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Monoclonal Antibodies
Frexalimab for Multiple Sclerosis (FREXALT 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
Have you ever taken the drug Teriflonimide?
Have you had one (1) flare up in the past year?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until week 168
Awards & highlights
Pivotal Trial
Summary
This trial compares a new treatment, frexalimab, with an existing pill, teriflunomide, in adults aged 18-55 who have relapsing multiple sclerosis. The study aims to see if frexalimab can reduce the frequency of symptom relapses better than teriflunomide. Participants will be monitored over several years.
Who is the study for?
Adults aged 18 to 55 with relapsing forms of multiple sclerosis (RMS) can join this trial. They must have had at least one relapse in the past year or two in the last two years, or a recent MRI showing specific brain lesions. Participants need an EDSS score of 5.5 or less and must follow local contraception rules.
What is being tested?
The trial is testing Frexalimab's effect on reducing annualized relapse rate compared to Teriflunomide, a daily oral medication for RMS. It includes regular visits over approximately 20-40 months, with MRIs and other assessments to track progress.
What are the potential side effects?
Potential side effects may include reactions related to immune system changes due to Frexalimab, digestive issues from activated charcoal or cholestyramine, and typical contrast agent reactions during MRI scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until week 168
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until week 168
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses
Secondary study objectives
Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period
Progression independent of relapse activity defined as the time to onset of 6-month cCDW
Time to onset of composite confirmed disability worsening (cCDW)
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FrexalimabExperimental Treatment5 Interventions
Participants will receive Frexalimab infusion and placebo tablet.
Group II: TeriflunomideActive Control5 Interventions
Participants will receive teriflunomide tablet and placebo infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Activated charcoal
2022
Completed Phase 1
~40
Placebo tablet
2020
Completed Phase 4
~6240
Cholestyramine
2018
Completed Phase 4
~340
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Sclerosis (MS) include immunomodulatory and immunosuppressive therapies that target various aspects of the immune system to reduce inflammation and prevent immune-mediated damage to the central nervous system. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the brain and spinal cord.
Dimethyl fumarate activates the Nrf2 pathway, providing anti-inflammatory and neuroprotective effects. Teriflunomide inhibits pyrimidine synthesis, reducing the proliferation of activated lymphocytes.
Monoclonal antibodies like alemtuzumab deplete specific immune cells, and natalizumab blocks immune cell migration into the central nervous system. These mechanisms are crucial for MS patients as they help manage relapses, reduce new lesion formation, and slow disease progression, thereby improving quality of life.
Mode of action and clinical studies with alemtuzumab.New and emerging immune-targeted drugs for the treatment of multiple sclerosis.
Mode of action and clinical studies with alemtuzumab.New and emerging immune-targeted drugs for the treatment of multiple sclerosis.
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,216 Previous Clinical Trials
4,046,232 Total Patients Enrolled
42 Trials studying Multiple Sclerosis
16,002 Patients Enrolled for Multiple Sclerosis