-any-systemic-treatment-100615299","NCT07290803","This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment","Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments","ARMADA-AD","Inclusion Criteria:\n\n* Patients aged more than or equal to (≥) 12 years at the time of consent.\n* Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.\n* Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)\n* Signed informed consent for registry participation by the patient or parent\u002Flegal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.\n\nExclusion Criteria:\n\n* Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.\n* Insufficient understanding of the study by the patient and\u002For parent\u002Fguardian.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":350,"type":22},1000,"The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.\n\nThe study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.",[264],"2026-08-05",{"date":333,"type":35},{"date":356,"type":35},"2025-11-17",{"date":358,"type":22},"2034-01-30",{"name":41,"class":42},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":379,"locationsCount":317},"100640630","rsv-immunisation-status-in-queensland-australia-100640630","NCT07615192","RSV Immunisation Status in Queensland (Australia)","Inclusion Criteria:\n\n* Be a parent of an infant born between 1 February 2024 and 15 April 2025\n* Be at least 18 years of age\n* Reside in Queensland, Australia\n* Read and agree to the Participant Information and Consent Form (PICF) before proceeding to the survey\n* Agree with Adverse Event (AE) reporting requirements before proceeding to the survey\n\nExclusion Criteria:\n\n\\- Have participated in any studies on infant respiratory diseases in the past 4 months\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.",{"count":367,"type":22},1200,"The primary objective of this study is to determine the nirsevimab immunisation rate in eligible infants (according to Queensland Paediatric Respiratory Syncytial Virus Prevention Program recommendation) in Queensland, Australia.\n\nThe study will focus on:\n\n1\\. Assessing the immunisation rates among eligible infants (born from 1 February 2024 to 15 April 2025) in their first Respiratory Syncytial Virus (RSV)-season in Queensland.\n\nSecondary objectives of this study are as follows:\n\n1. To analyse reasons of parents to decide for or against immunisation of their infant with nirsevimab.\n\n   1. This objective aims to assess potential influencing factors and evaluate the changes in acceptance across the three cohorts prior and post recommendation.\n   2. In this regard, demographic factors (e.g. education, income) will be included in the analysis where applicable to gain insights on their potential impact.\n2. To assess immunisation rates for further subgroups, e.g. by: a) risk group (defined chronic condition or pre-term birth status), b) regional areas of Queensland.\n3. To compare the vaccination coverage rate estimates with data captured via the Australian Immunisation Register.",[370],"RSV Immunization",[372],"nirsevimab; nirsevimab immunization rates","2026-07-30",{"date":375,"type":35},"2026-07-31",{"date":377,"type":35},"2026-05-29",{"date":62,"type":22},{"name":41,"class":42},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":17,"sex":18,"minAge":386,"maxAge":303,"enrollmentInfo":387,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":272},"100639164","post-marketing-surveillance-study-for-menquadfi-meningococcal-groups-a-c-y-w-polysaccharide-tetanus-toxoid-conjugate-vaccine-administered-in-participants-aged-6-weeks-to-55-years-in-republic-of-korea-100639164","NCT07621653","Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea","Inclusion Criteria:\n\n* Aged 6 weeks to 55 years on the day of MenQuadfi® vaccination\n* Evidence of a personally signed and dated informed consent document indicating that the participant or their parent(s)\u002Fother legally acceptable representative(s), if applicable, have been informed of all pertinent aspects of the study\n* Participants who have been vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion in the study according to the approved local product label\n\nExclusion Criteria:\n\n* Participating or planning participation in any other clinical studies investigating a vaccine, drug, medical device, or medical procedure at the time of the study enrolment (or in 4 weeks preceding the enrolment)\n* Having a previous history of enrollment in this study (participants who have already been enrolled once in this study are not eligible for re-enrollment)\n* Being applicable to contraindications in the approved local product label of MenQuadfi®; anyone with a known systemic hypersensitivity reaction to any component of this vaccine or after previous administration of the vaccine or a vaccine containing the same components\n\nNote: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","6 Weeks",{"count":388,"type":22},706,"This surveillance is to investigate the safety profile of MenQuadfi®, when administered to participants aged 6 weeks to 55 years under the real-world clinical practice settings as per approved indications, including the Adverse Drug Reactions (ADRs)\\*.