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  2. Participate in Research
  3. Investigating the safety of frexalimab in adults with relapsing MS
Research Study

Master Protocol of Two Independent, Randomized, Double-blind Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

Principal Investigator
Alice Schabas

Overview

Body Locations and Systems
Brain and Nerves
Multiple Sclerosis
Immune System
ClinicalTrials.gov#
NCT06141473
Status
Recruiting
Start/End Dates
Nov 1, 2024 Aug 31, 2025
Locations
Djavad Mowafaghian Centre for Brain Health
Phone
604-822-1756
Email Address
ms.nmo_research@ubc.ca
Purpose of Study

The purpose of this 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 who are 18 to 55 years of age at the time of enrollment. 

Participants will either receive either frexalimab or teriflunomide for a duration depending on when they start their participation, up to approximately 40 months, potentially more. Frexalimab will be administered intravenously (IV; through an infusion line with a needle in the upper limb vein) every four weeks at the study site, or at the participant’s home under certain conditions. Teriflunomide will be administered orally once per day. Neither the participants nor their local study team will know which treatment they are assigned to while in the study. Participants will be randomly assigned to receive either IV frexalimab and an oral pill placebo OR oral teriflunomide and an IV placebo.

Eligibility

Visit ClinicalTrials.gov for more information.

Disclaimer

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific research studies only. If you have specific questions which require clinical expertise, please call your primary care physician.

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