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4HH",{"type":46,"coordinates":171},[172,173],-1.61396,54.97328,{"lat":173,"lon":172},{"type":176,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100591761","phase-2-a-study-to-investigate-the-efficacy-and-safety-of-rilzabrutinib-in-adult-participants-with-graves-disease-100591761",false,"NCT06984627","A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease","An Open-label Phase 2 Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease","Inclusion Criteria:\n\n* Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening.\n* A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at screening and a clinical activity score (CAS) ≥3 for the most severely affected eye, and associated with one or more of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis ≥2 mm, and\u002For intermittent or constant diplopia.\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* History of hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis).\n* History of thyroid storm or at high risk of developing thyroid storm as determined by evaluating clinician.\n* Enlarged thyroid goiter causing upper airway obstruction and\u002For requiring surgical intervention during the study period.\n* For participant with Graves' orbitopathy, requires immediate surgical ophthalmological intervention or is planning corrective surgery\u002Firradiation during the course of the study.\n* Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months.\n* Corneal decompensation unresponsive to medical management.\n* Onset of Graves' orbitopathy symptoms \\>9 months prior to baseline.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","18 Years","75 Years",{"count":188,"type":189},30,"ESTIMATED","INTERVENTIONAL",[192],"PHASE2","This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.\n\nStudy details include:\n\n* Screening period (up to 4 weeks).\n* Treatment period (up to 16 weeks).\n* Follow-up period (4 weeks). The number of visits will be up to 13.",[195],"Graves' Disease","2026-05-21",{"date":198,"type":199},"2026-05-22","ACTUAL",{"date":201,"type":199},"2025-09-02",{"date":203,"type":189},"2026-09-23",{"name":5,"class":6},13]