Rilzabrutinib treatment for adults with Graves' disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, parallel-group, two-arm study comparing two doses of rilzabrutinib in adults (age ≥18) who have active Graves' disease, with or without active Graves' orbitopathy. Participants undergo up to 4 weeks of screening, up to 16 weeks of treatment, and a 4-week follow-up, with as many as 13 clinic visits. A subset of participants will have active Graves' orbitopathy confirmed by ophthalmic exam and a clinical activity score (CAS) ≥3. The main focus is to measure the treatment effect and safety of each dose over the treatment period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Investigational Site Number : 0320002
  Buenos Aires, Argentina Recruiting
• Investigational Site Number : 0320001
  Buenos Aires, Argentina Recruiting
• Investigational Site Number : 0320003
  Córdoba, Argentina Recruiting
• Investigational Site Number : 1240003
  Calgary, Alberta, Canada Recruiting
• Investigational Site Number : 1240002
  Surrey, British Columbia, Canada Recruiting
• Investigational Site Number : 1240001
  Sherbrooke, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Efgartigimod for Graves' Disease in adults

  We are testing if efgartigimod given under the skin can help adults with Graves' disease by improving thyroid function and whether it is safe and tolerable.

  Recruiting at 35 sites Phase 3 argenx · Carlsbad, California and 34 other locations · NCT07570316

• ETHY-001 safety and activity in Thyroid Eye Disease (TED)

  This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.

  Recruiting at 2 sites Phase 1 Ethyreal Bio, Inc. · Orland Park, Illinois and 2 other locations · NCT07885605

• Rilzabrutinib in adults with severe kidney impairment vs. normal kidney function

  This study tests how rilzabrutinib behaves in the body and its safety in adults with severe kidney impairment compared to healthy adults.

  Recruiting Phase 1 Sanofi · Hialeah, Florida · NCT07853131

• Early risk stratification of thyroid eye disease in newly diagnosed Graves' disease

  This study tests whether early eye-related signs, blood and tear biomarkers, or eye surface features can predict who with Graves’ disease will develop thyroid eye disease within a year.

  Recruiting University of Copenhagen · Herlev · NCT07812194

• Felzartamab for Graves’ Disease: See if it helps control thyroids and reduce need for ATDs

  This study tests felzartamab vs placebo in adults with Graves’ disease to see if it can normalize thyroid hormones and let people stop anti-thyroid drugs.

  Recruiting at 14 sites Phase 2 Biogen · Glendale, Arizona and 13 other locations · NCT07722546

• AI-based MRI and ultrasound for thyroid-related eye disease

  This study tests an AI model using orbital MRI and eye ultrasound to help diagnose activity and severity of thyroid-associated ophthalmopathy and predict its course in adults.

  Recruiting Shanghai Changzheng Hospital · Shanghai, Huangpu District · NCT07716397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.