Phase 2 Randomized Study Evaluating Oral Rilzabrutinib Doses in Adults With Graves Disease With or Without Orbitopathy

What this Trial Is About

Researchers are evaluating the effects and safety of two different doses of rilzabrutinib in adults with Graves disease, including those with and without Graves orbitopathy. This Phase 2, randomized, parallel-group study aims to measure how these doses impact thyroid hormone levels, particularly FT4, over a treatment period. Participants will receive one of two oral doses of rilzabrutinib during the treatment phase lasting up to 16 weeks. The study includes a screening period of up to 4 weeks before treatment begins and a 4-week follow-up after treatment ends. Participants are randomly assigned to either of the two rilzabrutinib dose groups for evaluation. During the study, participants will attend up to 13 visits where their thyroid hormone levels FT4 and FT3 will be measured, along with monitoring for any adverse events. The primary outcome is the percent change in FT4 levels at Week 16, with secondary outcomes including changes in FT3 levels and safety assessments up to Week 20. The total duration for each participant is about 24 weeks, including screening, treatment, and follow-up periods.

A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease