A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
A legfontosabb adatok
- Fázis
- 2. fázis
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Forrás: NCT06984627: ki vehet részt
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Sanofi
- Azonosító
- NCT06984627
- A regiszteradat frissítve
- 2026. október 28.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
An Open-label Phase 2 Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
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.
Study details include:
* Screening period (up to 4 weeks). * Treatment period (up to 16 weeks). * Follow-up period (4 weeks). The number of visits will be up to 13.
Bevonási feltételek: Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening; 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/or intermittent or constant diplopia; Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Kizáró feltételek: Enlarged thyroid goiter causing upper airway obstruction and/or requiring surgical intervention during the study period; For participant with Graves' orbitopathy, requires immediate surgical ophthalmological intervention or is planning corrective surgery/irradiation during the course of the study; Onset of Graves' orbitopathy symptoms >9 months prior to baseline; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial; History of hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis); History of thyroid storm or at high risk of developing thyroid storm as determined by evaluating clinician; Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months; Corneal decompensation unresponsive to medical management.