Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
FREXALT
Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis
3 other identifiers
interventional
1,655
41 countries
382
Brief Summary
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis 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 depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration.
- The study intervention duration will vary similarly as the study duration.
- The scheduled visits will include monthly visits for the first 6 months and quarterly visits thereafter until the common end of study (EOS), or premature end of treatment (pEOT) after which 3 follow-up visits will be performed
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
382 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 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 6, 2027
July 20, 2026
July 1, 2026
3.4 years
November 9, 2023
July 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses
ARR during the study period assessed by protocol-defined adjudicated relapses. This endpoint will be analyzed in the ITT population of each study using a negative binomial model with the total number of adjudicated relapses per participant occurring during the observation period as the response variable and with terms for treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, ≥4), and geographical region (US, non-US).
Until Week 156
Secondary Outcomes (16)
Time to onset of composite confirmed disability worsening (cCDW)
Until Week 156
Time to onset of cCDW, confirmed over 3 months
Until Week 156
Time to onset of individual components of the composite, confirmed over 3-months or 6-months
Until Week 156
Time to onset of confirmed disability improvement (CDI)
Until Week 156
Progression independent of relapse activity defined as the time to onset of 6-month cCDW
Until Week 156
- +11 more secondary outcomes
Study Arms (2)
Frexalimab
EXPERIMENTALParticipants will receive Frexalimab infusion and placebo tablet.
Teriflunomide
ACTIVE COMPARATORParticipants will receive teriflunomide tablet and placebo infusion.
Interventions
oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed.
oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.
Eligibility Criteria
You may qualify if:
- The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
- The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)
- The participant must have at least 1 of the following prior to screening:
- ≥1 documented relapse within the previous year OR
- ≥2 documented relapses within the previous 2 years, OR
- ≥1 documented Gd enhancing lesion on an MRI scan within the previous year.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
You may not qualify if:
- The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
- 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.
- Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia.
- 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 had a relapse in the 30 days prior to randomization.
- The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (382)
University of Alabama at Birmingham- Site Number : 8401135
Birmingham, Alabama, 35233, United States
North Central Neurology Associates- Site Number : 8401100
Cullman, Alabama, 35058, United States
Alabama Neurology Associates- Site Number : 8400115
Homewood, Alabama, 35209, United States
St. Joseph's Hospital and Medical Center- Site Number : 8401139
Phoenix, Arizona, 85013, United States
Perseverance Research Center- Site Number : 8401138
Scottsdale, Arizona, 85253, United States
Clinical Endpoints- Site Number : 8400050
Scottsdale, Arizona, 85258, United States
The Neurology Center of Southern California - Carlsbad- Site Number : 8400023
Carlsbad, California, 92011, United States
University of California Irvine - School of Medicine- Site Number : 8401143
Irvine, California, 92697, United States
Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122
Laguna Hills, California, 92653, United States
Chemidox Clinical Trials- Site Number : 8401157
Lancaster, California, 93534, United States
Hoag Memorial Hospital Presbyterian- Site Number : 8401031
Newport Beach, California, 92663, United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood, California, 90048, United States
University of Colorado - Anschutz Medical Campus- Site Number : 8401001
Aurora, Colorado, 80045, United States
Advanced Neurology of Colorado- Site Number : 8401148
Fort Collins, Colorado, 80528, United States
Hartford Healthcare Medical Group- Site Number : 8401069
Norwich, Connecticut, 06360, United States
New England Institute for Clinical Research- Site Number : 8400114
Stamford, Connecticut, 06905, United States
MedStar Georgetown University Hospital- Site Number : 8400044
Washington D.C., District of Columbia, 20007, United States
Neurology of Central Florida- Site Number : 8401147
Altamonte Springs, Florida, 32714, United States
Neurology Offices of South Florida - Boca Raton- Site Number : 8401169
Boca Raton, Florida, 33428, United States
First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071
Boca Raton, Florida, 33486, United States
Nova Clinical Research - Bradenton- Site Number : 8400189
Bradenton, Florida, 34209, United States
Mayo Clinic in Florida- Site Number : 8401093
Jacksonville, Florida, 32224, United States
Neurology Associates - Maitland- Site Number : 8400010
Maitland, Florida, 32751, United States
University of Miami Hospital- Site Number : 8401177
Miami, Florida, 33136, United States
Design Neuroscience Center- Site Number : 8401191
Miami Lakes, Florida, 33016, 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 : 8401105
West Palm Beach, Florida, 33407, United States
Velocity Clinical Research - Savannah Neurology- Site Number : 8400061
Savannah, Georgia, 31406, United States
Joi Life Wellness Group LLC- Site Number : 8401192
Smyrna, Georgia, 30080, United States
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8401111
Evanston, Illinois, 60201, United States
Consultants in Neurology- Site Number : 8401020
Northbrook, Illinois, 60062, United States
Springfield Clinic 1st - 900 Building- Site Number : 8400043
Springfield, Illinois, 62702, United States
IU Health Physicians - Fort Wayne - Hope Drive- Site Number : 8400058
Fort Wayne, Indiana, 46815, United States
Neuroscience Institute Center- Site Number : 8400053
Merrillville, Indiana, 46410, United States
University of Iowa- Site Number : 8400029
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center- Site Number : 8400084
Kansas City, Kansas, 66160, United States
Kc Research Center- Site Number : 8400032
Roeland Park, Kansas, 66205, United States
Baptist Health Lexington- Site Number : 8401149
Lexington, Kentucky, 40503, United States
Norton Neurology Services- Site Number : 8401103
Louisville, Kentucky, 40207, United States
NeuroMedical Clinic of Central Louisiana- Site Number : 8401159
Alexandria, Louisiana, 71301, United States
The NeuroMedical Center- Site Number : 8401182
Baton Rouge, Louisiana, 70810, United States
Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
New Orleans, Louisiana, 70121, United States
International Neurorehabilitation Institute- Site Number : 8400089
Lutherville, Maryland, 21093, United States
Boston Clinical Trials- Site Number : 8401178
Boston, Massachusetts, 02131, United States
Beth Israel Deaconess Medical Center - Boston- Site Number : 8401041
Boston, Massachusetts, 02215, United States
Neurology Center of New England- Site Number : 8401164
Foxborough, Massachusetts, 02035, United States
Henry Ford Hospital- Site Number : 8401091
Detroit, Michigan, 48202, United States
Michigan Institute for Neurological Disorders- Site Number : 8400004
Farmington Hills, Michigan, 48334, United States
Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
Owosso, Michigan, 48867, United States
Rochester Medical Group- Site Number : 8401172
Rochester Hills, Michigan, 48307, 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
The MS Center for Innovations in Care- Site Number : 8401141
St Louis, Missouri, 63131, 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
Rutgers University- Site Number : 8401067
New Brunswick, New Jersey, 08903, United States
The University of New Mexico- Site Number : 8401090
Albuquerque, New Mexico, 87106, United States
South Shore Neurologic Associates - Patchogue- Site Number : 8400063
