Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
FREVIVA
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
3 other identifiers
interventional
943
27 countries
311
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-sclerosis
Started Dec 2023
Typical duration for phase_3 multiple-sclerosis
311 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2023
CompletedFirst Posted
Study publicly available on registry
November 21, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 24, 2028
May 14, 2026
May 1, 2026
4.2 years
November 9, 2023
May 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period
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
Up to 36 months
Secondary Outcomes (15)
Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period
Up to 36 months
Time to onset of individual components of the composite, confirmed over 3-months or 6 months in the double-blind treatment period
Up to 36 months
Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period
Up to 36 months
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
Up to 36 months
Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6
Up to 36 months
- +10 more secondary outcomes
Study Arms (2)
Frexalimab
EXPERIMENTALFrexalimab IV administration
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (311)
Alabama Neurology Associates- Site Number : 8400115
Homewood, Alabama, 35209, United States
Perseverance Research Center- Site Number : 8400138
Scottsdale, Arizona, 85253, United States
Imaging Endpoints- Site Number : 8400050
Scottsdale, Arizona, 85258, United States
Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134
Berkeley, California, 94705, United States
University of California Irvine - School of Medicine- Site Number : 8400143
Irvine, California, 92697, United States
University of California San Diego - La Jolla- Site Number : 8400095
La Jolla, California, 92037, United States
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184
Los Angeles, California, 90027, United States
Hoag Memorial Hospital Presbyterian- Site Number : 8400031
Newport Beach, California, 92663, United States
Stanford Neuroscience Health Center- Site Number : 8400120
Palo Alto, California, 94304, United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood, California, 90048, United States
University of Colorado - Anschutz Medical Campus- Site Number : 8400001
Aurora, Colorado, 80045, United States
Advanced Neurology of Colorado- Site Number : 8400148
Fort Collins, Colorado, 80528, United States
Yale University School of Medicine- Site Number : 8400081
New Haven, Connecticut, 06510, United States
Hartford Healthcare Medical Group- Site Number : 8400069
Norwich, Connecticut, 06360, United States
MedStar Georgetown University Hospital- Site Number : 8400044
Washington D.C., District of Columbia, 20007, United States
Neurology of Central Florida- Site Number : 8400147
Altamonte Springs, Florida, 32714, United States
MS & Neuromuscular Center of Excellence- Site Number : 8400015
Clearwater, Florida, 33761, United States
Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054
Gainesville, Florida, 32608, United States
Neurology Associates - Maitland- Site Number : 8400010
Maitland, Florida, 32751, United States
Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060
Orlando, Florida, 32806, United States
Axiom Clinical Research of Florida- Site Number : 8400049
Tampa, Florida, 33609, 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
Joi Life Wellness Group LLC- Site Number : 8400192
Smyrna, Georgia, 30080, United States
Rush University Medical Center- Site Number : 8400102
Chicago, Illinois, 60612, United States
University of Chicago Medical Center- Site Number : 8400055
Chicago, Illinois, 60637, United States
Consultants in Neurology- Site Number : 8400020
Northbrook, Illinois, 60062, United States
Neuroscience Institute Center- Site Number : 8400053
Merrillville, Indiana, 46410, United States
University of Iowa- Site Number : 8400029
Iowa City, Iowa, 52242-1009, United States
University of Kansas Medical Center- Site Number : 8400084