\n\n\\*It includes ADRs that were not fully recognized in clinical practice, or unexpected ADRs which refer to those not listed in the approved drug labeling.",[391,29],"Meningococcal Immunization",{"date":393,"type":35},"2026-07-29",{"date":395,"type":35},"2026-07-01",{"date":397,"type":22},"2027-11-23",{"name":41,"class":42},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":407,"maxAge":408,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100591087","phase-3-the-efficacy-and-safety-of-rilzabrutinib-in-participants-aged-10-to-65-years-with-sickle-cell-disease-100591087","NCT06975865","The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease","A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Flexible-adaptive, Group Sequential Study to Evaluate the Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease","LIBRA","Inclusion Criteria:\n\n* Participants who have been diagnosed with SCD.\n* Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events.\n* Participants who are either not on hydroxyurea and\u002For L-glutamine at the Screening Visit and does not plan to receive them during the course of the study or has received HU and\u002For L-glutamine for a minimum of 6 months. Participants on hydroxyurea and\u002For L-glutamine must have been on a stable weight-based dose level (mg\u002Fkg) for at least 3 months prior to the Screening Visit, with the intent to continue at the same weight-based dose level for the duration of the study, except for safety reasons.\n* Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* For participants ≥10 to \\\u003C18 years of age: the parent(s)\u002Flegal guardian(s) must provide written informed consent prior to any study-related procedures being performed.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply: Participants with medical 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 with no evidence of metastatic disease for the past 3 years.\n* Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings.\n* Participants with history of stroke, or history of abnormal transcranial doppler.\n* Participants with uncontrolled or active HBV infection and\u002For HCV infection including those receiving antiviral therapy at the time of screening.\n* HIV infection.\n* A history of active or latent tuberculosis (TB)\n* Positive COVID-19 molecular test.\n* Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and\u002For voxelotor (OXBRYTA®) within 30 days prior to the Screening visit.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","10 Years","65 Years",{"count":410,"type":22},192,[56],"This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the efficacy, and safety of rilzabrutinib in participants with sickle-cell disease (SCD).\n\nStudy details include:\n\n* Study duration: a 52-week double-blind period (Part A), followed by an open-label LTE period (Part B). Double-blind period has two parts, 50% (adult only) until the interim analysis (a proof-concept part analogous to a phase 2b study), and 50% (adult and children) after the interim analysis. Only the participants who complete double-blind treatment period (Part A) are eligible to continue to the LTE period. The duration of the LTE period (Part B) will be from the first-participant-in (FPI)-LTE (Part B) until the last participant who enters the LTE has completed 52 weeks.\n* Treatment duration: 52-week double-blind period (Part A); LTE period (Part B) from the (FPI until the last participant who enters the LTE has completed 52 weeks.\n* Visit frequency: Week visits based on the Schedule of Assessments.",[414],"Sickle Cell Disease",{"date":393,"type":35},{"date":417,"type":35},"2025-08-12",{"date":419,"type":22},"2028-12-29",{"name":41,"class":42},53,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":441},"100538385","phase-3-a-study-to-test-the-efficacy-and-safety-of-riliprubart-against-the-usual-treatment-of-intravenous-immunoglobulin-ivig-in-people-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100538385","NCT06290141","A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy","VITALIZE","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)\u002FPeripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).\n* Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.\n* Participants must have responded to IVIg in the past 5 years.\n* Participant must be on a stable maintenance dosage of IVIg.\n* Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).\n* Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN\u002FPNS 2021 CIDP guidelines.\n* Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.\n* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening.\n* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention.\n* Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant\n* Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.\n* Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy.\n* Sensory CIDP, distal CIDP and focal CIDP variants.\n* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.\n* Poorly controlled diabetes\n* Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections).\n* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.\n* Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening).\n* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment.\n* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.\n* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.\n* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.\n* Recent treatment with plasma exchange\n* Treatment within 3 months prior to dosing with immunosuppressive\u002F immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive\u002F chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine).\n* Prior treatment with riliprubart.\n* Recent use of any specific complement system inhibitor (eg, eculizumab).\n* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.\n* Prior treatment with B-cell depleting agents such as rituximab within 6 months.\n* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).\n* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening.\n* Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.\n* Positive result of any of the following tests:\n\n  * hepatitis B surface antigen (HbsAg).\n  * anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \\[anti-HBs Ab\\] are also positive, indicating natural immunity).\n  * anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained.\n  * anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.\n* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.\n* Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n* Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.\n* Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.\n* Recent treatment with efgartigimod.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":209,"type":22},[56],"The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.",[434],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":393,"type":35},{"date":437,"type":35},"2024-08-21",{"date":439,"type":22},"2029-01-12",{"name":41,"class":42},129,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":17,"sex":18,"minAge":207,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":456,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100649303","phase-1-phase-12-study-of-respiratory-syncytial-virus-and-human-metapneumovirus-rsvhmpv-vaccine-candidate-in-adults-60-years-of-age-and-older-100649303","NCT07734649","Phase 1\u002F2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older","A Phase 1\u002F2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)","Inclusion Criteria:\n\n* Aged 60 years or older on the day of inclusion\n* Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)\n\nExclusion Criteria:\n\n* History of laboratory-confirmed RSV and\u002For laboratory-confirmed HMPV infection affecting the participant and\u002For the participant's household in the previous 12 months\n* Previous history of myocarditis, pericarditis, and\u002For myopericarditis\n* Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and\u002For myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n* Previous history of Guillain-Barré Syndrome\n* Any vaccine given 4 weeks before or 4 weeks after study intervention\n* Previous vaccination against RSV and\u002For HMPV with an investigational or marketed vaccine\n* Receipt of any mRNA vaccine\u002Fproduct in the 2 months preceding study intervention administration\n* Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months\n* Any screening laboratory parameter with laboratory abnormality \\> Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":450,"type":22},2400,[25,26],"This study is a Phase 1\u002F2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved\u002Flicensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.\n\nThe study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \\[6 dose levels\\], placebo and 4 control groups).\n\nThe duration of the study will be approximately 12 months for each participant.",[454,455,29],"Respiratory Syncytial Virus Immunization","Human Metapneumovirus Immunization",[457,458],"RSV","HMPV","2026-07-27",{"date":393,"type":35},{"date":462,"type":35},"2026-07-22",{"date":464,"type":22},"2028-05-03",{"name":41,"class":42},17,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":133},"100628893","the-impact-of-dupilumab-treatment-on-anxiety-and-depression-symptoms-in-patients-with-moderate-to-severe-atopic-dermatitis-100628893","NCT07467564","The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis","The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries","DERMIND-AD","Inclusion Criteria:\n\n* Participants who have moderate to severe AD with signs and symptoms of anxiety and\u002For depression.\n* Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation\n* Participants and\u002For their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.\n\nExclusion Criteria:\n\n* Females who are pregnant, lactating, or planning\u002Fintending to be pregnant in the next 6 months.\n* Participants who are participating in another trial.\n* Participants with active chronic or acute infection requiring systemic treatment.\n* Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.