- Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06141473.
- The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years….
- Sponsor: Sanofi.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will have variable duration depending on the recruitment rate,…
- : * The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria. * The participant has an EDSS score ≤5.5 at the first visit (Screening Visit) * The participant must have at least 1 of the following prior to screening: * ≥1 documented relapse within the previous year OR * ≥2 documented relapses within the previous 2 years, OR * ≥1 documented Gd enhancing lesion on an MRI scan within the previous year. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.