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RECRUITINGPhase 3INTERVENTIONAL

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

Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. - Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. * Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary 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.

Treatments Being Tested

DRUG

Frexalimab

SAR441344 Solution for IV infusion

DRUG

Teriflunomide

Aubagio oral tablet

DRUG

Placebo infusion

Solution for IV infusion

DRUG

Placebo tablet

Oral tablet

DRUG

MRI contrast-enhancing agents

IV, as per respective label

DRUG

Cholestyramine

oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed.

DRUG

Activated charcoal

oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.

Locations (20)

University of Alabama at Birmingham- Site Number : 8401135
Birmingham, Alabama, United States
North Central Neurology Associates- Site Number : 8401100
Cullman, Alabama, United States
Alabama Neurology Associates- Site Number : 8400115
Homewood, Alabama, United States
St. Joseph's Hospital and Medical Center- Site Number : 8401139
Phoenix, Arizona, United States
Perseverance Research Center- Site Number : 8401138
Scottsdale, Arizona, United States
Clinical Endpoints- Site Number : 8400050
Scottsdale, Arizona, United States
The Neurology Center of Southern California - Carlsbad- Site Number : 8400023
Carlsbad, California, United States
University of California Irvine - School of Medicine- Site Number : 8401143
Irvine, California, United States
Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122
Laguna Hills, California, United States
Chemidox Clinical Trials- Site Number : 8401157
Lancaster, California, United States
Hoag Memorial Hospital Presbyterian- Site Number : 8401031
Newport Beach, California, United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood, California, United States
University of Colorado - Anschutz Medical Campus- Site Number : 8401001
Aurora, Colorado, United States
Advanced Neurology of Colorado- Site Number : 8401148
Fort Collins, Colorado, United States
Hartford Healthcare Medical Group- Site Number : 8401069
Norwich, Connecticut, United States
New England Institute for Clinical Research- Site Number : 8400114
Stamford, Connecticut, United States
MedStar Georgetown University Hospital- Site Number : 8400044
Washington D.C., District of Columbia, United States
Neurology of Central Florida- Site Number : 8401147
Altamonte Springs, Florida, United States
Neurology Offices of South Florida - Boca Raton- Site Number : 8401169
Boca Raton, Florida, United States
First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071
Boca Raton, Florida, United States