A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis
3 other identifiers
interventional
2,500
44 countries
323
Brief Summary
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]). SUBSTUDY: ToleDYNAMIC substudy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2024
Longer than P75 for phase_3
323 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
April 15, 2024
CompletedStudy Start
First participant enrolled
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
February 13, 2026
February 1, 2026
5 years
April 15, 2024
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation
From baseline until the End of study approximately 3 years per participant
Number of Participants with Potentially clinically significant abnormalities (PCSAs)
Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs and safety findings on MRI during the study period.
From baseline until the End of study approximately 3 years per participant
Secondary Outcomes (5)
Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies
From baseline until the End of study approximately 3 years per participant
Annualized Relapse Rate (ARR) for RMS only
From baseline until the End of study approximately 3 years per participant
Number of new and/or enlarging T2-hyperintense lesions per year
From baseline until the End of study approximately 3 years per participant
Change from baseline in total volume of T2-hyperintense lesions
From baseline until the End of study approximately 3 years per participant
ToleDYNAMIC substudy Change from baseline in biomarkers
From baseline until 12 months per participant
Study Arms (2)
Tolebrutinib
EXPERIMENTAL* Participants will receive OL tolebrunitib 60 mg once daily. * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.
Teriflunomide
ACTIVE COMPARATOR* participants will receive teriflunomide 14 mg daily * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment (either tolebrutinib or teriflunomide) as per their randomization from the parent study. If unblinded to teriflunomide parent study treatment assignment, these RMS participants will continue teriflunomide in the LTS17043 study.
Interventions
Pharmaceutical form:Tablet-Route of administration:oral
Pharmaceutical form:Tablet-Route of administration:oral
Eligibility Criteria
You may qualify if:
- \- Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
- \- The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- The participant is at risk for or has a persistent chronic, active (including fever higher than 38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator
- For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection
- Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit
- Current alcohol intake equal to or exceeding the following at the opt-in visit: more than 2 drinks per day for men and more than 1 drink per day for women
- Abnormal ECG during the opt-in visit considered in the Investigator's judgment to be clinically significant, such as QTcF \>500 msec, in the context of this study.
- A bleeding disorder, known platelet dysfunction, abnormal platelet count (\<100,000/microliter), history of significant bleeding event or other conditions and planned procedures that may predispose the participant to excessive bleeding during the study, as judged by the Investigator.
- For participants initiating OL tolebrutinib in the LTS17043 study: Confirmed unblinding visit (RMS) or opt-in visit (PMS) alanine aminotransferase (ALT) more than 1.5 × upper limit of normal (ULN) OR aspartate aminotransferase (AST) more than 1.5 × ULN OR alkaline phosphatase more than 2 × ULN (unless caused by non-liver-related disorder or explained by a stable chronic liver disorder) OR total bilirubin more than 1.5 × ULN (unless due to Gilbert syndrome or non-liver-related disorder).
- Acute liver disease, cirrhosis, chronic liver disease (unless considered stable for more than 6 months).
- Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial results difficult or that would put the patient at risk by participating in the trial, as judged by the Investigator.
- The participant is receiving treatment during the study period with drugs not permitted by the study protocol, including potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes.
