🏛️ Verified NIH Record • Updated 2025-09-11

Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis (NCT04879628)

A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Sanofi

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

Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: * To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures * To evaluate the safety and tolerability of SAR441344 * To evaluate pharmacokinetics of SAR441344

Who can join: Review the eligibility criteria below.

Location: Center for Neurology and Spine- Site Number : 8400007 — Phoenix, Arizona

Age range: 18 Years to 55 Years

📋 "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 (37 Sites)

Showing the first 25 of 37 sites.

  • Center for Neurology and Spine- Site Number : 8400007 — Phoenix, Arizona
  • University of South Florida Site Number : 8400001 — Tampa, Florida
  • The Neurological Institute Site Number : 8400004 — Charlotte, North Carolina
  • Medical College of Wisconsin- Site Number : 8400006 — Milwaukee, Wisconsin
  • Investigational Site Number : 1000002 — Pleven,
  • Investigational Site Number : 1000003 — Sofia,
  • Investigational Site Number : 1000001 — Sofia,
  • Investigational Site Number : 1240001 — Gatineau, Quebec
  • Investigational Site Number : 2030003 — Brno,
  • Investigational Site Number : 2030002 — Hradec Králové,
  • Investigational Site Number : 2030001 — Jihlava,
  • Investigational Site Number : 2030005 — Ostrava - Poruba,
  • Investigational Site Number : 2030004 — Teplice,
  • Investigational Site Number : 2500006 — Calais,
  • Investigational Site Number : 2760012 — Leipzig,
  • Investigational Site Number : 2760004 — Münster,
  • Investigational Site Number : 6430002 — Kazan',
  • Investigational Site Number : 6430007 — Moscow,
  • Investigational Site Number : 6430006 — Moscow,
  • Investigational Site Number : 6430001 — Moscow,
  • Investigational Site Number : 6430003 — Saint Petersburg,
  • Investigational Site Number : 6430005 — Saint Petersburg,
  • Investigational Site Number : 6430004 — Saint Petersburg,
  • Investigational Site Number : 6430008 — Tyumen,
  • Investigational Site Number : 7240004 — Barcelona, Barcelona [Barcelona]

💰 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.

💡 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 ↗