Graves' Disease study: Rilzabrutinib dose
Official title A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
ClinicalTrials.gov ID: NCT06984627
What this study is testing
What is Rilzabrutinib dose 1?
This is an investigational oral tablet being studied as a potential treatment for Graves' disease. is designed to block a specific enzyme called BTK that helps control immune system activity.
Also referred to as SAR444671.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well and how safely rilzabrutinib works for people with Graves' disease.
- Who it's for
- Adults 18 or older who have Graves' disease, whether or not they have Graves' orbitopathy (eye problems).
- What's involved
- Participants will receive one of two doses of rilzabrutinib and attend up to 13 visits for screening, treatment, and follow‑up, including medical tests and assessments.
- Time commitment
- The study lasts about 24 weeks, including a screening period of up to 4 weeks, a treatment period of up to 16 weeks, and a 4‑week follow‑up, with multiple clinic visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of...
- A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at screening and a clinical activity...
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in...
You likely can't join if
- History of hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute...
- 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...
- Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months.
- Corneal decompensation unresponsive to medical management.
See the full eligibility 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...
- 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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The study team makes the final eligibility decision.
Where it is enrolling
- Buenos Aires, Argentina
- Córdoba, Argentina
- Calgary, Alberta, Canada
- Surrey, British Columbia, Canada
- Sherbrooke, Quebec, Canada
- Concepción, Biobio, Chile
- Iquique, Tarapacá, Chile
- Athens, Greece
- Larissa, Greece
- Milan, Milano, Italy
- Merano, Italy
- Palermo, Italy
- Pisa, Italy
- Seville, Sevilla, Spain
- Milton Keynes, Buckinghamshire, United Kingdom
- Newcastle upon Tyne, England, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Buenos Aires, Argentina; Córdoba, Argentina; Calgary, Alberta, Canada; Surrey, British Columbia, Canada; Sherbrooke, Quebec, Canada; Concepción, Biobio, Chile and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.