Kansas City, Kansas, 66103, United States
Baptist Health Lexington- Site Number : 8400149
Lexington, Kentucky, 40503, United States
NeuroMedical Clinic of Central Louisiana- Site Number : 8400159
Alexandria, Louisiana, 71301, United States
Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
New Orleans, Louisiana, 70121, United States
University of Maryland School of Medicine - Baltimore- Site Number : 8400185
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital- Site Number : 8400080
Baltimore, Maryland, 21287, United States
Tufts Medical Center- Site Number : 8400003
Boston, Massachusetts, 02111, United States
Boston Clinical Trials- Site Number : 8400178
Boston, Massachusetts, 02131, United States
Neurology Center of New England- Site Number : 8400164
Foxborough, Massachusetts, 02035, United States
The Elliot Lewis Center- Site Number : 8400033
Wellesley, Massachusetts, 02481, United States
UMass Memorial Medical Center - University Campus- Site Number : 8400028
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital- Site Number : 8400091
Detroit, Michigan, 48202, United States
Michigan Institute for Neurological Disorders- Site Number : 8400004
Farmington Hills, Michigan, 48334, United States
Trinity Health Grand Rapids- Site Number : 8400150
Grand Rapids, Michigan, 49503, United States
Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
Owosso, Michigan, 48867, United States
Rochester Medical Group- Site Number : 8400172
Rochester Hills, Michigan, 48307, United States
Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400077
Golden Valley, Minnesota, 55422, United States
M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056
Minneapolis, Minnesota, 55455, United States
Minnesota Center for Multiple Sclerosis- Site Number : 8400073
Plymouth, Minnesota, 55446, United States
Sharlin Health and Neurology- Site Number : 8400016
Ozark, Missouri, 65721, United States
Washington University- Site Number : 8400076
St Louis, Missouri, 63110, United States
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045
Las Vegas, Nevada, 89106, United States
Renown Regional Medical Center- Site Number : 8400066
Reno, Nevada, 89502, United States
Holy Name Medical Center- Site Number : 8400101
Teaneck, New Jersey, 07666, United States
The University of New Mexico- Site Number : 8400090
Albuquerque, New Mexico, 87106, United States
Dent Neurologic Institute - Amherst- Site Number : 8400129
Amherst, New York, 14226, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400011
New York, New York, 10029, United States
Columbia University Irving Medical Center- Site Number : 8400088
New York, New York, 10032, 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
Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040
Winston-Salem, North Carolina, 27103, United States
Sanford Brain and Spine Center- Site Number : 8400085
Fargo, North Dakota, 58103, United States
Riverhills Neuroscience- Site Number : 8400007
Cincinnati, Ohio, 45212, United States
University of Cincinnati Medical Center- Site Number : 8400117
Cincinnati, Ohio, 45219, 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
UC Health - Elizabeth Place- Site Number : 8400008
Dayton, Ohio, 45408, United States
Oklahoma Medical Research Foundation- Site Number : 8400039
Oklahoma City, Oklahoma, 73104, United States
Providence St. Vincent's Medical Center- Site Number : 8400052
Portland, Oregon, 97225, United States
Penn State Health Milton South Hershey Medical Center- Site Number : 8400176
Hershey, Pennsylvania, 17033, United States
Premier Neurology- Site Number : 8400047
Greer, South Carolina, 29650, United States
Vanderbilt Multiple Sclerosis Center- Site Number : 8400130
Nashville, Tennessee, 37215, United States
Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
Dallas, Texas, 75243, 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
Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018
Sherman, Texas, 75092, United States
University of Vermont Medical Center- Site Number : 8400042
Burlington, Vermont, 05401, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8400109
