Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: PlaceboDrug: FrexalimabDrug: MRI contrast-enhancing agents
- Registration Number
- NCT06141486
- Lead Sponsor
- Sanofi
- Brief 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 approximately 51 months 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 have variable duration ranging from approximately 27 to 51 months.
* The study intervention duration will vary ranging from approximately 12 to 51 months.
* The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 858
- Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
- Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
- Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
- Absence of clinical relapses for at least 24 months.
- The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- 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.
- History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
- 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 sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- The participant was previously exposed to frexalimab.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo Frexalimab MRI contrast-enhancing agents Frexalimab IV administration Placebo MRI contrast-enhancing agents Matching placebo Frexalimab Frexalimab Frexalimab IV administration
- Primary Outcome Measures
Name Time Method Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months Until Week 204 Defined as Increase from the baseline expanded disability status scale (EDSS) score of ≥1.0 point when the baseline is \<5.5, or ≥0.5 point when the baseline is ≥5.5, OR Increase of ≥20% from the baseline time in the 9 hole peg test (9HPT),OR Increase of ≥20% from the baseline time in the timed 25 foot walk (T25FW) test
- Secondary Outcome Measures
Name Time Method Number of participants with antibody over time Until Week 204 Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs) Until Week 204 Time to onset of individual components of the composite, confirmed over 3-months or 6-months Until Week 204 Percent change in brain volume loss as detected by MRI scans at the end of study (EOS) compared to Month 6 From Week 24 to Week 204 Number of new and/or enlarging T2hyperintense lesions per scan as detected by MRI, and number of new and/or enlarging T2-hyperintense lesions per scan as detected by MRI Until Week 204 defined as the sum of the individual number of new and/or enlarging T2-hyperintense lesions at all scheduled visits starting after baseline up to and including the EOS visit
Change in cognitive function at the EOS compared to baseline as assessed by symbol digit modalities test (SDMT) Baseline, Until Week 204 Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time Baseline, Until Week 204 Change from baseline in serum Ig levels over time Until Week 204 Annualized relapse rate during the study period assessed by protocol defined adjudicated relapses Until Week 204 Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period Until Week 204 12-lead ECG (electrocardiogram) will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
Frexalimab plasma concentration over time Until Week 204 Time to onset of composite cCDP confirmed over 3 months Until Week 204 Time to onset of confirmed disability improvement (CDI) Until Week 204 defined as decrease from the baseline EDSS score of ≥1.0 or ≥ 0.5 points when baseline is ≤5.5 or \>5.5 points, respectively, confirmed over 6 months.
Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time Baseline, Until Week 204 Change from baseline in plasma neurofilament light chain (NfL) levels over time Until Week 204
Trial Locations
- Locations (190)
Investigational Site Number : 3480004
🇭🇺Budapest, Hungary
Investigational Site Number : 3560006
🇮🇳Shimla, India
Investigational Site Number : 3920016
🇯🇵Kodaira, Tokyo, Japan
Investigational Site Number : 5280001
🇳🇱Sittard-geleen, Netherlands
Investigational Site Number : 1560001
🇨🇳Shanghai, China
Investigational Site Number : 1560006
🇨🇳Taiyuan, China
Investigational Site Number : 1560012
🇨🇳Tianjin, China
Investigational Site Number : 1560009
🇨🇳Wuhan, China
Investigational Site Number : 1560013
🇨🇳Xi An, China
Investigational Site Number : 1560034
🇨🇳Zhengzhou, China
Investigational Site Number : 3920003
🇯🇵Koriyama, Fukushima, Japan
Investigational Site Number : 7920003
🇹🇷Sultangazi, Turkey
Investigational Site Number : 7920017
🇹🇷VAN, Turkey
Investigational Site Number : 8260001
🇬🇧Exeter, Devon, United Kingdom
Investigational Site Number : 1560010
🇨🇳Jiazhuang, China
Investigational Site Number : 2500010
🇫🇷Saint-herblain, France
Investigational Site Number : 1561027
🇨🇳Harbin, China
Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060
🇺🇸Orlando, Florida, United States
NeuroMedical Clinic of Central Louisiana- Site Number : 8400159
🇺🇸Alexandria, Louisiana, United States
DelRicht Research- Site Number : 8400182
🇺🇸Baton Rouge, Louisiana, 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
🇺🇸Foxboro, Massachusetts, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400011
🇺🇸New York, New York, United States
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
🇺🇸Charlotte, North Carolina, United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083
🇺🇸Plano, Texas, United States
Investigational Site Number : 0360005
🇦🇺Saint Leonards, New South Wales, Australia
Investigational Site Number : 0560007
🇧🇪Kortrijk, Belgium
Universidade Federal de Goias- Site Number : 0760024
🇧🇷Goiânia, Goiás, Brazil
Hospital Moinhos de Vento- Site Number : 0760005
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
PSEG Centro de Pesquisa Clínica- Site Number : 0760021
🇧🇷São Paulo, Brazil
Investigational Site Number : 1240012
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 2030002
🇨🇿Hradec Kralove, Czechia
Investigational Site Number : 2030006
🇨🇿Jihlava, Czechia
Investigational Site Number : 2030003
🇨🇿Prague, Czechia
Investigational Site Number : 2030004
🇨🇿Prague, Czechia
Investigational Site Number : 2030009
🇨🇿Teplice, Czechia
Investigational Site Number : 2030001
🇨🇿Zlín, Czechia
Investigational Site Number : 7240007
🇪🇸Seville, Andalucia, Spain
Investigational Site Number : 7240010
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009
🇪🇸Barakaldo, Bizkaia, Spain
Investigational Site Number : 7240013
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number : 7240017
🇪🇸Majadahonda, Madrid, Spain
Investigational Site Number : 7240001
🇪🇸Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 7240004
🇪🇸Córdoba, Spain
Investigational Site Number : 7240002
🇪🇸Madrid, Spain
Investigational Site Number : 7240018
🇪🇸Murcia, Spain
Investigational Site Number : 7240005
🇪🇸Málaga, Spain
Investigational Site Number : 7240008
🇪🇸Valencia, Spain
Investigational Site Number : 7920016
🇹🇷Istanbul, Turkey
Alabama Neurology Associates- Site Number : 8400115
🇺🇸Birmingham, Alabama, United States
Phoenix Neurological Associates - Phoenix- Site Number : 8400074
🇺🇸Phoenix, Arizona, 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
The Neurology Center of Southern California - Carlsbad- Site Number : 8400023
🇺🇸Carlsbad, California, United States
University of California San Diego Site Number : 8400095
🇺🇸La Jolla, California, United States
Keck School of Medicine of University of Southern California- Site Number : 8400118
🇺🇸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 New Haven Hospital- Site Number : 8400081
🇺🇸New Haven, Connecticut, United States
Hartford Healthcare Medical Group- Site Number : 8400069
🇺🇸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, District of Columbia, United States
Neurology of Central Florida- Site Number : 8400147
🇺🇸Altamonte Springs, Florida, United States
University of Florida College of Medicine- Site Number : 8400054
🇺🇸Gainesville, Florida, United States
Mayo Clinic Hospital Jacksonville- Site Number : 8400093
🇺🇸Jacksonville, Florida, United States
Neurology Associates - Maitland- Site Number : 8400010
🇺🇸Maitland, Florida, United States
MS & Neuromuscular Center of Excellence- Site Number : 8400015
🇺🇸Oldsmar, 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 Medical Group- Site Number : 8400105
🇺🇸West Palm Beach, Florida, United States
Velocity Clinical Research - Savannah Neurology- Site Number : 8400061
🇺🇸Savannah, Georgia, United States
Rush University Medical Center- Site Number : 8400102
🇺🇸Chicago, Illinois, United States
Consultants in Neurology- Site Number : 8400020
🇺🇸Northbrook, Illinois, United States
OSF Center for Health- Site Number : 8400030
🇺🇸Peoria, Illinois, United States
Springfield Clinic 1st - 800 Building- Site Number : 8400043
🇺🇸Springfield, 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
College Park Family Care Center - Overland Park- Site Number : 8400032
🇺🇸Overland Park, Kansas, 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
The Elliot Lewis Center- Site Number : 8400033
🇺🇸Wellesley, Massachusetts, United States
University of Massachusetts Chan Medical School- 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
Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
🇺🇸Owosso, Michigan, United States
Minnesota Center for Multiple Sclerosis- Site Number : 8400073
🇺🇸Plymouth, Minnesota, United States
Sharlin Health & Neurology- Site Number : 8400016
🇺🇸Ozark, Missouri, United States
Washington University- Site Number : 8400076
🇺🇸Saint 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
Dartmouth-Hitchcock Medical Center - Lebanon - 1 Medical Center Drive- Site Number : 8400098
🇺🇸Lebanon, New Hampshire, United States
Rutgers University- Site Number : 8400067
🇺🇸New Brunswick, New Jersey, 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
Columbia University Irving Medical Center- Site Number : 8400088
🇺🇸New York, New York, United States
Stony Brook University- Site Number : 8400094
🇺🇸Stony Brook, New York, United States
Raleigh Neurology Associates- Site Number : 8400014
🇺🇸Raleigh, North Carolina, United States
Wake Forest Baptist Health- Site Number : 8400040
🇺🇸Winston-Salem, North Carolina, United States
Sanford Neuroscience Clinic- Site Number : 8400085
🇺🇸Fargo, North Dakota, United States
Riverhills Neuroscience- Site Number : 8400007
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati - Internal Medicine- 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
