Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04879628
The ClinicalTrials.gov registry entry for NCT04879628 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (78% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype
RECRUITING · Phase 2
-
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
RECRUITING · Phase 2
-
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
RECRUITING · Phase 2
-
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
RECRUITING · Phase 2
-
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
RECRUITING · Phase 2
-
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.