Patchogue, New York, 11772, United States
Montefiore Medical Center - Einstein Campus- Site Number : 8401145
The Bronx, New York, 10461, United States
The Neurological Institute- Site Number : 8401166
Charlotte, North Carolina, 28204, 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 : 8401085
Fargo, North Dakota, 58103, United States
Dayton Center for Neurological Disorders- Site Number : 8400079
Centerville, Ohio, 45459, United States
University of Cincinnati Medical Center- Site Number : 8401117
Cincinnati, Ohio, 45219, United States
The Ohio State University- Site Number : 8401009
Columbus, Ohio, 43210, United States
OhioHealth Riverside Methodist Hospital- Site Number : 8401092
Columbus, Ohio, 43214, United States
The Boster Center for Multiple Sclerosis- Site Number : 8400006
Columbus, Ohio, 43235, United States
UC Health - Elizabeth Place- Site Number : 8401008
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
Oregon Neurology Associates- Site Number : 8400188
Springfield, Oregon, 97477, United States
Abington Neurological Associates- Site Number : 8401065
Abington, Pennsylvania, 19001, United States
Penn State Health Milton South Hershey Medical Center- Site Number : 8401176
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University Hospital- Site Number : 8400035
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital- Site Number : 8401173
Pittsburgh, Pennsylvania, 15212, United States
UPMC Magee-Womens Hospital- Site Number : 8401133
Pittsburgh, Pennsylvania, 15213, United States
Premier Neurology- Site Number : 8401047
Greer, South Carolina, 29650, United States
Hope Neurology- Site Number : 8400019
Knoxville, Tennessee, 37922, United States
Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
Dallas, Texas, 75243, United States
ANESC Research- Site Number : 8400187
El Paso, Texas, 79912, United States
Baylor College of Medicine Medical Center- Site Number : 8401170
Houston, Texas, 77030, United States
North Texas Institute of Neurology & Headache - Plano- Site Number : 8401083
Plano, Texas, 75024, United States
UT Health - San Antonio- Site Number : 8401167
San Antonio, Texas, 78229, 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
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8401109
Fairfax, Virginia, 22031, United States
Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8401128
Vienna, Virginia, 22182, United States
Sentara Family Medicine Physicians - Virginia Beach - Glenn Mitchell Drive- Site Number : 8401168
Virginia Beach, Virginia, 23456, United States
Swedish Medical Center - Seattle- Site Number : 8400078
Seattle, Washington, 98104, United States
University of Washington Medical Center - Northwest- Site Number : 8401146
Seattle, Washington, 98133, United States
MultiCare Tacoma General Hospital- Site Number : 8401140
Tacoma, Washington, 98405, United States
Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034
Milwaukee, Wisconsin, 53215, 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 : 0320008
Buenos Aires, 1023, Argentina
Investigational Site Number : 0321010
Buenos Aires, 1055, Argentina
Investigational Site Number : 0320009
Buenos Aires, 1060, Argentina
Investigational Site Number : 0320001
Buenos Aires, 1425, Argentina
Investigational Site Number : 0321011
Córdoba, 5004, Argentina
Investigational Site Number : 0400001
Innsbruck, 6020, Austria
Investigational Site Number : 0401002
Linz, 4020, Austria
Investigational Site Number : 0401003
Vienna, 1180, Austria
Investigational Site Number : 0560006
Ghent, 9000, Belgium
Investigational Site Number : 0560005
Overpelt, 3900, Belgium
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0761029
Vitória, Espírito Santo, 29055-450, Brazil
Centro de Pesquisas da Clínica IBIS- Site Number : 0761030
Salvador, Estado de Bahia, 41820-020, Brazil
Clinica AMO- Site Number : 0761017
Salvador, Estado de Bahia, 41823-010, Brazil
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
Brasília, Federal District, 70200-730, Brazil
Universidade Federal de Goias- Site Number : 0761024
Goiânia, Goiás, 74605-020, Brazil
Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0761025
Belo Horizonte, Minas Gerais, 30150-320, Brazil
Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0761001
Curitiba, Paraná, 81210-310, Brazil
Hospital Moinhos de Vento- Site Number : 0761005
Porto Alegre, Rio Grande do Sul, 90035-902, Brazil
IMV Pesquisa Neurológica- Site Number : 0761031
Porto Alegre, Rio Grande do Sul, 90110-000, Brazil
Instituto Ceos- Site Number : 0761028
Porto Alegre, Rio Grande do Sul, 90480-020, Brazil
InsCer - Instituto do Cérebro da PUCRS- Site Number : 0761009
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Clínica Neurológica- Site Number : 0761007
Joinville, Santa Catarina, 89202-165, Brazil
Hospital E Maternidade Christovão Da Gama- Site Number : 0761022
Santo André, São Paulo, 09030-010, Brazil
CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0761002
São Paulo, 01228-000, Brazil
Centro de Pesquisas Clínicas - São Paulo- Site Number : 0761027
São Paulo, 01228-200, Brazil
PSEG Centro de Pesquisa Clínica- Site Number : 0761021
São Paulo, 04038-002, Brazil
Jordy Sinapse- Site Number : 0761004
São Paulo, 04515-000, Brazil
Investigational Site Number : 1000009
Blagoevgrad, 2700, Bulgaria
Investigational Site Number : 1001008
Panagyurishte, 4500, Bulgaria
Investigational Site Number : 1000007
Pazardzhik, 4400, Bulgaria
Investigational Site Number : 1000002
Pleven, 5800, Bulgaria
Investigational Site Number : 1001010
Pleven, 5800, Bulgaria
Investigational Site Number : 1000004
Sofia, 1407, Bulgaria
Investigational Site Number : 1001001
Sofia, 1431, Bulgaria
Investigational Site Number : 1001006
Sofia, 1606, Bulgaria
Investigational Site Number : 1000005
Sofia, 1680, Bulgaria
Investigational Site Number : 1000012
Sofia, 1700, Bulgaria
Investigational Site Number : 1240017
Edmonton, Alberta, T6G 2B7, Canada
Investigational Site Number : 1240007
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Investigational Site Number : 1240014
London, Ontario, N6a 4l6, Canada
Investigational Site Number : 1240002
Ottawa, Ontario, K1H 8L6, Canada
Investigational Site Number : 1240001
Gatineau, Quebec, J8Y 1W2, Canada
Investigational Site Number : 1240004
Granby, Quebec, J2G 1T7, Canada
Investigational Site Number : 1240008
Lévis, Quebec, G6W 0M5, Canada
Investigational Site Number : 1240003
Québec, Quebec, G1J 1Z4, Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 8320325, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, 8330032, Chile
Investigational Site Number : 1521001
Santiago, Reg Metropolitana de Santiago, 8380456, Chile
Investigational Site Number : 1521005
Las Condes, 7550000, Chile
Investigational Site Number : 1521003
Santiago, 8431657, 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 : 1561029
Chengdu, 610072, China
Investigational Site Number : 1560015
Chongqing, 400016, China
Investigational Site Number : 1560020
Dongguan, 523000, China
Investigational Site Number : 1561028
Fuzhou, 350001, China
Investigational Site Number : 1561026
Guangzhou, 510180, China
Investigational Site Number : 1560002
Guangzhou, 510630, China
Investigational Site Number : 1561023
Hangzhou, 310003, China
Investigational Site Number : 1561027
Harbin, 150001, China
Investigational Site Number : 1560019
Hohhot, 010050, China
Investigational Site Number : 1560040
Hohhot, 010070, China
Investigational Site Number : 1560010
Jiazhuang, 050000, China
Investigational Site Number : 1561025
Jinan, 250014, China
Investigational Site Number : 1560018
Nanjing, 210008, China
Investigational Site Number : 1560001
Shanghai, 200040, China
Investigational Site Number : 1560043
Shanghai, 200127, China
Investigational Site Number : 1560014
Shenyang, 110004, China
Investigational Site Number : 1560030
Suzhou, 215006, China
Investigational Site Number : 1560006
Taiyuan, 030001, China
Investigational Site Number : 1560012
Tianjin, 300052, China
Investigational Site Number : 1560016
Wenzhou, 325035, China
Investigational Site Number : 1560009
Wuhan, 430030, China
Investigational Site Number : 1560013
Xi'an, 710038, China
Investigational Site Number : 1560021
Yinchuan, 750004, China
Investigational Site Number : 1911001
Zagreb, 10000, Croatia
Investigational Site Number : 2031011
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 : 2031007