Medical Center at 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
Thomas Jefferson University Hospital- Site Number : 8400035
🇺🇸Philadelphia, Pennsylvania, United States
Premier Neurology- Site Number : 8400047
🇺🇸Greer, South Carolina, United States
Hope Neurology- Site Number : 8400019
🇺🇸Knoxville, Tennessee, United States
Vanderbilt Multiple Sclerosis Center- Site Number : 8400130
🇺🇸Nashville, Tennessee, 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 Neurology- Site Number : 8400109
🇺🇸Fairfax, Virginia, United States
Riverside Neurology Specialists - Newport News- Site Number : 8400132
🇺🇸Newport News, Virginia, United States
Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8400128
🇺🇸Vienna, Virginia, United States
West Virginia University School of Medicine- Site Number : 8400131
🇺🇸Morgantown, West Virginia, United States
Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034
🇺🇸Milwaukee, Wisconsin, United States
Investigational Site Number : 0320007
🇦🇷Buenos Aires, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320001
🇦🇷Caba, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320003
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0320002
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0360001
🇦🇺Woolloongabba, Queensland, Australia
Investigational Site Number : 0360002
🇦🇺Melbourne, Victoria, Australia
Investigational Site Number : 0560005
🇧🇪Overpelt, Belgium
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
🇧🇷Brasília, Distrito Federal, Brazil
Clínica Neurológica- Site Number : 0760007
🇧🇷Joinville, Santa Catarina, Brazil
CPQuali Pesquisa Clinica - São Paulo- Site Number : 0760002
🇧🇷São Paulo, Brazil
Jordy Sinapse- Site Number : 0760004
🇧🇷São Paulo, Brazil
Investigational Site Number : 1240011
🇨🇦Calgary, Alberta, Canada
Investigational Site Number : 1240005
🇨🇦Burnaby, British Columbia, Canada
Investigational Site Number : 1240010
🇨🇦Vancouver, British Columbia, Canada
Investigational Site Number : 1240002
🇨🇦Ottawa, Ontario, Canada
Investigational Site Number : 1240001
🇨🇦Gatineau, Quebec, Canada
Investigational Site Number : 1240008
🇨🇦Lévis, Quebec, Canada
Investigational Site Number : 1240009
🇨🇦Montreal, Quebec, Canada
Investigational Site Number : 1240016
🇨🇦Pointe-claire, Quebec, Canada
Investigational Site Number : 1240003
🇨🇦Québec City, Quebec, Canada
Investigational Site Number : 1240006
🇨🇦Sherbrooke, Quebec, Canada
Investigational Site Number : 1520002
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1560007
🇨🇳Beijing, China
Investigational Site Number : 1560005
🇨🇳Beijing, China
Investigational Site Number : 1560008
🇨🇳Beijing, China
Investigational Site Number : 1560003
🇨🇳Changchun, China
Investigational Site Number : 1560011
🇨🇳Changsha, China
Investigational Site Number : 1560004
🇨🇳Chengdu, China
Investigational Site Number : 1560002
🇨🇳Guangzhou, China
Investigational Site Number : 3920014
🇯🇵Asahikawa, Hokkaido, Japan
Investigational Site Number : 3920007
🇯🇵Himeji, Hyogo, Japan
Investigational Site Number : 3920010
🇯🇵Sagamihara, Kanagawa, Japan
Investigational Site Number : 3920015
🇯🇵Higashimatsuyama, Saitama, Japan
Investigational Site Number : 3920001
🇯🇵Kyoto, Japan
Investigational Site Number : 3920011
🇯🇵Tokyo, Japan
Investigational Site Number : 3920012
🇯🇵Tokyo, Japan
Investigational Site Number : 4100001
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100007
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100002
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100004
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100003
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
San Juan MS Center- Site Number : 8400106
🇵🇷Guaynabo, Puerto Rico
Investigational Site Number : 7920006
🇹🇷Akdeniz, Turkey
Investigational Site Number : 7920018
🇹🇷Ankara, Turkey
Investigational Site Number : 7920011
🇹🇷Ankara, Turkey
Investigational Site Number : 7920013
🇹🇷Bursa, Turkey
Investigational Site Number : 7920005
🇹🇷Eskişehir, Turkey
Investigational Site Number : 7920012
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920002
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920007
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920019
🇹🇷Izmir, Turkey
Investigational Site Number : 7920008
🇹🇷Izmir, Turkey
Investigational Site Number : 7920001
🇹🇷Izmit, Turkey
Investigational Site Number : 7920014
🇹🇷Kayseri, Turkey
Investigational Site Number : 7920015
🇹🇷Konya, Turkey
Investigational Site Number : 7920004
🇹🇷Samsun, Turkey
Investigational Site Number : 8260003
🇬🇧Canterbury, Kent, United Kingdom
Investigational Site Number : 8260009
🇬🇧Fazakerley, Liverpool, United Kingdom
Investigational Site Number : 8260013
🇬🇧London, London, City Of, United Kingdom
Investigational Site Number : 8260005
🇬🇧Swansea, Neath Port Talbot, United Kingdom
Investigational Site Number : 8260004
🇬🇧Oxford, Oxfordshire, United Kingdom
Investigational Site Number : 8260007
🇬🇧Cardiff, Vale Of Glamorgan, The, United Kingdom
Investigational Site Number : 8260011
🇬🇧Gwent, United Kingdom
Investigational Site Number : 8260006
🇬🇧Newcastle Upon Tyne, United Kingdom