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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graves' Disease

Interventions

Type	Name	Description
DRUG	Rilzabrutinib dose 1	Pharmaceutical form:Tablet-Route of administration:Oral
DRUG	Rilzabrutinib dose 2	Pharmaceutical form:Tablet-Route of administration:Oral

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-08-25
• Completion: 2026-09-23
• First posted: 2025-05-22
• Last updated: 2026-04-03

Locations

13 sites across 5 countries: Canada, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study