- NOTE: 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 (352)
The University of Alabama at Birmingham- Site Number : 8400013
Birmingham, Alabama, 35233, United States
~North Central Neurology Associates, PC- Site Number : 8400009
Cullman, Alabama, 35058, United States
Center for Neurology and Spine- Site Number : 8400089
Phoenix, Arizona, 85018, United States
Collaborative Neuroscience Research- Site Number : 8400045
Los Alamitos, California, 90720, United States
USC- Site Number : 8400143
Los Angeles, California, 90033, United States
University of California San Diego Medical Center- Site Number : 8400101
San Diego, California, 92037-0943, United States
Regina Berkovich, MD, PhD- Site Number : 8400059
West Hollywood, California, 90048, United States
University of Colorado- Site Number : 8400012
Denver, Colorado, 80262, United States
Advanced Neurosciences Research- Site Number : 8400025
Fort Collins, Colorado, 80528, United States
Georgetown University Medical Center- Site Number : 8400119
Washington D.C., District of Columbia, 20007, United States
SFM Clinical Research, LLC- Site Number : 8400029
Boca Raton, Florida, 33487, United States
University of Florida Health- Site Number : 8400159
Gainesville, Florida, 32608, United States
Neurology Associates- Site Number : 8409902
Maitland, Florida, 32751, United States
University of Miami- Site Number : 8400063
Miami, Florida, 33136, United States
Aqualane Clinical Research- Site Number : 8400027
Naples, Florida, 34105, United States
Axiom Clinical Research of Florida- Site Number : 8400001
Tampa, Florida, 33609-4052, United States
University of South Florida- Site Number : 8409905
Tampa, Florida, 33612, United States
Velocity Clinical Research- Site Number : 8409903
Savannah, Georgia, 31406, United States
Consultants In Neurology- Site Number : 8409906
Northbrook, Illinois, 60062, United States
Springfield Clinic, LLP- Site Number : 8400071
Springfield, Illinois, 62702, United States
Indiana University Health, Inc- Site Number : 8400039
Fort Wayne, Indiana, 46815, United States
University of Kansas Medical Center- Site Number : 8400023
Kansas City, Kansas, 66160-7321, United States
University of Kentucky- Site Number : 8400106
Lexington, Kentucky, 40536, United States
Norton Neurology MS Services- Site Number : 8400127
Louisville, Kentucky, 40207, United States
The NeuroMedical Center- Site Number : 8400057
Baton Rouge, Louisiana, 70810, United States
Ochsner Clinic Foundation- Site Number : 8400107
New Orleans, Louisiana, 70121, United States
Tufts Medical Center- Site Number : 8400072
Boston, Massachusetts, 02111, United States
University of Massachusetts- Site Number : 8400014
Worcester, Massachusetts, 01655, United States
Wayne State University- Site Number : 8400046
Detroit, Michigan, 48201, United States
Michigan Institute Neuro Disorders- Site Number : 8400058
Farmington Hills, Michigan, 48334, United States
Memorial Healthcare Institute for Neuroscience- Site Number : 8400033
Owosso, Michigan, 48867, United States
Minneapolis Clinic of Neurology- Site Number : 8400051
Golden Valley, Minnesota, 55422, United States
Mayo Clinic- Site Number : 8400111
Rochester, Minnesota, 55905, United States
Sharlin Health & Neurology- Site Number : 8400093
Ozark, Missouri, 65721, United States
Missouri Baptist Medical Center- Site Number : 8400019
St Louis, Missouri, 63131, United States
Lou Ruvo Center for Brain Health- Site Number : 8400117
Las Vegas, Nevada, 89106, United States
University of New Mexico- Site Number : 8400032
Albuquerque, New Mexico, 87131, United States
Mount Sinai Medical Center- Site Number : 8400038
New York, New York, 10021, United States
NYU Langone South Shore Neurologic Associates- Site Number : 8400100
Patchogue, New York, 11772, United States
Neurology Associates of Stony Brook- Site Number : 8400042
Stony Brook, New York, 11794, United States
Wake Forest University Baptist Medical Center- Site Number : 8400116
Winston-Salem, North Carolina, 27157, United States
Dayton Center for Neurological Disorders- Site Number : 8400081
Centerville, Ohio, 45459, United States
Cleveland Clinic Foundation-Mellen Center for MS- Site Number : 8400125
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center- Site Number : 8400150
Columbus, Ohio, 43221, United States
The Boster Center for Multiple Sclerosis- Site Number : 8400147
Columbus, Ohio, 43235, United States
UC Health, LLC- Site Number : 8409901
Dayton, Ohio, 45417, United States
Providence Multiple Sclerosis Center- Site Number : 8400020
Portland, Oregon, 97225, United States
Premier Neurology- Site Number : 8400069
Greenville, South Carolina, 29605, United States
HOPE Neurology- Site Number : 8409904
Knoxville, Tennessee, 37922, United States
Lone Star Neurology of San Antonio- Site Number : 8400036
San Antonio, Texas, 78258, United States
University of Vermont - Larner College of Medicine- Site Number : 8400130
Burlington, Vermont, 05405, United States
Neurological Associates- Site Number : 8400097
Richmond, Virginia, 23229, United States
Investigational Site Number : 0320002
CABA, Buenos Aires, C1012AAR, Argentina
Investigational Site Number : 0320004
CABA, Buenos Aires, C1023AAB, Argentina
Investigational Site Number : 0320007
CABA, Buenos Aires F.D., C1021, Argentina
Investigational Site Number : 0320001
CABA, Buenos Aires F.D., C1424, Argentina
Investigational Site Number : 0329901
CABA, Buenos Aires F.D., C1425 BKU, Argentina
Investigational Site Number : 0320003
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320006
Córdoba, 5000, Argentina
Investigational Site Number : 0320005
San Miguel de Tucumán, 4000, Argentina
Investigational Site Number : 0360001
St Leonards, New South Wales, 2065, Australia
Investigational Site Number : 0360006
Kent Town, South Australia, 5067, Australia
Investigational Site Number : 0360007
Melbourne, Victoria, 3065, Australia
Investigational Site Number : 0400003
Innsbruck, 6020, Austria
Investigational Site Number : 0400004
Linz, 4020, Austria
Investigational Site Number : 0400002
Vienna, 1090, Austria
Investigational Site Number : 0560005
Bruges, 8000, Belgium
Investigational Site Number : 0560009
Brussels, 1070, Belgium
Investigational Site Number : 0560004
Ghent, 9000, Belgium
Investigational Site Number : 0560006
Leuven, 3000, Belgium
Investigational Site Number : 0560008
Liège, 4000, Belgium
Investigational Site Number : 0560001
Overpelt, 3900, Belgium
Investigational Site Number : 0560007
Woluwe-Saint-Lambert, 1200, Belgium
HC UFG - Hospital Das Clinicas de Goias- Site Number : 0760003
Goiânia, Goiás, 74605-020, Brazil
Instituto de Neurologia de Curitiba- Site Number : 0760002
Curitiba, Paraná, 81210-310, Brazil
Hospital Sao Lucas da PUCRS- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
CPQuali Pesquisa Clinica- Site Number : 0760007
São Paulo, São Paulo, 01228-000, Brazil
Investigational Site Number : 1000002
Pleven, 5809, Bulgaria
Investigational Site Number : 1000005
Plovdiv, 4002, Bulgaria
Investigational Site Number : 1000004
Sofia, 1113, Bulgaria
Investigational Site Number : 1000008
Sofia, 1407, Bulgaria
Investigational Site Number : 1000001
Sofia, 1431, Bulgaria
Investigational Site Number : 1000006
Sofia, 1431, Bulgaria
Investigational Site Number : 1000011
Sofia, 1606, Bulgaria
Investigational Site Number : 1000009
Sofia, 1680, Bulgaria
Investigational Site Number : 1240002
Edmonton, Alberta, T6G 2C8, Canada
Investigational Site Number : 1240017
Burnaby, British Columbia, V5G 2X6, Canada
Investigational Site Number : 1249901
Vancouver, British Columbia, V6T 2B5, Canada
Investigational Site Number : 1240011
Halifax, Nova Scotia, B3H4K4, Canada
Investigational Site Number : 1240012
Hamilton, Ontario, L8L 2X2, Canada
Investigational Site Number : 1240003
Ottawa, Ontario, K1H 8L6, Canada
Investigational Site Number : 1240008
Toronto, Ontario, M4N 3M5, Canada
Investigational Site Number : 1240013
Toronto, Ontario, M5B 1W8, Canada
Investigational Site Number : 1240006
Gatineau, Quebec, J8Y 1W2, Canada
Investigational Site Number : 1240021
Lévis, Quebec, G6W0M5, Canada
Investigational Site Number : 1240004
Montreal, Quebec, H2X 0A9, Canada
Investigational Site Number : 1240015
Montreal, Quebec, H3A 2B4, Canada
Investigational Site Number : 1240007
Sherbrooke, Quebec, J1H 5N4, Canada
Investigational Site Number : 1240001
Québec, G1J 1Z4, Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7650568, Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, 833-0024, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8380456, Chile
Investigational Site Number : 1520003
Santiago, 8431657, Chile
Investigational Site Number : 1560006
Beijing, 100034, China
Investigational Site Number : 1560023
Beijing, 100191, China
Investigational Site Number : 1560009
Beijing, 100730, China
Investigational Site Number : 1560025
Beijing, 100730, China
Investigational Site Number : 1560004
Changchun, 130021, China
Investigational Site Number : 1560015
Changsha, 410008, China
Investigational Site Number : 1560005
Chengdu, 610041, China
Investigational Site Number : 1560019
Chongqing, 400016, China
Investigational Site Number : 1560035
Fuzhou, 350005, China
Investigational Site Number : 1569903
Guangzhou, 510630, China
Investigational Site Number : 1560027
Hohhot, 010020, China
Investigational Site Number : 1560044
Nanjing, 210008, China
Investigational Site Number : 1560042
Nanjing, 210029, China
Investigational Site Number : 1569901
Shanghai, 200040, China
Investigational Site Number : 1560018
Shenyang, 110004, China
Investigational Site Number : 1560014
Shijiazhuang, 050000, China
Investigational Site Number : 1560008
Taiyuan, 030001, China
Investigational Site Number : 1560020
Tianjin, 300052, China
Investigational Site Number : 1560026
Wenzhou, 325000, China
Investigational Site Number : 1560011
Wuhan, 430030, China
Investigational Site Number : 1560017
Xi'an, 710038, China
Investigational Site Number : 1700001
Bogotá, K1K 4L2, Colombia
Investigational Site Number : 1910001
Zagreb, 10000, Croatia
Investigational Site Number : 1910002
Zagreb, 10000, Croatia
Investigational Site Number : 2039907
Brno, 62500, Czechia
Investigational Site Number : 2030002
Brno, 65691, Czechia
Investigational Site Number : 2039903
Hradec Králové, 50005, Czechia
Investigational Site Number : 2039901
Jihlava, 58633, Czechia
Investigational Site Number : 2039902
Ostrava - Poruba, 70852, Czechia
Investigational Site Number : 2039904
Pardubice, 53203, Czechia
Investigational Site Number : 2030008
Prague, 10034, Czechia
Investigational Site Number : 2039906
Prague, 12808, Czechia
Investigational Site Number : 2039905
Praha 5 - Motol, 15000, Czechia
Investigational Site Number : 2030003
Teplice, 41501, Czechia
Investigational Site Number : 2030007
Zlín, 76275, Czechia
Investigational Site Number : 2080001
Esbjerg, 6700, Denmark
Investigational Site Number : 2080005
