NCT04879628

Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed description

The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	SAR441344 IV	Pharmaceutical form: Solution Route of administration: IV infusion
DRUG	placebo IV	Pharmaceutical form: Solution Route of administration: IV infusion
DRUG	SAR441344 SC	Pharmaceutical form: Solution Route of administration: SC injection
DRUG	placebo SC	Pharmaceutical form: Solution Route of administration: SC injection
DRUG	MRI contrast-enhancing preparations	gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem

Timeline

• Start date: 2021-06-07
• Primary completion: 2022-09-21
• Completion: 2027-08-23
• First posted: 2021-05-10
• Last updated: 2025-09-30
• Results posted: 2025-09-30

Locations

37 sites across 10 countries: United States, Bulgaria, Canada, Czechia, France, Germany, Russia, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study