Ostrava, 708 52, Czechia
Investigational Site Number : 2030010
Pardubice, 532 03, Czechia
Investigational Site Number : 2031003
Prague, 100 34, Czechia
Investigational Site Number : 2031004
Prague, 128 08, Czechia
Investigational Site Number : 2031008
Prague, 150 06, Czechia
Investigational Site Number : 2031009
Teplice, 415 01, Czechia
Investigational Site Number : 2030001
Zlín, 762 75, Czechia
Investigational Site Number : 2081002
Esbjerg, 6700, Denmark
Investigational Site Number : 2081001
Glostrup Municipality, 2600, Denmark
Investigational Site Number : 2501017
Calais, 62107, France
Investigational Site Number : 2501018
Colmar, 68024, France
Investigational Site Number : 2501006
La Tronche, 38700, France
Investigational Site Number : 2501009
Lille, 59037, France
Investigational Site Number : 2501002
Nice, 06001, France
Investigational Site Number : 2501010
Saint-Herblain, 44800, France
Investigational Site Number : 2761009
Bielefeld, 33647, Germany
Investigational Site Number : 2760010
Bochum, 44791, Germany
Investigational Site Number : 2761016
Böblingen, 71034, Germany
Investigational Site Number : 2760012
Dresden, 01307, Germany
Investigational Site Number : 2760002
Düsseldorf, 40225, Germany
Investigational Site Number : 2761013
Erbach im Odenwald, 64711, Germany
Investigational Site Number : 2761011
Essen, 45147, Germany
Investigational Site Number : 2761017
Giessen, 35392, Germany
Investigational Site Number : 2761014
Heidelberg, 69117, Germany
Investigational Site Number : 2761007
Jena, 07747, Germany
Investigational Site Number : 2760003
Leipzig, 04103, Germany
Investigational Site Number : 2761008
Marburg, 35043, Germany
Investigational Site Number : 2761006
Münster, 48149, Germany
Investigational Site Number : 2760001
Ulm, 89073, Germany
Investigational Site Number : 3001005
Athens, 124 62, Greece
Investigational Site Number : 3000004
Ioannina, 455 00, Greece
Investigational Site Number : 3001001
Larissa, 411 10, Greece
Investigational Site Number : 3000002
Thessaloniki, 546 36, Greece
Investigational Site Number : 3001006
Thessaloniki, 552 36, Greece
Investigational Site Number : 3441001
Shatin, 999077, Hong Kong
Investigational Site Number : 3481003
Budapest, 1033, Hungary
Investigational Site Number : 3481004
Budapest, 1138, Hungary
Investigational Site Number : 3480002
Győr, 9024, Hungary
Investigational Site Number : 3480001
Kaposvár, 7400, Hungary
Investigational Site Number : 3481005
Pécs, 7623, Hungary
Investigational Site Number : 3560002
Chandigarh, 160012, India
Investigational Site Number : 3561008
Hyderabad, 500082, India
Investigational Site Number : 3560020
Kochi, 682040, India
Investigational Site Number : 3560010
Nagpur, 440012, India
Investigational Site Number : 3561005
Nashik, 422005, India
Investigational Site Number : 3560017
New Delhi, 110029, India
Investigational Site Number : 3561023
New Delhi, 110060, India
Investigational Site Number : 3561006
Shimla, 171001, India
Investigational Site Number : 3561004
Thiruvananthapuram, 695011, India
Investigational Site Number : 3760001
Haifa, 3109601, Israel
Investigational Site Number : 3760003
Ramat Gan, 5262100, Israel
Investigational Site Number : 3760002
Safed, 1311001, Israel
Investigational Site Number : 3801025
Cona, Ferrara, 44124, Italy
Investigational Site Number : 3800004
Florence, Firenze, 50134, Italy
Investigational Site Number : 3801011
Genoa, Genova, 16132, Italy
Investigational Site Number : 3800002
Milan, Milano, 20132, Italy
Investigational Site Number : 3800016
Milan, Milano, 20133, Italy
Investigational Site Number : 3800032
Monza, Monza E Brianza, 20052, Italy
Investigational Site Number : 3801010
Naples, Napoli, 80131, Italy
Investigational Site Number : 3800015
Rome, Roma, 00133, Italy
Investigational Site Number : 3800001
Rome, Roma, 00149, Italy
Investigational Site Number : 3801013
Rome, Roma, 00161, Italy
Investigational Site Number : 3800021
Rome, Roma, 00168, Italy
Investigational Site Number : 3801024
Orbassano, Torino, 10043, Italy
Investigational Site Number : 3801012
Catania, 95123, Italy
Investigational Site Number : 3800014
Chieti, 66100, Italy
Investigational Site Number : 3800033
Como, 22100, Italy