Holstebro, 7500, Denmark
Investigational Site Number : 2080004
Odense, 5000, Denmark
Investigational Site Number : 2330001
Tallinn, 11315, Estonia
Investigational Site Number : 2460001
Tampere, 33520, Finland
Investigational Site Number : 2460002
Turku, 20520, Finland
Investigational Site Number : 2500019
Besançon, 25030, France
Investigational Site Number : 2500011
Bron, 69500, France
Investigational Site Number : 2500005
Clermont-Ferrand, 63000, France
Investigational Site Number : 2500015
Gonesse, 95500, France
Investigational Site Number : 2500009
Lille, 59037, France
Investigational Site Number : 2500006
Montpellier, 34295, France
Investigational Site Number : 2500008
Nancy, 54035, France
Investigational Site Number : 2500010
Nantes, 44093, France
Investigational Site Number : 2500002
Nice, 06001, France
Investigational Site Number : 2500017
Nîmes, 30029, France
Investigational Site Number : 2500014
Paris, 75013, France
Investigational Site Number : 2500007
Paris, 75019, France
Investigational Site Number : 2500004
Poissy, 78300, France
Investigational Site Number : 2500003
Rennes, 35033, France
Investigational Site Number : 2500001
Strasbourg, 67091, France
Investigational Site Number : 2500012
Toulouse, 31059, France
Investigational Site Number : 2680004
Tbilisi, 0101, Georgia
Investigational Site Number : 2680009
Tbilisi, 0159, Georgia
Investigational Site Number : 2680003
Tbilisi, 0160, Georgia
Investigational Site Number : 2760005
Bayreuth, 95445, Germany
Investigational Site Number : 2760009
Berlin, 10117, Germany
Investigational Site Number : 2760015
Berlin, 10713, Germany
Investigational Site Number : 2760014
Berlin, 12099, Germany
Investigational Site Number : 2760020
Bochum, 44791, Germany
Investigational Site Number : 2760001
Dresden, 01307, Germany
Investigational Site Number : 2769901
Düsseldorf, 40225, Germany
Investigational Site Number : 2760012
Essen, 45147, Germany
Investigational Site Number : 2760002
Giessen, 35392, Germany
Investigational Site Number : 2760016
Hamburg, 22179, Germany
Investigational Site Number : 2760018
München, 81377, Germany
Investigational Site Number : 2760008
Münster, 48149, Germany
Investigational Site Number : 2760011
Ulm, 89081, Germany
Investigational Site Number : 2760003
Würzburg, 97074, Germany
Investigational Site Number : 3000001
Athens, 115 28, Greece
Investigational Site Number : 3000006
Athens, 11525, Greece
Investigational Site Number : 3000002
Athens, 12462, Greece
Investigational Site Number : 3000004
Larissa, 41110, Greece
Investigational Site Number : 3000007
Marousi, 15125, Greece
Investigational Site Number : 3000003
Thessaloniki, 54636, Greece
Investigational Site Number : 3000009
Thessaloniki, 55236, Greece
Investigational Site Number : 3440001
Shatin, NT, 000, Hong Kong
Investigational Site Number : 3489901
Budapest, 1033, Hungary
Investigational Site Number : 3489903
Budapest, 1138, Hungary
Investigational Site Number : 3480007
Budapest, 1152, Hungary
Investigational Site Number : 3480002
Pécs, 7623, Hungary
Investigational Site Number : 3560014
Bengaluru, 560001, India
Investigational Site Number : 3569904
Chandigarh, 160015, India
Investigational Site Number : 3560002
Delhi, 110060, India
Investigational Site Number : 3560007
Gūrgaon, 122001, India
Investigational Site Number : 3569903
Gūrgaon, 122002, India
Investigational Site Number : 3569901
Mangaluru, 575018, India
Investigational Site Number : 3560009
Nagpur, 440012, India
Investigational Site Number : 3569902
New Delhi, 110029, India
Investigational Site Number : 3560004
Thiruvananthapuram, 695011, India
Investigational Site Number : 3760003
