Evaluating Frexalimab for Relapsing Multiple Sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of frexalimab compared to teriflunomide in adults with relapsing forms of multiple sclerosis. Participants aged 18 to 55 will be monitored for their annualized relapse rate over a variable duration of 12 to 40 months. The study includes regular follow-up visits and MRI assessments to track disease progression and treatment response. The trial will involve both active treatments and placebo controls to ensure robust data collection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
* The participant has an EDSS score ≤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.
* Contraceptive use by men or 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 PPMS according to the 2017 revision of the McDonald diagnostic criteria
* 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.
* Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia.
* 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 had a relapse in the 30 days prior to randomization.
* The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it's running

• University of Alabama at Birmingham- Site Number : 8401135
  Birmingham, Alabama, United States Recruiting
• North Central Neurology Associates- Site Number : 8401100
  Cullman, Alabama, United States Recruiting
• Alabama Neurology Associates- Site Number : 8400115
  Homewood, Alabama, United States Recruiting
• St. Joseph's Hospital and Medical Center- Site Number : 8401139
  Phoenix, Arizona, United States Recruiting
• Perseverance Research Center- Site Number : 8401138
  Scottsdale, Arizona, United States Recruiting
• Clinical Endpoints- Site Number : 8400050
  Scottsdale, Arizona, United States Recruiting

+334 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free number for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing under-the-skin versus intravenous frexalimab for adults with multiple sclerosis

  This will test whether subcutaneous frexalimab given every 4 weeks works as well as intravenous frexalimab every 4 weeks for adults with relapsing MS or non-relapsing secondary progressive MS.

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• Treadmill-based virtual reality walking training for MS patients

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  Recruiting Shepherd Center, Atlanta GA · Atlanta, Georgia · NCT07927439

• Virtual Reality and Mental Practice to Improve Balance and Walking in Relapsing MS

  This study tests whether virtual reality training or mental practice can improve balance and walking in people with relapsing–remitting multiple sclerosis.

  Recruiting Cairo University · Giza, Giza Governorate · NCT07918339

• REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

  This study tests how AHSCT compares to high-efficacy MS medicines in adults treated in routine clinical care.

  Recruiting Imperial College London · London and 2 other locations · NCT07899502

• Tolebrutinib in real-world MS care for patients treated by clinicians

  This real-world study sees how tolebrutinib is used for multiple sclerosis patients and what outcomes look like in everyday practice.

  Recruiting Sanofi · Marina, Abu Dhabi Emirate · NCT07898371

• Pilates via live video vs. prerecorded videos for people with multiple sclerosis

  This study tests whether live, coach-led Pilates sessions through video calls are more beneficial than prerecorded Pilates videos for adults with MS.

  Recruiting Yuzuncu Yil University · Van · NCT07893925

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.