Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
- Conditions
- Primary Progressive Multiple Sclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT04458051
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 767
- 18 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
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.
- Receiving potent and moderate inducers of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.
- Receiving anticoagulant or antiplatelet therapy (such as aspirin >81mg/day, clopidogrel, warfarin).
- Contraindications to magnetic resonance imaging (MRI). NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR442168 Tolebrutinib Dose 1 of oral SAR442168 once daily Placebo Placebo Placebo to match the SAR442168 once daily
- Primary Outcome Measures
Name Time Method 6-month composite Confirmed Disability Progression (cCDP) Up to approximately 60 months 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
- Secondary Outcome Measures
Name Time Method Percent change in Brain volume (BV) From 6 months up to approximately 60 months Percent change in brain volume (BV) as detected by brain MRI at the EOS compared to month 6
6-month Confirmed Disability Progression (CDP) Up to approximately 60 months Time to onset of 6-month CDP as assessed by EDSS score
3-month composite Confirmed Disability Progression (cCDP) Up to approximately 60 months Time to onset of 3-month cCDP
Change in T2 hyperintense lesions by MRI From screening MRI to approximately 60 months Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)
Time to onset of confirmed disability improvement (CDI) Up to approximately 60 months Time to onset of CDI defined as ≥1.0-point decrease on the EDSS score from baseline confirmed over at least 6 months
Change in cognitive function as assessed by SDMT From Baseline up to approximately 60 months Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT)
Change in cognitive function as assessed by CVLT-II From Baseline up to approximately 60 months Change in cognitive function at the EOS compared to baseline as assessed by the California Verbal Learning Test II (CVLT-II) where available
Change in Multiple Sclerosis Quality of Life From Baseline up to approximately 60 months Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline
Safety and Tolerability From screening up to approximately 60 months Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)
Population pharmacokinetics Months 6, 9 and 12 Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12
Change in plasma neurofilament light chain (NfL) From Baseline up to approximately 60 months Change in NfL levels from at the EOS compared to baseline
Change in lymphocyte phenotype subsets From Baseline up to approximately 60 months Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants
Changes in serum Immunoglobulin level From Baseline up to approximately 60 months Changes in serum Immunoglobulin level at the EOS compared to baseline
Change in serum chitinase-3 like protein 1 (Chi3L1) From Baseline up to approximately 60 months Change in serum Chi3L1 at EOS compared to baseline
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (277)
Multiple Sclerosis Center- Site Number : 8400143
🇺🇸Los Angeles, California, United States
University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137
🇺🇸San Francisco, California, United States
Neurology Associates, PA- Site Number : 8400004
🇺🇸Maitland, Florida, United States
Consultants In Neurology- Site Number : 8400011
🇺🇸Northbrook, Illinois, United States
Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107
🇺🇸New Orleans, Louisiana, United States
The Memorial Hospital- Site Number : 8400033
🇺🇸Owosso, Michigan, United States
University Of Nebraska- Site Number : 8400129
🇺🇸Omaha, Nebraska, United States
Duke Neurological Disorders Clinic- Site Number : 8400098
🇺🇸Durham, North Carolina, United States
Meridian Clinical Research, LLC- Site Number : 8400005
🇺🇸Raleigh, North Carolina, United States
The Ohio State University Wexner Medical Center- Site Number : 8400150
🇺🇸Columbus, Ohio, United States
UC San Diego ACTRI Site Number : 8400101
🇺🇸La Jolla, California, United States
Collaborative Neuroscience Research Site Number : 8400045
🇺🇸Los Alamitos, California, United States
Multiple Sclerosis Center of California Site Number : 8400135
🇺🇸Newport Beach, California, United States
SC3 Research - Pasadena Site Number : 8400070
🇺🇸Pasadena, California, United States
Harbor UCLA Site Number : 8400088
🇺🇸Torrance, California, United States
Regina Berkovich, MD, PhD Site Number : 8400059
🇺🇸West Hollywood, California, United States
Advanced Neurosciences Research Site Number : 8400025
🇺🇸Fort Collins, Colorado, United States
South Florida Neurology Associates Site Number : 8400029
🇺🇸Boca Raton, Florida, United States
MS & Neuromuscular Center of Excellence Site Number : 8400172
🇺🇸Clearwater, Florida, United States
University of Florida, Fixel Center for Neurology Site Number : 8400159
🇺🇸Gainesville, Florida, United States
University of South Florida Site Number : 8400006
🇺🇸Tampa, Florida, United States
Velocity Clinical Research Site Number : 8400003
🇺🇸Savannah, Georgia, United States
Hawaii Pacific Neuroscience Site Number : 8400103
🇺🇸Honolulu, Hawaii, United States
Methodist Hospital Site Number : 8400164
🇺🇸Merrillville, Indiana, United States
College Park Family Care Center Site Number : 8400044
🇺🇸Overland Park, Kansas, United States
University of Kentucky Site Number : 8400106
🇺🇸Lexington, Kentucky, United States
International Neurorehabilitation Institute Site Number : 8400034
🇺🇸Lutherville, Maryland, United States
Tufts Medical Center Site Number : 8400072
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Site Number : 8400014
🇺🇸Worcester, Massachusetts, United States
Michigan Institute For Neurological Disorders Site Number : 8400058
🇺🇸Farmington Hills, Michigan, United States
Mayo Clinic Site Number : 8400111
🇺🇸Rochester, Minnesota, United States
Sharlin Health & Neurology Site Number : 8400093
🇺🇸Ozark, Missouri, United States
Hackensack University Hospital Site Number : 8400047
🇺🇸Hackensack, New Jersey, United States
University of New Mexico Site Number : 8400032
🇺🇸Albuquerque, New Mexico, United States
Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038
🇺🇸New York, New York, United States
Neurology Associates of Stony Brook Site Number : 8400042
🇺🇸Stony Brook, New York, United States
Atrium Health Wake Forest Baptist Site Number : 8400116
🇺🇸Winston-Salem, North Carolina, United States
Riverhills Neuroscience - Norwood Site Number : 8400167
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Site Number : 8400125
🇺🇸Cleveland, Ohio, United States
The Boster Center for Multiple Sclerosis Site Number : 8400147
🇺🇸Columbus, Ohio, United States
Providence Multiple Sclerosis Center Site Number : 8400020
🇺🇸Portland, Oregon, United States
Jefferson Neurology Associates Site Number : 8400016
🇺🇸Philadelphia, Pennsylvania, United States
Mountain View Clinical Research Site Number : 8400024
🇺🇸Greer, South Carolina, United States
Mt Olympus Medical Research Site Number : 8400163