Fairfax, Virginia, 22031, United States
Swedish Medical Center - Seattle- Site Number : 8400078
Seattle, Washington, 98104, United States
Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038
Milwaukee, Wisconsin, 53226, United States
Investigational Site Number : 0320003
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320002
Buenos Aires, 1012, Argentina
Investigational Site Number : 0321010
Buenos Aires, 1055, Argentina
Investigational Site Number : 0320007
Buenos Aires, 1060, Argentina
Investigational Site Number : 0320001
Buenos Aires, 1425, Argentina
Investigational Site Number : 0360005
Saint Leonards, New South Wales, 2065, Australia
Investigational Site Number : 0360001
Woolloongabba, Queensland, 4102, Australia
Investigational Site Number : 0360002
Melbourne, Victoria, 3084, Australia
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 : 0560003
Melsbroek, 1820, Belgium
Investigational Site Number : 0560005
Overpelt, 3900, Belgium
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760029
Vitória, Espírito Santo, 29055-450, Brazil
Centro de Pesquisas da Clínica IBIS- Site Number : 0760030
Salvador, Estado de Bahia, 41820-020, Brazil
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
Brasília, Federal District, 70200-730, Brazil
Universidade Federal de Goias- Site Number : 0760024
Goiânia, Goiás, 74605-020, Brazil
Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760025
Belo Horizonte, Minas Gerais, 30150-320, Brazil
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760001
Curitiba, Paraná, 81210-310, Brazil
Hospital Moinhos de Vento- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, 90035-902, Brazil
IMV Pesquisa Neurológica- Site Number : 0760031
Porto Alegre, Rio Grande do Sul, 90110-000, Brazil
Instituto Ceos- Site Number : 0760028
Porto Alegre, Rio Grande do Sul, 90480-020, Brazil
Clínica Neurológica- Site Number : 0760007
Joinville, Santa Catarina, 89202-165, Brazil
Prognosis Centro de Pesquisa- Site Number : 0760032
Santo André, São Paulo, 09040-010, Brazil
CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0760002
São Paulo, 01228-000, Brazil
PSEG Centro de Pesquisa Clínica- Site Number : 0760021
São Paulo, 04038-002, Brazil
Jordy Sinapse- Site Number : 0760004
São Paulo, 04515-000, Brazil
Hospital Israelita Albert Einstein- Site Number : 0760026
São Paulo, 05651-901, Brazil
Investigational Site Number : 1000009
Blagoevgrad, 2700, Bulgaria
Investigational Site Number : 1000008
Panagyurishte, 4500, Bulgaria
Investigational Site Number : 1000007
Pazardzhik, 4400, Bulgaria
Investigational Site Number : 1000002
Pleven, 5800, Bulgaria
Investigational Site Number : 1000010
Pleven, 5800, Bulgaria
Investigational Site Number : 1000004
Sofia, 1407, Bulgaria
Investigational Site Number : 1000001
Sofia, 1431, Bulgaria
Investigational Site Number : 1000006
Sofia, 1606, Bulgaria
Investigational Site Number : 1000005
Sofia, 1680, Bulgaria
Investigational Site Number : 1240011
Calgary, Alberta, T2N 2T9, Canada
Investigational Site Number : 1240005
Burnaby, British Columbia, V5G 2X6, Canada
Investigational Site Number : 1240010
Vancouver, British Columbia, V6T 2B5, Canada
Investigational Site Number : 1240018
Moncton, New Brunswick, E1C 2Z3, Canada
Investigational Site Number : 1240014
London, Ontario, N6A 5A5, Canada
Investigational Site Number : 1240002
Ottawa, Ontario, K1H 8L6, Canada
Investigational Site Number : 1240015
Toronto, Ontario, M4N 3M5, Canada
Investigational Site Number : 1240012
Toronto, Ontario, M5B 1W8, Canada
Investigational Site Number : 1240001
Gatineau, Quebec, J8Y 1W2, Canada
Investigational Site Number : 1240008
Lévis, Quebec, G6W 0M5, Canada
Investigational Site Number : 1240009
Montreal, Quebec, H2X 3E4, Canada
Investigational Site Number : 1240003
Québec, Quebec, G1J 1Z4, Canada
Investigational Site Number : 1240006
Sherbrooke, Quebec, J1H 5N4, Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 8320325, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8380456, Chile
Investigational Site Number : 1560007
