Multiple Sclerosis (MS) Clinical Trials

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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

Status: Active_not_recruiting
Location: See all (303) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

• For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

Locations
United States
Alabama
Alabama Neurology Associates- Site Number : 8400115
Homewood
Arizona
Imaging Endpoints- Site Number : 8400050
Scottsdale
Perseverance Research Center- Site Number : 8400138
Scottsdale
California
Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134
Berkeley
University of California Irvine - School of Medicine- Site Number : 8400143
Irvine
University of California San Diego - La Jolla- Site Number : 8400095
La Jolla
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184
Los Angeles
Hoag Memorial Hospital Presbyterian- Site Number : 8400031
Newport Beach
Stanford Neuroscience Health Center- Site Number : 8400120
Palo Alto
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood
Colorado
University of Colorado - Anschutz Medical Campus- Site Number : 8400001
Aurora
Advanced Neurology of Colorado- Site Number : 8400148
Fort Collins
Connecticut
Yale University School of Medicine- Site Number : 8400081
New Haven
Hartford Healthcare Medical Group- Site Number : 8400069
Norwich
Washington, D.c.
MedStar Georgetown University Hospital- Site Number : 8400044
Washington D.c.
Florida
Neurology of Central Florida- Site Number : 8400147
Altamonte Springs
MS & Neuromuscular Center of Excellence- Site Number : 8400015
Clearwater
Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054
Gainesville
Neurology Associates - Maitland- Site Number : 8400010
Maitland
Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060
Orlando
Axiom Clinical Research of Florida- Site Number : 8400049
Tampa
University of South Florida- Site Number : 8400013
Tampa
Palm Beach Neurology- Site Number : 8400105
West Palm Beach
Georgia
Joi Life Wellness Group LLC- Site Number : 8400192
Smyrna
Iowa
University of Iowa- Site Number : 8400029
Iowa City
Illinois
Rush University Medical Center- Site Number : 8400102
Chicago
University of Chicago Medical Center- Site Number : 8400055
Chicago
Consultants in Neurology- Site Number : 8400020
Northbrook
Indiana
Neuroscience Institute Center- Site Number : 8400053
Merrillville
Kansas
University of Kansas Medical Center- Site Number : 8400084
Kansas City
Kentucky
Baptist Health Lexington- Site Number : 8400149
Lexington
Louisiana
NeuroMedical Clinic of Central Louisiana- Site Number : 8400159
Alexandria
Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
New Orleans
Massachusetts
Boston Clinical Trials- Site Number : 8400178
Boston
Tufts Medical Center- Site Number : 8400003
Boston
Neurology Center of New England- Site Number : 8400164
Foxborough
The Elliot Lewis Center- Site Number : 8400033
Wellesley
UMass Memorial Medical Center - University Campus- Site Number : 8400028
Worcester
Maryland
Johns Hopkins Hospital- Site Number : 8400080
Baltimore
University of Maryland School of Medicine - Baltimore- Site Number : 8400185
Baltimore
Michigan
Henry Ford Hospital- Site Number : 8400091
Detroit
Michigan Institute for Neurological Disorders- Site Number : 8400004
Farmington Hills
Trinity Health Grand Rapids- Site Number : 8400150
Grand Rapids
Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
Owosso
Rochester Medical Group- Site Number : 8400172
Rochester Hills
Minnesota
Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400077
Golden Valley
M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056
Minneapolis
Minnesota Center for Multiple Sclerosis- Site Number : 8400073
Plymouth
Missouri
Sharlin Health and Neurology- Site Number : 8400016
Ozark
Washington University- Site Number : 8400076
St Louis
North Carolina
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
Charlotte
Raleigh Neurology Associates- Site Number : 8400014
Raleigh
Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040
Winston-salem
North Dakota
Sanford Brain and Spine Center- Site Number : 8400085
Fargo
New Jersey
Holy Name Medical Center- Site Number : 8400101
Teaneck
New Mexico
The University of New Mexico- Site Number : 8400090
Albuquerque
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045
