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Clinical Trials in the USA / NCT07325292
Recruiting Phase 3

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

NCT07325292 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2026-01-14
Last updated
2026-09-15

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

FrexalimabFrexalimabMRI contrast-enhancing preparations

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
North Central Neurology Associates- Site Number : 8401100 Cullman Alabama Recruiting
Alabama Neurology Associates- Site Number : 8400115 Homewood Alabama Recruiting
Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195 Phoenix Arizona Recruiting
Perseverance Research Center- Site Number : 8400138 Scottsdale Arizona Recruiting
Private Practice - Dr. Regina Berkovich- Site Number : 8400005 West Hollywood California Recruiting
Advanced Neurology of Colorado- Site Number : 8400148 Fort Collins Colorado Recruiting
Neurology of Central Florida- Site Number : 8400147 Altamonte Springs Florida Recruiting
Aqualane Clinical Research- Site Number : 8400026 Naples Florida Recruiting
Neurology Associates of Ormond Beach- Site Number : 8400086 Ormond Beach Florida Recruiting
Palm Beach Neurology- Site Number : 8400105 West Palm Beach Florida Recruiting
Joi Life Wellness Group LLC- Site Number : 8400192 Smyrna Georgia Recruiting
Consultants in Neurology- Site Number : 8400020 Northbrook Illinois Recruiting
Baltimore Veterans Affairs Medical Center- Site Number : 8400163 Baltimore Maryland Recruiting
Michigan Institute for Neurological Disorders- Site Number : 8400004 Farmington Hills Michigan Recruiting
Holy Name Medical Center- Site Number : 8400101 Teaneck New Jersey Recruiting
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002 Charlotte North Carolina Recruiting
Raleigh Neurology Associates- Site Number : 8400014 Raleigh North Carolina Recruiting
The Ohio State University- Site Number : 8400009 Columbus Ohio Recruiting
The Boster Center for Multiple Sclerosis- Site Number : 8400006 Columbus Ohio Recruiting
Hope Neurology- Site Number : 8400019 Knoxville Tennessee Recruiting
ANESC Research- Site Number : 8400187 El Paso Texas Recruiting
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082 Plano Texas Recruiting
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083 Plano Texas Recruiting
Investigational Site Number : 0560001 Bruges Belgium Recruiting
Investigational Site Number : 0560008 Brussels Belgium Recruiting
Investigational Site Number : 0560006 Ghent Belgium Recruiting
Investigational Site Number : 0560007 Kortrijk Belgium Recruiting
Investigational Site Number : 0560005 Overpelt Belgium Recruiting
Investigational Site Number : 1560005 Beijing China Recruiting
Investigational Site Number : 1560004 Chengdu China Recruiting
Investigational Site Number : 1561029 Chengdu China Recruiting
Investigational Site Number : 1560010 Jiazhuang China Recruiting
Investigational Site Number : 3800016 Milan Milano Recruiting
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia Site Number : 3800019 Foggia Italy Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico Site Number : 3800038 Roma Italy Recruiting
Azienda Ospedaliera San Camillo Forlanini Site Number : 3800001 Roma Italy Recruiting
Investigational Site Number : 3920017 Sapporo Hokkaido Recruiting
Investigational Site Number : 3920008 Yahaba Iwate Recruiting
Investigational Site Number : 3920001 Kyoto Japan Recruiting
Investigational Site Number : 3920012 Tokyo Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07325292 on ClinicalTrials.gov ↗ ← All trials in the USA