A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
NCT ID: NCT06984627
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-09-02
2026-09-23
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rilzabrutinib dose 1
Rilzabrutinib
Rilzabrutinib dose 1
Pharmaceutical form:Tablet-Route of administration:Oral
Rilzabrutinib dose 2
Rilzabrutinib
Rilzabrutinib dose 2
Pharmaceutical form:Tablet-Route of administration:Oral
Interventions
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Rilzabrutinib dose 1
Pharmaceutical form:Tablet-Route of administration:Oral
Rilzabrutinib dose 2
Pharmaceutical form:Tablet-Route of administration:Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at screening and a clinical activity score (CAS) ≥3 for the most severely affected eye, and associated with one or more of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis ≥2 mm, and/or intermittent or constant diplopia.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
* History of thyroid storm or at high risk of developing thyroid storm as determined by evaluating clinician.
* Enlarged thyroid goiter causing upper airway obstruction and/or requiring surgical intervention during the study period.
* For participant with Graves' orbitopathy, requires immediate surgical ophthalmological intervention or is planning corrective surgery/irradiation during the course of the study.
* Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months.
* Corneal decompensation unresponsive to medical management.
* Onset of Graves' orbitopathy symptoms \>9 months prior to baseline. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number : 1240003
Calgary, Alberta, Canada
Investigational Site Number : 1240002
Surrey, British Columbia, Canada
Investigational Site Number : 1240001
Sherbrooke, Quebec, Canada
Investigational Site Number : 2760002
Essen, , Germany
Investigational Site Number : 2760001
Frankfurt, , Germany
Investigational Site Number : 3800001
Milan, Milano, Italy
Investigational Site Number : 3800003
Palermo, , Italy
Investigational Site Number : 3800002
Pisa, , Italy
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240001
Pamplona, Navarre, Spain
Investigational Site Number : 8260003
Milton Keynes, Buckinghamshire, United Kingdom
Investigational Site Number : 8260001
Newcastle upon Tyne, England, United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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PDY18663 Plain Language Results Summary
Other Identifiers
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2025-521023-75
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1316-0208
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PDY18663
Identifier Type: -
Identifier Source: org_study_id