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RECRUITING

NCT07325292

PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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 for participants receiving frexalimab SC or IV, 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.

Official title: A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-01-14

Completion Date

2028-11-30

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Multiple Sclerosis

Interventions

DRUG

Frexalimab

Pharmaceutical form:Solution for injection-Route of administration:SC injection

DRUG

Frexalimab

Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion

DRUG

MRI contrast-enhancing preparations

Route of administration:IV injection

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.

Locations (68)

North Central Neurology Associates- Site Number : 8401100

Cullman, Alabama, United States

Alabama Neurology Associates- Site Number : 8400115

Homewood, Alabama, United States

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

Phoenix, Arizona, United States

Perseverance Research Center- Site Number : 8400138

Scottsdale, Arizona, United States

Center for Neurosciences - Tucson- Site Number : 8400194

Tucson, Arizona, United States

Chemidox Clinical Trials- Site Number : 8401157

Lancaster, California, United States

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

West Hollywood, California, United States

Rocky Mountain Regional VA Medical Center- Site Number : 8400121

Aurora, Colorado, United States

Advanced Neurology of Colorado- Site Number : 8400148

Fort Collins, Colorado, United States

Neurology of Central Florida- Site Number : 8400147

Altamonte Springs, Florida, United States

Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054

Gainesville, Florida, United States

Aqualane Clinical Research- Site Number : 8400026

Naples, Florida, United States

Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060

Orlando, Florida, United States

Neurology Associates of Ormond Beach- Site Number : 8400086

Ormond Beach, 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

Atlanta Neuroscience Institute- Site Number : 8400075

Atlanta, Georgia, United States

Joi Life Wellness Group Llc- Site Number : 8400192

Smyrna, Georgia, United States

Consultants in Neurology- Site Number : 8400020

Northbrook, Illinois, United States

Baltimore Veterans Affairs Medical Center- Site Number : 8400163

Baltimore, Maryland, United States

Neurology Center of New England- Site Number : 8400164

Foxborough, Massachusetts, United States

Michigan Institute for Neurological Disorders- Site Number : 8400004

Farmington Hills, Michigan, United States

Holy Name Medical Center- Site Number : 8400101

Teaneck, New Jersey, United States

Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

Charlotte, North Carolina, United States

Raleigh Neurology Associates- Site Number : 8400014

Raleigh, North Carolina, United States

The Ohio State University- Site Number : 8400009

Columbus, Ohio, United States

The Boster Center for Multiple Sclerosis- Site Number : 8400006

Columbus, Ohio, United States

Abington Neurological Associates- Site Number : 8401065

Abington, Pennsylvania, United States

Hope Neurology- Site Number : 8400019

Knoxville, Tennessee, United States

ANESC Research- Site Number : 8400187

El Paso, Texas, United States

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

Plano, Texas, United States

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

Plano, Texas, United States

Neurology Center of San Antonio- Site Number : 8400099

San Antonio, Texas, United States

Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038

Milwaukee, Wisconsin, United States

Investigational Site Number : 0560001

Bruges, Belgium

Investigational Site Number : 0560008

Brussels, Belgium

Investigational Site Number : 0560006

Ghent, Belgium

Investigational Site Number : 0560007

Kortrijk, Belgium

Investigational Site Number : 0560005

Overpelt, Belgium

L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003

Brasília, Federal District, Brazil

Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760001

Curitiba, Paraná, Brazil

Clínica Neurológica- Site Number : 0760007

Joinville, Santa Catarina, Brazil

Investigational Site Number : 1560005

Beijing, China

Investigational Site Number : 1560004

Chengdu, China

Investigational Site Number : 1561029

Chengdu, China

Investigational Site Number : 1560020

Dongguan, China

Investigational Site Number : 1560002

Guangzhou, China

Investigational Site Number : 1560010

Jiazhuang, China

Investigational Site Number : 1560014

Shenyang, China

Investigational Site Number : 3800037

Montichiari, Brescia, Italy

Investigational Site Number : 3800016

Milan, Milano, Italy

Investigational Site Number : 3800036

Rozzano, Milano, Italy

Investigational Site Number : 3801007

Cagliari, Italy

Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia Site Number : 3800019

Foggia, Italy

Fondazione Policlinico Universitario Campus Bio-Medico Site Number : 3800038

Roma, Italy

Azienda Ospedaliera San Camillo Forlanini Site Number : 3800001

Roma, Italy

Investigational Site Number : 3920003

Kōriyama, Fukushima, Japan

Investigational Site Number : 3920017

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920008

Yahaba, Iwate, Japan

Investigational Site Number : 3920015

Higashi-Matsuyama, Saitama, Japan

Investigational Site Number : 3920016

Kodaira, Tokyo, Japan

Investigational Site Number : 3920001

Kyoto, Japan

Investigational Site Number : 3920012

Tokyo, Japan

Investigational Site Number : 7240010

Barcelona, Catalunya [Cataluña], Spain

Investigational Site Number : 7240001

Pozuelo de Alarcón, Madrid, Spain

Investigational Site Number : 7240014

Vigo, Pontevedra [Pontevedra], Spain

Investigational Site Number : 7240023

Madrid, Spain

Investigational Site Number : 7240005

Málaga, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)