🇺🇸Katy, Texas, United States
Neurology Center of San Antonio Site Number : 8400036
🇺🇸San Antonio, Texas, United States
Investigational Site Number : 0320002
🇦🇷Caba, Buenos Aires, Argentina
Investigational Site Number : 0320003
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0360005
🇦🇺Concord, New South Wales, Australia
Investigational Site Number : 0360006
🇦🇺St Leonards, New South Wales, Australia
Investigational Site Number : 0360003
🇦🇺Hobart, Tasmania, Australia
Investigational Site Number : 0400004
🇦🇹Linz, Austria
Investigational Site Number : 0400002
🇦🇹Wien, Austria
Investigational Site Number : 1120004
🇧🇾Vitebsk, Belarus
Investigational Site Number : 1120005
🇧🇾Vitebsk, Belarus
Investigational Site Number : 0560009
🇧🇪Bruxelles, Belgium
Investigational Site Number : 0560004
🇧🇪Gent, Belgium
Investigational Site Number : 0560008
🇧🇪Liège, Belgium
Investigational Site Number : 0560001
🇧🇪Pelt, Belgium
Investigational Site Number : 0560007
🇧🇪Sint-Lambrechts-Woluwe, Belgium
Instituto de Neurologia de Curitiba Site Number : 0760002
🇧🇷Curitiba, Paraná, Brazil
CPQuali Pesquisa Clinica Site Number : 0760007
🇧🇷Sao Paulo, São Paulo, Brazil
Investigational Site Number : 1000002
🇧🇬Pleven, Bulgaria
Investigational Site Number : 1000004
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1000008
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1000001
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1000011
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1240002
🇨🇦Edmonton, Alberta, Canada
Investigational Site Number : 1240016
🇨🇦Vancouver, British Columbia, Canada
Investigational Site Number : 1240012
🇨🇦Hamilton, Ontario, Canada
Investigational Site Number : 1240003
🇨🇦Ottawa, Ontario, Canada
Investigational Site Number : 1240013
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1240004
🇨🇦Montreal, Quebec, Canada
Investigational Site Number : 1240015
🇨🇦Montreal, Quebec, Canada
Investigational Site Number : 1240007
🇨🇦Sherbrooke, Quebec, Canada
Investigational Site Number : 1240001
🇨🇦Quebec, Canada
Investigational Site Number : 1240021
🇨🇦Quebec, Canada
Investigational Site Number : 1520002
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1560003
🇨🇳Beijing, China
Investigational Site Number : 1560012
🇨🇳Beijing, China
Investigational Site Number : 1560009
🇨🇳Beijing, China
Investigational Site Number : 1560025
🇨🇳Beijing, China
Investigational Site Number : 1560004
🇨🇳Changchun, China
Investigational Site Number : 1560015
🇨🇳Changsha, China
Investigational Site Number : 1560005
🇨🇳Chengdu, China
Investigational Site Number : 1560035
🇨🇳Fuzhou, China
Investigational Site Number : 1560002
🇨🇳Guangzhou, China
Investigational Site Number : 1560027
🇨🇳Hohhot, China
Investigational Site Number : 1560001
🇨🇳Shanghai, China
Investigational Site Number : 1560008
🇨🇳Taiyuan, China
Investigational Site Number : 1560026
🇨🇳Wenzhou, China
Investigational Site Number : 1700001
🇨🇴Bogota, Colombia
Investigational Site Number : 1700003
🇨🇴Bogotá, Colombia
Investigational Site Number : 1910001
🇭🇷Zagreb, Croatia
Investigational Site Number : 1910002
🇭🇷Zagreb, Croatia
Investigational Site Number : 2030002
🇨🇿Brno, Czechia
Investigational Site Number : 2030004
🇨🇿Hradec Kralove, Czechia
Investigational Site Number : 2030001
🇨🇿Jihlava, Czechia
Investigational Site Number : 2030003
🇨🇿Teplice, Czechia
Investigational Site Number : 2080001
🇩🇰Esbjerg, Denmark
Investigational Site Number : 2080005
🇩🇰Holstebro, Denmark
Investigational Site Number : 2330001
🇪🇪Tallinn, Estonia
Investigational Site Number : 2500011
