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NCT04879628 · ClinicalTrials.gov registry record · Phase 2
Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
A Phase 2 study of Multiple Sclerosis, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 20
- Study locations
NCT04879628: Active Phase 2 study of Multiple Sclerosis, sponsored by Sanofi.
NCT04879628 is a Phase 2 study of Multiple Sclerosis that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 129 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04879628, a Phase 2 study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: * To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures * To evaluate the safety and tolerability of SAR441344 * To evaluate pharmacokinetics of SAR441344
Primary Outcome
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.
Conditions Studied
Interventions
- DRUG SAR441344 IV
- DRUG SAR441344 SC
- DRUG MRI contrast-enhancing preparations
- DRUG placebo IV
- DRUG placebo SC
Study Locations (20)
Other
- Investigational Site Number : 1000002 - Pleven
- Investigational Site Number : 1000003 - Sofia
- Investigational Site Number : 1000001 - Sofia
- Investigational Site Number : 2030003 - Brno
- Investigational Site Number : 2030002 - Hradec Králové
- Investigational Site Number : 2030001 - Jihlava
- Investigational Site Number : 2030005 - Ostrava - Poruba
- Investigational Site Number : 2030004 - Teplice
- Investigational Site Number : 2500006 - Calais
- Investigational Site Number : 2760012 - Leipzig
- Investigational Site Number : 2760004 - Münster
- Investigational Site Number : 6430002 - Kazan'
- Investigational Site Number : 6430007 - Moscow
- Investigational Site Number : 6430006 - Moscow
- Investigational Site Number : 6430001 - Moscow
Arizona
- Center for Neurology and Spine- Site Number : 8400007 - Phoenix
Florida
- University of South Florida Site Number : 8400001 - Tampa
North Carolina
- The Neurological Institute Site Number : 8400004 - Charlotte
Wisconsin
- Medical College of Wisconsin- Site Number : 8400006 - Milwaukee
Quebec
- Investigational Site Number : 1240001 - Gatineau
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2027-08-23 |
| Phase | Phase 2 |
What the registry record for NCT04879628 still lists
NCT04879628 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 5 interventions - of which SAR441344 IV is the first listed.
NCT04879628 names 20 study sites across 6 states, led by Other, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT04879628 about?
NCT04879628 is a clinical study titled "Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis". Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: * To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures * To evaluate the safety and tolerability of SAR441344 * To e...
What is the current status of trial NCT04879628?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2021-06-07. Estimated completion is 2027-08-23.
What conditions does trial NCT04879628 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04879628?
The interventions under investigation include: SAR441344 IV (DRUG), SAR441344 SC (DRUG), MRI contrast-enhancing preparations (DRUG), placebo IV (DRUG), placebo SC (DRUG).
Who is sponsoring clinical trial NCT04879628?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04879628 being conducted?
This trial has 20 study locations across Arizona, Florida, North Carolina, Wisconsin, Quebec. 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 NCT04879628's enrollment target sits among peer trials
129 103rd of 315 higher than 212 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.
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