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Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis

← catalyst calendar

NCT07325292 · readout in 330 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
160estimated
Sites
38
Countries
Belgium, China, Italy +2

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
DateFiledBasisWhat it is
Start2026-01-14actualWhen the study began enrolling
Primary completion2027-07-15estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2028-11-30estimatedThe whole study's end, after follow-up
First posted2026-01-08actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-14actualThe 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 — also filed as SAR441344
  • Drug: Frexalimab — also filed as SAR441344
  • Drug: MRI contrast-enhancing preparations

Primary outcomes

what the primary-completion date above is the date OF
Area under the curve over the interval W20 to W24(part A)
measured Until Week 24
Trough concentration at steady state(part A)
measured Until Week 24

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