Actively Recruiting
An Open-label Phase 2 Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Led by Sanofi · Updated on 2026-05-22
30
Participants Needed
13
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating rilzabrutinib in adult participants aged 18 to 75 years with Graves' disease, including those with and without Graves' orbitopathy. This open-label Phase 2 study aims to measure the treatment effects and safety of two different doses of rilzabrutinib. The study is sponsored by Sanofi and focuses on participants with active hyperthyroidism related to Graves' disease. Participants are randomly assigned to receive one of two oral doses of rilzabrutinib tablets. The study includes a screening period of up to 4 weeks, followed by a treatment period lasting up to 16 weeks. After treatment, there is a 4-week follow-up period. Throughout these phases, participants will attend up to 13 visits to monitor their response and safety. During the study, researchers will assess changes in thyroid hormone levels, specifically the percent change from baseline in free thyroxine (FT4) and free triiodothyronine (FT3) at Week 16. They will also evaluate how many participants achieve normal FT4 and FT3 levels. Safety will be monitored by tracking any adverse events and withdrawals related to treatment. Participants will undergo clinical evaluations and ophthalmic exams as needed during their involvement, which lasts about 24 weeks in total including screening and follow-up.
CONDITIONS
Brief Title
A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Confirmed diagnosis of Graves' disease with active hyperthyroidism
- Participants may have active Graves' orbitopathy confirmed by ophthalmic exam with a clinical activity score of 3 or higher
- Men and women using contraception methods according to local regulations during the study
You will not qualify if you...
- History of hyperthyroidism not caused by Graves' disease
- History of thyroid storm or high risk of thyroid storm
- Enlarged thyroid causing airway obstruction or requiring surgery during the study
- For those with Graves' orbitopathy, need for immediate surgery or planned corrective surgery/irradiation during study
- Sight-threatening Graves' orbitopathy or optic neuropathy causing decreased vision in last 6 months
- Corneal decompensation not responding to medical treatment
- Onset of Graves' orbitopathy symptoms more than 9 months before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive oral Rilzabrutinib tablets as part of the study treatment.
Regular visits during the 16-week treatment period
Duration - Up to 4 weeks
Participants are monitored for safety and outcomes after completing treatment.
Visits up to Week 20
Trial Site Locations
Total: 13 locations
1
Investigational Site Number : 1240003
Calgary, Alberta, Canada, T2N 4L7
Actively Recruiting
2
Investigational Site Number : 1240002
Surrey, British Columbia, Canada, V3T 4G8
Actively Recruiting
3
Investigational Site Number : 1240001
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
4
Investigational Site Number : 2760002
Essen, Germany, 45147
Actively Recruiting
5
Investigational Site Number : 2760001
Frankfurt, Germany, 60590
Actively Recruiting
6
Investigational Site Number : 3800001
Milan, Milano, Italy, 20122
Actively Recruiting
7
Investigational Site Number : 3800003
Palermo, Italy, 90127
Actively Recruiting
8
Investigational Site Number : 3800002
Pisa, Italy, 56126
Actively Recruiting
9
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
10
Investigational Site Number : 7240001
Pamplona, Navarre, Spain, 31008
Actively Recruiting
11
Investigational Site Number : 7240004
Seville, Sevilla, Spain, 41009
Actively Recruiting
12
Investigational Site Number : 8260003
Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
Actively Recruiting
13
Investigational Site Number : 8260001
Newcastle upon Tyne, England, United Kingdom, NE2 4HH
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here