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Monoclonal Antibodies

Frexalimab for Multiple Sclerosis

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

The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.

≥1 documented relapse within the previous year OR ≥2 documented relapses within the previous 2 years, OR ≥1 documented Gd enhancing lesion on an MRI scan within the previous year.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 24 to week 156

Awards & highlights

Study Summary

This trial is testing if an injection of frexalimab is better than taking a daily teriflunomide pill in treating relapsing forms of MS in adults 18-55.

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.Check my eligibility

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.See study design

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 below

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I was diagnosed with RMS based on the latest criteria.

Select...

I have had at least one relapse in the past year or two relapses in two years, or an MRI showed a new lesion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 24 to week 156

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 24 to week 156

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 24 to week 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses

Secondary outcome measures

Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time

Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time

Change from baseline in plasma neurofilament light chain (NfL) levels over time

+13 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,513,580 Total Patients Enrolled

41 Trials studying Multiple Sclerosis

15,363 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can geriatric patients participate in this clinical examination?

"This trial requires potential participants to be between 18 and 55 years old."

Answered by AI

Is it still feasible to become a participant in this research endeavor?

"According to clinicaltrials.gov, the current status of this medical trial is recruitment. It was initially posted on December 14th 2023 and was last adjusted on December 7th 2023."

Answered by AI

How many participants is this research endeavor enrolling?

"Affirmative. According to the clinicaltrials.gov website, this medical trial is actively recruiting participants from two centres with plans of enrolling 1400 patients since its original post on December 14th 2023 and last edit on December 7th 2023."

Answered by AI

What potential hazards can be associated with Frexalimab usage?

"Frexalimab was given a rating of 3 due to the existing clinical data that supports its safety and efficacy, which is why it has graduated to Phase 3."

Answered by AI

Is it possible for me to participate in this research?

"This clinical trial is seeking 1400 patients with multiple sclerosis aged 18-55 to partake in the study. To be eligible, these individuals must meet a few criteria: have been diagnosed according to 2017 McDonald diagnostic guidelines; EDSS score ≤5.5 at initial screening visit; one relapse within 12 months or two relapses in 24 months OR Gd enhancing lesion on MRI scan from previous year and contraceptive methods consistent with local regulations for trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

2023. "Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06141473.

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