Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
Start Date
1/14/2026
Completion Date
11/30/2028
Summary
This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 for participants receiving frexalimab SC or IV, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.
Eligibility Criteria
Age Range: 18 years to 60 years
Interventions
Frexalimab
Frexalimab
MRI contrast-enhancing preparations
Conditions
Locations
North Central Neurology Associates- Site Number : 8401100
Cullman, Alabama 35058
United States
Alabama Neurology Associates- Site Number : 8400115
Homewood, Alabama 35209
United States
Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195
Phoenix, Arizona 85032
United States
Perseverance Research Center- Site Number : 8400138
Scottsdale, Arizona 85253
United States
Center for Neurosciences - Tucson- Site Number : 8400194
Tucson, Arizona 85718
United States
Chemidox Clinical Trials- Site Number : 8401157
Lancaster, California 93534
United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood, California 90048
United States
Rocky Mountain Regional VA Medical Center- Site Number : 8400121
Aurora, Colorado 80045
United States
Advanced Neurology of Colorado- Site Number : 8400148
Fort Collins, Colorado 80528
United States
Neurology of Central Florida- Site Number : 8400147
Altamonte Springs, Florida 32714
United States
Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054
Gainesville, Florida 32608
United States
Aqualane Clinical Research- Site Number : 8400026
Naples, Florida 34105
United States
Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060
Orlando, Florida 32806
United States
Neurology Associates of Ormond Beach- Site Number : 8400086
Ormond Beach, Florida 32174
United States
University of South Florida- Site Number : 8400013
Tampa, Florida 33612
United States
Palm Beach Neurology- Site Number : 8400105
West Palm Beach, Florida 33407
United States
Atlanta Neuroscience Institute- Site Number : 8400075
Atlanta, Georgia 30327
United States
Joi Life Wellness Group Llc- Site Number : 8400192
Smyrna, Georgia 30080
United States
Consultants in Neurology- Site Number : 8400020
Northbrook, Illinois 60062
United States
Baltimore Veterans Affairs Medical Center- Site Number : 8400163
Baltimore, Maryland 21201
United States
Neurology Center of New England- Site Number : 8400164
Foxborough, Massachusetts 02035
United States
Michigan Institute for Neurological Disorders- Site Number : 8400004
Farmington Hills, Michigan 48334
United States
Holy Name Medical Center- Site Number : 8400101
Teaneck, New Jersey 07666
United States
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
Charlotte, North Carolina 28210
United States
Raleigh Neurology Associates- Site Number : 8400014
Raleigh, North Carolina 27607
United States
The Ohio State University- Site Number : 8400009
Columbus, Ohio 43210
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
ANESC Research- Site Number : 8400187
El Paso, Texas 79912
United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082
Plano, Texas 75024
United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083
Plano, Texas 75024
United States
Neurology Center of San Antonio- Site Number : 8400099
San Antonio, Texas 78258
United States
Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038
Milwaukee, Wisconsin 53226
United States
Investigational Site Number : 0560001
Bruges, 8000
Belgium
Investigational Site Number : 0560008
Brussels, 1200
Belgium
Investigational Site Number : 0560006
Ghent, 9000
Belgium
Investigational Site Number : 0560007
Kortrijk, 8500
Belgium
Investigational Site Number : 0560005
Overpelt, 3900
Belgium
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
Brasília, Federal District 70200-730
Brazil
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760001
Curitiba, Paraná 81210-310
Brazil
Clínica Neurológica- Site Number : 0760007
Joinville, Santa Catarina 89202-165
Brazil
Investigational Site Number : 1560005
Beijing, 100034
China
Investigational Site Number : 1560004
Chengdu, 610041
China
Investigational Site Number : 1561029
Chengdu, 610072
China
Investigational Site Number : 1560020
Dongguan, 523000
China
Investigational Site Number : 1560002
Guangzhou, 510630
China
Investigational Site Number : 1560010
Jiazhuang, 050000
China
Investigational Site Number : 1560014
Shenyang, 110004
China
Investigational Site Number : 3800037
Montichiari, Brescia 25018
Italy
Investigational Site Number : 3800016
Milan, Milano 20133
Italy
Investigational Site Number : 3800036
Rozzano, Milano 20089
Italy
Investigational Site Number : 3801007
Cagliari, 09126
Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia Site Number : 3800019
Foggia, 71122
Italy
Fondazione Policlinico Universitario Campus Bio-Medico Site Number : 3800038
Roma, 00128
Italy
Azienda Ospedaliera San Camillo Forlanini Site Number : 3800001
Roma, 00152
Italy
Investigational Site Number : 3920003
Kōriyama, Fukushima 963-8052
Japan
Investigational Site Number : 3920017
Sapporo, Hokkaido 063-0005
Japan
Investigational Site Number : 3920008
Yahaba, Iwate 028-3695
Japan
Investigational Site Number : 3920015
Higashi-Matsuyama, Saitama 355-0005
Japan
Investigational Site Number : 3920016
Kodaira, Tokyo 187-8551
Japan
Investigational Site Number : 3920001
Kyoto, 616-8255
Japan
Investigational Site Number : 3920012
Tokyo, 160-8582
Japan
Investigational Site Number : 7240010
Barcelona, Catalunya [Cataluña] 08035
Spain
Investigational Site Number : 7240001
Pozuelo de Alarcón, Madrid 28223
Spain
Investigational Site Number : 7240014
Vigo, Pontevedra [Pontevedra] 36312
Spain
Investigational Site Number : 7240023
Madrid, 28007
Spain
Investigational Site Number : 7240005
Málaga, 29010
Spain