CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 129 enrolled
Drug / intervention
SAR441344 IV +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04879628
NCT04879628Phase 2Active

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

Sanofi·interventional·Posted May 10, 2021·Updated Sep 30, 2025

In Brief

A Phase 2 clinical trial evaluating SAR441344 IV, placebo IV, and 3 other interventions for Multiple Sclerosis. Active but no longer recruiting, targeting 129 participants across 37 sites in 10 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Canada, Czechia, France, Germany, Russia, Spain, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 2Active
202220232024202520262027
First PostedMay 10, 2021
Enrollment StartJun 7, 2021
Primary CompletionSep 21, 2022
Study CompletionAug 23, 2027
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.1 years ago

Interventions

SAR441344 IVdrug

Pharmaceutical form: Solution Route of administration: IV infusion

placebo IVdrug

Pharmaceutical form: Solution Route of administration: IV infusion

SAR441344 SCdrug

Pharmaceutical form: Solution Route of administration: SC injection

placebo SCdrug

Pharmaceutical form: Solution Route of administration: SC injection

MRI contrast-enhancing preparationsdrug

gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem