Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
PERSEUS
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
4 other identifiers
interventional
767
38 countries
270
Brief Summary
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Longer than P75 for phase_3
270 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
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2025
CompletedJanuary 7, 2026
January 1, 2026
5.3 years
July 1, 2020
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
6-month composite Confirmed Disability Progression (cCDP)
Time to onset of 6-month cCDP defined as follows: Increase over at least 6 months of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.5, or ≥0.5 points when the baseline EDSS score is \>5.5, or ≥20% from the baseline T25-FW, or ≥20% from the baseline 9-HPT
Up to approximately 60 months
Secondary Outcomes (14)
6-month Confirmed Disability Progression (CDP)
Up to approximately 60 months
3-month composite Confirmed Disability Progression (cCDP)
Up to approximately 60 months
Change in T2 hyperintense lesions by MRI
From screening MRI to approximately 60 months
Time to onset of confirmed disability improvement (CDI)
Up to approximately 60 months
Percent change in Brain volume (BV)
From 6 months up to approximately 60 months
- +9 more secondary outcomes
Study Arms (2)
SAR442168
EXPERIMENTALDose 1 of oral SAR442168 once daily
Placebo
PLACEBO COMPARATORPlacebo to match the SAR442168 once daily
Interventions
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
Eligibility Criteria
You may qualify if:
- to 55 years of age inclusive
- Diagnosis of PPMS according to the 2017 McDonald criteria
- Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive
- Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
- Contraceptive use consistent with local regulations for individuals participating in clinical studies
- Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP) or is a WOCBP and agrees to use an acceptable contraceptive method
- the participant must not have access to ocrelizumab (eg, ocrelizumab not available on the national market or not reimbursed for the approved indication).
- the participant must have access to and be eligible to be treated with ocrelizumab but: 1) does not tolerate it due to side effects or safety reasons; and/or 2) has failed ocrelizumab treatment due to perceived lack of efficacy
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Participant has conditions that would adversely affect study participation such as short life expectancy.
- Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
- Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator
- History of malignancy within 5 years prior to screening.
- History of alcohol or drug abuse within 1 year prior to Screening.
- Hospitalized for psychiatric disease within 2 years prior to Screening.
- Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
- A bleeding disorder or known platelet dysfunction at any time prior to the screening visit.
- A platelet count \<150 000/μL at the screening visit.
- A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal
- Lymphocyte count below the lower limit of normal at Screening.
- Recent live (attenuated) vaccine within 2 months before the first treatment visit.
- Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
- The participant has received medications/treatments for MS within a specified time frame.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (277)
UC San Diego ACTRI Site Number : 8400101
La Jolla, California, 92037, United States
Collaborative Neuroscience Research Site Number : 8400045
Los Alamitos, California, 90720, United States
Multiple Sclerosis Center- Site Number : 8400143
Los Angeles, California, 90033, United States
Multiple Sclerosis Center of California Site Number : 8400135
Newport Beach, California, 92663, United States
SC3 Research - Pasadena Site Number : 8400070
Pasadena, California, 91105, United States
University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137
