[{"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:":563},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,42,66,90,120,140,160,183,205,228,249,273,293,312,326,348,368,391,411,432,454,474,497,517,538],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053627","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-100053627",false,"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.","ALL","18 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28],"Chronic Inflammatory Demyelinating Polyneuropathy","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2024-08-21",{"date":37,"type":22},"2029-01-12",{"name":39,"class":40},"Sanofi","INDUSTRY",129,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100053976","phase-1-a-safety-and-efficacy-study-of-one-time-sar402663-in-adults-with-neovascular-age-related-macular-degeneration-100053976","NCT06660667","A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration","A Phase 1\u002F2 Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR402663 in Participants With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Between 50 and 90 years of age\n* Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)\n* Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20\u002F32 and 20\u002F400 and for expansion (Part II) between 20\u002F25 and 20\u002F200\n* Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye\n* Demonstrated a response to anti-VEGF treatment\n\nExclusion Criteria:\n\n* Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments\n* History of active ocular infection in the study eye in 6 months prior to screening\n* Active uncontrolled glaucoma in the study eye\n* History of uveitis in either eye\n* Current use of ocular corticosteroids in the study eye\n* Previous gene therapy\n* Any significant poorly controlled illness that would preclude study compliance and follow up\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","50 Years","90 Years",{"count":52,"type":22},66,[54,55],"PHASE1","PHASE2","This is a Phase 1\u002FPhase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration.\n\nParticipants will be enrolled in one of 2 parts:\n\n* In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants\n* In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants, investigators and outcomes assessors will be masked to dose.\n\nAfter receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5.",[58],"Neovascular Age-related Macular Degeneration",{"date":32,"type":33},{"date":61,"type":33},"2024-11-21",{"date":63,"type":22},"2031-06-30",{"name":39,"class":40},18,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":18,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100534614","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-subcutaneous-amlitelimab-on-background-topical-corticosteroids-therapy-in-participants-aged-12-years-and-older-with-moderate-to-severe-ad-who-have-had-an-inadequate-response-to-prior-biologic-therapy-or-an-oral-jak-inhibitor-100534614","NCT06241118","A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor","A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment","AQUA","Inclusion Criteria:\n\n* Participants must be 12 years of age (when signing informed consent form)\n* Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)\n* Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.\n* v-IGA-AD of 3 or 4 at baseline visit\n* EASI score of 16 or higher at baseline\n* AD involvement of 10% or more of BSA at baseline\n* Weekly average of daily PP-NRS of ≥ 4 at baseline visit.\n* Able and willing to comply with requested study visits and procedures\n* Body weight ≥25 kg\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Skin co-morbidity that would adversely affect the ability to undertake AD assessments\n* Known history of or suspected significant current immunosuppression\n* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \\>5 years prior to baseline)\n* History of solid organ or stem cell transplant\n* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline\n* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit\n* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB\n* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit\n* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening\n* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial","12 Years",{"count":76,"type":22},636,[25],"This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.\n\nThe purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.\n\nStudy details include:\n\nAt the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).\n\nThe study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \\[RIVER-AD\\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.\n\nThe study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \\[RIVER-AD\\]) including a 2 to 4-week screening and a 36-week randomized double-blind period.\n\nThe total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \\[RIVER-AD\\] study).",[80],"Dermatitis Atopic","2026-07-01",{"date":83,"type":33},"2026-07-02",{"date":85,"type":33},"2024-02-29",{"date":87,"type":22},"2028-09-29",{"name":39,"class":40},150,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":18,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":100,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100640105","the-study-of-chronic-obstructive-pulmonary-disease-copd-participants-treated-with-dupilumab-stride-registry-100640105","NCT07612878","The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry","STRIDE","Inclusion Criteria:\n\n* COPD patients who are newly referred to start dupilumab treatment\n* Age ≥ 40 years\n* Standard of care spirometry performed concurrently with the baseline visit or within 90 days prior to the baseline visit\n\nExclusion Criteria:\n\n* Patients who have contraindication to dupilumab according to the United States Prescribing Information (USPI)\n* Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments\n* Patients currently participating in any interventional clinical trial The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial","40 Years",{"count":99,"type":22},350,"24 Months","OBSERVATIONAL","The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD. Secondary objectives are to determine whether treatment with dupilumab reduces moderate and\u002For severe COPD exacerbations; to determine the impact of treatment on lung function in COPD participants; to determine whether treatment with dupilumab improves the quality of life in COPD participants; and to describe safety of dupilumab among COPD participants. The external control cohort will include participants with COPD from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. In addition, chest images will be collected and banked for future research projects and consented participants will perform home spirometry.",[104],"COPD (Chronic Obstructive Pulmonary Disease)",[106,107,108,109,110,111],"COPD","Dupilumab","Dupixent","Chronic Obstructive Pulmonary Disease","Exacerbation","Home Spirometry","NOT_YET_RECRUITING","2026-06-30",{"date":83,"type":33},{"date":116,"type":22},"2026-07-31",{"date":118,"type":22},"2029-11-30",{"name":39,"class":40},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":52},"100610283","phase-2-a-study-to-investigate-efficacy-and-safety-with-sar445399-in-adult-participants-with-moderate-to-severe-hidradenitis-suppurativa-100610283","NCT07225569","A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa","A Randomized, Double-blind, Placebo-controlled, Phase 2, Dose-finding Study to Investigate the Efficacy and Safety of SAR445399 in Participants With Moderate to Severe Hidradenitis Suppurativa","CLAROS","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participants with a history of signs and symptoms consistent with 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 inguino-crural fold), with at least 1 body site being Hurley Stage II or III.\n* Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.\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 or 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 in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.\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 or suspected current immunosuppression\n* History of solid organ transplant or stem cell transplant.\n* History of splenectomy\n* 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* Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":129,"type":22},144,[55],"This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa.\n\nThe purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa.\n\nThe study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.",[133],"Hidradenitis Suppurativa",{"date":81,"type":33},{"date":136,"type":33},"2025-12-29",{"date":138,"type":22},"2027-12-01",{"name":39,"class":40},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":18,"minAge":147,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":65},"100609488","phase-1-a-safety-and-efficacy-study-of-a-one-time-intravitreal-injection-of-sar446597-in-participants-with-geographic-atrophy-secondary-to-age-related-macular-degeneration-100609488","NCT07215234","A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","A Phase 1\u002F2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","Inclusion Criteria:\n\n* 60 years old or above\n* Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)\n* Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20\u002F40 and 20\u002F320 and for expansion (Part II) equal or better than 20\u002F200\n* Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II\n\nExclusion Criteria:\n\n* GA in the study eye caused by a disease different than AMD\n* Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye\n* Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments\n* Current or history of systemic complement targeting treatment in the past 12 months\n* Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye\n* History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye\n* History of active ocular infection in the study eye in 6 months prior to screening\n* Presence of active ocular or periocular infections\n* Active uncontrolled glaucoma in the study eye\n* History of uveitis or scleritis in either eye\n* Previous gene therapy in either eye\n* Any significant poorly controlled illness that would preclude study compliance and follow up\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":149,"type":22},104,[54,55],"This is a sequential Phase 1\u002F2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).\n\nThe core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase.\n\nThe treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).",[153],"Geographic Atrophy",{"date":81,"type":33},{"date":156,"type":33},"2025-10-09",{"date":158,"type":22},"2032-07-22",{"name":39,"class":40},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":18,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"100607159","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-crohns-disease-100607159","NCT07184931","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","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 Crohn's Disease","STARSCAPE-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 Crohn's Disease (CD) 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 (ATs)\n\nExclusion Criteria:\n\n* Participants with Ulcerative Colitis (UC) or indeterminate colitis\n* Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapy prior to baseline\n* Participants receiving prohibited medications or therapies\n* Participants with previous exposure to anti-TL1A investigational therapy\n\nThe 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":171,"type":22},980,[25],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* Up to 5-week 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* 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.