RecruitingPhase 3NCT07325292

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

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

Sponsor

Sanofi

Enrollment

160 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

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 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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of giving a drug called frexalimab — as a subcutaneous injection (under the skin, like an insulin shot) versus as an intravenous infusion (through a drip) — in people with multiple sclerosis (MS). Researchers want to see if the injection method works just as well as the infusion, which would make treatment more convenient. **You may be eligible if...** - You are 18–55 years old with relapsing MS (Group A): you must have had at least 1 relapse in the past year, 2 in the past 2 years, or 1 active brain lesion on MRI in the past year - OR you are 18–60 years old with non-relapsing secondary progressive MS (Group B): your MS has been worsening steadily for 12 months without relapses, and your disability score is between 3.0 and 6.5 - You have a documented prior diagnosis of relapsing-remitting MS **You may NOT be eligible if...** - You have primary progressive MS (worsening from the start without relapses) - You have other serious medical conditions or immune system problems - You are pregnant or not willing to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFrexalimab

Pharmaceutical form:Solution for injection-Route of administration:SC injection

DRUGFrexalimab

Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion

DRUGMRI contrast-enhancing preparations

Route of administration:IV injection

Locations(18)

North Central Neurology Associates- Site Number : 8401100

Cullman, Alabama, United States

Alabama Neurology Associates- Site Number : 8400115

Homewood, Alabama, United States

Perseverance Research Center- Site Number : 8400138

Scottsdale, Arizona, United States

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

West Hollywood, California, United States

Neurology of Central Florida- Site Number : 8400147

Altamonte Springs, Florida, United States

Aqualane Clinical Research- Site Number : 8400026

Naples, Florida, United States

Neurology Associates of Ormond Beach- Site Number : 8400086

Ormond Beach, Florida, United States

Palm Beach Neurology- Site Number : 8400105

West Palm Beach, Florida, United States

Joi Life Wellness Group LLC- Site Number : 8400192

Smyrna, Georgia, United States

Michigan Institute for Neurological Disorders- Site Number : 8400004

Farmington Hills, Michigan, United States

Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

Charlotte, North Carolina, United States

Raleigh Neurology Associates- Site Number : 8400014

Raleigh, North Carolina, United States

Hope Neurology- Site Number : 8400019

Knoxville, Tennessee, United States

ANESC Research- Site Number : 8400187

El Paso, Texas, United States

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

Plano, Texas, United States

Investigational Site Number : 0560001

Bruges, Belgium

Investigational Site Number : 0560007

Kortrijk, Belgium

Investigational Site Number : 0560005

Overpelt, Belgium

View Full Details on ClinicalTrials.gov

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NCT07325292

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