Last updated 47 days ago

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

30 patients around the world

Available in Spain, Argentina

Sanofi

1Research sites

30Patients around the world

This study is for people with

Graves' disease

To 75 Years

All Gender

: 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.

: 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.

Instituto Médico Strusberg - Córdoba

Recruiting

Av. Emilio Olmos 247, X5000 Córdoba, Argentina

SponsorSanofi

Study typeInterventional

Conditions

Graves' disease

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06984627