Investigational Site Number : 3800019
Foggia, 71100, Italy
Investigational Site Number : 3801028
Modena, 41125, Italy
Investigational Site Number : 3801026
Novara, 28100, Italy
Investigational Site Number : 3800017
Palermo, 90127, Italy
Investigational Site Number : 3801022
Palermo, 90127, Italy
Investigational Site Number : 3801029
Parma, 43100, Italy
Investigational Site Number : 3801005
Pavia, 27100, Italy
Investigational Site Number : 3801030
Ravenna, 48121, Italy
Investigational Site Number : 3801031
Udine, 33100, Italy
Investigational Site Number : 3800020
Verona, 37134, Italy
Investigational Site Number : 3920003
Kōriyama, Fukushima, 963-8052, Japan
Investigational Site Number : 3920014
Asahikawa, Hokkaido, 070-0901, Japan
Investigational Site Number : 3920006
Asahikawa, Hokkaido, 070-8530, Japan
Investigational Site Number : 3920017
Sapporo, Hokkaido, 063-0005, Japan
Investigational Site Number : 3920008
Yahaba, Iwate, 028-3695, 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 : 3920009
Tachikawa, Tokyo, 190-8531, 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 : 3920004
Tokyo, 152-8902, Japan
Investigational Site Number : 3920012
Tokyo, 160-8582, Japan
Investigational Site Number : 4401001
Vilnius, 08661, Lithuania
Investigational Site Number : 4581001
Kuala Lumpur, 50586, Malaysia
Investigational Site Number : 4841007
Guadalajara, Jalisco, 44670, Mexico
Investigational Site Number : 4840002
Monterrey, Nuevo León, 64460, Mexico
Investigational Site Number : 4841005
Culiacán, Sinaloa, 80020, Mexico
Investigational Site Number : 4840011
Mérida, Yucatán, 97070, Mexico
Investigational Site Number : 4841009
Mexico City, 04700, Mexico
Investigational Site Number : 4841003
Tlalnepantla, 54055, Mexico
Investigational Site Number : 4840001
Veracruz, 91900, Mexico
Investigational Site Number : 6160002
Plewiska, Greater Poland Voivodeship, 62-064, Poland
Investigational Site Number : 6160018
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Investigational Site Number : 6161005
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Investigational Site Number : 6161017
Lublin, Lublin Voivodeship, 20-002, Poland
Investigational Site Number : 6161008
Lodz, Lódzkie, 90-324, Poland
Investigational Site Number : 6161016
Warsaw, Masovian Voivodeship, 02-172, Poland
Investigational Site Number : 6160006
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Investigational Site Number : 6161010
Katowice, Silesian Voivodeship, 40-081, Poland
Investigational Site Number : 6160019
Katowice, Silesian Voivodeship, 40-686, Poland
Investigational Site Number : 6160004
Zabrze, Silesian Voivodeship, 41-800, Poland
Investigational Site Number : 6160020
Żory, Silesian Voivodeship, 44-240, Poland
Investigational Site Number : 6161011
Katowice, 40571, Poland
Investigational Site Number : 6161014
Krakow, 31-271, Poland
Investigational Site Number : 6161015
Kielce, Świętokrzyskie Voivodeship, 25-726, Poland
Investigational Site Number : 6200001
Braga, 4710-243, Portugal
Investigational Site Number : 6201005
Coimbra, 3000-075, Portugal
Investigational Site Number : 6200009
Guimarães, 4800-055, Portugal
Investigational Site Number : 6201011
Lisbon, 1169-050, Portugal
Investigational Site Number : 6201012
Lisbon, 1500-650, Portugal
Investigational Site Number : 6200002
Matosinhos Municipality, 4464-513, Portugal
San Juan MS Center- Site Number : 8401106
Guaynabo, 00969, Puerto Rico
Investigational Site Number : 6421004
Bucharest, 050098, Romania
Investigational Site Number : 6420002
Campulung Muscel, 115100, Romania
Investigational Site Number : 6421001
Constanța, 900123, Romania
Investigational Site Number : 6820001
Riyadh, 11461, Saudi Arabia
Investigational Site Number : 6820002
Riyadh, 11525, Saudi Arabia
Investigational Site Number : 7021001
Singapore, 308433, Singapore
Investigational Site Number : 7031001
Bratislava - Kramare, 831 01, Slovakia
Investigational Site Number : 7030007
Martin, 036 01, Slovakia
Investigational Site Number : 7030004
Nitra, 950 01, Slovakia
Investigational Site Number : 7030003
Trnava, 917 75, Slovakia
Investigational Site Number : 7101002
Cape Town, 7405, South Africa
Investigational Site Number : 7101001