🇫🇷Bron, France
Investigational Site Number : 2500005
🇫🇷Clermont Ferrand, France
Investigational Site Number : 2500015
🇫🇷Gonesse, France
Investigational Site Number : 2500009
🇫🇷Lille, France
Investigational Site Number : 2500006
🇫🇷Montpellier, France
Investigational Site Number : 2500008
🇫🇷Nancy, France
Investigational Site Number : 2500017
🇫🇷Nimes, France
Investigational Site Number : 2500014
🇫🇷Paris, France
Investigational Site Number : 2500007
🇫🇷Paris, France
Investigational Site Number : 2500004
🇫🇷Poissy, France
Investigational Site Number : 2500003
🇫🇷Rennes, France
Investigational Site Number : 2500001
🇫🇷Strasbourg, France
Investigational Site Number : 2500012
🇫🇷Toulouse, France
Investigational Site Number : 2680005
🇬🇪Tbilisi, Georgia
Investigational Site Number : 2680009
🇬🇪Tbilisi, Georgia
Investigational Site Number : 2680003
🇬🇪Tbilisi, Georgia
Investigational Site Number : 2680004
🇬🇪Tbilisi, Georgia
Investigational Site Number : 2760005
🇩🇪Bayreuth, Germany
Investigational Site Number : 2760009
🇩🇪Berlin, Germany
Investigational Site Number : 2760015
🇩🇪Berlin, Germany
Investigational Site Number : 2760020
🇩🇪Bochum, Germany
Investigational Site Number : 2760001
🇩🇪Dresden, Germany
Investigational Site Number : 2760021
🇩🇪Düsseldorf, Germany
Investigational Site Number : 2760012
🇩🇪Essen, Germany
Investigational Site Number : 2760002
🇩🇪Gießen, Germany
Investigational Site Number : 2760006
🇩🇪Hannover, Germany
Investigational Site Number : 2760018
🇩🇪München, Germany
Investigational Site Number : 2760008
🇩🇪Münster, Germany
Investigational Site Number : 2760004
🇩🇪Rostock, Germany
Investigational Site Number : 2760011
🇩🇪Ulm, Germany
Investigational Site Number : 3000001
🇬🇷Athens, Greece
Investigational Site Number : 3000006
🇬🇷Athens, Greece
Investigational Site Number : 3000002
🇬🇷Athens, Greece
Investigational Site Number : 3000004
🇬🇷Larisa, Greece
Investigational Site Number : 3000007
🇬🇷Maroussi, Greece
Investigational Site Number : 3000003
🇬🇷Thessaloniki, Greece
Investigational Site Number : 3000009
🇬🇷Thessaloniki, Greece
Investigational Site Number : 3480206
🇭🇺Budapest, Hungary
Investigational Site Number : 3480202
🇭🇺Budapest, Hungary
Investigational Site Number : 3480203
🇭🇺Budapest, Hungary
Investigational Site Number : 3560014
🇮🇳Bengaluru, India
Investigational Site Number : 3560004
🇮🇳Mangaluru, India
Investigational Site Number : 3560005
🇮🇳New Delhi, India
Investigational Site Number : 3760008
🇮🇱Jerusalem, Israel
Investigational Site Number : 3760001
🇮🇱Ramat Gan, Israel
Investigational Site Number : 3760004
🇮🇱Safed, Israel
Investigational Site Number : 3800002
🇮🇹Pozzilli, Isernia, Italy
Investigational Site Number : 3800007
🇮🇹Cagliari, Italy
Investigational Site Number : 3800015
🇮🇹Catania, Italy
Investigational Site Number : 3800018
🇮🇹Chieti, Italy
Investigational Site Number : 3800016
🇮🇹Firenze, Italy
Investigational Site Number : 3800001
🇮🇹Milano, Italy
Investigational Site Number : 3800003
🇮🇹Napoli, Italy
Investigational Site Number : 3800006
🇮🇹Napoli, Italy
Investigational Site Number : 3800013
🇮🇹Roma, Italy
Investigational Site Number : 3920016
🇯🇵Chiba-shi, Chiba, Japan
Investigational Site Number : 3920008
🇯🇵Koriyama-shi, Fukushima, Japan
Investigational Site Number : 3920022
🇯🇵Morioka-shi, Iwate, Japan
Investigational Site Number : 3920023
🇯🇵Sagamihara-shi, Kanagawa, Japan
Investigational Site Number : 3920011
🇯🇵Kyoto-shi, Kyoto, Japan
Investigational Site Number : 3920020
🇯🇵Sendai-shi, Miyagi, Japan
Investigational Site Number : 3920005
🇯🇵Niigata-shi, Niigata, Japan