\n* Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.\n* Participants on antidepressants\u002Fanti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants\u002Fanti-anxiety. In addition, those who will use antidepressants\u002Fanti-anxiety medications throughout the study will be excluded from the analysis.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":476,"type":22},184,"This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.",[264],{"date":313,"type":35},{"date":481,"type":35},"2026-02-24",{"date":483,"type":22},"2027-05-24",{"name":41,"class":42},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":111},"100607564","phase-3-a-52-week-study-of-rilzabrutinib-efficacy-and-safety-compared-to-placebo-in-adults-diagnosed-with-igg4-related-disease-100607564","NCT07190196","A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease","A Randomized, Phase 3, Double-blind, 52-week Study to Evaluate the Efficacy and Safety of Rilzabrutinib (SAR444671) Compared to Placebo in Adult Participants With Active IgG4-related Disease","RILIEF","Inclusion Criteria:\n\n* Participants must have a clinical diagnosis of IgG4-RD confirmed by the Adjudication Committee.\n* Participants meeting Step 1 Entry criteria of 2019 ACR\u002FEULAR classification criteria for IgG4-RD and Total inclusion points are ≥20\n* Participants with active disease in at least 1 organ system, excluding lymph nodes, with active disease defined by an IgG4-RD Responder Index organ\u002Fsite activity score ≥2 based on the manifestations of disease activity in the last 28 days.\n* Participants with history or current involvement of at least 1 organ\u002Fsite (excluding lymph nodes) affected with IgG4-RD.\n* Participants with active IgG4-RD controlled for at least 2 weeks while on a stable dose of GC.\n* Participants willing to taper off GC after starting IMP.\n* Participants willing and able to participate in repeated study protocol mandated or clinically indicated imaging procedures to assess IgG4-RD such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), or ultrasound.\n* Participants who have an up-to-date vaccination status as per local guidelines. The last dose of live vaccines should be received at least 30 days before Day 1.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Meet any Step 2 Exclusion criteria from the 2019 ACR\u002FEULAR classification criteria for IgG4-RD.\n* History of retroperitoneal fibrosis, sclerosing mesenteritis, fibrosing mediastinitis, or other overwhelmingly fibrotic expression of IgG4-RD that is the sole disease manifestation.\n* Active malignancy or history of malignancy within 5 years before Day 1, except completely treated in situ carcinoma of the cervix, completely treated, and resolved nonmetastatic squamous or basal cell carcinoma of the skin.\n* Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.\n* History of serious infections with the potential for recurrence (as judged by the Investigator), with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate to severe infection at Screening (Grade 2 or higher).\n* Current or chronic history of liver disease unrelated to IgG4-RD.\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, bariatric surgery, or significant bowel resection that would preclude adequate rilzabrutinib\u002Fplacebo absorption.\n* History of solid organ transplant.\n* Planned major surgical procedure during the participation in this study.\n* History of drug abuse within the previous 12 months.\n* Alcoholism or excessive alcohol use, defined as regular consumption of more than approximately 3 standard drinks per day.\n* Prior participation in any rilzabrutinib studies or other BTK inhibitor studies.\n* History of treatment with an investigational drug within 6 months or 5 half-lives of the investigational drug, whichever is longer.\n* Laboratory abnormalities at the screening visit identified by the central laboratory The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":494,"type":22},124,[56],"This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD.\n\nThe purpose of this study is to measure time to adjudicated IgG4-RD clinical disease flare, and other relevant efficacy endpoints including flare-free rate, control of IgG4-RD disease activity, use of GC rescue and safety parameters such as treatment-emergent adverse events, clinical laboratory values and electrocardiograms (ECG) in participants aged 18 years and above, diagnosed with IgG4-RD and treated with rilzabrutinib tablets over a 52-week placebo-controlled period.\n\nStudy details include:\n\nThe study duration will be up to 60 weeks, including a Screening period of 4 to 6 weeks, a 52-week double blind treatment period, and 2 weeks of follow up (plus an optional OLE of 108 weeks).