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Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
NCT06141486 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Frexalimab
- DRUG MRI contrast-enhancing agents
Study Locations (20)
California
- Sutter East Bay Medical Foundation- Site Number : 8400134 — Berkeley
- The Research Center of Southern California, LLC- Site Number : 8400023 — Carlsbad
- University of California, Irvine- Site Number : 8400143 — Irvine
- University of California San Diego- Site Number : 8400095 — La Jolla
- Southern California Permanente Medical Group- Site Number : 8400184 — Los Angeles
- University of Southern California, Los Angeles- Site Number : 8400118 — Los Angeles
- Hoag Memorial Hospital- Site Number : 8400031 — Newport Beach
- Stanford Neuroscience Health Center- Site Number : 8400120 — Palo Alto
- Regina Berkovich, MD, PhD- Site Number : 8400005 — West Hollywood
Arizona
- Dignity Health St. Joseph's Hospital and Medical Center- Site Number : 8400139 — Phoenix
- HonorHealth Neurology- Site Number : 8400074 — Scottsdale
- Perseverance Research Center- Site Number : 8400138 — Scottsdale
- Imaging EndPoints- Site Number : 8400050 — Scottsdale
Connecticut
- Yale University- Site Number : 8400081 — New Haven
- Hartford Healthcare Medical Group- Site Number : 8400069 — Norwich
- New England Institute for Clinical Research- Site Number : 8400114 — Stamford
Colorado
- University of Colorado Health Science Center- Site Number : 8400001 — Aurora
- Advanced Neurosciences Research- Site Number : 8400148 — Fort Collins
Alabama
- Alabama Neurology Associates- Site Number : 8400115 — Birmingham
District of Columbia
- Georgetown University Hospital- Site Number : 8400044 — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2023-12-27 |
| Est. Completion | 2028-03-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06141486
The ClinicalTrials.gov registry entry for NCT06141486 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 900 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 3 interventions — of which Placebo 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: NCT06141486 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Connecticut. 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 NCT06141486 about?
NCT06141486 is a clinical study titled "Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis". 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 participant...
What is the current status of trial NCT06141486?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2023-12-27. Estimated completion is 2028-03-24.
What conditions does trial NCT06141486 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 NCT06141486?
The interventions under investigation include: Placebo (DRUG), Frexalimab (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 NCT06141486?
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 NCT06141486 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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