← Back to Search

Monoclonal Antibodies

Frexalimab for Multiple Sclerosis (FREVIVA Trial)

Phase 3
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absence of clinical relapses for at least 24 months.
Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until week 204
Awards & highlights

Summary

This trial is studying a drug called frexalimab to see if it can help delay disability progression in people with a certain type of multiple sclerosis. The study will last between 27 to

Who is the study for?
Adults aged 18 to 60 with nonrelapsing Secondary Progressive Multiple Sclerosis (nrSPMS) can join this trial. They must have had a prior diagnosis of Relapsing-Remitting MS, evidence of disability progression in the past year without relapses for at least two years, and an EDSS score between 3.0 and 6.5.
What is being tested?
The study is testing Frexalimab's effectiveness in slowing down disability progression compared to a placebo over approximately 27 to 51 months. Participants will be randomly assigned to either the drug or placebo group and will visit the clinic up to 27 times.
What are the potential side effects?
Potential side effects are not specified here, but generally, drugs like Frexalimab could cause immune system changes leading to infections, infusion reactions, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't had any symptoms or relapses for at least 2 years.
Select...
I have been diagnosed with Secondary Progressive Multiple Sclerosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until week 204
This trial's timeline: 3 weeks for screening, Varies for treatment, and until week 204 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months
Secondary study objectives
Number of new and/or enlarging T2hyperintense lesions per scan as detected by MRI, and number of new and/or enlarging T2-hyperintense lesions per scan as detected by MRI
Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period
Time to onset of confirmed disability improvement (CDI)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FrexalimabExperimental Treatment2 Interventions
Frexalimab IV administration
Group II: PlaceboPlacebo Group2 Interventions
Matching placebo

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,187 Previous Clinical Trials
3,978,920 Total Patients Enrolled
41 Trials studying Multiple Sclerosis
15,905 Patients Enrolled for Multiple Sclerosis
~572 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top