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

Description

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.

Conditions

Multiple Sclerosis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Alabama Neurology Associates- Site Number : 8400115, Birmingham, Alabama, United States, 35209

Phoenix

Phoenix Neurological Associates - Phoenix- Site Number : 8400074, Phoenix, Arizona, United States, 85018

Scottsdale

Perseverance Research Center- Site Number : 8400138, Scottsdale, Arizona, United States, 85254

Scottsdale

Imaging Endpoints- Site Number : 8400050, Scottsdale, Arizona, United States, 85258

Berkeley

Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134, Berkeley, California, United States, 94705

Carlsbad

The Neurology Center of Southern California - Carlsbad- Site Number : 8400023, Carlsbad, California, United States, 92011

La Jolla

University of California San Diego Site Number : 8400095, La Jolla, California, United States, 92037

Los Angeles

Keck School of Medicine of University of Southern California- Site Number : 8400118, Los Angeles, California, United States, 90033

Newport Beach

Hoag Memorial Hospital Presbyterian- Site Number : 8400031, Newport Beach, California, United States, 92663

Palo Alto

Stanford Neuroscience Health Center- Site Number : 8400120, Palo Alto, California, United States, 94304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
  • * 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2028-03-24