drugset / Trial / NCT06984627

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

NCT06984627

Phase 2 Recruiting 30 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-09-02
Primary completion
2026-08-25
Completion
2026-09-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilzabrutinib Small molecule Oral

Indications