Frexalimab for Multiple Sclerosis (FREVIVA Trial)

Verified 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

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Has your MS gotten worse in the past year?

Must not have

Do you need a wheelchair in order to move around?

Have you had a major relapse in the past 24 months?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until week 204

Awards & highlights

Pivotal Trial

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

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You need to use birth control methods that follow the rules in your area if you want to take part in the study.

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You must have proof of getting more disabled in the year before being screened for the trial. A special committee will check if you are eligible.

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I have been diagnosed with RRMS according to the 2017 McDonald criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You must have a score between 3.0 and 6.5 on the EDSS test at the screening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until week 204

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)