\n\nThe number of visits will be 16 (plus an optional 9 visits during the OLE).",[498],"Immunoglobulin G4 Related Disease",{"date":313,"type":35},{"date":501,"type":35},"2025-09-26",{"date":503,"type":22},"2030-12-25",{"name":41,"class":42},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":317},"100590558","real-world-study-of-treatment-outcomes-in-chronic-inflammatory-demyelinating-polyneuropathypolyradiculoneuropathy-cidp-100590558","NCT06968975","Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy\u002FPolyradiculoneuropathy (CIDP)","Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy\u002FPolyradiculoneuropathy (CIDP)","ORBIT-CIDP","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Neurologist-confirmed diagnosis of CIDP found in the medical record, with the last neurologist visit prior to enrollment containing no information that suggests this diagnosis was reversed\n* Active use of at least one of the following CIDP treatments for three months or longer, with no evidence of discontinuation of this therapy as of the last neurologist visit prior to enrollment\n\n  * immunoglobulin\n  * corticosteroids, with the exception of prednisone (or equivalent) monotherapy at 10mg or less per day\n  * plasma exchange\n  * efgartigimod alfa\n  * azathioprine\n  * mycophenolate mofetil\n  * cyclosporine\n  * rituximab\n  * methotrexate\n* Signed informed consent\n* Residual impairment, disability, or neurological deficits at enrollment, as defined by a raw I-RODS score of 44 or below\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Evidence of participation in any interventional clinical trial with an investigational drug at the time of enrollment\n* Hyperreflexia (increased reflexes) recorded in the medical record during a neurological exam the year before enrollment and after CIDP diagnosis\n* Aged under 18 at the time of enrollment\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":514,"type":22},200,"This study is an observational, ambispective, descriptive, non-interventional study of people with a chronic inflammatory demyelinating polyneuropathy\u002Fpolyradiculoneuropathy (CIDP) diagnosis in the United States with residual impairment, disability, or neurological deficits after at least three months of treatment with standard of care therapy. The study is expected to last two years. Enrollment is expected to continue for one year. Depending on when the participant is enrolled, a participant can be followed for between one and two years, through the end of study, approximately two years after the study starts.",[517],"Polyneuropathy, Inflammatory Demyelinating, Chronic","2026-07-23",{"date":520,"type":35},"2026-07-24",{"date":522,"type":35},"2025-04-11",{"date":524,"type":22},"2027-05-17",{"name":41,"class":42},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":17,"sex":184,"minAge":19,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":542,"leadSponsor":544,"locationsCount":4},"100648810","phase-1-study-to-compare-the-plasma-concentration-of-belumosudil-given-as-an-oral-suspension-and-as-a-tablet-to-healthy-adult-male-participants-100648810","NCT07726914","Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants","An Open-label, Randomized, Phase 1, 2-treatment, 2-period, 2-sequence, Cross-over, Bioequivalence Study Comparing Belumosudil Oral Suspension (Test Formulation) With Belumosudil Tablet (Commercially Available Reference Formulation) in Healthy Adult Male Participants Under Fed Condition","Inclusion Criteria:\n\n* Healthy male participant between 18 to 45 years of age, inclusive\n* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n* Body weight between 50.0 and 115.0 kg, inclusive, and BMI between 18.0 and 32.0 kg\u002Fm2, inclusive\n* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* Capable of giving signed informed consent\n\nExclusion Criteria, participants are excluded from the study if any of the following criteria apply:\n\n* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness\n* Frequent headaches and\u002For migraine, recurrent nausea and\u002For vomiting (for vomiting only: more than twice a month).\n* Blood donation (usually approximately 500 mL) within 2 months before inclusion\n* Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP ≥30 mmHg within 3 minutes when changing from supine to standing position\n* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the IMP formulation or allergic disease diagnosed and treated by a physician\n* History or current presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). Medically prescribed cannabis is not allowed\n* Smoking regularly more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking (occasional smoker can be enrolled)\n* Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)\n* Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicaemia) within the 3 months or 90 days prior to screening\n* Known or suspected malignancy, autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status or any factor that would predispose participants to develop infection (eg, open skin lesion, recurrent issue related to poor dentition, perianal fissures, history of splenectomy, primary immunodeficiency)\n* Any medication (including proton pump inhibitors, CYP3A inducers or strong and moderate CYP3A inhibitors, St John's Wort, or ginseng) within 14 days before study treatment administration or 5 half-lives, whichever is longer\n* Use of any herbal medicines within 2 weeks before each IMP administration and up to the end of PK sampling following the IMP administration\n* Any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion\n* Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 90 days or 5 half-lives whichever is longer, before inclusion in this clinical study\n* Positive result on any of the following tests: HBs Ag, anti-HBc Ab (total or IgM), anti-HCV antibodies, anti-HIV 1 and 2 antibodies\n* Confirmed positive result on urine drug screen (amphetamines\u002Fmethamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates)\n* Confirmed positive alcohol breath test\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","45 Years",{"count":535,"type":22},58,[25],"The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants aged 18 to 45 years, inclusive.