Pretoria, 0040, South Africa
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 : 4100006
Seoul, Seoul-teukbyeolsi, 02841, 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 : 4100008
Seoul, Seoul-teukbyeolsi, 06591, South Korea
Investigational Site Number : 7240018
Murcia, Almería, 30120, Spain
Investigational Site Number : 7240010
Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7241009
Barakaldo, Basque Country, 48903, Spain
Investigational Site Number : 7240013
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Investigational Site Number : 7240001
Pozuelo de Alarcón, Madrid, 28223, Spain
Investigational Site Number : 7241014
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 : 7241023
Madrid, 28007, Spain
Investigational Site Number : 7240002
Madrid, 28034, Spain
Investigational Site Number : 7240003
Madrid, 28040, Spain
Investigational Site Number : 7241022
Madrid, 28040, Spain
Investigational Site Number : 7240005
Málaga, 29010, Spain
Investigational Site Number : 7240011
Valladolid, 47003, Spain
Investigational Site Number : 7561001
Bern, 3010, Switzerland
Investigational Site Number : 1581001
Kaohsiung City, 833, Taiwan
Investigational Site Number : 7641002
Bangkok, 10330, Thailand
Investigational Site Number : 7641001
Bangkok, 10700, Thailand
Investigational Site Number : 7641004
Khon Kaen, 40002, Thailand
Investigational Site Number : 7921018
Ankara, 06010, Turkey (Türkiye)
Investigational Site Number : 7920011
Ankara, 06800, Turkey (Türkiye)
Investigational Site Number : 7921020
Bursa, 16059, Turkey (Türkiye)
Investigational Site Number : 7921013
Bursa, 16310, Turkey (Türkiye)
Investigational Site Number : 7921005
Eskişehir, 26480, Turkey (Türkiye)
Investigational Site Number : 7920012
Istanbul, 34010, Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number : 7921016
Istanbul, 34200, Turkey (Türkiye)
Investigational Site Number : 7921009
Istanbul, 34668, Turkey (Türkiye)
Investigational Site Number : 7920007
Istanbul, 34785, Turkey (Türkiye)
Investigational Site Number : 7921019
Izmir, 35340, Turkey (Türkiye)
Investigational Site Number : 7920008
Izmir, 35360, Turkey (Türkiye)
Investigational Site Number : 7920001
İzmit, 41001, Turkey (Türkiye)
Investigational Site Number : 7921014
Kayseri, 38039, Turkey (Türkiye)
Investigational Site Number : 7920015
Konya, 42075, Turkey (Türkiye)
Investigational Site Number : 7921006
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number : 7921004
Samsun, 55139, Turkey (Türkiye)
Investigational Site Number : 7920003
Sultangazi, 34265, Turkey (Türkiye)
Investigational Site Number : 7920017
Van, 65080, Turkey (Türkiye)
Investigational Site Number : 8040007
Chernivtsi, 58000, Ukraine
Investigational Site Number : 8040001
Chernivtsi, 58023, Ukraine
Investigational Site Number : 8040009
Ivano-Frankivsk, 76019, Ukraine
Investigational Site Number : 8041003
Krykhivtsi, 76493, Ukraine
Investigational Site Number : 8041006
Kyiv, 02091, Ukraine
Investigational Site Number : 8040008
Lutsk, 43005, Ukraine
Investigational Site Number : 8040004
Lviv, 79010, Ukraine
Investigational Site Number : 8041002
Lviv, 79029, Ukraine
Investigational Site Number : 8041005
Vinnytsia, 21050, Ukraine
Investigational Site Number : 7840002
Abu Dhabi, 15258, United Arab Emirates
Investigational Site Number : 7841002
Abu Dhabi, 15258, United Arab Emirates
Investigational Site Number : 8260001
Exeter, Devon, EX2 5DW, United Kingdom
Investigational Site Number : 8260013
London, England, E11 1NR, United Kingdom
Investigational Site Number : 8260010
Inverness, Highland, IV2 3UJ, United Kingdom
Investigational Site Number : 8261003
Canterbury, Kent, CT1 3NG, United Kingdom
Investigational Site Number : 8261008
Salford, Manchester, M6 8HD, United Kingdom
Related Publications (1)
Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
PMID: 39899371DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-dummy
- 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 13, 2023
Primary Completion (Estimated)
May 6, 2027
Study Completion (Estimated)
May 6, 2027
Last Updated
July 20, 2026
Record last verified: 2026-07
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