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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513527-17-00

Acronym

ACT16877

Enrollment

Registered

2024-08-08

Start date

2021-06-07

Completion date

Unknown

Last updated

2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

Number of new Gadolinium (Gd)-enhancing T1hyperintense (GdE T1) lesions at week 12

Detailed description

Total number of GdE T1 lesions at week 12, Adverse events (AEs) and serious adverse events (SAEs) until week 316, Antidrug antibodies (ADA) until week 316, Pharmacokinetic (PK) parameters: Cmax until week 316, PK parameter: tmax until week 316, PK parameter: AUC0-tau until week 316, PK parameter: t1/2z until week 316

Interventions

DRUGMatched Placebo for test product Frexalimab

DRUGFrexalimab

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Number of new Gadolinium (Gd)-enhancing T1hyperintense (GdE T1) lesions at week 12	—

Secondary

Measure	Time frame
Total number of GdE T1 lesions at week 12, Adverse events (AEs) and serious adverse events (SAEs) until week 316, Antidrug antibodies (ADA) until week 316, Pharmacokinetic (PK) parameters: Cmax until week 316, PK parameter: tmax until week 316, PK parameter: AUC0-tau until week 316, PK parameter: t1/2z until week 316	—

Countries

Bulgaria, Czechia, France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026