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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

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 from week 24 to week 204

Awards & highlights

Study 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.Check my eligibility

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.See study design

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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I haven't had any symptoms or relapses for at least 2 years.

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I have been diagnosed with Secondary Progressive Multiple Sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 24 to week 204

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 24 to week 204

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 24 to week 204 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months

Secondary outcome measures

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

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 multiple sclerosis (MS)-8a over time

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FrexalimabExperimental Treatment2 Interventions

Frexalimab IV administration

Group II: PlaceboPlacebo Group2 Interventions

Matching placebo

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,122 Total Patients Enrolled

41 Trials studying Multiple Sclerosis

15,905 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.

Are there any available slots for patients to participate in this research study?

"Indeed, the data available on clinicaltrials.gov confirms that this research trial is currently in the recruitment phase. The initial posting date for this study was December 27th, 2023 and the most recent update occurred on January 26th, 2024. The study aims to enroll a total of 858 participants spread across ten different research sites."

Answered by AI

Which specific criteria must individuals meet in order to be considered eligible for participation in this clinical study?

"This clinical trial aims to recruit a total of 858 individuals, between the ages of 18 and 60, who have been diagnosed with multiple sclerosis (MS). To be eligible for participation, patients must meet the following criteria: "

Answered by AI

What is the current number of participants enrolled in this clinical investigation?

"A total of 858 eligible participants are required to partake in this research endeavor. Potential subjects have the opportunity to enroll at various locations, such as Sharlin Health & Neurology Site Number: 8400016 situated in Ozark, Missouri and Regina Berkovich, MD, PhD Site Number: 8400005 located in West Hollywood, California."

Answered by AI

Is there an age restriction for participants in this medical trial, specifically excluding those under the age of 30?

"Patients between the ages of 18 and 60 are eligible to participate in this clinical trial. However, there are separate trials available for patients under the age of 18 (35 trials) and patients over the age of 65 (385 trials)."

Answered by AI

Are there a considerable number of medical facilities across the United States conducting this research study?

"There are 10 active study sites participating in this trial, including Sharlin Health & Neurology Site Number: 8400016 located in Ozark, Regina Berkovich, MD, PhD Site Number: 8400005 situated in West Hollywood, and Axiom Clinical Research of Florida Site Number: 8400049 found in Tampa. There are also additional locations available for patient enrollment at 10 other sites."

Answered by AI

Has Frexalimab received the official endorsement of the FDA?

"Based on the study's classification as a Phase 3 trial, which indicates both efficacy and safety data have been collected from multiple rounds of testing, our team at Power rates Frexalimab with a safety score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

2023. "Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06141486.

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