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Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
NCT06141473 · View on ClinicalTrials.gov ↗
Study Summary
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 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 Studied
Interventions
- DRUG Frexalimab
- DRUG Teriflunomide
- DRUG Placebo infusion
- DRUG Placebo tablet
- DRUG MRI contrast-enhancing agents
Study Locations (20)
California
- The Neurology Center of Southern California - Carlsbad- Site Number : 8400023 — Carlsbad
- University of California Irvine - School of Medicine- Site Number : 8401143 — Irvine
- Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122 — Laguna Hills
- Chemidox Clinical Trials- Site Number : 8401157 — Lancaster
- Hoag Memorial Hospital Presbyterian- Site Number : 8401031 — Newport Beach
- Private Practice - Dr. Regina Berkovich- Site Number : 8400005 — West Hollywood
Alabama
- University of Alabama at Birmingham- Site Number : 8401135 — Birmingham
- North Central Neurology Associates- Site Number : 8401100 — Cullman
- Alabama Neurology Associates- Site Number : 8400115 — Homewood
Arizona
- St. Joseph's Hospital and Medical Center- Site Number : 8401139 — Phoenix
- Perseverance Research Center- Site Number : 8401138 — Scottsdale
- Clinical Endpoints- Site Number : 8400050 — Scottsdale
Florida
- Neurology of Central Florida- Site Number : 8401147 — Altamonte Springs
- Neurology Offices of South Florida - Boca Raton- Site Number : 8401169 — Boca Raton
- First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071 — Boca Raton
Colorado
- University of Colorado - Anschutz Medical Campus- Site Number : 8401001 — Aurora
- Advanced Neurology of Colorado- Site Number : 8401148 — Fort Collins
Connecticut
- Hartford Healthcare Medical Group- Site Number : 8401069 — Norwich
- New England Institute for Clinical Research- Site Number : 8400114 — Stamford
District of Columbia
- MedStar Georgetown University Hospital- Site Number : 8400044 — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2027-05-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06141473
The ClinicalTrials.gov registry entry for NCT06141473 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 5 interventions — of which Frexalimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06141473 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06141473 about?
NCT06141473 is a clinical study titled "Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis". 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 ...
What is the current status of trial NCT06141473?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,600 participants. The study started on 2023-12-13. Estimated completion is 2027-05-06.
What conditions does trial NCT06141473 study?
This clinical trial studies the following conditions: Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06141473?
The interventions under investigation include: Frexalimab (DRUG), Teriflunomide (DRUG), Placebo infusion (DRUG), Placebo tablet (DRUG), MRI contrast-enhancing agents (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06141473?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06141473 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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