Haifa, 31096, Israel
Investigational Site Number : 3760006
Rehovot, 76100, Israel
Investigational Site Number : 3760004
Safed, 13100, Israel
Investigational Site Number : 3760001
Tel Litwinsky, 52621, Israel
Investigational Site Number : 3800002
Pozzilli, Isernia, 86077, Italy
Investigational Site Number : 3800010
Milan, Lombardy, 20133, Italy
Investigational Site Number : 3800001
Milan, Milano, 20132, Italy
Investigational Site Number : 3800009
Rome, Roma, 00168, Italy
Investigational Site Number : 3800012
Florence, Tuscany, 50134, Italy
Investigational Site Number : 3800011
Bergamo, 24127, Italy
Investigational Site Number : 3800007
Cagliari, 09126, Italy
Investigational Site Number : 3800015
Catania, 95123, Italy
Investigational Site Number : 3800018
Chieti, 66100, Italy
Investigational Site Number : 3800016
Florence, 50134, Italy
Investigational Site Number : 3800014
Genova, 16132, Italy
Investigational Site Number : 3800006
Naples, 80138, Italy
Investigational Site Number : 3800008
Pavia, 27100, Italy
Investigational Site Number : 3800005
Roma, 00152, Italy
Investigational Site Number : 3800009
Roma, 00168, Italy
Investigational Site Number : 3800013
Roma, 00189, Italy
Investigational Site Number : 3920016
Chiba, Chiba, 260-8677, Japan
Investigational Site Number : 3920022
Morioka, Iwate, 020-8505, Japan
Investigational Site Number : 3920023
Sagamihara-shi, Kanagawa, 252-0392, Japan
Investigational Site Number : 3920011
Kyoto, Kyoto, 616-8255, Japan
Investigational Site Number : 3920020
Sendai, Miyagi, 980-8574, Japan
Investigational Site Number : 3920004
Moriguchi-shi, Osaka, 570-8507, Japan
Investigational Site Number : 3920001
Osaka, Osaka, 556-0016, Japan
Investigational Site Number : 3920018
Kawagoe-shi, Saitama, 350-8550, Japan
Investigational Site Number : 3920014
Bunkyo-ku, Tokyo, 113-8431, Japan
Investigational Site Number : 3920010
Ōta-ku, Tokyo, 146-0065, Japan
Investigational Site Number : 3920015
Toyama, Toyama, 930-0194, Japan
Investigational Site Number : 4280002
Riga, LV-1002, Latvia
Investigational Site Number : 4280003
Riga, LV-1005, Latvia
Investigational Site Number : 4400003
Kaunas, 50161, Lithuania
Investigational Site Number : 4400004
Šiauliai, LT-76231, Lithuania
Investigational Site Number : 4400001
Vilnius, 08661, Lithuania
Investigational Site Number : 4840004
Guadalajara, Jalisco, 44670, Mexico
Investigational Site Number : 4840002
Benito Juárez, Mexico City, 03100, Mexico
Investigational Site Number : 4840001
Mexico City, Mexico City, 06700, Mexico
Investigational Site Number : 4840003
Veracruz. Mexico City, Veracruz, 91900, Mexico
Investigational Site Number : 5280001
Amsterdam, 1081 HV, Netherlands
Investigational Site Number : 5280003
Breda, 4818 CK, Netherlands
Investigational Site Number : 5280006
Groningen, 9728NT, Netherlands
Investigational Site Number : 5280002
Heerlen, 6419 PC, Netherlands
Investigational Site Number : 5780003
Bergen, 5021, Norway
Investigational Site Number : 5780001
Oslo, 0450, Norway
Investigational Site Number : 6160008
Plewiska, Greater Poland Voivodeship, 62-064, Poland
Investigational Site Number : 6160003
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Investigational Site Number : 6160012
Lublin, Lublin Voivodeship, 20-410, Poland
Investigational Site Number : 6160001
Lodz, Lódzkie, 90-549, Poland
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, 01-211, Poland
Investigational Site Number : 6160006
Warsaw, Masovian Voivodeship, 01-684, Poland
Investigational Site Number : 6160009
Glogow Mlp., Podkarpackie Voivodeship, 36-060, Poland
Investigational Site Number : 6160004
