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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT06984627

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Rilzabrutinib dose 1 (Drug)
    Pharmaceutical form:Tablet-Route of administration:Oral
  • Rilzabrutinib dose 2 (Drug)
    Pharmaceutical form:Tablet-Route of administration:Oral

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.

Conditions

Graves' Disease

Locations

  • Investigational Site Number : 0320002 — Buenos Aires, Argentina
  • Investigational Site Number : 0320001 — Buenos Aires, Argentina
  • Investigational Site Number : 0320003 — Córdoba, Argentina
  • 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 : 1520001 — Concepción, Biobio, Chile
  • Investigational Site Number : 1520002 — Iquique, Tarapacá, Chile
  • Investigational Site Number : 2760002 — Essen, Germany
  • Investigational Site Number : 2760001 — Frankfurt, Germany
  • Investigational Site Number : 3000002 — Athens, Greece
  • Investigational Site Number : 3000001 — Athens, Greece
  • Investigational Site Number : 3000003 — Larissa, Greece
  • Investigational Site Number : 3480001 — Pécs, Hungary
  • Investigational Site Number : 3800001 — Milan, Milano, Italy
  • Investigational Site Number : 3800004 — Milan, Milano, Italy
  • Investigational Site Number : 3800005 — Merano, 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 : 7240004 — Seville, Sevilla, Spain
  • Investigational Site Number : 8260003 — Milton Keynes, Buckinghamshire, United Kingdom
  • Investigational Site Number : 8260001 — Newcastle upon Tyne, England, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record