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

Study acronym: Frexcite
StatusRecruiting
PhasePhase 3
SponsorSanofi
Started

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Record History

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  1. Trial sites expanded: 40 → 68 locations
  2. Study sites: 38 to 40
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 11 entries
  3. Trial sites expanded: 34 → 38 locationsv12
  4. Secondary endpoints revised (11)v11
  5. Study sites: 32 to 34v10
  6. Trial sites expanded: 24 → 32 locationsv9
  7. Trial sites expanded: 18 → 24 locationsv8
  8. Trial sites expanded: 10 → 18 locationsv7
  9. Study sites: 9 to 10v6
  10. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 6 to 11
    v5
  11. Study sites: 7 to 9v4
  12. Study sites: 4 to 7v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Jan 1, 2026 to Jan 14, 2026
    v2
  14. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
285 trials monitored
See 12 trials at risk
Multiple Sclerosis
1,018 trials monitored
See 34 trials at risk
This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 for participants receiving frexalimab SC or IV, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.
Trial Details
NCT Number NCT07325292
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov