Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
129actual
Sites
37
Countries
Bulgaria, Canada, Czechia +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-06-07 | actual | When the study began enrolling |
| Primary completion | 2022-09-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-08-23 | estimated | The whole study's end, after follow-up |
| First posted | 2021-05-10 | actual | When this record first appeared on the registry |
| Results posted | 2025-09-30 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-09-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Multiple Sclerosis
Interventions
- Drug: SAR441344 IV
- Drug: placebo IV
- Drug: SAR441344 SC
- Drug: placebo SC
- Drug: MRI contrast-enhancing preparations
Primary outcome
what the primary-completion date above is the date OFMean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)
measured Week 8 and Week 12
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-18 · 4.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-10-18 · 700 KB · SAP_001.pdf
Publications
- PMID 38354138 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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