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
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
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:
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:
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 above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Phoenix, Arizona 85013, United States
Carlsbad, California 92011, United States
Irvine, California 92697, United States
Laguna Hills, California 92653, United States
Newport Beach, California 92663, United States
West Hollywood, California 90048, United States
Aurora, Colorado 80045, United States
Stamford, Connecticut 06905, United States
Washington D.C., District of Columbia 20007, United States
Boca Raton, Florida 33428, United States
Boca Raton, Florida 33486, United States
Orlando, Florida 32806, United States
Savannah, Georgia 31406, United States
Evanston, Illinois 60201, United States
Springfield, Illinois 62702, United States
Fort Wayne, Indiana 46815, United States
Alexandria, Louisiana 71301, United States
New Orleans, Louisiana 70121, United States
Lutherville, Maryland 21093, United States
Boston, Massachusetts 02215, United States
Foxborough, Massachusetts 02035, United States
Farmington Hills, Michigan 48334, United States
Owosso, Michigan 48867, United States
Minneapolis, Minnesota 55455, United States
Plymouth, Minnesota 55446, United States
Las Vegas, Nevada 89106, United States
Patchogue, New York 11772, United States
The Bronx, New York 10461, United States
Charlotte, North Carolina 28210, United States
Winston-Salem, North Carolina 27103, United States
Centerville, Ohio 45459, United States
Oklahoma City, Oklahoma 73104, United States
Hershey, Pennsylvania 17033, United States
Philadelphia, Pennsylvania 19107, United States
Dallas, Texas 75243, United States
Plano, Texas 75024, United States
Sherman, Texas 75092, United States
Fairfax, Virginia 22031, United States
Vienna, Virginia 22182, United States
Virginia Beach, Virginia 23456, United States
Seattle, Washington 98133, United States
Milwaukee, Wisconsin 53215, United States
Milwaukee, Wisconsin 53226, United States
Vitória, Espírito Santo 29055-450, Brazil
Salvador, Estado de Bahia 41820-020, Brazil
Brasília, Federal District 70200-730, Brazil
Belo Horizonte, Minas Gerais 30150-320, Brazil
Curitiba, Paraná 81210-310, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Santo André, São Paulo 09030-010, Brazil
Joyo-Shi, 610-0113, Japan
Bratislava - Kramare, 831 01, Slovakia