Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will have variable duration depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * The scheduled visits will include monthly visits for the first 6 months and quarterly visits thereafter until the common end of study (EOS), or premature end of treatment (pEOT) after which 3 follow-up visits will be performed

Key facts

Study ID

NCT06141473

Run by

Sanofi

People needed

1655

Starts

2023-12-13

Expected to finish

2027-05-06

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• North Central Neurology Associates- Site Number : 8401100 — Cullman, Alabama, United States
• Alabama Neurology Associates- Site Number : 8400115 — Homewood, Alabama, United States
• St. Joseph's Hospital and Medical Center- Site Number : 8401139 — Phoenix, Arizona, United States
• Perseverance Research Center- Site Number : 8401138 — Scottsdale, Arizona, United States
• Clinical Endpoints- Site Number : 8400050 — Scottsdale, Arizona, United States
• The Neurology Center of Southern California - Carlsbad- Site Number : 8400023 — Carlsbad, California, United States
• University of California Irvine - School of Medicine- Site Number : 8401143 — Irvine, California, United States
• Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122 — Laguna Hills, California, United States
• Chemidox Clinical Trials- Site Number : 8401157 — Lancaster, California, United States
• Hoag Memorial Hospital Presbyterian- Site Number : 8401031 — Newport Beach, California, United States
• Private Practice - Dr. Regina Berkovich- Site Number : 8400005 — West Hollywood, California, United States
• University of Colorado - Anschutz Medical Campus- Site Number : 8401001 — Aurora, Colorado, United States
• Advanced Neurology of Colorado- Site Number : 8401148 — Fort Collins, Colorado, United States
• Hartford Healthcare Medical Group- Site Number : 8401069 — Norwich, Connecticut, United States
• New England Institute for Clinical Research- Site Number : 8400114 — Stamford, Connecticut, United States
• MedStar Georgetown University Hospital- Site Number : 8400044 — Washington D.C., District of Columbia, United States
• Neurology of Central Florida- Site Number : 8401147 — Altamonte Springs, Florida, United States
• Neurology Offices of South Florida - Boca Raton- Site Number : 8401169 — Boca Raton, Florida, United States
• First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071 — Boca Raton, Florida, United States
• Nova Clinical Research - Bradenton- Site Number : 8400189 — Bradenton, Florida, United States
• Mayo Clinic in Florida- Site Number : 8401093 — Jacksonville, Florida, United States
• Neurology Associates - Maitland- Site Number : 8400010 — Maitland, Florida, United States
• University of Miami Hospital- Site Number : 8401177 — Miami, Florida, United States
• Design Neuroscience Center- Site Number : 8401191 — Miami Lakes, Florida, United States
• University of Alabama at Birmingham- Site Number : 8401135 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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