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A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Led by Sanofi · Updated on 2026-04-03
30
Participants Needed
13
Research Sites
55 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official 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...
- Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening.
- Participants with active Graves' orbitopathy confirmed by ophthalmic exam and a clinical activity score of 3 or higher for the most affected eye, plus one or more of these: lid retraction 2 mm or more, moderate or severe soft tissue involvement, proptosis 2 mm or more, or intermittent or constant double vision.
- Men and women using contraception methods consistent with local regulations for clinical study participation.
You will not qualify if you...
- History of hyperthyroidism from causes other than Graves' disease, such as toxic multinodular goiter, autonomous thyroid nodule, or acute inflammatory thyroiditis.
- History of thyroid storm or high risk of developing thyroid storm as judged by the clinician.
- Enlarged thyroid causing upper airway blockage or needing surgery during the study.
- Participants with Graves' orbitopathy needing immediate surgical eye intervention or planning surgery or irradiation during the study.
- Sight-threatening Graves' orbitopathy or vision loss due to optic nerve damage within the past 6 months.
- Corneal damage not responding to medical treatment.
- Symptoms of Graves' orbitopathy starting more than 9 months before the study begins.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Investigational Site Number : 1240003
Calgary, Alberta, Canada, T2N 4L7
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2
Investigational Site Number : 1240002
Surrey, British Columbia, Canada, V3T 2V6
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3
Investigational Site Number : 1240001
Sherbrooke, Quebec, Canada, J1H 5N4
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4
Investigational Site Number : 2760002
Essen, Germany, 45147
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5
Investigational Site Number : 2760001
Frankfurt, Germany, 60590
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6
Investigational Site Number : 3800001
Milan, Milano, Italy, 20122
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7
Investigational Site Number : 3800003
Palermo, Italy, 90127
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8
Investigational Site Number : 3800002
Pisa, Italy, 56126
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9
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], Spain, 08036
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10
Investigational Site Number : 7240001
Pamplona, Navarre, Spain, 31008
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11
Investigational Site Number : 7240004
Seville, Sevilla, Spain, 41009
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12
Investigational Site Number : 8260003
Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
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13
Investigational Site Number : 8260001
Newcastle upon Tyne, England, United Kingdom, NE2 4HH
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Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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