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

Study of an Investigational Study Drug for Graves’ Disease

Recruiting
18 years - 75 years
All
Phase 2
30 participants needed

Study Overview

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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Graves' Disease
  • Age: 18 years - 75 years
  • Gender: All

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.

The purpose of this research study is to learn about the effects and safety of an investigational study drug in adults with Graves’ disease who have active hyperthyroidism (an overactive thyroid). Some participants may also have Graves’ orbitopathy, which is an eye condition linked to Graves’ disease.

Participants will receive one of two dose levels of the investigational study drug.

Who can participate:
Adults with Graves’ disease may be able to participate if they:

  • Are 18 years or older
  • Have a confirmed diagnosis of Graves’ disease with active hyperthyroidism, with or without active Graves’ orbitopathy

Study timeline and visits:
Participation lasts up to 24 weeks. The number of visits will be up to 13.

Updated on 06 Jul 2026. Study ID: NCT06984627

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