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RecruitingPhase 3

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

Sanofi · NCT07325292

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
160
US sites recruiting
34
Study start
January 14, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Frexalimab; Frexalimab; MRI contrast-enhancing preparations

Conditions: Multiple Sclerosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • North Central Neurology Associates- Site Number : 8401100

    Cullman, AL 35058

  • Alabama Neurology Associates- Site Number : 8400115

    Homewood, AL 35209

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

    Phoenix, AZ 85032

  • Perseverance Research Center- Site Number : 8400138

    Scottsdale, AZ 85253

  • Center for Neurosciences - Tucson- Site Number : 8400194

    Tucson, AZ 85718

  • Chemidox Clinical Trials- Site Number : 8401157

    Lancaster, CA 93534

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

    West Hollywood, CA 90048

  • Rocky Mountain Regional VA Medical Center- Site Number : 8400121

    Aurora, CO 80045

  • Advanced Neurology of Colorado- Site Number : 8400148

    Fort Collins, CO 80528

  • Neurology of Central Florida- Site Number : 8400147

    Altamonte Springs, FL 32714

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

    Gainesville, FL 32608

  • Aqualane Clinical Research- Site Number : 8400026

    Naples, FL 34105

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

    Orlando, FL 32806

  • Neurology Associates of Ormond Beach- Site Number : 8400086

    Ormond Beach, FL 32174

  • University of South Florida- Site Number : 8400013

    Tampa, FL 33612

  • Palm Beach Neurology- Site Number : 8400105

    West Palm Beach, FL 33407

  • Atlanta Neuroscience Institute- Site Number : 8400075

    Atlanta, GA 30327

  • Joi Life Wellness Group Llc- Site Number : 8400192

    Smyrna, GA 30080

  • Consultants in Neurology- Site Number : 8400020

    Northbrook, IL 60062

  • Baltimore Veterans Affairs Medical Center- Site Number : 8400163

    Baltimore, MD 21201

  • Neurology Center of New England- Site Number : 8400164

    Foxborough, MA 02035

  • Michigan Institute for Neurological Disorders- Site Number : 8400004

    Farmington Hills, MI 48334

  • Holy Name Medical Center- Site Number : 8400101

    Teaneck, NJ 07666

  • Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

    Charlotte, NC 28210

  • Raleigh Neurology Associates- Site Number : 8400014

    Raleigh, NC 27607

  • The Ohio State University- Site Number : 8400009

    Columbus, OH 43210

  • The Boster Center for Multiple Sclerosis- Site Number : 8400006

    Columbus, OH 43235

  • Abington Neurological Associates- Site Number : 8401065

    Abington, PA 19001

  • Hope Neurology- Site Number : 8400019

    Knoxville, TN 37922

  • ANESC Research- Site Number : 8400187

    El Paso, TX 79912

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

    Plano, TX 75024

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

    Plano, TX 75024

  • Neurology Center of San Antonio- Site Number : 8400099

    San Antonio, TX 78258

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

    Milwaukee, WI 53226

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
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Non-inferiority Study of Frexalimab Subcutaneous Administration… (NCT07325292) | Bored Studies