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

RecruitingPhase 2

Sponsor: Sanofi

Conditions: Graves' Disease

Interventions: Rilzabrutinib dose 1, Rilzabrutinib dose 2

Countries: Canada, Germany, Italy, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening.
* 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 hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis).
* 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.

Locations (15)

Calgary, Alberta, Canada
Surrey, British Columbia, Canada
Sherbrooke, Quebec, Canada
Essen, Germany
Frankfurt, Germany
Merano, Bolzano / Bozen, Italy
Milan, Milano, Italy
Milan, Milano, Italy
Palermo, Italy
Pisa, Italy
Barcelona, Catalunya [Cataluña], Spain
Pamplona, Navarre, Spain
Seville, Sevilla, Spain
Milton Keynes, Buckinghamshire, United Kingdom
Newcastle upon Tyne, England, United Kingdom