🏛️ Verified NIH Record • Updated 2026-07-16

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis (NCT06141473)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

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 event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * The scheduled visits will include monthly visits for the first 6 months and quarterly visits thereafter until the common end of study (EOS), or premature end of treatment (pEOT) after which 3 follow-up visits will be performed

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham- Site Number : 8401135 — Birmingham, Alabama

Age range: 18 Years to 55 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (382 Sites)

Showing the first 25 of 382 sites.

  • University of Alabama at Birmingham- Site Number : 8401135 — Birmingham, Alabama
  • North Central Neurology Associates- Site Number : 8401100 — Cullman, Alabama
  • Alabama Neurology Associates- Site Number : 8400115 — Homewood, Alabama
  • St. Joseph's Hospital and Medical Center- Site Number : 8401139 — Phoenix, Arizona
  • Perseverance Research Center- Site Number : 8401138 — Scottsdale, Arizona
  • Clinical Endpoints- Site Number : 8400050 — Scottsdale, Arizona
  • The Neurology Center of Southern California - Carlsbad- Site Number : 8400023 — Carlsbad, California
  • University of California Irvine - School of Medicine- Site Number : 8401143 — Irvine, California
  • Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122 — Laguna Hills, California
  • Chemidox Clinical Trials- Site Number : 8401157 — Lancaster, California
  • Hoag Memorial Hospital Presbyterian- Site Number : 8401031 — Newport Beach, California
  • Private Practice - Dr. Regina Berkovich- Site Number : 8400005 — West Hollywood, California
  • University of Colorado - Anschutz Medical Campus- Site Number : 8401001 — Aurora, Colorado
  • Advanced Neurology of Colorado- Site Number : 8401148 — Fort Collins, Colorado
  • Hartford Healthcare Medical Group- Site Number : 8401069 — Norwich, Connecticut
  • New England Institute for Clinical Research- Site Number : 8400114 — Stamford, Connecticut
  • MedStar Georgetown University Hospital- Site Number : 8400044 — Washington D.C., District of Columbia
  • Neurology of Central Florida- Site Number : 8401147 — Altamonte Springs, Florida
  • Neurology Offices of South Florida - Boca Raton- Site Number : 8401169 — Boca Raton, Florida
  • First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071 — Boca Raton, Florida
  • Nova Clinical Research - Bradenton- Site Number : 8400189 — Bradenton, Florida
  • Mayo Clinic in Florida- Site Number : 8401093 — Jacksonville, Florida
  • Neurology Associates - Maitland- Site Number : 8400010 — Maitland, Florida
  • University of Miami Hospital- Site Number : 8401177 — Miami, Florida
  • Design Neuroscience Center- Site Number : 8401191 — Miami Lakes, Florida

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