Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
← catalyst calendarNCT06141473 · readout in 259 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,655actual
Sites
382
Countries
Argentina, Austria, Belgium +38
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 | 2023-12-13 | actual | When the study began enrolling |
| Primary completion | 2027-05-06 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-05-06 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-20 | 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: Frexalimab
- Drug: Teriflunomide
- Drug: Placebo infusion
- Drug: Placebo tablet
- Drug: MRI contrast-enhancing agents
- Drug: Cholestyramine
- Drug: Activated charcoal
Primary outcome
what the primary-completion date above is the date OFAnnualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses
measured Until Week 156
Publications
- PMID 39899371 — 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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