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Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
Sponsor: Sanofi
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
Conditions
Interventions
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
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