Katowice, Silesian Voivodeship, 40-686, Poland
Investigational Site Number : 6160002
Katowice, Silesian Voivodeship, 40571, Poland
Investigational Site Number : 6160011
Zabrze, Silesian Voivodeship, 41-800, Poland
Investigational Site Number : 6200001
Braga, 4710-243, Portugal
Investigational Site Number : 6200005
Coimbra, 3000-075, Portugal
Investigational Site Number : 6200011
Lisbon, 1169-050, Portugal
Investigational Site Number : 6200007
Lisbon, 1349-019, Portugal
Investigational Site Number : 6200012
Lisbon, 1500-650, Portugal
Investigational Site Number : 6200006
Lisbon, 1649-035, Portugal
Investigational Site Number : 6200002
Matosinhos Municipality, 4464-513, Portugal
Investigational Site Number : 6200004
Santa Maria da Feira, 4520-211, Portugal
San Juan MS Center- Site Number : 8400015
Guaynabo, 00969, Puerto Rico
Investigational Site Number : 6420015
Brasov, 500283, Romania
Investigational Site Number : 6420008
Bucharest, 022328, Romania
Investigational Site Number : 6420004
Campulung Muscel, 115100, Romania
Investigational Site Number : 6420006
Cluj-Napoca, 400012, Romania
Investigational Site Number : 6420003
Constanța, 900123, Romania
Investigational Site Number : 6420013
Oradea, 410154, Romania
Investigational Site Number : 6420005
Sibiu, 550052, Romania
Investigational Site Number : 6420002
Timișoara, 300723, Romania
Investigational Site Number : 6880001
Belgrade, 11000, Serbia
Investigational Site Number : 6880003
Belgrade, 11000, Serbia
Investigational Site Number : 6880006
Belgrade, 11000, Serbia
Investigational Site Number : 6880002
Kragujevac, 34000, Serbia
Investigational Site Number : 6880005
Novi Sad, 21000, Serbia
Investigational Site Number : 7030001
Bratislava, 821 01, Slovakia
Investigational Site Number : 7030002
Martin, 03659, Slovakia
Investigational Site Number : 7030004
Nitra, 949 01, Slovakia
Investigational Site Number : 7100001
Pretoria, 0041, South Africa
Investigational Site Number : 4100001
Goyang-si, Gyeonggi-do, 10408, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 03080, South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, 03722, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 135-710, South Korea
Investigational Site Number : 7249908
A Coruña, A Coruña [La Coruña], 15006, Spain
Investigational Site Number : 7249907
Seville, Andalusia, 41009, Spain
Investigational Site Number : 7249906
Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7249912
Barcelona, Barcelona [Barcelona], 08036, Spain
Investigational Site Number : 7249919
L'Hospitalet de Llobregat, Barcelona [Barcelona], 08907, Spain
Investigational Site Number : 7249913
Barakaldo, Bizkaia, 48903, Spain
Investigational Site Number : 7249921
Santiago de Compostela, Galicia [Galicia], 15706, Spain
Investigational Site Number : 7249918
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Investigational Site Number : 7249911
Salt, Girona [Gerona], 17190, Spain
Investigational Site Number : 7249904
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Investigational Site Number : 7249902
Lleida / Lleida, Lleida [Lérida], 25198, Spain
Investigational Site Number : 7249901
Majadahonda, Madrid, 28222, Spain
Investigational Site Number : 7249905
Pozuelo de Alarcón, Madrid, 28223, Spain
Investigational Site Number : 7249909
Madrid / Madrid, Madrid, Comunidad de, 28007, Spain
Investigational Site Number : 7249914
Córdoba, 14004, Spain
Investigational Site Number : 7249903
Madrid, 28034, Spain
Investigational Site Number : 7249910
Madrid, 28040, Spain
Investigational Site Number : 7249915
Málaga, 29010, Spain
Investigational Site Number : 7249916
Murcia, 30120, Spain