San Francisco, California, 94158, United States
Harbor UCLA Site Number : 8400088
Torrance, California, 90502, United States
Regina Berkovich, MD, PhD Site Number : 8400059
West Hollywood, California, 90048, United States
Advanced Neurosciences Research Site Number : 8400025
Fort Collins, Colorado, 80528, United States
South Florida Neurology Associates Site Number : 8400029
Boca Raton, Florida, 33487, United States
MS & Neuromuscular Center of Excellence Site Number : 8400172
Clearwater, Florida, 33761, United States
University of Florida, Fixel Center for Neurology Site Number : 8400159
Gainesville, Florida, 32601, United States
Neurology Associates, PA- Site Number : 8400004
Maitland, Florida, 32761, United States
University of South Florida Site Number : 8400006
Tampa, Florida, 33612, United States
Velocity Clinical Research Site Number : 8400003
Savannah, Georgia, 31406, United States
Hawaii Pacific Neuroscience Site Number : 8400103
Honolulu, Hawaii, 96817, United States
Consultants In Neurology- Site Number : 8400011
Northbrook, Illinois, 60062, United States
Methodist Hospital Site Number : 8400164
Merrillville, Indiana, 46410, United States
College Park Family Care Center Site Number : 8400044
Overland Park, Kansas, 66210, United States
University of Kentucky Site Number : 8400106
Lexington, Kentucky, 40536, United States
Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107
New Orleans, Louisiana, 70121, United States
International Neurorehabilitation Institute Site Number : 8400034
Lutherville, Maryland, 21093, United States
Tufts Medical Center Site Number : 8400072
Boston, Massachusetts, 02111, United States
University of Massachusetts Site Number : 8400014
Worcester, Massachusetts, 01655, United States
Michigan Institute For Neurological Disorders Site Number : 8400058
Farmington Hills, Michigan, 48334, United States
The Memorial Hospital- Site Number : 8400033
Owosso, Michigan, 48867, United States
Mayo Clinic Site Number : 8400111
Rochester, Minnesota, 55905, United States
Sharlin Health & Neurology Site Number : 8400093
Ozark, Missouri, 65721, United States
University Of Nebraska- Site Number : 8400129
Omaha, Nebraska, 68198, United States
Hackensack University Hospital Site Number : 8400047
Hackensack, New Jersey, 07601, United States
University of New Mexico Site Number : 8400032
Albuquerque, New Mexico, 87131, United States
Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038
New York, New York, 10029-6501, United States
Neurology Associates of Stony Brook Site Number : 8400042
Stony Brook, New York, 11794, United States
Duke Neurological Disorders Clinic- Site Number : 8400098
Durham, North Carolina, 27710, United States
Meridian Clinical Research, LLC- Site Number : 8400005
Raleigh, North Carolina, 27607, United States
Atrium Health Wake Forest Baptist Site Number : 8400116
Winston-Salem, North Carolina, 27103, United States
Riverhills Neuroscience - Norwood Site Number : 8400167
Cincinnati, Ohio, 45212, United States
Cleveland Clinic 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
Providence Multiple Sclerosis Center Site Number : 8400020
Portland, Oregon, 97225, United States
Jefferson Neurology Associates Site Number : 8400016
Philadelphia, Pennsylvania, 19107, United States
Mountain View Clinical Research Site Number : 8400024
Greer, South Carolina, 29651-1817, United States
Mt Olympus Medical Research Site Number : 8400163
Katy, Texas, 77450, United States
Neurology Center of San Antonio Site Number : 8400036
San Antonio, Texas, 78258, United States
Investigational Site Number : 0320002
CABA, Buenos Aires, C1012AAR, Argentina
Investigational Site Number : 0320003
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0360005
Concord, New South Wales, 2139, Australia
Investigational Site Number : 0360006
St Leonards, New South Wales, 2065, Australia
Investigational Site Number : 0360003
Hobart, Tasmania, 7001, Australia
Investigational Site Number : 0400004
Linz, 4021, Austria
Investigational Site Number : 0400002
Vienna, 1090, Austria