\n\nThe number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.",[175],"Crohn's Disease",{"date":81,"type":33},{"date":178,"type":33},"2025-10-01",{"date":180,"type":22},"2029-05-14",{"name":39,"class":40},301,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"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 an adjudicated clinical diagnosis of IgG4-RD\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 at screening in at least one organ system, excluding lymph nodes, as an IgG4-RD Responder Index total activity score ≥ 2\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":192,"type":22},124,[25],"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 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 4 to 6-week screening period, 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).",[196],"Immunoglobulin G4 Related Disease","2026-06-29",{"date":81,"type":33},{"date":200,"type":33},"2025-09-26",{"date":202,"type":22},"2030-12-25",{"name":39,"class":40},79,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":18,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100576899","phase-2-efficacy-and-safety-of-teplizumab-in-japanese-participants-with-stage-2-type-1-diabetes-100576899","NCT06791291","Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes","Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 1 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.","KIBOU-T1D","Inclusion Criteria:\n\n* Male or female Japanese participant, 1 (inclusive) to 34 years (inclusive) of age, at the time of signing the informed consent. Japanese: born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.\n* Confirmed diagnosis of Stage 2 T1D based on following criteria:\n* Participant is positive for 2 or more T1D related auto-antibodies (confirmed by written medical history and\u002For obtained at study screening). The autoantibodies that are to be confirmed are anti-GAD (glutamic acid decarboxylase), anti-IA2 (insulinoma-associated antigen 2), anti-insulin, anti-ZnT8 (zinc transporter 8), and\u002For ICA (islet cell antibody).\n* Oral glucose tolerance test (OGTT) or blood HbA1c confirms the participant has dysglycemia without overt hyperglycemia.\n* Participant must be in good health (except for being Stage 2 T1D) as determined by medical e)valuation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) XE \" ECG \" \\\\f Abbreviation \\\\t \"electrocardiogram\" .\n* Participant is up to date with routine age-appropriate immunizations according to current local specific guideline prior to randomization.\n* Female participants should use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A female participant is considered fertile (woman of childbearing potential - WOCBP) from the time of menarche until becoming postmenopausal unless permanently sterile. Female participants are eligible to participate if one of the following conditions applies:\n* Is a woman of nonchildbearing potential (WONCBP) OR\n* Is a WOCBP and agrees to keep abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or use other highly effective contraceptive method, from signing of the informed consent to at least 3 months and 2 weeks after randomization and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.\n\nA WOCBP must have at least a negative highly sensitive pregnancy test within 48 hours before the administration of study intervention.\n\nIf a urine test cannot be confirmed as negative (eg, an ambiguous result), a blood pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Any presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic (except Stage 2 T1D), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.\n* Participant has clinical signs and symptoms consistent with COVID19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening. Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).\n* For participant ≥18 years, blood donation of 400 mL within 12 weeks (male) or 16 weeks (female), 200 mL within 4 weeks or apheresis donation within 2 weeks before randomization; for participant \\\u003C18 years, blood donation of any volume within 16 weeks before randomization; for any participant, blood transfusion (any volume) within 2 months before randomization.\n* Presence or history of drug hypersensitivity to any biologic medication, or clinically significant allergic disease as diagnosed and treated by a physician. Participants with known hypersensitivity to teplizumab or components of the teplizumab injection (including sodium phosphate, sodium chloride, polysorbate 80).\n* Participants with a history of active or latent or inactive tuberculosis (TB), including chest X-ray consistent with TB, regardless of treatment, or have a positive QuantiFERON-TB Gold test or T-SPOT TB test at screening.\n* At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein Barr virus (EBV), or history of infectious mononucleosis within 3 months before enrollment.\n* At screening, participant has laboratory or clinical evidence of acute or clinically active infection with cytomegalovirus (CMV).\n* Participants with a history of invasive opportunistic infections, such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis, irrespective of resolution.\n* Participants have other autoimmune diseases, except clinically stable autoimmune thyroid disease, or celiac disease.\n* Participants with a history of malignancy occurring within 5 years before randomization (except successfully treated carcinoma in situ of the cervix, or adequately treated nonmetastatic squamous cell or basal cell carcinoma of the skin).\n* Participants with fever (temperature ≥38.0°C) within 48 hours before randomization; or with chronic persistent or recurring infection(s) requiring active treatment with antibiotics, antiviral or antifungals within 4 weeks before randomization; or with other frequent recurrent infections deemed unacceptable as per Investigator's judgement.\n* If female, pregnancy (defined as positive blood or urine pregnancy test) or breast-feeding.\n* Participant has recent or planned vaccinations as follows:\n* Live vaccines: within 8 weeks before randomization, and\u002For within 54 weeks after randomization.\n* Non-live vaccines: any initial non-live vaccination within 2 weeks before randomization, and\u002For within 8 weeks after randomization.\n* Participant has a current or prior (within 30 days before randomization) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including high dose, inhaled, extensive topical, or systemic glucocorticoids.\n* Participant has a current or prior (within 30 days before randomization) treatment that is known to significantly influence glucose tolerance (anti-hyperglycemic agents, atypical antipsychotics, diphenylhydantoin, niacin etc.).