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RECRUITINGPhase 3INTERVENTIONAL

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

A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Frexalimab

SAR441344 Solution for IV infusion

DRUG

Placebo

Solution for IV infusion

DRUG

MRI contrast-enhancing agents

IV, as per respective label

Locations (20)

Alabama Neurology Associates- Site Number : 8400115
Birmingham, Alabama, United States
Dignity Health St. Joseph's Hospital and Medical Center- Site Number : 8400139
Phoenix, Arizona, United States
HonorHealth Neurology- Site Number : 8400074
Scottsdale, Arizona, United States
Perseverance Research Center- Site Number : 8400138
Scottsdale, Arizona, United States
Imaging EndPoints- Site Number : 8400050
Scottsdale, Arizona, United States
Sutter East Bay Medical Foundation- Site Number : 8400134
Berkeley, California, United States
The Research Center of Southern California, LLC- Site Number : 8400023
Carlsbad, California, United States
University of California, Irvine- Site Number : 8400143
Irvine, California, United States
University of California San Diego- Site Number : 8400095
La Jolla, California, United States
Southern California Permanente Medical Group- Site Number : 8400184
Los Angeles, California, United States
University of Southern California, Los Angeles- Site Number : 8400118
Los Angeles, California, United States
Hoag Memorial Hospital- Site Number : 8400031
Newport Beach, California, United States
Stanford Neuroscience Health Center- Site Number : 8400120
Palo Alto, California, United States
Regina Berkovich, MD, PhD- Site Number : 8400005
West Hollywood, California, United States
University of Colorado Health Science Center- Site Number : 8400001
Aurora, Colorado, United States
Advanced Neurosciences Research- Site Number : 8400148
Fort Collins, Colorado, United States
Yale University- Site Number : 8400081
New Haven, Connecticut, United States
Hartford Healthcare Medical Group- Site Number : 8400069
Norwich, Connecticut, United States
New England Institute for Clinical Research- Site Number : 8400114
Stamford, Connecticut, United States
Georgetown University Hospital- Site Number : 8400044
Washington D.C., District of Columbia, United States