Investigational Site Number : 1120004
Vitebsk, 210009, Belarus
Investigational Site Number : 1120005
Vitebsk, 210037, Belarus
Investigational Site Number : 0560009
Brussels, 1070, Belgium
Investigational Site Number : 0560004
Ghent, 9000, Belgium
Investigational Site Number : 0560008
Liège, 4000, Belgium
Investigational Site Number : 0560001
Overpelt, 3900, Belgium
Investigational Site Number : 0560007
Woluwe-Saint-Lambert, 1200, Belgium
Instituto de Neurologia de Curitiba Site Number : 0760002
Curitiba, Paraná, 81210-310, Brazil
CPQuali Pesquisa Clinica Site Number : 0760007
São Paulo, São Paulo, 01228-000, Brazil
Investigational Site Number : 1000002
Pleven, 5809, 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 : 1000011
Sofia, 1606, Bulgaria
Investigational Site Number : 1240002
Edmonton, Alberta, T6G 2C8, Canada
Investigational Site Number : 1240016
Vancouver, British Columbia, V6T 2B5, Canada
Investigational Site Number : 1240012
Hamilton, Ontario, L8L 2X2, Canada
Investigational Site Number : 1240003
Ottawa, Ontario, K1H 8L6, Canada
Investigational Site Number : 1240013
Toronto, Ontario, M5B 1W8, 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 : 1240021
Québec, G1W 4R4, Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7650568, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8380456, Chile
Investigational Site Number : 1560003
Beijing, 100032, China
Investigational Site Number : 1560012
Beijing, 100053, 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 : 1560035
Fuzhou, 350005, China
Investigational Site Number : 1560002
Guangzhou, 510630, China
Investigational Site Number : 1560027
Hohhot, 010050, China
Investigational Site Number : 1560001
Shanghai, 200040, China
Investigational Site Number : 1560008
Taiyuan, 030001, China
Investigational Site Number : 1560026
Wenzhou, 325000, China
Investigational Site Number : 1700003
Bogotá, 111321, Colombia
Investigational Site Number : 1700001
Bogotá, Colombia
Investigational Site Number : 1910001
Zagreb, 10000, Croatia
Investigational Site Number : 1910002
Zagreb, 10000, Croatia
Investigational Site Number : 2030002
Brno, 65691, Czechia
Investigational Site Number : 2030004
Hradec Králové, 50005, Czechia
Investigational Site Number : 2030001
Jihlava, 58633, Czechia
Investigational Site Number : 2030003
Teplice, 415 29, Czechia
Investigational Site Number : 2080001
Esbjerg, 6700, Denmark
Investigational Site Number : 2080005
Holstebro, 7500, Denmark
Investigational Site Number : 2330001
Tallinn, 11315, Estonia
Investigational Site Number : 2500011
Bron, 69500, France
Investigational Site Number : 2500005
Clermont-Ferrand, 63003, 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 : 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, 67098, France
Investigational Site Number : 2500012
Toulouse, 31059, France
Investigational Site Number : 2680005
Tbilisi, 0114, Georgia
Investigational Site Number : 2680009
Tbilisi, 0159, Georgia
Investigational Site Number : 2680003
Tbilisi, 0160, Georgia
Investigational Site Number : 2680004
Tbilisi, 0172, 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 : 2760020
Bochum, 44791, Germany
Investigational Site Number : 2760001
Dresden, 01307, Germany
Investigational Site Number : 2760021
Düsseldorf, 40225, Germany
Investigational Site Number : 2760012
Essen, 45147, Germany
Investigational Site Number : 2760002
Giessen, 35385, Germany
Investigational Site Number : 2760006
Hanover, 30625, Germany
Investigational Site Number : 2760018
München, 81377, Germany
Investigational Site Number : 2760008
Münster, 48149, Germany
Investigational Site Number : 2760004
Rostock, 18055, Germany
Investigational Site Number : 2760011
Ulm, 89081, 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, 546 36, Greece
Investigational Site Number : 3000009
Thessaloniki, 55236, Greece
Investigational Site Number : 3480206
Budapest, 1033, Hungary
Investigational Site Number : 3480202
Budapest, 1083, Hungary
Investigational Site Number : 3480203
Budapest, 1138, Hungary
Investigational Site Number : 3560014