Beijing, 100005, China
Investigational Site Number : 1560005
Beijing, 100034, China
Investigational Site Number : 1560008
Beijing, 100050, China
Investigational Site Number : 1560003
Changchun, 130021, China
Investigational Site Number : 1560011
Changsha, 410008, China
Investigational Site Number : 1560004
Chengdu, 610041, China
Investigational Site Number : 1560045
Fuzhou, 350005, China
Investigational Site Number : 1560002
Guangzhou, 510630, China
Investigational Site Number : 1561027
Harbin, 150001, China
Investigational Site Number : 1560010
Jiazhuang, 050000, China
Investigational Site Number : 1560001
Shanghai, 200040, China
Investigational Site Number : 1560006
Taiyuan, 030001, China
Investigational Site Number : 1560012
Tianjin, 300121, China
Investigational Site Number : 1560009
Wuhan, 430030, China
Investigational Site Number : 1560013
Xi'an, 710038, China
Investigational Site Number : 1560034
Zhengzhou, 450052, China
Investigational Site Number : 2030011
Brno, 625 00, Czechia
Investigational Site Number : 2030005
Brno, 656 91, Czechia
Investigational Site Number : 2030002
Hradec Králové, 500 05, Czechia
Investigational Site Number : 2030006
Jihlava, 586 01, Czechia
Investigational Site Number : 2030007
Ostrava, 708 52, Czechia
Investigational Site Number : 2030008
Prague, 150 06, Czechia
Investigational Site Number : 2030009
Teplice, 415 01, Czechia
Investigational Site Number : 2030001
Zlín, 762 75, Czechia
Investigational Site Number : 2500005
Créteil, 94010, France
Investigational Site Number : 2500017
Gonesse, 95500, France
Investigational Site Number : 2500006
La Tronche, 38700, France
Investigational Site Number : 2500009
Lille, 59037, France
Investigational Site Number : 2500016
Nancy, 54035, France
Investigational Site Number : 2500002
Nice, 06001, France
Investigational Site Number : 2500018
Orsay, 91400, France
Investigational Site Number : 2500007
Paris, 75019, France
Investigational Site Number : 2500014
Paris, 75651, France
Investigational Site Number : 2500003
Rennes, 35033, France
Investigational Site Number : 2500010
Saint-Herblain, 44800, France
Investigational Site Number : 2500001
Strasbourg, 67200, France
Investigational Site Number : 2760009
Bielefeld, 33647, Germany
Investigational Site Number : 2760010
Bochum, 44791, Germany
Investigational Site Number : 2760012
Dresden, 01307, Germany
Investigational Site Number : 2760002
Düsseldorf, 40225, Germany
Investigational Site Number : 2760013
Erbach im Odenwald, 64711, Germany
Investigational Site Number : 2760011
Essen, 45147, Germany
Investigational Site Number : 2760014
Heidelberg, 69117, Germany
Investigational Site Number : 2760007
Jena, 07747, Germany
Investigational Site Number : 2760003
Leipzig, 04103, Germany
Investigational Site Number : 2760008
Marburg, 35043, Germany
Investigational Site Number : 2760006
Münster, 48149, Germany
Investigational Site Number : 2760001
Ulm, 89073, Germany
Investigational Site Number : 3000003
Athens, 115 25, Greece
Investigational Site Number : 3000005
Athens, 124 62, Greece
Investigational Site Number : 3000004
Ioannina, 455 00, Greece
Investigational Site Number : 3000001
Larissa, 411 10, Greece
Investigational Site Number : 3000002
Thessaloniki, 546 36, Greece
Investigational Site Number : 3480003
Budapest, 1033, Hungary
Investigational Site Number : 3480004
Budapest, 1138, Hungary
Investigational Site Number : 3480006
Budapest, 1145, Hungary
Investigational Site Number : 3480002
Győr, 9024, Hungary
Investigational Site Number : 3560024
Bengaluru, 560022, India
Investigational Site Number : 3560008
Hyderabad, 500082, India
Investigational Site Number : 3560017
New Delhi, 110029, India
Investigational Site Number : 3560006
Shimla, 171001, India
Investigational Site Number : 3800034
Augusta, Catania, 96011, Italy
Investigational Site Number : 3800025
Cona, Ferrara, 44124, Italy
Investigational Site Number : 3800004
Florence, Firenze, 50134, Italy
Investigational Site Number : 3800011
Genoa, Genova, 16132, Italy
Investigational Site Number : 3800002
Milan, Milano, 20132, Italy
