Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis (NCT07325292)
A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis
🩺 Plain-English Summary (8th-Grade Level)
This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 for participants receiving frexalimab SC or IV, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.
Who can join: Review the eligibility criteria below.
Location: North Central Neurology Associates- Site Number : 8401100 — Cullman, Alabama
Age range: 18 Years to 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (38 Sites)
Showing the first 25 of 38 sites.
- North Central Neurology Associates- Site Number : 8401100 — Cullman, Alabama
- Alabama Neurology Associates- Site Number : 8400115 — Homewood, Alabama
- Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195 — Phoenix, Arizona
- Perseverance Research Center- Site Number : 8400138 — Scottsdale, Arizona
- Private Practice - Dr. Regina Berkovich- Site Number : 8400005 — West Hollywood, California
- Advanced Neurology of Colorado- Site Number : 8400148 — Fort Collins, Colorado
- Neurology of Central Florida- Site Number : 8400147 — Altamonte Springs, Florida
- Aqualane Clinical Research- Site Number : 8400026 — Naples, Florida
- Neurology Associates of Ormond Beach- Site Number : 8400086 — Ormond Beach, Florida
- Palm Beach Neurology- Site Number : 8400105 — West Palm Beach, Florida
- Joi Life Wellness Group LLC- Site Number : 8400192 — Smyrna, Georgia
- Consultants in Neurology- Site Number : 8400020 — Northbrook, Illinois
- Michigan Institute for Neurological Disorders- Site Number : 8400004 — Farmington Hills, Michigan
- Holy Name Medical Center- Site Number : 8400101 — Teaneck, New Jersey
- Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002 — Charlotte, North Carolina
- Raleigh Neurology Associates- Site Number : 8400014 — Raleigh, North Carolina
- The Ohio State University- Site Number : 8400009 — Columbus, Ohio
- The Boster Center for Multiple Sclerosis- Site Number : 8400006 — Columbus, Ohio
- Hope Neurology- Site Number : 8400019 — Knoxville, Tennessee
- ANESC Research- Site Number : 8400187 — El Paso, Texas
- North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082 — Plano, Texas
- North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083 — Plano, Texas
- Investigational Site Number : 0560001 — Bruges,
- Investigational Site Number : 0560008 — Brussels,
- Investigational Site Number : 0560006 — Ghent,
📞 Contact the Study Coordinator
Phone: (800) 633-1610
Email: Contact-US@sanofi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.