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Monoclonal Antibodies

Frexalimab for Multiple Sclerosis

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening
Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until week 316
Awards & highlights

Study Summary

This trial is testing a new drug, SAR441344, to see if it can reduce the number of new active brain lesions in people with multiple sclerosis.

Who is the study for?
This trial is for adults aged 18-55 with relapsing multiple sclerosis (RMS), who've had at least one relapse in the past year or a new brain lesion recently. They must weigh between 45 to 120 kg, have a BMI of 18.0 to 35.0, and agree to use contraception according to local guidelines.Check my eligibility
What is being tested?
The study tests SAR441344's effectiveness on reducing new active brain lesions in RMS patients, compared against placebos. It involves intravenous (IV) and subcutaneous (SC) injections, along with MRI scans using contrast agents.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to SAR441344 being a humanized monoclonal antibody; however, specific side effects are not listed but will be monitored for safety and tolerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one relapse in the past year or a recent MRI showing active brain lesions.
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My weight is between 45 and 120 kg, and my BMI is between 18.0 and 35.0.
Select...
I am between 18 and 55 years old.
Select...
I have been diagnosed with RMS according to the 2017 McDonald criteria.
Select...
My weight is between 45 to 120 kg and my BMI is between 18.0 to 35.0.
Select...
I am able to understand and sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until week 316
This trial's timeline: 3 weeks for screening, Varies for treatment, and until week 316 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions
Secondary outcome measures
Adverse events (AEs) and serious adverse events (SAEs)
Antidrug antibodies (ADA)
Number of new or enlarging T2 lesions
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Subcutaneous (SC) SAR441344Experimental Treatment2 Interventions
SAR441344 SC
Group II: Intravenous (IV) SAR441344Experimental Treatment2 Interventions
SAR441344 IV
Group III: IV PlaceboPlacebo Group2 Interventions
Placebo IV
Group IV: SC PlaceboPlacebo Group2 Interventions
Placebo SC

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,351 Total Patients Enrolled
40 Trials studying Multiple Sclerosis
14,134 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,170 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
11,462 Patients Enrolled for Multiple Sclerosis

Media Library

SAR441344 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04879628 — Phase 2
Multiple Sclerosis Research Study Groups: Subcutaneous (SC) SAR441344, Intravenous (IV) SAR441344, IV Placebo, SC Placebo
Multiple Sclerosis Clinical Trial 2023: SAR441344 Highlights & Side Effects. Trial Name: NCT04879628 — Phase 2
SAR441344 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04879628 — Phase 2

Frequently Asked Questions

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

Does this research study accept participants of all ages, including those under 65?

"The age boundary for this research is 18 to 55. For those younger than 18, there are 43 other trials they can join while 391 studies accept patients over 65 years of age."

Answered by AI

For what kind of research participants is this trial most suited?

"This trial seeks 129 individuals with multiple sclerosis who are between 18 and 55 years of age. To be considered eligible, candidates must have a body weight in the range of 45 to 120 kilograms (inclusive) and a BMI ranging from 18.0 to 35.0 kg/m2 (inclusive). Furthermore, both men and women involved in this study ought to comply with local regulations regarding contraception methods while taking part in clinical studies."

Answered by AI

Is enrollment in this experiment currently available?

"The clinicaltrials.gov page for this trial indicates that it is no longer recruiting patients; the original post date was June 7th 2021 and the last update occurred on October 10th 2022. However, there are currently 549 other trials that still need participants to join them in their research endeavours."

Answered by AI

Is this medical experiment being undertaken in numerous health centers across North America?

"Seven sites are participating in the trial, including Milwaukee (8400003), Phoenix (8400007) and Gatineau (8400006). Additionally, there are four other recruitment locations."

Answered by AI

Has SAR441344 SC been granted authorization from the FDA?

"Due to the lack of efficacy data, SAR441344 SC was given a safety score 2 on our scale. This assessment is based off the fact that this trial is currently in phase two, meaning there are some indications of safety but no evidence demonstrating effectiveness yet."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
2021. "Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04879628.
All > Multiple Sclerosis
~34 spots leftby Apr 2025
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