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RECRUITING
NCT07325292
PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-01-14

Completion Date

2028-11-30

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

Frexalimab

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

DRUG

Frexalimab

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

DRUG

MRI contrast-enhancing preparations

Route of administration:IV injection

Locations (10)

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

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