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

NCT07325292 · Sanofi
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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
About this study
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 or 11 for participants receiving frexalimab SC or IV, respectively, 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.
Eligibility 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.
Study design
Enrollment target: 160 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2026-01-14
Estimated completion: 2028-11-30
Last updated: 2026-05-29
Interventions
Drug: FrexalimabDrug: FrexalimabDrug: MRI contrast-enhancing preparations
Primary outcomes
  • Area under the curve over the interval W20 to W24(part A) (Until Week 24)
  • Trough concentration at steady state(part A) (Until Week 24)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · Contact-US@sanofi.com · 800-633-1610
All locations (32)
North Central Neurology Associates- Site Number : 8401100Recruiting
Cullman, Alabama, United States
Alabama Neurology Associates- Site Number : 8400115Recruiting
Homewood, Alabama, United States
Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195Recruiting
Phoenix, Arizona, United States
Perseverance Research Center- Site Number : 8400138Recruiting
Scottsdale, Arizona, United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005Recruiting
West Hollywood, California, United States
Advanced Neurology of Colorado- Site Number : 8400148Recruiting
Fort Collins, Colorado, United States
Neurology of Central Florida- Site Number : 8400147Recruiting
Altamonte Springs, Florida, United States
Aqualane Clinical Research- Site Number : 8400026Recruiting
Naples, Florida, United States
Neurology Associates of Ormond Beach- Site Number : 8400086Recruiting
Ormond Beach, Florida, United States
Palm Beach Neurology- Site Number : 8400105Recruiting
West Palm Beach, Florida, United States
Joi Life Wellness Group LLC- Site Number : 8400192Recruiting
Smyrna, Georgia, United States
Consultants in Neurology- Site Number : 8400020Recruiting
Northbrook, Illinois, United States
Michigan Institute for Neurological Disorders- Site Number : 8400004Recruiting
Farmington Hills, Michigan, United States
Holy Name Medical Center- Site Number : 8400101Recruiting
Teaneck, New Jersey, United States
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002Recruiting
Charlotte, North Carolina, United States
Raleigh Neurology Associates- Site Number : 8400014Recruiting
Raleigh, North Carolina, United States
The Ohio State University- Site Number : 8400009Recruiting
Columbus, Ohio, United States
Hope Neurology- Site Number : 8400019Recruiting
Knoxville, Tennessee, United States
ANESC Research- Site Number : 8400187Recruiting
El Paso, Texas, United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082Recruiting
Plano, Texas, United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083Recruiting
Plano, Texas, United States
Investigational Site Number : 0560001Recruiting
Bruges, Belgium
Investigational Site Number : 0560008Recruiting
Brussels, Belgium
Investigational Site Number : 0560006Recruiting
Ghent, Belgium
Investigational Site Number : 0560007Recruiting
Kortrijk, Belgium
Investigational Site Number : 0560005Recruiting
Overpelt, Belgium
Investigational Site Number : 1560004Recruiting
Chengdu, China
Investigational Site Number : 1561029Recruiting
Chengdu, China
Investigational Site Number : 1560010Recruiting
Jiazhuang, China
Investigational Site Number : 3920017Recruiting
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920008Recruiting
Yahaba, Iwate, Japan
Investigational Site Number : 3920001Recruiting
Kyoto, Japan
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis · TrialPath