\n* Participant has received any anti-CD3 (cluster of differentiation 3) antibody treatment (including teplizumab) before randomization.\n* Participant who has received any biologic therapy within five half-lives of the therapy or within 6 months before randomization whichever is longer, or plan to receive any biologic therapy within 6 weeks after randomization.\n* Any participant enrolled or having participated, in this or any other clinical study involving an investigational medicinal product (IMP) or in any other type of medical research and is still in the exclusion period according to applicable regulations (eg, having received an IMP of new active pharmaceutical ingredient (API) within 4 months or that of an approved API within 3 months before the administration of this study's IMP).\n* Participant has any of the following hematologic parameters before randomization:\n* Lymphocyte count \\\u003C1.0 ×109\u002FL.\n* Neutrophil count \\\u003C1.5 ×109\u002FL.\n* Platelet count \\\u003C150 ×109\u002FL.\n* Hemoglobin \\\u003C100 g\u002FL.\n* Participant has any of the following liver function test abnormalities before randomization:\n* AST \\>2 × ULN (upper limit normal).\n* ALT \\>2 × 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* Positive result on any of the following tests:\n* Hepatitis B surface antigen or hepatitis B core antibody confirmed by positive HBV-DNA (hepatitis B virus DNA).\n* Anti-hepatitis C virus antibody confirmed by positive HCV-RNA (hepatitis C virus RNA).\n* Human immunodeficiency virus antigen\u002F antibodies.\n* Positive SARS-CoV-2 test.\n* Participant who has contraindications or known allergy to both nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, or anti-histamines and in the opinion of the Investigator, cannot participate in the study.\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 participant's potential participation in a clinical trial.","1 Year","34 Years",{"count":216,"type":22},10,[55],"This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment.\n\nTeplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA.\n\nGiven prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 1 to 34 years.",[220],"Type 1 Diabetes Mellitus",{"date":81,"type":33},{"date":223,"type":33},"2025-07-25",{"date":225,"type":22},"2028-03-06",{"name":39,"class":40},11,{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":204},"100522393","phase-3-a-study-to-test-how-effective-belumosudil-tablets-are-for-treating-adult-participants-with-chronic-lung-allograft-dysfunction-100522393","NCT06082037","A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction","A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study, Followed by Open-label Extensions, to Evaluate the Efficacy of Oral Belumosudil in Adult Participants With Chronic Lung Allograft Dysfunction (CLAD) Following Bilateral Lung Transplantation","ROCKaspire","Inclusion Criteria:\n\n* Participant ≥1 year post bilateral lung transplantation at the time of screening\n* Participants presenting with CLAD Stage 1 or 2: FEV1 from \\>50% to 80% of post-transplant baseline at screening and at randomization\n* Participants who have received at least 8 weeks of azithromycin (≥250 mg\u002Fday, at least 3 times a week) prior to randomization\n\nExclusion Criteria:\n\n* FEV1 ≤50% of the post-transplant baseline value (CLAD 3 and 4)\n* Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (\\>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":237,"type":22},180,[25],"This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy.\n\nStudy details include:\n\nThe study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE.\n\nThe treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE.\n\nThe number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE.\n\nFor participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.",[241],"Lung Transplant Rejection","2026-06-25",{"date":197,"type":33},{"date":245,"type":33},"2023-10-10",{"date":247,"type":22},"2030-10-01",{"name":39,"class":40},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":257,"minAge":213,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},"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","11 Years",{"count":260,"type":22},85,[25],"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.",[264],"Hemophilia","2026-06-24",{"date":242,"type":33},{"date":268,"type":33},"2025-12-18",{"date":270,"type":22},"2031-12-30",{"name":39,"class":40},30,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":74,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},"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":282,"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.",[285],"Atopic Dermatitis",{"date":242,"type":33},{"date":288,"type":33},"2025-11-17",{"date":290,"type":22},"2034-01-30",{"name":39,"class":40},59,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":18,"minAge":74,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},"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 Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score \u003C 16) Respond to Dupilumab Treatment","A Prospective Observational Study of Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score \u003C 16) Receiving Dupilumab","AD-BEASCUITS","Inclusion Criteria:\n\n* Male or female, aged between 12 and 17 years at the baseline visit\n* Patients with AD who have been prescribed dupilumab according to Agenzia Italiana del Farmaco (AIFA) reimbursement criteria and fulfilling the following criteria:\n\nPatients with EASI\\\u003C16 and\n\n1. Children's Dermatology Life Quality Index (CDLQI) ≥ 10 or\n2. Peak Pruritus Numerical Rating Scale (PP-NRS) ≥ 7 or\n3. localization in visible or sensitive areas (head\u002Fneck\u002Fhands or genitals)\n\n   * Patients able to understand and complete study-related questionnaires\n   * Provided signed informed consent or parental\u002Flegally acceptable representative consent and patient assent where applicable\n\nExclusion Criteria:\n\n* Prior use of dupilumab within 6 months prior the study entry\n* Patients currently participating in any interventional clinical trial which modifies patient care\n* Any condition that, in the opinion of the Investigator, may interfere with patient'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.","17 Years",{"count":89,"type":22},"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 participants with moderate to mild EASI score and severe itching and\u002For localized AD are therefore necessary to better understand the potential clinical benefits of dupilumab in these populations.