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Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Sponsor: Sanofi
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 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 scheduled visits will include monthly visits for the first 6 months and quarterly visits thereafter until the common end of study (EOS), or premature end of treatment (pEOT) after which 3 follow-up visits will be performed
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
1655
Start Date
2023-12-13
Completion Date
2027-05-06
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
Frexalimab
SAR441344 Solution for IV infusion
Teriflunomide
Aubagio oral tablet
Placebo infusion
Solution for IV infusion
Placebo tablet
Oral tablet
MRI contrast-enhancing agents
IV, as per respective label
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.
Activated charcoal
oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.
Locations (382)
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
Nova Clinical Research - Bradenton- Site Number : 8400189
Bradenton, Florida, United States
Mayo Clinic in Florida- Site Number : 8401093
Jacksonville, Florida, United States
Neurology Associates - Maitland- Site Number : 8400010
Maitland, Florida, United States
University of Miami Hospital- Site Number : 8401177
Miami, Florida, United States
Design Neuroscience Center- Site Number : 8401191
Miami Lakes, Florida, United States
Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060
Orlando, Florida, United States
Axiom Clinical Research of Florida- Site Number : 8400049
Tampa, Florida, United States
University of South Florida- Site Number : 8400013
Tampa, Florida, United States
Palm Beach Neurology- Site Number : 8401105
West Palm Beach, Florida, United States
Velocity Clinical Research - Savannah Neurology- Site Number : 8400061
Savannah, Georgia, United States
Joi Life Wellness Group LLC- Site Number : 8401192
Smyrna, Georgia, United States
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8401111
Evanston, Illinois, United States
Consultants in Neurology- Site Number : 8401020
Northbrook, Illinois, United States
Springfield Clinic 1st - 900 Building- Site Number : 8400043
Springfield, Illinois, United States
IU Health Physicians - Fort Wayne - Hope Drive- Site Number : 8400058
Fort Wayne, Indiana, United States
Neuroscience Institute Center- Site Number : 8400053
Merrillville, Indiana, United States
University of Iowa- Site Number : 8400029
Iowa City, Iowa, United States
University of Kansas Medical Center- Site Number : 8400084
Kansas City, Kansas, United States
Kc Research Center- Site Number : 8400032
Roeland Park, Kansas, United States
Baptist Health Lexington- Site Number : 8401149
Lexington, Kentucky, United States
Norton Neurology Services- Site Number : 8401103
Louisville, Kentucky, United States
NeuroMedical Clinic of Central Louisiana- Site Number : 8401159
Alexandria, Louisiana, United States
The NeuroMedical Center- Site Number : 8401182
Baton Rouge, Louisiana, United States
Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
New Orleans, Louisiana, United States
International Neurorehabilitation Institute- Site Number : 8400089
Lutherville, Maryland, United States
Boston Clinical Trials- Site Number : 8401178
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center - Boston- Site Number : 8401041
Boston, Massachusetts, United States
Neurology Center of New England- Site Number : 8401164
Foxborough, Massachusetts, United States
Henry Ford Hospital- Site Number : 8401091
Detroit, Michigan, United States
Michigan Institute for Neurological Disorders- Site Number : 8400004
Farmington Hills, Michigan, United States
Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
Owosso, Michigan, United States
Rochester Medical Group- Site Number : 8401172
Rochester Hills, Michigan, United States
M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056
Minneapolis, Minnesota, United States
Minnesota Center for Multiple Sclerosis- Site Number : 8400073
Plymouth, Minnesota, United States
Sharlin Health and Neurology- Site Number : 8400016
Ozark, Missouri, United States
Washington University- Site Number : 8400076
St Louis, Missouri, United States
The MS Center for Innovations in Care- Site Number : 8401141
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045
Las Vegas, Nevada, United States
Renown Regional Medical Center- Site Number : 8400066
Reno, Nevada, United States
Rutgers University- Site Number : 8401067
New Brunswick, New Jersey, United States
The University of New Mexico- Site Number : 8401090
Albuquerque, New Mexico, United States
South Shore Neurologic Associates - Patchogue- Site Number : 8400063
Patchogue, New York, United States
Montefiore Medical Center - Einstein Campus- Site Number : 8401145
The Bronx, New York, United States
The Neurological Institute- Site Number : 8401166
Charlotte, North Carolina, United States
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
Charlotte, North Carolina, United States
Raleigh Neurology Associates- Site Number : 8400014
Raleigh, North Carolina, United States
Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040
Winston-Salem, North Carolina, United States
Sanford Brain And Spine Center- Site Number : 8401085
Fargo, North Dakota, United States
Dayton Center for Neurological Disorders- Site Number : 8400079
Centerville, Ohio, United States
University of Cincinnati Medical Center- Site Number : 8401117
Cincinnati, Ohio, United States
The Ohio State University- Site Number : 8401009
Columbus, Ohio, United States
OhioHealth Riverside Methodist Hospital- Site Number : 8401092
Columbus, Ohio, United States
The Boster Center for Multiple Sclerosis- Site Number : 8400006
Columbus, Ohio, United States
UC Health - Elizabeth Place- Site Number : 8401008
Dayton, Ohio, United States
Oklahoma Medical Research Foundation- Site Number : 8400039
Oklahoma City, Oklahoma, United States
Providence St. Vincent's Medical Center- Site Number : 8400052
Portland, Oregon, United States
Oregon Neurology Associates- Site Number : 8400188
Springfield, Oregon, United States
Abington Neurological Associates- Site Number : 8401065
Abington, Pennsylvania, United States
Penn State Health Milton South Hershey Medical Center- Site Number : 8401176
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital- Site Number : 8400035
Philadelphia, Pennsylvania, United States
Allegheny General Hospital- Site Number : 8401173
Pittsburgh, Pennsylvania, United States
UPMC Magee-Womens Hospital- Site Number : 8401133
Pittsburgh, Pennsylvania, United States
Premier Neurology- Site Number : 8401047
Greer, South Carolina, United States
Hope Neurology- Site Number : 8400019
Knoxville, Tennessee, United States
Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
Dallas, Texas, United States
ANESC Research- Site Number : 8400187
El Paso, Texas, United States
Baylor College of Medicine Medical Center- Site Number : 8401170
Houston, Texas, United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8401083
Plano, Texas, United States
UT Health - San Antonio- Site Number : 8401167
San Antonio, Texas, United States
Neurology Center of San Antonio- Site Number : 8400099
San Antonio, Texas, United States
Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018
Sherman, Texas, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8401109
Fairfax, Virginia, United States
Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8401128
Vienna, Virginia, United States
Sentara Family Medicine Physicians - Virginia Beach - Glenn Mitchell Drive- Site Number : 8401168
Virginia Beach, Virginia, United States
Swedish Medical Center - Seattle- Site Number : 8400078
Seattle, Washington, United States
University of Washington Medical Center - Northwest- Site Number : 8401146
Seattle, Washington, United States
MultiCare Tacoma General Hospital- Site Number : 8401140
Tacoma, Washington, United States
Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034
Milwaukee, Wisconsin, United States
Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038
Milwaukee, Wisconsin, United States
Investigational Site Number : 0320003
Rosario, Santa Fe Province, Argentina