Investigational Site Number : 3920004
🇯🇵Moriguchi-shi, Osaka, Japan
Investigational Site Number : 3920001
🇯🇵Osaka-shi, Osaka, Japan
Investigational Site Number : 3920018
🇯🇵Kawagoe-shi, Saitama, Japan
Investigational Site Number : 3920014
🇯🇵Bunkyo-ku, Tokyo, Japan
Investigational Site Number : 3920003
🇯🇵Kodaira-shi, Tokyo, Japan
Investigational Site Number : 3920010
🇯🇵Ota-ku, Tokyo, Japan
Investigational Site Number : 3920017
🇯🇵Shinjuku-ku, Tokyo, Japan
Investigational Site Number : 3920015
🇯🇵Toyama-shi, Toyama, Japan
Investigational Site Number : 4280002
🇱🇻Riga, Latvia
Investigational Site Number : 4840004
🇲🇽Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840001
🇲🇽Cdmx, México, Mexico
Investigational Site Number : 4840005
🇲🇽Mexico city, Mexico
Investigational Site Number : 4840007
🇲🇽Tlalnepantla, Mexico
Investigational Site Number : 4840003
🇲🇽Veracruz, Mexico
Investigational Site Number : 5280003
🇳🇱Breda, Netherlands
Investigational Site Number : 5280006
🇳🇱Groningen, Netherlands
Investigational Site Number : 5280002
🇳🇱Sittard-Geleen, Netherlands
Investigational Site Number : 5780003
🇳🇴Bergen, Norway
Investigational Site Number : 5780005
🇳🇴Tromsø, Norway
Investigational Site Number : 6040004
🇵🇪Lima, Peru
Investigational Site Number : 6160003
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Investigational Site Number : 6160001
🇵🇱Lodz, Lódzkie, Poland
Investigational Site Number : 6160005
🇵🇱Warszawa, Mazowieckie, Poland
Investigational Site Number : 6160006
🇵🇱Warszawa, Mazowieckie, Poland
Investigational Site Number : 6160007
🇵🇱Katowice, Slaskie, Poland
Investigational Site Number : 6160004
🇵🇱Katowice, Slaskie, Poland
Investigational Site Number : 6200001
🇵🇹Braga, Portugal
Investigational Site Number : 6200007
🇵🇹Lisboa, Portugal
Investigational Site Number : 6200012
🇵🇹Lisboa, Portugal
Investigational Site Number : 6200002
🇵🇹Matosinhos, Portugal
Investigational Site Number : 6200010
🇵🇹Porto, Portugal
Investigational Site Number : 6200004
🇵🇹Santa Maria da Feira, Portugal
Investigational Site Number : 6420008
🇷🇴Bucuresti, Romania
Investigational Site Number : 6420004
🇷🇴Campulung Muscel, Romania
Investigational Site Number : 6420003
🇷🇴Constanta, Romania
Investigational Site Number : 6420013
🇷🇴Oradea, Romania
Investigational Site Number : 6420001
🇷🇴Targu Mures, Romania
Investigational Site Number : 6420002
🇷🇴Timișoara, Romania
Investigational Site Number : 6430018
🇷🇺Barnaul, Russian Federation
Investigational Site Number : 6430022
🇷🇺Ekaterinburg, Russian Federation
Investigational Site Number : 6430023
🇷🇺Kaliningrad, Russian Federation
Investigational Site Number : 6430004
🇷🇺Kazan, Russian Federation
Investigational Site Number : 6430021
🇷🇺Krasnoyarsk, Russian Federation
Investigational Site Number : 6430013
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430015
🇷🇺Rostov-on-Don, Russian Federation
Investigational Site Number : 6430017
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number : 6430009
🇷🇺Samara, Russian Federation
Investigational Site Number : 6430011
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430014
🇷🇺Nizhny Novgorod, Russian Federation
Investigational Site Number : 6430008
🇷🇺Pyatigorsk, Russian Federation
Investigational Site Number : 6430020
🇷🇺Saransk, Russian Federation
Investigational Site Number : 6430007
🇷🇺Tyumen, Russian Federation
Investigational Site Number : 6430006
🇷🇺Ufa, Russian Federation
Investigational Site Number : 6880001
🇷🇸Belgrade, Serbia
Investigational Site Number : 6880002
🇷🇸Kragujevac, Serbia
Investigational Site Number : 7100001
