Multiple Sclerosis Clinical Trial

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

Summary

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.

Study details include:

This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized.
The study intervention duration will vary ranging from approximately 20 to 40 months.
The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)

The participant must have at least 1 of the following prior to screening:

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

Exclusion Criteria:

The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
The participant has a history of infection or may be at risk for infection:
The presence of psychiatric disturbance or substance abuse.
History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
History or current hypogammaglobulinemia.
A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
The participant has had a relapse in the 30 days prior to randomization.
The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1400

Study ID:

NCT06141473

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 16 Locations for this study

See Locations Near You

Alabama Neurology Associates Site Number : 8400115
Birmingham Alabama, 35209, United States
Perseverance Research Center, LLC Site Number : 8401138
Scottsdale Arizona, 85253, United States
The Research Center of Southern California, LLC Site Number : 8400023
Carlsbad California, 92011, United States
Regina Berkovich, MD, PhD Site Number : 8400005
West Hollywood California, 90048, United States
Neurology Associates, PA Site Number : 8400010
Maitland Florida, 32761, United States
Axiom Clinical Research of Florida Site Number : 8400049
Tampa Florida, 33609, United States
College Park Family Care Center Site Number : 8400032
Overland Park Kansas, 66210, United States
International Neurorehabilitation Institute Site Number : 8400089
Lutherville Maryland, 21093, United States
Sharlin Health & Neurology Site Number : 8400016
Ozark Missouri, 65721, United States
Piedmont Healthcare/Research Site Number : 8400002
Charlotte North Carolina, 28210, United States
Velocity Clinical Research, Inc Site Number : 8400014
Raleigh North Carolina, 27607, United States
The Boster Center for Multiple Sclerosis Site Number : 8400006
Columbus Ohio, 43235, United States
Abington Neurological Associates Site Number : 8401065
Abington Pennsylvania, 19001, United States
HOPE Neurology Site Number : 8400019
Knoxville Tennessee, 37922, United States
Investigational Site Number : 1240001
Gatineau Quebec, J8Y 1, Canada
Investigational Site Number : 1240008
Levis Quebec, G6W0M, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1400

Study ID:

NCT06141473

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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