Investigational Site Number : 3800016
Milan, Milano, 20133, Italy
Investigational Site Number : 3800010
Naples, Napoli, 80131, Italy
Investigational Site Number : 3800006
Cefalù, Palermo, 90015, Italy
Investigational Site Number : 3800001
Rome, Roma, 00149, Italy
Investigational Site Number : 3800013
Rome, Roma, 00161, Italy
Investigational Site Number : 3800021
Rome, Roma, 00168, Italy
Investigational Site Number : 3800035
Gallarate, Varese, 21013, Italy
Investigational Site Number : 3800009
Bologna, 40139, Italy
Investigational Site Number : 3800014
Chieti, 66100, Italy
Investigational Site Number : 3800019
Foggia, 71100, Italy
Investigational Site Number : 3800026
Novara, 28100, Italy
Investigational Site Number : 3800017
Palermo, 90127, Italy
Investigational Site Number : 3800029
Parma, 43100, Italy
Investigational Site Number : 3800005
Pavia, 27100, Italy
Investigational Site Number : 3800003
Perugia, 06156, Italy
Investigational Site Number : 3800030
Ravenna, 48121, Italy
Investigational Site Number : 3920003
Kōriyama, Fukushima, 963-8052, Japan
Investigational Site Number : 3920014
Asahikawa, Hokkaido, 070-0901, Japan
Investigational Site Number : 3920007
Himeji, Hyōgo, 670-8560, Japan
Investigational Site Number : 3920010
Sagamihara, Kanagawa, 252-0315, Japan
Investigational Site Number : 3920015
Higashi-Matsuyama, Saitama, 355-0005, Japan
Investigational Site Number : 3920016
Kodaira, Tokyo, 187-8551, Japan
Investigational Site Number : 3920002
Chiba, 260-8677, Japan
Investigational Site Number : 3920013
Fukuoka, 812-8582, Japan
Investigational Site Number : 3800008
Joyo-Shi, 610-0113, Japan
Investigational Site Number : 3920001
Kyoto, 616-8255, Japan
Investigational Site Number : 3920011
Tokyo, 145-0065, Japan
Investigational Site Number : 3920012
Tokyo, 160-8582, Japan
Investigational Site Number : 2500015
Toyama, 939-2716, Japan
Investigational Site Number : 5280002
Rotterdam, 3015 CE, Netherlands
Investigational Site Number : 6160012
Poznan, Greater Poland Voivodeship, 60-309, Poland
Investigational Site Number : 6160018
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Investigational Site Number : 6160005
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Investigational Site Number : 6160006
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Investigational Site Number : 6160007
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Investigational Site Number : 6160010
Katowice, Silesian Voivodeship, 40-081, Poland
Investigational Site Number : 6160004
Zabrze, Silesian Voivodeship, 41-800, Poland
Investigational Site Number : 6160011
Katowice, 40571, Poland
Investigational Site Number : 6200001
Braga, 4710-243, Portugal
Investigational Site Number : 6200011
Lisbon, 1169-050, Portugal
Investigational Site Number : 6200007
Lisbon, 1349-019, Portugal
Investigational Site Number : 6200006
Lisbon, 1649-035, Portugal
Investigational Site Number : 6200002
Matosinhos Municipality, 4464-513, Portugal
Investigational Site Number : 6820001
Riyadh, 11461, Saudi Arabia
Investigational Site Number : 4100001
Goyang-si, Gyeonggi-do, 10408, South Korea
Investigational Site Number : 4100007
Seongnam-si, Gyeonggi-do, 13620, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 03080, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, 03722, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 06351, South Korea
Investigational Site Number : 7240018
Murcia, Almería, 30120, Spain
Investigational Site Number : 7240016
Barcelona, Barcelona [Barcelona], 08003, Spain
Investigational Site Number : 7240010
Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7240009
Barakaldo, Basque Country, 48903, Spain
Investigational Site Number : 7240011
L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907, Spain
Investigational Site Number : 7240012
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Investigational Site Number : 7240024
Girona, Girona [Gerona], 17190, Spain
Investigational Site Number : 7240013
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Investigational Site Number : 7240015
Lleida, Lleida [Lérida], 25198, Spain
