Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis (NCT06141486)
A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.
Who can join: Review the eligibility criteria below.
Location: Alabama Neurology Associates- Site Number : 8400115 — Homewood, 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 (311 Sites)
Showing the first 25 of 311 sites.
- Alabama Neurology Associates- Site Number : 8400115 — Homewood, Alabama
- Perseverance Research Center- Site Number : 8400138 — Scottsdale, Arizona
- Imaging Endpoints- Site Number : 8400050 — Scottsdale, Arizona
- Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134 — Berkeley, California
- University of California Irvine - School of Medicine- Site Number : 8400143 — Irvine, California
- University of California San Diego - La Jolla- Site Number : 8400095 — La Jolla, California
- Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184 — Los Angeles, California
- Hoag Memorial Hospital Presbyterian- Site Number : 8400031 — Newport Beach, California
- Stanford Neuroscience Health Center- Site Number : 8400120 — Palo Alto, California
- Private Practice - Dr. Regina Berkovich- Site Number : 8400005 — West Hollywood, California
- University of Colorado - Anschutz Medical Campus- Site Number : 8400001 — Aurora, Colorado
- Advanced Neurology of Colorado- Site Number : 8400148 — Fort Collins, Colorado
- Yale University School of Medicine- Site Number : 8400081 — New Haven, Connecticut
- Hartford Healthcare Medical Group- Site Number : 8400069 — Norwich, Connecticut
- MedStar Georgetown University Hospital- Site Number : 8400044 — Washington D.C., District of Columbia
- Neurology of Central Florida- Site Number : 8400147 — Altamonte Springs, Florida
- MS & Neuromuscular Center of Excellence- Site Number : 8400015 — Clearwater, Florida
- Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054 — Gainesville, Florida
- Neurology Associates - Maitland- Site Number : 8400010 — Maitland, Florida
- Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060 — Orlando, Florida
- Axiom Clinical Research of Florida- Site Number : 8400049 — Tampa, Florida
- University of South Florida- Site Number : 8400013 — Tampa, Florida
- Palm Beach Neurology- Site Number : 8400105 — West Palm Beach, Florida
- Joi Life Wellness Group LLC- Site Number : 8400192 — Smyrna, Georgia
- Rush University Medical Center- Site Number : 8400102 — Chicago, Illinois
💰 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.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.