Las Vegas
Renown Regional Medical Center- Site Number : 8400066
Reno
New York
Dent Neurologic Institute - Amherst- Site Number : 8400129
Amherst
Columbia University Irving Medical Center- Site Number : 8400088
New York
Icahn School of Medicine at Mount Sinai- Site Number : 8400011
New York
Ohio
Riverhills Neuroscience- Site Number : 8400007
Cincinnati
University of Cincinnati Medical Center- Site Number : 8400117
Cincinnati
The Boster Center for Multiple Sclerosis- Site Number : 8400006
Columbus
The Ohio State University- Site Number : 8400009
Columbus
UC Health - Elizabeth Place- Site Number : 8400008
Dayton
Oklahoma
Oklahoma Medical Research Foundation- Site Number : 8400039
Oklahoma City
Oregon
Providence St. Vincent's Medical Center- Site Number : 8400052
Portland
Pennsylvania
Penn State Health Milton South Hershey Medical Center- Site Number : 8400176
Hershey
South Carolina
Premier Neurology- Site Number : 8400047
Greer
Tennessee
Vanderbilt Multiple Sclerosis Center- Site Number : 8400130
Nashville
Texas
Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
Dallas
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083
Plano
Neurology Center of San Antonio- Site Number : 8400099
San Antonio
Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018
Sherman
Virginia
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8400109
Fairfax
Vermont
University of Vermont Medical Center- Site Number : 8400042
Burlington
Washington
Swedish Medical Center - Seattle- Site Number : 8400078
Seattle
Wisconsin
Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038
Milwaukee
Other Locations
Argentina
Investigational Site Number : 0320001
Buenos Aires
Investigational Site Number : 0320002
Buenos Aires
Investigational Site Number : 0320007
Buenos Aires
Investigational Site Number : 0321010
Buenos Aires
Investigational Site Number : 0320003
Rosario
Australia
Investigational Site Number : 0360002
Melbourne
Investigational Site Number : 0360005
Saint Leonards
Investigational Site Number : 0360001
Woolloongabba
Belgium
Investigational Site Number : 0560001
Bruges
Investigational Site Number : 0560008
Brussels
Investigational Site Number : 0560006
Ghent
Investigational Site Number : 0560007
Kortrijk
Investigational Site Number : 0560003
Melsbroek
Investigational Site Number : 0560005
Overpelt
Brazil
Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760025
Belo Horizonte
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
Brasília
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760001
Curitiba
Universidade Federal de Goias- Site Number : 0760024
Goiânia
Clínica Neurológica- Site Number : 0760007
Joinville
Hospital Moinhos de Vento- Site Number : 0760005
Porto Alegre
IMV Pesquisa Neurológica- Site Number : 0760031
Porto Alegre
Instituto Ceos- Site Number : 0760028
Porto Alegre
Centro de Pesquisas da Clínica IBIS- Site Number : 0760030
Salvador
Prognosis Centro de Pesquisa- Site Number : 0760032
Santo André
CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0760002
São Paulo
Hospital Israelita Albert Einstein- Site Number : 0760026
São Paulo
Jordy Sinapse- Site Number : 0760004
São Paulo
PSEG Centro de Pesquisa Clínica- Site Number : 0760021
São Paulo
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760029
Vitória
Bulgaria
Investigational Site Number : 1000009
Blagoevgrad
Investigational Site Number : 1000008
Panagyurishte
Investigational Site Number : 1000007
Pazardzhik
Investigational Site Number : 1000002
Pleven
Investigational Site Number : 1000010
Pleven
Investigational Site Number : 1000001
Sofia
Investigational Site Number : 1000004
Sofia
Investigational Site Number : 1000005
Sofia
Investigational Site Number : 1000006
Sofia
Canada
Investigational Site Number : 1240005
Burnaby
Investigational Site Number : 1240011
Calgary
Investigational Site Number : 1240001
Gatineau
Investigational Site Number : 1240008
Lévis
Investigational Site Number : 1240014
London
Investigational Site Number : 1240018
Moncton
Investigational Site Number : 1240009
Montreal
Investigational Site Number : 1240002
Ottawa
Investigational Site Number : 1240003
Québec
Investigational Site Number : 1240006
Sherbrooke
Investigational Site Number : 1240012
Toronto
Investigational Site Number : 1240015
Toronto
