Actively Recruiting
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
Led by Sanofi · Updated on 2026-04-21
160
Participants Needed
18
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet either Group A or Group B criteria as detailed.
- Group A (RMS): Age 18 to 55 years at consent.
- Group A: Diagnosed with RMS per 2017 revised McDonald criteria.
- Group A: Expanded Disability Status Scale (EDSS) score of 5.5 or less at screening.
- Group A: At least 1 documented relapse within the past year, or 2 relapses within past 2 years, or 1 Gd enhancing lesion on MRI within past year.
- Group B (nrSPMS): Previous RRMS diagnosis per 2017 revised McDonald criteria.
- Group B: Age 18 to 60 years at consent.
- Group B: Current SPMS diagnosis per 2013 clinical course criteria.
- Group B: Documented disability progression in 12 months before screening.
- Group B: No clinical relapses for at least 24 months.
- Group B: EDSS score between 3.0 and 6.5 inclusive at screening.
- Men and women must use contraception consistent with local regulations during study participation.
You will not qualify if you...
- Diagnosis of primary progressive MS per 2017 McDonald criteria.
- History or risk of infection including fever within 28 days before screening.
- Presence of psychiatric disturbance or substance abuse.
- History or risk of thromboembolic events, myocardial infarction, stroke, antiphospholipid syndrome, or need for antithrombotic treatment.
- Current hypogammaglobulinemia or history of primary hypogammaglobulinemia.
- History or presence of diseases mimicking MS symptoms.
- Contraindications for MRI.
AI-Screening
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Trial Site Locations
Total: 18 locations
1
North Central Neurology Associates- Site Number : 8401100
Cullman, Alabama, United States, 35058
Actively Recruiting
2
Alabama Neurology Associates- Site Number : 8400115
Homewood, Alabama, United States, 35209
Actively Recruiting
3
Perseverance Research Center- Site Number : 8400138
Scottsdale, Arizona, United States, 85253
Actively Recruiting
4
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood, California, United States, 90048
Actively Recruiting
5
Neurology of Central Florida- Site Number : 8400147
Altamonte Springs, Florida, United States, 32714
Actively Recruiting
6
Aqualane Clinical Research- Site Number : 8400026
Naples, Florida, United States, 34105
Actively Recruiting
7
Neurology Associates of Ormond Beach- Site Number : 8400086
Ormond Beach, Florida, United States, 32174
Actively Recruiting
8
Palm Beach Neurology- Site Number : 8400105
West Palm Beach, Florida, United States, 33407
Actively Recruiting
9
Joi Life Wellness Group LLC- Site Number : 8400192
Smyrna, Georgia, United States, 30080
Actively Recruiting
10
Michigan Institute for Neurological Disorders- Site Number : 8400004
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
11
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
Charlotte, North Carolina, United States, 28210
Actively Recruiting
12
Raleigh Neurology Associates- Site Number : 8400014
Raleigh, North Carolina, United States, 27607
Actively Recruiting
13
Hope Neurology- Site Number : 8400019
Knoxville, Tennessee, United States, 37922
Actively Recruiting
14
ANESC Research- Site Number : 8400187
El Paso, Texas, United States, 79912
Actively Recruiting
15
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083
Plano, Texas, United States, 75024
Actively Recruiting
16
Investigational Site Number : 0560001
Bruges, Belgium, 8000
Actively Recruiting
17
Investigational Site Number : 0560007
Kortrijk, Belgium, 8500
Actively Recruiting
18
Investigational Site Number : 0560005
Overpelt, Belgium, 3900
Actively Recruiting
Research Team
T
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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