\n\nStudy details include:\n\nThe study duration will be approximately 40 days. The treatment period will be up to 8 days. At least 3 days post-treatment follow-up period. end of study: 6±1 days from the last dose. The number of visits will be 3.",[168],"2026-07-21",{"date":520,"type":35},{"date":333,"type":22},{"date":543,"type":22},"2026-09-28",{"name":41,"class":42},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":562,"leadSponsor":564,"locationsCount":317},"100646326","phase-2-a-dose-optimizationexpansion-study-of-sar445877-in-adult-chinese-participants-with-advanced-gastric-or-gastroesophageal-junction-cancer-100646326","NCT07692204","A Dose Optimization\u002FExpansion Study of SAR445877 in Adult Chinese Participants With Advanced Gastric or Gastroesophageal Junction Cancer","A Phase 2, Open-label, Dose Optimization\u002FExpansion Study of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Gastric or Gastroesophageal Junction Cancer","Inclusion Criteria:\n\nAge\n\n\\- Participant must be at least 18 years of age inclusive (or country's legal age of majority if \\>18 years), at the time of signing the informed consent.\n\nCancer diagnosis:\n\n* Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 \\& 3 GEJ.\n* Participants with unknown HER2\u002Fneu status must have their HER2\u002Fneu status determined locally. Participants with HER2\u002Fneu negative are eligible. Participants with HER2\u002Fneu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible.\n\nPrior anticancer therapy:\n\n\\- Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1\u002FPD-L1-based treatment or anti-Claudin 18.2 based treatment depending on local standard of care.\n\nMeasurable Disease:\n\n\\- At least 1 measurable lesion per RECIST 1.1 criteria.\n\nExclusion Criteria:\n\nMedical conditions\n\n* Eastern Cooperative Oncology Group(ECOG)performance status of ≥2.\n* Predicted life expectancy ≤3 months.\n* Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment.\n* Active brain metastases or leptomeningeal metastases.\n* Known microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumor.\n* History of treatment-related immune-mediated (or immune-related) AEs from immune- modulatory agents (including but not limited to anti-PD1\u002FPD-L1 agents and anti cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity, or have not resolved to Grade ≤1.\n* Has any condition requiring ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine.\n* Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration.\n* Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related AEs (irAEs).\n* Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.\n* Organ transplant requiring immunosuppressive treatment.\n* Uncontrolled or active infection with human immunodeficiency virus (HIV ), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency.\n\nNote: Other Inclusion\u002FExclusion criteria may apply. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":198,"type":22},[26],"This is a Phase 2, open-label, dose optimization\u002Fexpansion study to assess the preliminary efficacy and safety of SAR445877 as a monotherapy for Chinese participants aged at least 18 years with advanced Gastric Cancer(GC)\u002FGastroesophageal Junction cancer (GEJ). Participants with advanced GC\u002FGEJ who relapsed to at least 1 prior regimen which may or may not include an anti-PD1\u002FPD-L1-based treatment depending on local standard of care, regardless combined positivity score (CPS) will be randomized in this study.\n\nIn this study, SAR445877 will be assessed as a monotherapy in approximately 30 participants with advanced unresectable or metastatic GC or Siewert Type 2 and 3 GEJ, and for whom receiving the standard of care (SOC) is not in his or her best interest, or where no SOC is established. Human epidermal growth factor receptor 2 (HER2) positive cases will not be eligible unless they have progressed on a HER2 targeted therapy. Those participants should have received at least 1 prior line of anti-cancer treatment which may or may not include an anti-PD1\u002FPD-L1-based treatment depending on local standard of care. Metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases are not eligible.",[556,557],"Gastric Cancer","Oesophageal Carcinoma","2026-07-16",{"date":560,"type":35},"2026-07-20",{"date":395,"type":35},{"date":563,"type":22},"2028-08-02",{"name":41,"class":42},""]