\n\nThis is an Italian multicenter, 52-week observational (non-interventional) study which will collect data on the characteristics of adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score less than (\\\u003C) 16, eligible for systemic dupilumab treatment according to Italian reimbursement criteria. It will study the real-world effectiveness and safety of dupilumab in this population, the effect of dupilumab on itching (pruritus), sleep, quality of life and related outcomes, localized AD in sensitive\u002Fvisible areas, and on coexisting atopic conditions in adolescent participants who receive dupilumab for AD. It will also document dupilumab treatment satisfaction and dupilumab discontinuation in the study participants.",[80],{"date":197,"type":33},{"date":307,"type":33},"2023-11-30",{"date":309,"type":22},"2028-03-31",{"name":39,"class":40},9,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":18,"minAge":74,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":318,"phases":4,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":322,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":325,"locationsCount":4},"100645035","managed-access-program-of-venglustat-in-pediatric-and-adult-patients-with-type-3-gaucher-disease-gd3-100645035","NCT07675031","Managed Access Program of Venglustat in Pediatric and Adult Patients With Type 3 Gaucher Disease (GD3).","Inclusion criteria:\n\n* ≥ 12 years of age\n* Clinical diagnosis of GD3 with at least 1 CNS manifestation\n* Body weight ≥15 kg\n* On a stable ERT dose for at least 6 months\n* Clinically stable with respect to hematologic manifestations\n* Clinically stable with respect to spleen and liver volume\n* If the patient has a history of seizures, they must be well controlled without use of medications that are strong\u002Fmoderate inducers or strong\u002Fmoderate inhibitors of CYP3A\n* Documented negative pregnancy test\n* Contraceptive use consistent with local regulations.\n\nExclusion criteria:\n\n* Inability to safely swallow (or chew and swallow) a venglustat tablet\n* Use of any investigational drugs within the last 30 days or 5 half-lives or gene therapy at any time\n* Current use of any unapproved therapy for GD\n* Pregnant or breastfeeding females\n* Drug contraindications\n* History of major organ transplant (eg, bone marrow or liver)\n* History of drug and\u002For alcohol abuse within the last year\n* Patients with severe depression and\u002For a history of a major affective disorder in the past year\n* Patients with suicidal ideation or behavior prior to study.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","EXPANDED_ACCESS","The objective of this program is to provide early access to venglustat for certain patients with Gaucher disease type 3 in response to unsolicited requests from healthcare providers. No approved therapies for the CNS manifestations of the disease are currently available. The program will provide access to venglustat prior to registration and the availability of commercial product (including reimbursement where applicable) in the country of the patient.",[321],"Type 3 Gaucher Disease","AVAILABLE","2026-06-22",{"date":113,"type":33},{"name":39,"class":40},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":332,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"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.",true,{"count":334,"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.",[337],"RSV Immunization",[339],"nirsevimab; nirsevimab immunization rates",{"date":341,"type":33},"2026-06-23",{"date":343,"type":33},"2026-05-29",{"date":345,"type":22},"2026-07-20",{"name":39,"class":40},1,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":147,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":367},"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.",{"count":21,"type":22},[25],"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 or 11 for participants receiving frexalimab SC or IV, respectively, 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.",[360],"Multiple Sclerosis",{"date":341,"type":33},{"date":363,"type":33},"2026-01-14",{"date":365,"type":22},"2028-11-30",{"name":39,"class":40},34,{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":18,"minAge":376,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":390},"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":379,"type":22},192,[25],"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.",[383],"Sickle Cell Disease",{"date":341,"type":33},{"date":386,"type":33},"2025-08-12",{"date":388,"type":22},"2028-12-29",{"name":39,"class":40},53,{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":332,"sex":18,"minAge":19,"maxAge":147,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":347},"100642064","phase-1-pharmacokinetics-and-tolerability-of-subcutaneous-dupilumab-coformulated-with-berahyaluronidase-alfa-and-dupilumab-without-berahyaluronidase-alfa-in-healthy-participants-100642064","NCT07646548","Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants","Phase 1, Single Center, Open-label, Randomized, Parallel-group Study to Evaluate Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants","Inclusion Criteria:\n\n* Male and\u002For female participant, between 18 and 60 years of age, inclusive, at the time of signing the informed consent.\n* Determined to be healthy by the Investigator using a comprehensive clinical assessment (detailed medical history and complete physical examination).\n* Body weight between 50.0 and 100.0 kg, inclusive.\n* BMI between 18.0 and 32.0 kg\u002Fm2 (inclusive).\n\nExclusion Criteria:\n\n* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), 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, any volume, 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 of ≥30 mmHg within 3 minutes when changing from supine to standing position.