🇿🇦Pretoria, South Africa
Investigational Site Number : 7240012
🇪🇸La Coruña, A Coruña [La Coruña], Spain
Investigational Site Number : 7240015
🇪🇸Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240007
🇪🇸Sevilla, Andalucia, Spain
Investigational Site Number : 7240010
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240013
🇪🇸Bilbao, Bizkaia, Spain
Investigational Site Number : 7240011
🇪🇸Salt, Girona [Gerona], Spain
Investigational Site Number : 7240016
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number : 7240002
🇪🇸Majadahonda, Madrid, Spain
Investigational Site Number : 7240001
🇪🇸Pozuelo De Alarcón, Madrid, Spain
Investigational Site Number : 7240004
🇪🇸Córdoba, Spain
Investigational Site Number : 7240003
🇪🇸Madrid, Spain
Investigational Site Number : 7240005
🇪🇸Malaga, Spain
Investigational Site Number : 7240006
🇪🇸Murcia, Spain
Investigational Site Number : 7240014
🇪🇸Palma de Mallorca, Spain
Investigational Site Number : 7240008
🇪🇸Valencia, Spain
Investigational Site Number : 7520001
🇸🇪Göteborg, Sweden
Investigational Site Number : 7520005
🇸🇪Motala, Sweden
Investigational Site Number : 7640001
🇹🇭Bangkok, Thailand
Investigational Site Number : 7920009
🇹🇷Ankara, Turkey
Investigational Site Number : 7920014
🇹🇷Ankara, Turkey
Investigational Site Number : 7920005
🇹🇷Eskisehir, Turkey
Investigational Site Number : 7920010
🇹🇷Hatay, Turkey
Investigational Site Number : 7920016
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920003
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920002
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920007
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920015
🇹🇷Izmir, Turkey
Investigational Site Number : 7920018
🇹🇷Izmir, Turkey
Investigational Site Number : 7920001
🇹🇷Izmit, Turkey
Investigational Site Number : 7920017
🇹🇷Konya, Turkey
Investigational Site Number : 7920011
🇹🇷Kutahya, Turkey
Investigational Site Number : 7920012
🇹🇷Mersin, Turkey
Investigational Site Number : 7920013
🇹🇷Samsun, Turkey
Investigational Site Number : 8040020
🇺🇦Chernivtsi, Ukraine
Investigational Site Number : 8040012
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number : 8040017
🇺🇦Kharkiv, Ukraine
Investigational Site Number : 8040025
🇺🇦Kharkiv, Ukraine
Investigational Site Number : 8040023
🇺🇦Kharkiv, Ukraine
Investigational Site Number : 8040014
🇺🇦Kyiv, Ukraine
Investigational Site Number : 8040013
🇺🇦Kyiv, Ukraine
Investigational Site Number : 8040015
🇺🇦Kyiv, Ukraine
Investigational Site Number : 8040011
🇺🇦Lutsk, Ukraine
Investigational Site Number : 8040002
🇺🇦Lviv, Ukraine
Investigational Site Number : 8040007
🇺🇦Lviv, Ukraine
Investigational Site Number : 8040010
🇺🇦Odesa, Ukraine
Investigational Site Number : 8040024
🇺🇦Vinnytsya, Ukraine
Investigational Site Number : 8260003
🇬🇧Exeter, Devon, United Kingdom
Investigational Site Number : 8260016
🇬🇧Canterbury, Kent, United Kingdom
Investigational Site Number : 8260006
🇬🇧London, London, City Of, United Kingdom
Investigational Site Number : 8260005
🇬🇧London, London, City Of, United Kingdom
Investigational Site Number : 8260010
🇬🇧Swansea, Neath Port Talbot, United Kingdom
Investigational Site Number : 8260012
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Investigational Site Number : 8260013
🇬🇧Oxford, Oxfordshire, United Kingdom
Investigational Site Number : 8260001
🇬🇧Cardiff, Vale Of Glamorgan, The, United Kingdom
Investigational Site Number : 8260009
🇬🇧Bristol, United Kingdom
Investigational Site Number : 8260019
🇬🇧Salford, United Kingdom
Investigational Site Number : 8260007
🇬🇧Sheffield, United Kingdom