Bengaluru, 560001, India
Investigational Site Number : 3560004
Mangaluru, 575018, India
Investigational Site Number : 3560005
New Delhi, 110029, India
Investigational Site Number : 3760008
Jerusalem, 91120, Israel
Investigational Site Number : 3760001
Ramat Gan, 5266202, Israel
Investigational Site Number : 3760004
Safed, 13100, Israel
Investigational Site Number : 3800002
Pozzilli, Isernia, 86077, 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 : 3800001
Milan, 20132, Italy
Investigational Site Number : 3800003
Naples, 80131, Italy
Investigational Site Number : 3800006
Naples, 80138, Italy
Investigational Site Number : 3800013
Roma, 00189, Italy
Investigational Site Number : 3920016
Chiba, Chiba, 260-8677, Japan
Investigational Site Number : 3920008
Koriyama-shi, Fukushima, 963-8052, 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 : 3920005
Niigata, Niigata, 951-8520, 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 : 3920003
Kodaira-shi, Tokyo, 187-8551, Japan
Investigational Site Number : 3920010
Ōta-ku, Tokyo, 146-0065, Japan
Investigational Site Number : 3920017
Shinjuku-ku, Tokyo, 160-8582, Japan
Investigational Site Number : 3920015
Toyama, Toyama, 930-0194, Japan
Investigational Site Number : 4280002
Riga, LV-1002, Latvia
Investigational Site Number : 4840004
Guadalajara, Jalisco, 44670, Mexico
Investigational Site Number : 4840001
Mexico City, Mexico City, 06700, Mexico
Investigational Site Number : 4840005
Mexico City, 14050, Mexico
Investigational Site Number : 4840007
Tlalnepantla, 54055, Mexico
Investigational Site Number : 4840003
Veracruz, 91910, Mexico
Investigational Site Number : 5280003
Breda, 4818 CK, Netherlands
Investigational Site Number : 5280006
Groningen, 9728NT, Netherlands
Investigational Site Number : 5280002
Sittard-Geleen, 6162 BG, Netherlands
Investigational Site Number : 5780003
Bergen, 5021, Norway
Investigational Site Number : 5780005
Tromsø, 9038, Norway
Investigational Site Number : 6040004
Lima, 15084, Peru
Investigational Site Number : 6160003
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, 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 : 6160007
Katowice, Silesian Voivodeship, 40-684, Poland
Investigational Site Number : 6160004
Katowice, Silesian Voivodeship, 40-686, Poland
Investigational Site Number : 6200001
Braga, 4710-243, Portugal
Investigational Site Number : 6200007
Lisbon, 1349-019, Portugal
Investigational Site Number : 6200012
Lisbon, 1500-650, Portugal
Investigational Site Number : 6200002
Matosinhos Municipality, 4464-513, Portugal
Investigational Site Number : 6200010
Porto, 4099-001, Portugal
Investigational Site Number : 6200004
Santa Maria da Feira, 4520-211, Portugal
Investigational Site Number : 6420008
Bucharest, 022328, Romania
Investigational Site Number : 6420004
Campulung Muscel, 115100, Romania
Investigational Site Number : 6420003
Constanța, 900123, Romania
Investigational Site Number : 6420013
Oradea, 410154, Romania
Investigational Site Number : 6420001
Târgu Mureş, 540136, Romania
Investigational Site Number : 6420002
Timișoara, 300736, Romania
Investigational Site Number : 6430018
Barnaul, 656043, Russia
Investigational Site Number : 6430023
Kaliningrad, 236035, Russia
Investigational Site Number : 6430004
Kazan', 420032, Russia
Investigational Site Number : 6430021
Krasnoyarsk, 660029, Russia
Investigational Site Number : 6430013
Moscow, 117997, Russia
Investigational Site Number : 6430011
Moscow, 129128, Russia
Investigational Site Number : 6430014
Nizhny Novgorod, 603137, Russia
Investigational Site Number : 6430008
Pyatigorsk, 357538, Russia
Investigational Site Number : 6430015
Rostov-on-Don, 344022, Russia
Investigational Site Number : 6430017
Saint Petersburg, 197376, Russia
Investigational Site Number : 6430009
Samara, 443095, Russia
Investigational Site Number : 6430020
Saransk, 430032, Russia
Investigational Site Number : 6430007
Tyumen, 625000, Russia
Investigational Site Number : 6430006
Ufa, 450005, Russia
Investigational Site Number : 6430022
Yekaterinburg, 620102, Russia
