Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Description

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 of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. * The study intervention duration will vary ranging from approximately 12 to 40 months. * The assessment of scheduled visits will include 1 common end of study \[EOS\] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.

Conditions

Multiple Sclerosis

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Study Overview

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Study Details

Study overview

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 of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. * The study intervention duration will vary ranging from approximately 12 to 40 months. * The assessment of scheduled visits will include 1 common end of study \[EOS\] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.

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

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Alabama Neurology Associates- Site Number : 8400115, Birmingham, Alabama, United States, 35209

Birmingham

University of Alabama at Birmingham- Site Number : 8401135, Birmingham, Alabama, United States, 35233

Cullman

North Central Neurology Associates- Site Number : 8401100, Cullman, Alabama, United States, 35058

Phoenix

St. Joseph's Hospital and Medical Center- Site Number : 8401139, Phoenix, Arizona, United States, 85013

Scottsdale

Perseverance Research Center- Site Number : 8401138, Scottsdale, Arizona, United States, 85254

Scottsdale

Imaging Endpoints- Site Number : 8400050, Scottsdale, Arizona, United States, 85258

Carlsbad

The Neurology Center of Southern California - Carlsbad- Site Number : 8400023, Carlsbad, California, United States, 92011

Irvine

UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8401143, Irvine, California, United States, 92697

Laguna Hills

Multiple Sclerosis Center of California- Site Number : 8401122, Laguna Hills, California, United States, 92653

West Hollywood

Private Practice - Dr. Regina Berkovich- Site Number : 8400005, West Hollywood, California, United States, 90048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
  • * The participant has a history of infection or may be at risk for infection:
  • * The presence of psychiatric disturbance or substance abuse.
  • * History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
  • * History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
  • * A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
  • * The participant has had a relapse in the 30 days prior to randomization.
  • * The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2027-05-06