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NCT07325292PHASE3Recruiting

Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis

Sanofi

Start Date

1/14/2026

Completion Date

11/30/2028

Summary

This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.

Eligibility Criteria

Age Range: 18 years to 60 years

Inclusion Criteria: The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group: Group A (RMS) * The 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 in accordance with the 2017 revised McDonald criteria. * The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit). * The participant must have at least 1 of the following prior to screening: * 1 documented relapse within the previous year OR * 2 documented relapses within the previous 2 years, OR * 1 documented Gd enhancing lesion on an MRI scan within the previous year. Group B (nrSPMS) * Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria * The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent. * The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013. * The participant must have documented evidence of disability progression observed during the 12 months before screening. * The participant must have an absence of clinical relapses for at least 24 months. * The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit). Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply: \- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria. * The participant has a history of infection or may be at risk for infection: * Fever within 28 days of the Screening Visit * 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 antiphospholipid syndrome and any participants requiring antithrombotic treatment. * Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia. * A history or presence of disease that can mimic MS symptoms. * The participant has a contraindication for MRI. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interventions

DRUG

Frexalimab

DRUG

Frexalimab

DRUG

MRI contrast-enhancing preparations

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Conditions

Multiple Sclerosis

Locations

North Central Neurology Associates- Site Number : 8401100

Cullman, Alabama 35058

United States

Alabama Neurology Associates- Site Number : 8400115

Homewood, Alabama 35209

United States

Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195

Phoenix, Arizona 85032

United States

Perseverance Research Center- Site Number : 8400138

Scottsdale, Arizona 85253

United States

Private Practice - Dr. Regina Berkovich- Site Number : 8400005

West Hollywood, California 90048

United States

Advanced Neurology of Colorado- Site Number : 8400148

Fort Collins, Colorado 80528

United States

Neurology of Central Florida- Site Number : 8400147

Altamonte Springs, Florida 32714

United States

Aqualane Clinical Research- Site Number : 8400026

Naples, Florida 34105

United States

Neurology Associates of Ormond Beach- Site Number : 8400086

Ormond Beach, Florida 32174

United States

Palm Beach Neurology- Site Number : 8400105

West Palm Beach, Florida 33407

United States

Joi Life Wellness Group LLC- Site Number : 8400192

Smyrna, Georgia 30080

United States

Consultants in Neurology- Site Number : 8400020

Northbrook, Illinois 60062

United States

Michigan Institute for Neurological Disorders- Site Number : 8400004

Farmington Hills, Michigan 48334

United States

Holy Name Medical Center- Site Number : 8400101

Teaneck, New Jersey 07666

United States

Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

Charlotte, North Carolina 28210

United States

Raleigh Neurology Associates- Site Number : 8400014

Raleigh, North Carolina 27607

United States

The Ohio State University- Site Number : 8400009

Columbus, Ohio 43210

United States

The Boster Center for Multiple Sclerosis- Site Number : 8400006

Columbus, Ohio 43235

United States

Hope Neurology- Site Number : 8400019

Knoxville, Tennessee 37922

United States

ANESC Research- Site Number : 8400187

El Paso, Texas 79912

United States

North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082

Plano, Texas 75024

United States

North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083

Plano, Texas 75024

United States

Investigational Site Number : 0560001

Bruges, 8000

Belgium

Investigational Site Number : 0560008

Brussels, 1200

Belgium

Investigational Site Number : 0560006

Ghent, 9000

Belgium

Investigational Site Number : 0560007

Kortrijk, 8500

Belgium

Investigational Site Number : 0560005

Overpelt, 3900

Belgium

Investigational Site Number : 1560005

Beijing, 100034

China

Investigational Site Number : 1560004

Chengdu, 610041

China

Investigational Site Number : 1561029

Chengdu, 610072

China

Investigational Site Number : 1560010

Jiazhuang, 050000

China

Investigational Site Number : 3920017

Sapporo, Hokkaido 063-0005

Japan

Investigational Site Number : 3920008

Yahaba, Iwate 028-3695

Japan

Investigational Site Number : 3920001

Kyoto, 616-8255

Japan