\n* Presence or history of drug hypersensitivity, or clinically significant allergic disease as diagnosed and treated by a physician. Participants with known hypersensitivity to any of the study interventions, or components thereof.\n* History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).\n* Regular smoking of more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking during the study (occasional smoker can be enrolled).\n* Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).\n* If female, pregnancy (defined as positive urine pregnancy test); breast-feeding.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":399,"type":22},40,[54],"This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa.\n\nThe purpose of this study is to assess the pharmacokinetic (PK) characteristics of a single SC dose of dupilumab coformulated with berahyaluronidase alfa and dupilumab without berahyaluronidase alfa in healthy participants aged ≥18 and ≤60 years.\n\nStudy details include:\n\n* The study duration will be approximately up to 12 to 15 weeks.\n* The treatment will be administered as a single dose on Day 1.\n* The number of visits will be 14.",[403],"Healthy Volunteers","2026-06-19",{"date":265,"type":33},{"date":407,"type":33},"2026-06-11",{"date":409,"type":22},"2026-09-30",{"name":39,"class":40},{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":23,"phases":420,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100614947","phase-4-sarilumab-efficacy-and-safety-in-adults-with-early-polymyalgia-rheumatica-100614947","NCT07286214","Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica","A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica","Inclusion Criteria:\n\n* Adults ≥50 years with polymyalgia rheumatica according to the EULAR\u002FACR classification criteria\n* Meet criteria for newly diagnosed PMR (received ≤6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg\u002Fday for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving ≥5 mg\u002Fd prednisone)\n* Participants must be willing and able to take prednisone of 15 mg\u002Fday at randomization\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* Diagnosis of Giant Cell Arteritis (GCA)\n* Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia\n* Inadequately treated hypothyroidism\n* Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster\n* Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)\n* Immunosuppressive therapies including systemic corticosteroids\n* Malignancy\n* Organ transplant recipient\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":419,"type":22},300,[421],"PHASE4","This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens.\n\nThe study will consist of the following visits:\n\nVisit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.",[424],"Polymyalgia Rheumatica",{"date":341,"type":33},{"date":427,"type":33},"2026-05-12",{"date":429,"type":22},"2029-07-16",{"name":39,"class":40},14,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":453},"100582729","phase-2-a-study-to-investigate-efficacy-and-safety-of-sar441566-in-patients-with-ulcerative-colitis-100582729","NCT06867094","A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis","A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate-to-severe Ulcerative Colitis","SPECIFI-UC","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent\n* Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period\n* Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent \\>15 cm from the anal verge\n* Must have received prior treatment for UC (either \"a\" or \"b\" below or a combination of both \"a\" and \"b\"):\n\n  1. History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR\n  2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12\u002F23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC\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\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis\n* Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study\n* Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study\n* Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools\n* Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines\n* Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and\u002For hepatitis C virus antibody (HCVAb) at the screening visit\n* Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex\n* Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening\n* Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening\n* History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.\n* If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \\>10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.\n* Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug\n* Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral\u002Fintramuscular anti-infectives within 14 days prior to the screening visit\n* Participants requiring or receiving any parental nutrition and\u002For exclusive enteral nutrition\n* Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening\n* Participants who received fecal microbial transplantation within 30 days prior to screening\n* Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)\n* Participants who received IV corticosteroids within 14 days prior to screening or during screening period\n* Screening laboratory and other analyses show abnormal results.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","75 Years",{"count":442,"type":22},204,[55],"This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.\n\nThis study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.\n\nAdditionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study).\n\n* The study duration will be up to 59 weeks.\n* The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.