Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.

Key facts

Study ID: NCT06141486
Run by: Sanofi
People needed: 943
Starts: 2023-12-27
Expected to finish: 2028-03-24
Last updated by the study team: 2026-05-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
Absence of clinical relapses for at least 24 months.
The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

You may not qualify if…

The participant has a history of infection or may be at risk for infection.
The presence of psychiatric disturbance or substance abuse.
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.
Current hypogammaglobulinemia defined by immunoglobulin levels (IgG and/or IgM) below the lower limits of normal (LLN) at Screening or a history of primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening.
A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
The participant has sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
The participant was previously exposed to frexalimab.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

Perseverance Research Center- Site Number : 8400138 — Scottsdale, Arizona, United States
Imaging Endpoints- Site Number : 8400050 — Scottsdale, Arizona, United States
Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134 — Berkeley, California, United States
University of California Irvine - School of Medicine- Site Number : 8400143 — Irvine, California, United States
University of California San Diego - La Jolla- Site Number : 8400095 — La Jolla, California, United States
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184 — Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian- Site Number : 8400031 — Newport Beach, California, United States
Stanford Neuroscience Health Center- Site Number : 8400120 — Palo Alto, California, United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005 — West Hollywood, California, United States
University of Colorado - Anschutz Medical Campus- Site Number : 8400001 — Aurora, Colorado, United States
Advanced Neurology of Colorado- Site Number : 8400148 — Fort Collins, Colorado, United States
Yale University School of Medicine- Site Number : 8400081 — New Haven, Connecticut, United States
Hartford Healthcare Medical Group- Site Number : 8400069 — Norwich, Connecticut, United States
MedStar Georgetown University Hospital- Site Number : 8400044 — Washington D.C., District of Columbia, United States
Neurology of Central Florida- Site Number : 8400147 — Altamonte Springs, Florida, United States
MS & Neuromuscular Center of Excellence- Site Number : 8400015 — Clearwater, Florida, United States
Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054 — Gainesville, Florida, United States
Neurology Associates - Maitland- Site Number : 8400010 — Maitland, Florida, United States
Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060 — Orlando, Florida, United States
Axiom Clinical Research of Florida- Site Number : 8400049 — Tampa, Florida, United States
University of South Florida- Site Number : 8400013 — Tampa, Florida, United States
Palm Beach Neurology- Site Number : 8400105 — West Palm Beach, Florida, United States
Joi Life Wellness Group LLC- Site Number : 8400192 — Smyrna, Georgia, United States
Rush University Medical Center- Site Number : 8400102 — Chicago, Illinois, United States
Alabama Neurology Associates- Site Number : 8400115 — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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