Investigational Site Number : 7249920
Palma de Mallorca, 07120, Spain
Investigational Site Number : 7249917
Valencia, 46026, Spain
Investigational Site Number : 7520001
Gothenburg, 41346, Sweden
Investigational Site Number : 7520002
Stockholm, 113 65, Sweden
Investigational Site Number : 7560002
Bern, 3010, Switzerland
Investigational Site Number : 1580007
Hsinchu, 30059, Taiwan
Investigational Site Number : 1580002
Taipei, 112, Taiwan
Investigational Site Number : 7640001
Bangkok Noi, 10700, Thailand
Investigational Site Number : 7920006
Ankara, 06100, Turkey (Türkiye)
Investigational Site Number : 7920005
Eskişehir, 26040, Turkey (Türkiye)
Investigational Site Number : 7920003
Istanbul, 34096, Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, 34303, Turkey (Türkiye)
Investigational Site Number : 7920009
Istanbul, 34668, Turkey (Türkiye)
Investigational Site Number : 7920007
Istanbul, 34785, Turkey (Türkiye)
Investigational Site Number : 7920014
Izmir, 35340, Turkey (Türkiye)
Investigational Site Number : 7920010
Izmir, 35360, Turkey (Türkiye)
Investigational Site Number : 7920001
Kocaeli, 41380, Turkey (Türkiye)
Investigational Site Number : 7920017
Konya, 42080, Turkey (Türkiye)
Investigational Site Number : 7929901
Kütahya, 43100, Turkey (Türkiye)
Investigational Site Number : 7929902
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number : 7929903
Samsun, 55200, Turkey (Türkiye)
Investigational Site Number : 8040020
Chernivtsi, 14029, Ukraine
Investigational Site Number : 8049912
Chernivtsi, 58000, Ukraine
Investigational Site Number : 8049904
Chernivtsi, 58023, Ukraine
Investigational Site Number : 8049905
Dnipro, 49089, Ukraine
Investigational Site Number : 8049908
Ivano-Frankivsk, 76493, Ukraine
Investigational Site Number : 8040025
Kharkiv, 61058, Ukraine
Investigational Site Number : 8049903
Kharkiv, 61068, Ukraine
Investigational Site Number : 8040018
Kharkiv, 61166, Ukraine
Investigational Site Number : 8049902
Kyiv, 01135, Ukraine
Investigational Site Number : 8049911
Kyiv, 02091, Ukraine
Investigational Site Number : 8049901
Kyiv, 03115, Ukraine
Investigational Site Number : 8049914
Lutsk, 43005, Ukraine
Investigational Site Number : 8049909
Lviv, 79010, Ukraine
Investigational Site Number : 8049906
Lviv, 79029, Ukraine
Investigational Site Number : 8049913
Odesa, 65025, Ukraine
Investigational Site Number : 8049910
Vinnytsia, 21001, Ukraine
Investigational Site Number : 8040024
Vinnytsia, 21009, Ukraine
Investigational Site Number : 8260003
Exeter, Devon, EX2 5DW, United Kingdom
Investigational Site Number : 8260016
Kent, Kent, CT1 3NG, United Kingdom
Investigational Site Number : 8260006
London, London, City of, EC1M 6BQ, United Kingdom
Investigational Site Number : 8260005
London, London, City of, SW17 0RE, United Kingdom
Investigational Site Number : 8260010
Swansea, Neath Port Talbot, SA6 6NL, United Kingdom
Investigational Site Number : 8260012
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Investigational Site Number : 8260013
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Investigational Site Number : 8260001
Cardiff, Vale of Glamorgan, the, CF4 4XN, United Kingdom
Investigational Site Number : 8260009
Bristol, BS161LE, United Kingdom
Investigational Site Number : 8260014
Newcastle upon Tyne, NE1 4LP, United Kingdom
Investigational Site Number : 8260019
Salford, M6 8HD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 17, 2024
Study Start
April 16, 2024
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Last Updated
February 13, 2026
Record last verified: 2026-02
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