\n* The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.",[446],"Colitis Ulcerative",{"date":341,"type":33},{"date":449,"type":33},"2025-03-28",{"date":451,"type":22},"2028-05-11",{"name":39,"class":40},115,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":473},"100484179","phase-1-a-first-in-human-dose-escalation-and-dose-expansion-study-of-sar445877-in-adult-participants-with-advanced-solid-tumors-100484179","NCT05584670","A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors","A Phase 1\u002F2, Open Label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Dose escalation Part 1A and Japan Cohort F\n\n   * Participants with advanced unresectable or metastatic solid tumors for which, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant\n2. Dose escalation Part 1B\n\n   * Participants with advanced unresectable or metastatic melanoma, NSCLC; renal cell carcinoma (RCC); HCC, colorectal cancer (MSI-H\u002FdMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). and for who, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant.\n3. Dose escalation Part 1C\n\n   * Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer\n   * Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.\n4. Dose expansion\u002Foptimization Part 2\n\n   Cancer diagnosis:\n   * Participants in Cohorts A1 and A2 (Part 2A): Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)\n   * Participants in Cohort B (part 2A): Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants (participants without cirrhosis must have had histological confirmation of diagnosis)\n   * Participants in Cohorts C1 and C2 (part 2A):\n\n     * Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 \\& 3 gastro esophageal junction (GEJ) adenocarcinoma\n     * Disease with any CPS scoring. No need for CPS determination at local laboratory\n     * Participants must have MSI (metastatic microsatellite instability) or MMR (mismatch repair) status known or determined locally and must have non-MSI-H or proficient MMR (pMMR) disease to be eligible.\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   * Participants in Part 2A Cohorts E1 and E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer.\n   * Participants in Part 2A Cohorts E1, and E2 and Part 2B Cohort E3 MSI status:\n\n   Participants must have MSI status known or determined locally and must have non- MSI-H disease to be eligible.\n   * Participants in Part 2A Cohorts E1, E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.\n   * Part 2C Cohorts G1, G2 and G3: Participants with histologically confirmed unresectable locally advanced or metastatic melanoma\n5. Prior anticancer therapy (For dose expansion\u002Foptimization Part 2 only)\n\n   * Participants in Cohorts A1 and A2: Participants must have received at least 1 systemic therapy for the metastatic setting and must not be amenable to the available SOC.\n   * Participants in Cohort B: Participants who have received at least 1 prior anticancer therapy, including an anti-PD1\u002FPD-L1 containing regimen, and for whom have progressed after a primary or secondary resistance to an anti-PD1\u002FPD-L1.\n   * Participants in Cohorts C1 and C2: 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 depending on local standard of care.\n   * Participants in Cohort D: Participants must have received at least 1 systemic therapy for their advanced\u002F metastatic setting and must not be amenable to the available SOC.\n   * Participants in Part 2A Cohorts E1 and E2 and Part 2D Cohorts H1 and H2 should have failed or relapsed on at least 2 prior regimens.\n   * Participants in cohort E3 should have failed or relapsed on at least 1 prior regimen. Participants who have received cetuximab or other anti-EGFR therapy as part of their prior line of treatment are eligible.\n   * Part 2C Cohorts G1, G2 and G3: Participants must have received at least one prior line of therapy for advanced\u002Fmetastatic melanoma and\u002For does not have any standard of care (SoC) treatment option or decline or is intolerant to be treated with SoC treatment.\n\nMeasurable Disease:\n\n* At least 1 measurable lesion per RECIST 1.1 criteria\n\nPart 1C and Part 2D: Adequate coagulation function for all participants. For participants receiving anti-coagulant therapy (except platelet anti-aggregates) the adequate therapeutic levels of INR should be confirmed.\n\nCapable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≥2\n* Predicted life expectancy ≤3 months\n* For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part 1.\n* Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment\n* Known active brain metastases or leptomeningeal metastases\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 adverse events\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.\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.",{"count":462,"type":22},542,[54,55],"This is a Phase 1\u002F2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors.\n\nThe study will include 2 parts:\n\nA dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable.\n\nA multicohort dose expansion\u002Fdose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion\u002Foptimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable.\n\nApproximately 542 participants will be exposed to the study intervention:\n\n* approximately 123 participants in part 1,\n* up to 410 participants in expansion\u002Fdose optimization part (part 2)\n* and up to 9 participants in Japan cohort F.",[466],"Solid Tumor",{"date":341,"type":33},{"date":469,"type":33},"2022-11-29",{"date":471,"type":22},"2028-06-28",{"name":39,"class":40},22,{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":496},"100624656","phase-2-a-study-to-investigate-the-efficacy-and-safety-of-frexalimab-versus-tacrolimus-in-adults-undergoing-kidney-transplantation-100624656","NCT07412470","A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation","A Seamless Phase 2\u002F3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients","FREXERA","Inclusion Criteria:\n\n* Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.\n* Participants with low to moderate immunological risk.\n\nExclusion Criteria:\n\n* Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death.\n* Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening.\n* Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation.\n* Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy\n* Evidence of active or latent TB, HIV, HBV or HCV infection.\n* Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.\n* Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","70 Years",{"count":484,"type":22},526,[55,25],"The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligible if they meet all inclusion and no exclusion criteria. Study details include:\n\n* The study and treatment duration will be up to approximately 5 years.