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Clinical Trials in the UK / NCT06141486
Active, not recruiting Phase 3

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

NCT06141486 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2023-12-27
Last updated
2026-05-14

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

FrexalimabPlaceboMRI contrast-enhancing agents

Frexalimab: SAR441344 Solution for IV infusion

Placebo: Solution for IV infusion

MRI contrast-enhancing agents: IV, as per respective label

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (311)

FacilityCityRegionStatus
Alabama Neurology Associates- Site Number : 8400115 Homewood Alabama
Perseverance Research Center- Site Number : 8400138 Scottsdale Arizona
Imaging Endpoints- Site Number : 8400050 Scottsdale Arizona
Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134 Berkeley California
University of California Irvine - School of Medicine- Site Number : 8400143 Irvine California
University of California San Diego - La Jolla- Site Number : 8400095 La Jolla California
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184 Los Angeles California
Hoag Memorial Hospital Presbyterian- Site Number : 8400031 Newport Beach California
Stanford Neuroscience Health Center- Site Number : 8400120 Palo Alto California
Private Practice - Dr. Regina Berkovich- Site Number : 8400005 West Hollywood California
University of Colorado - Anschutz Medical Campus- Site Number : 8400001 Aurora Colorado
Advanced Neurology of Colorado- Site Number : 8400148 Fort Collins Colorado
Yale University School of Medicine- Site Number : 8400081 New Haven Connecticut
Hartford Healthcare Medical Group- Site Number : 8400069 Norwich Connecticut
MedStar Georgetown University Hospital- Site Number : 8400044 Washington D.C. District of Columbia
Neurology of Central Florida- Site Number : 8400147 Altamonte Springs Florida
MS & Neuromuscular Center of Excellence- Site Number : 8400015 Clearwater Florida
Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054 Gainesville Florida
Neurology Associates - Maitland- Site Number : 8400010 Maitland Florida
Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060 Orlando Florida
Axiom Clinical Research of Florida- Site Number : 8400049 Tampa Florida
University of South Florida- Site Number : 8400013 Tampa Florida
Palm Beach Neurology- Site Number : 8400105 West Palm Beach Florida
Joi Life Wellness Group LLC- Site Number : 8400192 Smyrna Georgia
Rush University Medical Center- Site Number : 8400102 Chicago Illinois
University of Chicago Medical Center- Site Number : 8400055 Chicago Illinois
Consultants in Neurology- Site Number : 8400020 Northbrook Illinois
Neuroscience Institute Center- Site Number : 8400053 Merrillville Indiana
University of Iowa- Site Number : 8400029 Iowa City Iowa
University of Kansas Medical Center- Site Number : 8400084 Kansas City Kansas
Baptist Health Lexington- Site Number : 8400149 Lexington Kentucky
NeuroMedical Clinic of Central Louisiana- Site Number : 8400159 Alexandria Louisiana
Ochsner Medical Center - Jefferson Highway- Site Number : 8400027 New Orleans Louisiana
University of Maryland School of Medicine - Baltimore- Site Number : 8400185 Baltimore Maryland
Johns Hopkins Hospital- Site Number : 8400080 Baltimore Maryland
Tufts Medical Center- Site Number : 8400003 Boston Massachusetts
Boston Clinical Trials- Site Number : 8400178 Boston Massachusetts
Neurology Center of New England- Site Number : 8400164 Foxborough Massachusetts
The Elliot Lewis Center- Site Number : 8400033 Wellesley Massachusetts
UMass Memorial Medical Center - University Campus- Site Number : 8400028 Worcester Massachusetts

+ 271 more sites — see the full list on the official registry below.

More Sanofi trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06141486 on ClinicalTrials.gov ↗ ← All trials in the UK