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Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Sponsor: Sanofi
Summary
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.
Official title: A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
943
Start Date
2023-12-27
Completion Date
2028-03-24
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Frexalimab
SAR441344 Solution for IV infusion
Placebo
Solution for IV infusion
MRI contrast-enhancing agents
IV, as per respective label
Locations (311)
Alabama Neurology Associates- Site Number : 8400115
Homewood, Alabama, United States
Perseverance Research Center- Site Number : 8400138
Scottsdale, Arizona, United States
Imaging Endpoints- Site Number : 8400050
Scottsdale, Arizona, United States
Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134
Berkeley, California, United States
University of California Irvine - School of Medicine- Site Number : 8400143
Irvine, California, United States
University of California San Diego - La Jolla- Site Number : 8400095
La Jolla, California, United States
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian- Site Number : 8400031
Newport Beach, California, United States
Stanford Neuroscience Health Center- Site Number : 8400120
Palo Alto, California, United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood, California, United States
University of Colorado - Anschutz Medical Campus- Site Number : 8400001
Aurora, Colorado, United States
Advanced Neurology of Colorado- Site Number : 8400148
Fort Collins, Colorado, United States
Yale University School of Medicine- Site Number : 8400081
New Haven, Connecticut, United States
Hartford Healthcare Medical Group- Site Number : 8400069
Norwich, Connecticut, United States
MedStar Georgetown University Hospital- Site Number : 8400044
Washington D.C., District of Columbia, United States
Neurology of Central Florida- Site Number : 8400147
Altamonte Springs, Florida, United States
MS & Neuromuscular Center of Excellence- Site Number : 8400015
Clearwater, Florida, United States
Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054
Gainesville, Florida, United States
Neurology Associates - Maitland- Site Number : 8400010
Maitland, 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 : 8400105
West Palm Beach, Florida, United States
Joi Life Wellness Group LLC- Site Number : 8400192
Smyrna, Georgia, United States
Rush University Medical Center- Site Number : 8400102
Chicago, Illinois, United States
University of Chicago Medical Center- Site Number : 8400055
Chicago, Illinois, United States
Consultants in Neurology- Site Number : 8400020
Northbrook, Illinois, 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
Baptist Health Lexington- Site Number : 8400149
Lexington, Kentucky, United States
NeuroMedical Clinic of Central Louisiana- Site Number : 8400159
Alexandria, Louisiana, United States
Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
New Orleans, Louisiana, United States
University of Maryland School of Medicine - Baltimore- Site Number : 8400185
Baltimore, Maryland, United States
Johns Hopkins Hospital- Site Number : 8400080
Baltimore, Maryland, United States
Tufts Medical Center- Site Number : 8400003
Boston, Massachusetts, United States
Boston Clinical Trials- Site Number : 8400178
Boston, Massachusetts, United States
Neurology Center of New England- Site Number : 8400164
Foxborough, Massachusetts, United States
The Elliot Lewis Center- Site Number : 8400033
Wellesley, Massachusetts, United States
UMass Memorial Medical Center - University Campus- Site Number : 8400028
Worcester, Massachusetts, United States
Henry Ford Hospital- Site Number : 8400091
Detroit, Michigan, United States
Michigan Institute for Neurological Disorders- Site Number : 8400004
Farmington Hills, Michigan, United States
Trinity Health Grand Rapids- Site Number : 8400150
Grand Rapids, Michigan, United States
Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
Owosso, Michigan, United States
Rochester Medical Group- Site Number : 8400172
Rochester Hills, Michigan, United States
Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400077
Golden Valley, Minnesota, 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
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
Holy Name Medical Center- Site Number : 8400101
Teaneck, New Jersey, United States
The University of New Mexico- Site Number : 8400090
Albuquerque, New Mexico, United States
Dent Neurologic Institute - Amherst- Site Number : 8400129
Amherst, New York, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400011
New York, New York, United States
Columbia University Irving Medical Center- Site Number : 8400088
New York, New York, 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 : 8400085
Fargo, North Dakota, United States
Riverhills Neuroscience- Site Number : 8400007
Cincinnati, Ohio, United States
University of Cincinnati Medical Center- Site Number : 8400117
Cincinnati, Ohio, United States
The Ohio State University- Site Number : 8400009
Columbus, Ohio, United States
The Boster Center for Multiple Sclerosis- Site Number : 8400006
Columbus, Ohio, United States
UC Health - Elizabeth Place- Site Number : 8400008
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
Penn State Health Milton South Hershey Medical Center- Site Number : 8400176
Hershey, Pennsylvania, United States
Premier Neurology- Site Number : 8400047
Greer, South Carolina, United States
Vanderbilt Multiple Sclerosis Center- Site Number : 8400130
Nashville, Tennessee, United States
Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
Dallas, Texas, United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083
Plano, 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
University of Vermont Medical Center- Site Number : 8400042
Burlington, Vermont, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8400109
Fairfax, Virginia, United States
Swedish Medical Center - Seattle- Site Number : 8400078
Seattle, Washington, United States
Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038
Milwaukee, Wisconsin, United States
Investigational Site Number : 0320003
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0321010
Buenos Aires, Argentina
Investigational Site Number : 0320007
Buenos Aires, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0360005
Saint Leonards, New South Wales, Australia
Investigational Site Number : 0360001
Woolloongabba, Queensland, Australia
Investigational Site Number : 0360002
Melbourne, Victoria, Australia
Investigational Site Number : 0560001
Bruges, Belgium
Investigational Site Number : 0560008
Brussels, Belgium
Investigational Site Number : 0560006
Ghent, Belgium
Investigational Site Number : 0560007
Kortrijk, Belgium
Investigational Site Number : 0560003
Melsbroek, Belgium
Investigational Site Number : 0560005
Overpelt, Belgium
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760029
Vitória, Espírito Santo, Brazil
Centro de Pesquisas da Clínica IBIS- Site Number : 0760030
Salvador, Estado de Bahia, Brazil
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
Brasília, Federal District, Brazil
Universidade Federal de Goias- Site Number : 0760024
Goiânia, Goiás, Brazil
Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760025
Belo Horizonte, Minas Gerais, Brazil
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760001
Curitiba, Paraná, Brazil
Hospital Moinhos de Vento- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, Brazil