Recruiting
Phase 3

Frexalimab

Sponsor:

Sanofi

Code:

NCT07325292

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Frexalimab

Frexalimab

MRI contrast-enhancing preparations

Study Details

Brief 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.

Conditions

Multiple Sclerosis

Study ID

NCT07325292

Start date

Jan 14, 2026

Status verified date

Oct, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Frexalimab SC

Frexalimab SC (home self-administration via on-body delivery system(OBDS), is allowed from the beginning of Part B after appropriate training and participant and Investigator agreement)

experimental: Frexalimab IV

Frexalimab IV

Interventions

Frexalimab

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

Frexalimab

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

MRI contrast-enhancing preparations

Route of administration:IV injection

Primary outcome measure

  • Area under the curve over the interval W20 to W24(part A) [ Time Frame: Until Week 24 ]
  • Trough concentration at steady state(part A) [ Time Frame: Until Week 24 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

North Central Neurology Associates- Site Number : 8401100

Recruiting

Cullman, Alabama, United States, 35058

Alabama Neurology Associates- Site Number : 8400115

Recruiting

Homewood, Alabama, United States, 35209

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

Recruiting

Phoenix, Arizona, United States, 85032

Perseverance Research Center- Site Number : 8400138

Recruiting

Scottsdale, Arizona, United States, 85253

Center for Neurosciences - Tucson- Site Number : 8400194

Recruiting

Tucson, Arizona, United States, 85718

Chemidox Clinical Trials- Site Number : 8401157

Recruiting

Lancaster, California, United States, 93534

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

Recruiting

West Hollywood, California, United States, 90048

Rocky Mountain Regional VA Medical Center- Site Number : 8400121

Recruiting

Aurora, Colorado, United States, 80045

Advanced Neurology of Colorado- Site Number : 8400148

Recruiting

Fort Collins, Colorado, United States, 80528

Neurology of Central Florida- Site Number : 8400147

Recruiting

Altamonte Springs, Florida, United States, 32714

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

Recruiting

Gainesville, Florida, United States, 32608

Aqualane Clinical Research- Site Number : 8400026

Recruiting

Naples, Florida, United States, 34105

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

Recruiting

Orlando, Florida, United States, 32806

Neurology Associates of Ormond Beach- Site Number : 8400086

Recruiting

Ormond Beach, Florida, United States, 32174

University of South Florida- Site Number : 8400013

Recruiting

Tampa, Florida, United States, 33612

Palm Beach Neurology- Site Number : 8400105

Recruiting

West Palm Beach, Florida, United States, 33407

Atlanta Neuroscience Institute- Site Number : 8400075

Recruiting

Atlanta, Georgia, United States, 30327

Joi Life Wellness Group Llc- Site Number : 8400192

Recruiting

Smyrna, Georgia, United States, 30080

Consultants in Neurology- Site Number : 8400020

Recruiting

Northbrook, Illinois, United States, 60062

Baltimore Veterans Affairs Medical Center- Site Number : 8400163

Recruiting

Baltimore, Maryland, United States, 21201

Neurology Center of New England- Site Number : 8400164

Recruiting

Foxborough, Massachusetts, United States, 02035

Michigan Institute for Neurological Disorders- Site Number : 8400004

Recruiting

Farmington Hills, Michigan, United States, 48334

Holy Name Medical Center- Site Number : 8400101

Recruiting

Teaneck, New Jersey, United States, 07666

Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

Recruiting

Charlotte, North Carolina, United States, 28210

Raleigh Neurology Associates- Site Number : 8400014

Recruiting

Raleigh, North Carolina, United States, 27607

The Ohio State University- Site Number : 8400009

Recruiting

Columbus, Ohio, United States, 43210

The Boster Center for Multiple Sclerosis- Site Number : 8400006

Recruiting

Columbus, Ohio, United States, 43235

Abington Neurological Associates- Site Number : 8401065

Recruiting

Abington, Pennsylvania, United States, 19001

Hope Neurology- Site Number : 8400019

Recruiting

Knoxville, Tennessee, United States, 37922

ANESC Research- Site Number : 8400187

Recruiting

El Paso, Texas, United States, 79912

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

Recruiting

Plano, Texas, United States, 75024

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

Recruiting

Plano, Texas, United States, 75024

Neurology Center of San Antonio- Site Number : 8400099

Recruiting

San Antonio, Texas, United States, 78258

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

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Sanofi

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.