Recruiting
Phase 2

Rilzabrutinib

Sponsor:

Sanofi

Code:

NCT06984627

Conditions

Graves' Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rilzabrutinib dose 1

Rilzabrutinib dose 2

Study Details

Brief summary:

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

Graves' Disease

Study ID

NCT06984627

Start date

Sep 2, 2025

Status verified date

Jul, 2026

Completion date

Sep 23, 2026

Anticipated

Primary completion date

Aug 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rilzabrutinib dose 1

Rilzabrutinib

experimental: Rilzabrutinib dose 2

Rilzabrutinib

Interventions

Rilzabrutinib dose 1

Pharmaceutical form:Tablet-Route of administration:Oral

Rilzabrutinib dose 2

Pharmaceutical form:Tablet-Route of administration:Oral

Primary outcome measure

  • Percent change from baseline in FT4 levels [ Time Frame: At Week16 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Investigational Site Number : 1240003

Recruiting

Calgary, Alberta, Canada, T2N 4L7

Investigational Site Number : 1240002

Recruiting

Surrey, British Columbia, Canada, V3T 4G8

Investigational Site Number : 1240001

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Sanofi

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanofi on 2026-07-07.