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

May 21, 2026 updated by: Sanofi

An Open-label Phase 2 Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
        • Recruiting
        • Investigational Site Number : 1240003
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 4G8
        • Recruiting
        • Investigational Site Number : 1240002
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Investigational Site Number : 1240001
  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • Investigational Site Number : 2760002
      • Frankfurt, Germany, 60590
        • Recruiting
        • Investigational Site Number : 2760001
  • Italy
      • Palermo, Italy, 90127
        • Recruiting
        • Investigational Site Number : 3800003
      • Pisa, Italy, 56126
        • Recruiting
        • Investigational Site Number : 3800002
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • Investigational Site Number : 3800001
  • Spain
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Recruiting
        • Investigational Site Number : 7240002
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Investigational Site Number : 7240001
    • Sevilla
      • Seville, Sevilla, Spain, 41009
        • Recruiting
        • Investigational Site Number : 7240004
  • United Kingdom
    • Buckinghamshire
      • Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
        • Recruiting
        • Investigational Site Number : 8260003
    • England
      • Newcastle upon Tyne, England, United Kingdom, NE2 4HH
        • Recruiting
        • Investigational Site Number : 8260001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rilzabrutinib dose 1
Rilzabrutinib
Drug: Rilzabrutinib dose 1
Pharmaceutical form:Tablet-Route of administration:Oral
Other Names:
  • SAR444671
Experimental: Rilzabrutinib dose 2
Rilzabrutinib
Drug: Rilzabrutinib dose 2
Pharmaceutical form:Tablet-Route of administration:Oral
Other Names:
  • SAR444671

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in FT4 levels
Time Frame: At Week16
Free thyroxine
At Week16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in FT3 levels
Time Frame: At Week16
Free triiodothyronine
At Week16
Proportion of participants with FT4 levels within normal limits
Time Frame: At Week16
At Week16
Proportion of participants with FT3 levels within normal limits
Time Frame: At Week16
At Week16
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawals due to TEAEs during the study period
Time Frame: Up to week 20
Up to week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2025

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

September 23, 2026

Study Registration Dates

First Submitted

May 14, 2025

First Submitted That Met QC Criteria

May 14, 2025

First Posted (Actual)

May 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDY18663
  • 2025-521023-75 (Registry Identifier: CTIS)
  • U1111-1316-0208 (Other Grant/Funding Number: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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