\n* The number of visits will be approximately 38.",[488],"Kidney Transplant Rejection","2026-06-18",{"date":341,"type":33},{"date":492,"type":33},"2026-03-13",{"date":494,"type":22},"2033-08-15",{"name":39,"class":40},26,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":168,"maxAge":169,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":516},"100607160","phase-3-a-maintenance-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-crohns-disease-100607160","NCT07184944","A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","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 Crohn's Disease","STARSCAPE-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 STARSCAPE-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 patient's potential participation in a clinical trial",{"count":506,"type":22},751,[25],"This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study 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\n\nNote: 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 the Pivotal Maintenance Sub-Study\n* 240 weeks in OLE Sub-Study\n\nThe total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study",[175],{"date":323,"type":33},{"date":512,"type":33},"2026-01-22",{"date":514,"type":22},"2034-03-20",{"name":39,"class":40},35,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":23,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":537},"100593555","phase-3-study-to-evaluate-the-efficacy-and-safety-of-oral-rilzabrutinib-in-adults-with-immune-thrombocytopenia-itp-who-failed-first-line-treatment-100593555","NCT07007962","Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment","A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment","LUNA 4","Key Inclusion Criteria:\n\n* Male or female participants aged 18 years and older with a documented diagnosis of primary ITP in the medical history\n* Participant received at least one course of first-line therapy and had a history of response while on treatment\n* Participant has loss of response, relapse, or steroid dependency\n\nKey Exclusion Criteria:\n\n* Participants with Secondary ITP\n* Participants with Evans syndrome or history of myelodysplastic syndrome\n* Participants with history of lymphoma, leukemia, or any malignancy within the past 5 years except for non-melanoma skin malignancy.\n* Participants with history of solid organ transplant\n* Participants with history of coagulation or bleeding disorders other than ITP, including genetic conditions, other than ITP\n* Participant received advanced therapy for ITP or was splenectomized\n* Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":526,"type":22},60,[25],"This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.",[530],"Immune Thrombocytopenia",{"date":323,"type":33},{"date":533,"type":33},"2025-10-24",{"date":535,"type":22},"2028-12-30",{"name":39,"class":40},36,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":169,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":551,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":562},"100635034","phase-2-a-study-to-access-activity-and-safety-with-sar445399-compared-with-placebo-in-participants-aged-18-to-80-years-of-age-with-non-cystic-fibrosis-bronchiectasis-100635034","NCT07547436","A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age With Non-Cystic Fibrosis Bronchiectasis","A Randomized, Double-blinded, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Activity, Safety, and Tolerability of SAR445399 in Adult Participants With Non-Cystic Fibrosis Bronchiectasis (NCFB)","Inclusion Criteria:\n\n* Participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent\n* Clinical history consistent with NCFB, such as chronic productive cough and\u002For recurrent respiratory infections\n* Documented evidence of at least 2 PEx defined as episodes requiring a physician-prescribed course of antibiotics (oral and\u002For IV) for ≥5 days for signs and symptoms of respiratory infection within the 12 months prior to the Screening Visit\n* Radiologic evidence of bronchiectasis, confirmed by a chest HRCT\n* A minimum MPS of 4 (out of maximum 18) on chest HRCT performed before Baseline Visit\n* Current sputum production with a documented history of chronic expectoration lasting ≥3 months within the previous 12 months\n* Participants must have a post-bronchodilator FEV1 ≥30% of predicted normal value\n\nExclusion Criteria:\n\n* A primary diagnosis of smoking-related COPD or asthma as determined by the Investigator. Participants with comorbid smoking-related COPD may be included if bronchiectasis is confirmed as their primary diagnosis and is the predominant cause of their respiratory symptoms\n* Diagnosis of ABPA or any of the allergic bronchopulmonary mycoses\n* Active NTM lung infection or incomplete NTM treatment course\n* Bronchiectasis due to any of the following: CF, CVID, AAT or PCD\n* History of significant hemoptysis (requiring medical intervention and\u002For requiring blood transfusion)\n* Current tobacco smokers\n* Known or suspected immunosuppression, including history of invasive opportunistic infections (eg., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune-compromised status, as judged by the Investigator\n* Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease, including but not limited to connective tissue diseases (eg., systemic lupus erythematosus, scleroderma, polymyositis, dermatomyositis, mixed connective tissue disease), rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, Hashimoto's thyroiditis, Graves' disease, primary biliary cirrhosis, and psoriasis vulgaris\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":546,"type":22},70,[55],"This is a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score at 24 weeks of treatment with SAR445399 compared with placebo in adult participants aged 18 to 80 years with non-cystic fibrosis bronchiectasis (NCFB).",[550],"Non-cystic Fibrosis Bronchiectasis",[552,553,554],"Non-Cystic Fibrosis Bronchiectasis","NCFB","Bronchiectasis","2026-06-16",{"date":489,"type":33},{"date":558,"type":33},"2026-06-08",{"date":560,"type":22},"2028-08-07",{"name":39,"class":40},4,""]