Investigational Site Number : 6880001
Belgrade, 11000, Serbia
Investigational Site Number : 6880002
Kragujevac, 34000, Serbia
Investigational Site Number : 7100001
Pretoria, 0041, South Africa
Investigational Site Number : 7240012
A Coruña, A Coruña [La Coruña], 15006, Spain
Investigational Site Number : 7240015
Santiago de Compostela, A Coruña [La Coruña], 15706, Spain
Investigational Site Number : 7240007
Seville, Andalusia, 41009, Spain
Investigational Site Number : 7240010
Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7240013
Bilbao, Bizkaia, 48013, Spain
Investigational Site Number : 7240011
Salt, Girona [Gerona], 17190, Spain
Investigational Site Number : 7240016
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Investigational Site Number : 7240002
Majadahonda, Madrid, 28222, Spain
Investigational Site Number : 7240001
Pozuelo de Alarcón, Madrid, 28223, Spain
Investigational Site Number : 7240004
Córdoba, 14004, Spain
Investigational Site Number : 7240003
Madrid, 28007, Spain
Investigational Site Number : 7240005
Málaga, 29010, Spain
Investigational Site Number : 7240006
Murcia, 30120, Spain
Investigational Site Number : 7240014
Palma de Mallorca, 07120, Spain
Investigational Site Number : 7240008
Valencia, 46026, Spain
Investigational Site Number : 7520001
Gothenburg, 413 45, Sweden
Investigational Site Number : 7520005
Motala, 591 85, Sweden
Investigational Site Number : 7640001
Bangkok, 10700, Thailand
Investigational Site Number : 7920009
Ankara, 06100, Turkey (Türkiye)
Investigational Site Number : 7920014
Ankara, 06500, Turkey (Türkiye)
Investigational Site Number : 7920005
Eskişehir, 26040, Turkey (Türkiye)
Investigational Site Number : 7920010
Hatay, Turkey (Türkiye)
Investigational Site Number : 7920016
Istanbul, 34093, Turkey (Türkiye)
Investigational Site Number : 7920003
Istanbul, 34265, Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, 34303, Turkey (Türkiye)
Investigational Site Number : 7920007
Istanbul, 34785, Turkey (Türkiye)
Investigational Site Number : 7920015
Izmir, 35100, Turkey (Türkiye)
Investigational Site Number : 7920018
Izmir, 35340, Turkey (Türkiye)
Investigational Site Number : 7920001
İzmit, 41380, Turkey (Türkiye)
Investigational Site Number : 7920017
Konya, 42080, Turkey (Türkiye)
Investigational Site Number : 7920011
Kütahya, 43100, Turkey (Türkiye)
Investigational Site Number : 7920012
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number : 7920013
Samsun, Turkey (Türkiye)
Investigational Site Number : 8040020
Chernivtsi, 58023, Ukraine
Investigational Site Number : 8040012
Ivano-Frankivsk, 76493, Ukraine
Investigational Site Number : 8040017
Kharkiv, 61068, Ukraine
Investigational Site Number : 8040025
Kharkiv, 61068, Ukraine
Investigational Site Number : 8040023
Kharkiv, 61103, Ukraine
Investigational Site Number : 8040014
Kyiv, 01135, Ukraine
Investigational Site Number : 8040013
Kyiv, 02091, Ukraine
Investigational Site Number : 8040015
Kyiv, 03115, Ukraine
Investigational Site Number : 8040011
Lutsk, 43005, Ukraine
Investigational Site Number : 8040002
Lviv, 79010, Ukraine
Investigational Site Number : 8040007
Lviv, 79013, Ukraine
Investigational Site Number : 8040010
Odesa, 65025, Ukraine
Investigational Site Number : 8040024
Vinnytsia, 21001, Ukraine
Investigational Site Number : 8260003
Exeter, Devon, EX2 5DW, United Kingdom
Investigational Site Number : 8260016
Canterbury, 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 0QT, 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 4XY, United Kingdom
Investigational Site Number : 8260009
Bristol, BS10 5NB, United Kingdom
Investigational Site Number : 8260019
Salford, M6 8HD, United Kingdom
Investigational Site Number : 8260007
Sheffield, S5 7AU, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2020
First Posted
July 7, 2020
Study Start
August 13, 2020
Primary Completion
November 14, 2025
Study Completion
November 14, 2025
Last Updated
January 7, 2026
Record last verified: 2026-01
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