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Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT04879628•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
•The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.
•The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
•Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening.
•Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•Capable of giving signed informed consent.

Exclusion Criteria

•The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
•The participant had conditions or situations that would adversely affect participation in this study.
•The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.
•History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
•Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.
•The participant had received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.
•The participant had taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.
•The participant had an EDSS score \>5.5 at the first screening visit.
•The participant had a relapse in the 30 days prior to randomization.
•Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
+4 more criteria

Locations (37)

Center for Neurology and Spine- Site Number : 8400007

Phoenix, Arizona, United States

University of South Florida Site Number : 8400001

Tampa, Florida, United States

The Neurological Institute Site Number : 8400004

Charlotte, North Carolina, United States

Medical College of Wisconsin- Site Number : 8400006

Milwaukee, Wisconsin, United States

Investigational Site Number : 1000002

Pleven, Bulgaria

Investigational Site Number : 1000003

Sofia, Bulgaria

Investigational Site Number : 1000001

Sofia, Bulgaria

Investigational Site Number : 1240001

Gatineau, Quebec, Canada

Investigational Site Number : 2030003

Brno, Czechia

Investigational Site Number : 2030002

Hradec Králové, Czechia

Key Dates

Start Date

June 7, 2021

Primary Completion Date

September 21, 2022

Completion Date

August 23, 2027

Last Updated

September 30, 2025

Enrollment

129

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

SAR441344 IV

DRUG

placebo IV

DRUG

SAR441344 SC

DRUG

placebo SC

DRUG

MRI contrast-enhancing preparations

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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