Investigational Site Number : 1240010
Vancouver
Chile
Investigational Site Number : 1520001
Santiago
Investigational Site Number : 1520002
Santiago
China
Investigational Site Number : 1560005
Beijing
Investigational Site Number : 1560007
Beijing
Investigational Site Number : 1560008
Beijing
Investigational Site Number : 1560003
Changchun
Investigational Site Number : 1560011
Changsha
Investigational Site Number : 1560004
Chengdu
Investigational Site Number : 1560045
Fuzhou
Investigational Site Number : 1560002
Guangzhou
Investigational Site Number : 1561027
Harbin
Investigational Site Number : 1560010
Jiazhuang
Investigational Site Number : 1560001
Shanghai
Investigational Site Number : 1560006
Taiyuan
Investigational Site Number : 1560012
Tianjin
Investigational Site Number : 1560009
Wuhan
Investigational Site Number : 1560013
Xi'an
Investigational Site Number : 1560034
Zhengzhou
France
Investigational Site Number : 2500005
Créteil
Investigational Site Number : 2500017
Gonesse
Investigational Site Number : 2500006
La Tronche
Investigational Site Number : 2500009
Lille
Investigational Site Number : 2500016
Nancy
Investigational Site Number : 2500002
Nice
Investigational Site Number : 2500018
Orsay
Investigational Site Number : 2500007
Paris
Investigational Site Number : 2500014
Paris
Investigational Site Number : 2500003
Rennes
Investigational Site Number : 2500010
Saint-herblain
Investigational Site Number : 2500001
Strasbourg
Germany
Investigational Site Number : 2760009
Bielefeld
Investigational Site Number : 2760010
Bochum
Investigational Site Number : 2760012
Dresden
Investigational Site Number : 2760002
Düsseldorf
Investigational Site Number : 2760013
Erbach Im Odenwald
Investigational Site Number : 2760011
Essen
Investigational Site Number : 2760014
Heidelberg
Investigational Site Number : 2760007
Jena
Investigational Site Number : 2760003
Leipzig
Investigational Site Number : 2760008
Marburg
Investigational Site Number : 2760006
Münster
Investigational Site Number : 2760001
Ulm
Greece
Investigational Site Number : 3000003
Athens
Investigational Site Number : 3000005
Athens
Investigational Site Number : 3000004
Ioannina
Investigational Site Number : 3000001
Larissa
Investigational Site Number : 3000002
Thessaloniki
Hungary
Investigational Site Number : 3480003
Budapest
Investigational Site Number : 3480004
Budapest
Investigational Site Number : 3480006
Budapest
Investigational Site Number : 3480002
Győr
India
Investigational Site Number : 3560024
Bengaluru
Investigational Site Number : 3560008
Hyderabad
Investigational Site Number : 3560017
New Delhi
Investigational Site Number : 3560006
Shimla
Italy
Investigational Site Number : 3800034
Augusta
Investigational Site Number : 3800009
Bologna
Investigational Site Number : 3800006
Cefalù
Investigational Site Number : 3800014
Chieti
Investigational Site Number : 3800025
Cona
Investigational Site Number : 3800004
Florence
Investigational Site Number : 3800019
Foggia
Investigational Site Number : 3800035
Gallarate
Investigational Site Number : 3800011
Genoa
Investigational Site Number : 3800002
Milan
Investigational Site Number : 3800016
Milan
Investigational Site Number : 3800010
Naples
Investigational Site Number : 3800026
Novara
Investigational Site Number : 3800017
Palermo
Investigational Site Number : 3800029
Parma
Investigational Site Number : 3800005
Pavia
Investigational Site Number : 3800003
Perugia
Investigational Site Number : 3800030
Ravenna
Investigational Site Number : 3800001
Rome
Investigational Site Number : 3800013
Rome
Investigational Site Number : 3800021
Rome
Japan
Investigational Site Number : 3920014
Asahikawa
Investigational Site Number : 3920002
Chiba
Investigational Site Number : 3920013
Fukuoka
Investigational Site Number : 3920015
Higashi-matsuyama
Investigational Site Number : 3920007
Himeji
Investigational Site Number : 3800008
Joyo-shi
Investigational Site Number : 3920016
Kodaira
Investigational Site Number : 3920003
Kōriyama
Investigational Site Number : 3920001
Kyoto
Investigational Site Number : 3920010
Sagamihara
Investigational Site Number : 3920011
Tokyo
Investigational Site Number : 3920012
Tokyo
Investigational Site Number : 2500015
Toyama
Netherlands
Investigational Site Number : 5280002
Rotterdam
Poland
