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NCT06141486 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 900
- Enrollment target
- 20
- Study locations
NCT06141486: Recruiting Phase 3 study of Multiple Sclerosis, sponsored by Sanofi.
NCT06141486 is a Phase 3 study of Multiple Sclerosis that is actively recruiting participants, run by Sanofi. The registered enrollment target is 900 participants, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06141486, a Phase 3 study of Multiple Sclerosis, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 900 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Defined as Increase from the baseline expanded disability status scale (EDSS) score of ≥1.0 point when the baseline is \<5.5, or ≥0.5 point when the baseline is ≥5.5, OR Increase of ≥20% from the baseline time in the 9 hole peg test (9HPT),OR Increase of ≥20% from the baseline time in the timed 25 foot walk (T25FW) test
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 |
What NCT06141486 shows while recruiting
NCT06141486 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (55% higher).
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.
NCT06141486 names 20 study sites across 6 states, led by California, Arizona, Connecticut.
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.
What interventions are being tested in trial NCT06141486?
The interventions under investigation include: Placebo (DRUG), Frexalimab (DRUG), MRI contrast-enhancing agents (DRUG).
Who is sponsoring clinical trial NCT06141486?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06141486's enrollment target sits among peer trials
900 32nd of 315 higher than 284 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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