Investigational Site Number : 7240017
Majadahonda, Madrid, 28222, Spain
Investigational Site Number : 7240001
Pozuelo de Alarcón, Madrid, 28223, Spain
Investigational Site Number : 7240014
Pontevedra, Pontevedra [Pontevedra], 36312, Spain
Investigational Site Number : 7240007
Seville, Sevilla, 41009, Spain
Investigational Site Number : 7240004
Córdoba, 14004, Spain
Investigational Site Number : 7240006
Madrid, 28006, Spain
Investigational Site Number : 7240023
Madrid, 28007, Spain
Investigational Site Number : 7240002
Madrid, 28034, Spain
Investigational Site Number : 7240003
Madrid, 28040, Spain
Investigational Site Number : 7240022
Madrid, 28040, Spain
Investigational Site Number : 7240005
Málaga, 29010, Spain
Investigational Site Number : 7240008
Valencia, 46026, Spain
Investigational Site Number : 7240025
Zaragoza, 50009, Spain
Investigational Site Number : 7520001
Gothenburg, 413 45, Sweden
Investigational Site Number : 7520005
Huddinge, 141 57, Sweden
Investigational Site Number : 7520003
Malmö, 205 02, Sweden
Investigational Site Number : 7520002
Stockholm, 113 65, Sweden
Investigational Site Number : 7920018
Ankara, 06010, Turkey (Türkiye)
Investigational Site Number : 7920011
Ankara, 06800, Turkey (Türkiye)
Investigational Site Number : 7920020
Bursa, 16059, Turkey (Türkiye)
Investigational Site Number : 7920013
Bursa, 16310, Turkey (Türkiye)
Investigational Site Number : 7920005
Eskişehir, 26480, Turkey (Türkiye)
Investigational Site Number : 7920012
Istanbul, 34010, Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number : 7920016
Istanbul, 34200, Turkey (Türkiye)
Investigational Site Number : 7920009
Istanbul, 34668, Turkey (Türkiye)
Investigational Site Number : 7920007
Istanbul, 34785, Turkey (Türkiye)
Investigational Site Number : 7920019
Izmir, 35340, Turkey (Türkiye)
Investigational Site Number : 7920008
Izmir, 35360, Turkey (Türkiye)
Investigational Site Number : 7920001
İzmit, 41001, Turkey (Türkiye)
Investigational Site Number : 7920014
Kayseri, 38039, Turkey (Türkiye)
Investigational Site Number : 7920015
Konya, 42075, Turkey (Türkiye)
Investigational Site Number : 7920006
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number : 7920004
Samsun, 55139, Turkey (Türkiye)
Investigational Site Number : 7920003
Sultangazi, 34265, Turkey (Türkiye)
Investigational Site Number : 7920017
Van, 65080, Turkey (Türkiye)
Investigational Site Number : 8040001
Chernivtsi, 58023, Ukraine
Investigational Site Number : 8040009
Ivano-Frankivsk, 76019, Ukraine
Investigational Site Number : 8040003
Krykhivtsi, 76493, Ukraine
Investigational Site Number : 8040006
Kyiv, 02091, Ukraine
Investigational Site Number : 8040008
Lutsk, 43005, Ukraine
Investigational Site Number : 8040004
Lviv, 79010, Ukraine
Investigational Site Number : 8040002
Lviv, 79029, Ukraine
Investigational Site Number : 8040005
Vinnytsia, 21050, Ukraine
Investigational Site Number : 8260011
Gwent, Blaenau Gwent, NP20 2UB, United Kingdom
Investigational Site Number : 8260007
Cardiff, Cardiff [Caerdydd Gb-crd], CF14 4XW, United Kingdom
Investigational Site Number : 8260001
Exeter, Devon, EX2 5DW, United Kingdom
Investigational Site Number : 8260013
London, England, E11 1NR, United Kingdom
Investigational Site Number : 8260006
Newcastle upon Tyne, England, NE2 4HH, United Kingdom
Investigational Site Number : 8260010
Inverness, Highland, IV2 3UJ, United Kingdom
Investigational Site Number : 8260003
Canterbury, Kent, CT1 3NG, United Kingdom
Investigational Site Number : 8260008
Salford, Manchester, M6 8HD, United Kingdom
Investigational Site Number : 8260004
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Investigational Site Number : 8260005
Swansea, Swansea [Abertawe Gb-ata], SA6 6SG, United Kingdom
Investigational Site Number : 8260009
Liverpool, L97LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2023
First Posted
November 21, 2023
Study Start
December 27, 2023
Primary Completion (Estimated)
March 24, 2028
Study Completion (Estimated)
March 24, 2028
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org