Investigational Site Number : 6160007
Bialystok
Investigational Site Number : 6160018
Bydgoszcz
Investigational Site Number : 6160010
Katowice
Investigational Site Number : 6160011
Katowice
Investigational Site Number : 6160005
Krakow
Investigational Site Number : 6160012
Poznan
Investigational Site Number : 6160006
Rzeszów
Investigational Site Number : 6160004
Zabrze
Portugal
Investigational Site Number : 6200001
Braga
Investigational Site Number : 6200006
Lisbon
Investigational Site Number : 6200007
Lisbon
Investigational Site Number : 6200011
Lisbon
Investigational Site Number : 6200002
Matosinhos Municipality
Republic of Korea
Investigational Site Number : 4100001
Goyang-si
Investigational Site Number : 4100007
Seongnam-si
Investigational Site Number : 4100002
Seoul
Investigational Site Number : 4100003
Seoul
Investigational Site Number : 4100004
Seoul
Saudi Arabia
Investigational Site Number : 6820001
Riyadh
Spain
Investigational Site Number : 7240009
Barakaldo
Investigational Site Number : 7240010
Barcelona
Investigational Site Number : 7240016
Barcelona
Investigational Site Number : 7240004
Córdoba
Investigational Site Number : 7240012
Donostia / San Sebastian
Investigational Site Number : 7240024
Girona
Investigational Site Number : 7240011
L'hospitalet De Llobregat
Investigational Site Number : 7240013
Las Palmas De Gran Canaria
Investigational Site Number : 7240015
Lleida
Investigational Site Number : 7240002
Madrid
Investigational Site Number : 7240003
Madrid
Investigational Site Number : 7240006
Madrid
Investigational Site Number : 7240022
Madrid
Investigational Site Number : 7240023
Madrid
Investigational Site Number : 7240017
Majadahonda
Investigational Site Number : 7240005
Málaga
Investigational Site Number : 7240018
Murcia
Investigational Site Number : 7240014
Pontevedra
Investigational Site Number : 7240001
Pozuelo De Alarcón
Investigational Site Number : 7240007
Seville
Investigational Site Number : 7240008
Valencia
Investigational Site Number : 7240025
Zaragoza
Sweden
Investigational Site Number : 7520001
Gothenburg
Investigational Site Number : 7520005
Huddinge
Investigational Site Number : 7520003
Malmö
Investigational Site Number : 7520002
Stockholm
Turkey
Investigational Site Number : 7920011
Ankara
Investigational Site Number : 7920018
Ankara
Investigational Site Number : 7920013
Bursa
Investigational Site Number : 7920020
Bursa
Investigational Site Number : 7920005
Eskişehir
Investigational Site Number : 7920002
Istanbul
Investigational Site Number : 7920007
Istanbul
Investigational Site Number : 7920009
Istanbul
Investigational Site Number : 7920012
Istanbul
Investigational Site Number : 7920016
Istanbul
Investigational Site Number : 7920008
Izmir
Investigational Site Number : 7920019
Izmir
Investigational Site Number : 7920001
İzmit
Investigational Site Number : 7920014
Kayseri
Investigational Site Number : 7920015
Konya
Investigational Site Number : 7920006
Mersin
Investigational Site Number : 7920004
Samsun
Investigational Site Number : 7920003
Sultangazi
Investigational Site Number : 7920017
Van
Ukraine
Investigational Site Number : 8040001
Chernivtsi
Investigational Site Number : 8040009
Ivano-frankivsk
Investigational Site Number : 8040003
Krykhivtsi
Investigational Site Number : 8040006
Kyiv
Investigational Site Number : 8040008
Lutsk
Investigational Site Number : 8040002
Lviv
Investigational Site Number : 8040004
Lviv
Investigational Site Number : 8040005
Vinnytsia
United Kingdom
Investigational Site Number : 8260003
Canterbury
Investigational Site Number : 8260007
Cardiff
Investigational Site Number : 8260001
Exeter
Investigational Site Number : 8260011
Gwent
Investigational Site Number : 8260010
Inverness
Investigational Site Number : 8260009
Liverpool
Investigational Site Number : 8260013
London
Investigational Site Number : 8260006
Newcastle Upon Tyne
Investigational Site Number : 8260004
Oxford
Investigational Site Number : 8260008
Salford
Investigational Site Number : 8260005
Swansea
Time Frame
Start Date: 2023-12-27
Completion Date: 2028-03-24
Participants
Target number of participants: 943
Treatments
Experimental: Frexalimab
Frexalimab IV administration
Placebo_comparator: Placebo
Matching placebo
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov