Clinical trial NCT04458051: Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
Official title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Primary Progressive Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 767
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: 6-month composite Confirmed Disability Progression (cCDP)
timeFrame: Up to approximately 60 months
Secondary outcomes:
measure: 6-month Confirmed Disability Progression (CDP)
timeFrame: Up to approximately 60 months
measure: 3-month composite Confirmed Disability Progression (cCDP)
timeFrame: Up to approximately 60 months
measure: Change in T2 hyperintense lesions by MRI
timeFrame: From screening MRI to approximately 60 months
measure: Time to onset of confirmed disability improvement (CDI)
timeFrame: Up to approximately 60 months
measure: Percent change in Brain volume (BV)
timeFrame: From 6 months up to approximately 60 months
measure: Change in cognitive function as assessed by SDMT
timeFrame: From Baseline up to approximately 60 months
measure: Change in cognitive function as assessed by CVLT-II
timeFrame: From Baseline up to approximately 60 months
measure: Change in Multiple Sclerosis Quality of Life
timeFrame: From Baseline up to approximately 60 months
measure: Safety and Tolerability
timeFrame: From screening up to approximately 60 months
measure: Population pharmacokinetics
timeFrame: Months 6, 9 and 12
measure: Change in plasma neurofilament light chain (NfL)
timeFrame: From Baseline up to approximately 60 months
measure: Change in lymphocyte phenotype subsets
timeFrame: From Baseline up to approximately 60 months
measure: Changes in serum Immunoglobulin level
timeFrame: From Baseline up to approximately 60 months
measure: Change in serum chitinase-3 like protein 1 (Chi3L1)
timeFrame: From Baseline up to approximately 60 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego ACTRI Site Number : 8400101
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research Site Number : 8400045
state: California
city: Los Angeles
country: United States
facility: Multiple Sclerosis Center- Site Number : 8400143
state: California
city: Newport Beach
country: United States
facility: Multiple Sclerosis Center of California Site Number : 8400135
state: California
city: Pasadena
country: United States
facility: SC3 Research - Pasadena Site Number : 8400070
state: California
city: San Francisco
country: United States
facility: University of San Francisco, Sandler Neurosciences Center- Site Number : 8400137
state: California
city: Torrance
country: United States
facility: Harbor UCLA Site Number : 8400088
state: California
city: West Hollywood
country: United States
facility: Regina Berkovich, MD, PhD Site Number : 8400059
state: California
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research Site Number : 8400025
state: Colorado
city: Boca Raton
country: United States
facility: South Florida Neurology Associates Site Number : 8400029
state: Florida
city: Clearwater
country: United States
facility: MS & Neuromuscular Center of Excellence Site Number : 8400172
state: Florida
city: Gainesville
country: United States
facility: University of Florida, Fixel Center for Neurology Site Number : 8400159
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, PA- Site Number : 8400004
state: Florida
city: Tampa
country: United States
facility: University of South Florida Site Number : 8400006
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research Site Number : 8400003
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience Site Number : 8400103
state: Hawaii
city: Northbrook
country: United States
facility: Consultants In Neurology- Site Number : 8400011
state: Illinois
city: Merrillville
country: United States
facility: Methodist Hospital Site Number : 8400164
state: Indiana
city: Overland Park
country: United States
facility: College Park Family Care Center Site Number : 8400044
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Site Number : 8400106
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Baptist Clinical Trials Unit (CTU)- Site Number : 8400107
state: Louisiana
city: Lutherville
country: United States
facility: International Neurorehabilitation Institute Site Number : 8400034
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center Site Number : 8400072
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Site Number : 8400014
state: Massachusetts
city: Farmington Hills
country: United States
facility: Michigan Institute For Neurological Disorders Site Number : 8400058
state: Michigan
city: Owosso
country: United States
facility: The Memorial Hospital- Site Number : 8400033
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Site Number : 8400111
state: Minnesota
city: Ozark
country: United States
facility: Sharlin Health & Neurology Site Number : 8400093
state: Missouri
city: Omaha
country: United States
facility: University Of Nebraska- Site Number : 8400129
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Hospital Site Number : 8400047
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Site Number : 8400032
state: New Mexico
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai (Department of Endoc Site Number : 8400038
state: New York
city: Stony Brook
country: United States
facility: Neurology Associates of Stony Brook Site Number : 8400042
state: New York
city: Durham
country: United States
facility: Duke Neurological Disorders Clinic- Site Number : 8400098
state: North Carolina
city: Raleigh
country: United States
facility: Meridian Clinical Research, LLC- Site Number : 8400005
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Site Number : 8400116
state: North Carolina
city: Cincinnati
country: United States
facility: Riverhills Neuroscience - Norwood Site Number : 8400167
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Site Number : 8400125
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center- Site Number : 8400150
state: Ohio
city: Columbus
country: United States
facility: The Boster Center for Multiple Sclerosis Site Number : 8400147
state: Ohio
city: Portland
country: United States
facility: Providence Multiple Sclerosis Center Site Number : 8400020
state: Oregon
city: Philadelphia
country: United States
facility: Jefferson Neurology Associates Site Number : 8400016
state: Pennsylvania
city: Greer
country: United States
facility: Mountain View Clinical Research Site Number : 8400024
state: South Carolina
city: Katy
country: United States
facility: Mt Olympus Medical Research Site Number : 8400163
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio Site Number : 8400036
state: Texas
city: Caba
country: Argentina
facility: Investigational Site Number : 0320002
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320003
state: Santa Fe
city: Concord
country: Australia
facility: Investigational Site Number : 0360005
state: New South Wales
city: St Leonards
country: Australia
facility: Investigational Site Number : 0360006
state: New South Wales
city: Hobart
country: Australia
facility: Investigational Site Number : 0360003
state: Tasmania
city: Linz
country: Austria
facility: Investigational Site Number : 0400004
city: Wien
country: Austria
facility: Investigational Site Number : 0400002
city: Vitebsk
country: Belarus
facility: Investigational Site Number : 1120004
city: Vitebsk
country: Belarus
facility: Investigational Site Number : 1120005
city: Bruxelles
country: Belgium
facility: Investigational Site Number : 0560009
city: Gent
country: Belgium
facility: Investigational Site Number : 0560004
city: Liège
country: Belgium
facility: Investigational Site Number : 0560008
city: Pelt
country: Belgium
facility: Investigational Site Number : 0560001
city: Sint-Lambrechts-Woluwe
country: Belgium
facility: Investigational Site Number : 0560007
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba Site Number : 0760002
state: Paraná
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica Site Number : 0760007
state: São Paulo
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1000002
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000004
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000008
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000001
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000011
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240002
state: Alberta
city: Vancouver
country: Canada
facility: Investigational Site Number : 1240016
state: British Columbia
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240012
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site Number : 1240003
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240013
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240004
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number : 1240015
state: Quebec
city: Sherbrooke
country: Canada
facility: Investigational Site Number : 1240007
state: Quebec
city: Quebec
country: Canada
facility: Investigational Site Number : 1240001
city: Quebec
country: Canada
facility: Investigational Site Number : 1240021
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Beijing
country: China
facility: Investigational Site Number : 1560003
city: Beijing
country: China
facility: Investigational Site Number : 1560012
city: Beijing
country: China
facility: Investigational Site Number : 1560009
city: Beijing
country: China
facility: Investigational Site Number : 1560025
city: Changchun
country: China
facility: Investigational Site Number : 1560004
city: Changsha
country: China
facility: Investigational Site Number : 1560015
city: Chengdu
country: China
facility: Investigational Site Number : 1560005
city: Fuzhou
country: China
facility: Investigational Site Number : 1560035
city: Guangzhou
country: China
facility: Investigational Site Number : 1560002
city: Hohhot
country: China
facility: Investigational Site Number : 1560027
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Taiyuan
country: China
facility: Investigational Site Number : 1560008
city: Wenzhou
country: China
facility: Investigational Site Number : 1560026
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700001
city: Bogotá
country: Colombia
facility: Investigational Site Number : 1700003
city: Zagreb
country: Croatia
facility: Investigational Site Number : 1910001
city: Zagreb
country: Croatia
facility: Investigational Site Number : 1910002
city: Brno
country: Czechia
facility: Investigational Site Number : 2030002
city: Hradec Kralove
country: Czechia
facility: Investigational Site Number : 2030004
city: Jihlava
country: Czechia
facility: Investigational Site Number : 2030001
city: Teplice
country: Czechia
facility: Investigational Site Number : 2030003
city: Esbjerg
country: Denmark
facility: Investigational Site Number : 2080001
city: Holstebro
country: Denmark
facility: Investigational Site Number : 2080005
city: Tallinn
country: Estonia
facility: Investigational Site Number : 2330001
city: Bron
country: France
facility: Investigational Site Number : 2500011
city: Clermont Ferrand
country: France
facility: Investigational Site Number : 2500005
city: Gonesse
country: France
facility: Investigational Site Number : 2500015
city: Lille
country: France
facility: Investigational Site Number : 2500009
city: Montpellier
country: France
facility: Investigational Site Number : 2500006
city: Nancy
country: France
facility: Investigational Site Number : 2500008
city: Nimes
country: France
facility: Investigational Site Number : 2500017
city: Paris
country: France
facility: Investigational Site Number : 2500014
city: Paris
country: France
facility: Investigational Site Number : 2500007
city: Poissy
country: France
facility: Investigational Site Number : 2500004
city: Rennes
country: France
facility: Investigational Site Number : 2500003
city: Strasbourg
country: France
facility: Investigational Site Number : 2500001
city: Toulouse
country: France
facility: Investigational Site Number : 2500012
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680005
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680009
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680003
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680004
city: Bayreuth
country: Germany
facility: Investigational Site Number : 2760005
city: Berlin
country: Germany
facility: Investigational Site Number : 2760009
city: Berlin
country: Germany
facility: Investigational Site Number : 2760015
city: Bochum
country: Germany
facility: Investigational Site Number : 2760020
city: Dresden
country: Germany
facility: Investigational Site Number : 2760001
city: Düsseldorf
country: Germany
facility: Investigational Site Number : 2760021
city: Essen
country: Germany
facility: Investigational Site Number : 2760012
city: Gießen
country: Germany
facility: Investigational Site Number : 2760002
city: Hannover
country: Germany
facility: Investigational Site Number : 2760006
city: München
country: Germany
facility: Investigational Site Number : 2760018
city: Münster
country: Germany
facility: Investigational Site Number : 2760008
city: Rostock
country: Germany
facility: Investigational Site Number : 2760004
city: Ulm
country: Germany
facility: Investigational Site Number : 2760011
city: Athens
country: Greece
facility: Investigational Site Number : 3000001
city: Athens
country: Greece
facility: Investigational Site Number : 3000006
city: Athens
country: Greece
facility: Investigational Site Number : 3000002
city: Larisa
country: Greece
facility: Investigational Site Number : 3000004
city: Maroussi
country: Greece
facility: Investigational Site Number : 3000007
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000003
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000009
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480206
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480202
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480203
city: Bengaluru
country: India
facility: Investigational Site Number : 3560014
city: Mangaluru
country: India
facility: Investigational Site Number : 3560004
city: New Delhi
country: India
facility: Investigational Site Number : 3560005
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760008
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760001
city: Safed
country: Israel
facility: Investigational Site Number : 3760004
city: Pozzilli
country: Italy
facility: Investigational Site Number : 3800002
state: Isernia
city: Cagliari
country: Italy
facility: Investigational Site Number : 3800007
city: Catania
country: Italy
facility: Investigational Site Number : 3800015
city: Chieti
country: Italy
facility: Investigational Site Number : 3800018
city: Firenze
country: Italy
facility: Investigational Site Number : 3800016
city: Milano
country: Italy
facility: Investigational Site Number : 3800001
city: Napoli
country: Italy
facility: Investigational Site Number : 3800003
city: Napoli
country: Italy
facility: Investigational Site Number : 3800006
city: Roma
country: Italy
facility: Investigational Site Number : 3800013
city: Chiba-shi
country: Japan
facility: Investigational Site Number : 3920016
state: Chiba
city: Koriyama-shi
country: Japan
facility: Investigational Site Number : 3920008
state: Fukushima
city: Morioka-shi
country: Japan
facility: Investigational Site Number : 3920022
state: Iwate
city: Sagamihara-shi
country: Japan
facility: Investigational Site Number : 3920023
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Investigational Site Number : 3920011
state: Kyoto
city: Sendai-shi
country: Japan
facility: Investigational Site Number : 3920020
state: Miyagi
city: Niigata-shi
country: Japan
facility: Investigational Site Number : 3920005
state: Niigata
city: Moriguchi-shi
country: Japan
facility: Investigational Site Number : 3920004
state: Osaka
city: Osaka-shi
country: Japan
facility: Investigational Site Number : 3920001
state: Osaka
city: Kawagoe-shi
country: Japan
facility: Investigational Site Number : 3920018
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Investigational Site Number : 3920014
state: Tokyo
city: Kodaira-shi
country: Japan
facility: Investigational Site Number : 3920003
state: Tokyo
city: Ota-ku
country: Japan
facility: Investigational Site Number : 3920010
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Investigational Site Number : 3920017
state: Tokyo
city: Toyama-shi
country: Japan
facility: Investigational Site Number : 3920015
state: Toyama
city: Riga
country: Latvia
facility: Investigational Site Number : 4280002
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840004
state: Jalisco
city: Cdmx
country: Mexico
facility: Investigational Site Number : 4840001
state: México
city: Mexico city
country: Mexico
facility: Investigational Site Number : 4840005
city: Tlalnepantla
country: Mexico
facility: Investigational Site Number : 4840007
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840003
city: Breda
country: Netherlands
facility: Investigational Site Number : 5280003
city: Groningen
country: Netherlands
facility: Investigational Site Number : 5280006
city: Sittard-Geleen
country: Netherlands
facility: Investigational Site Number : 5280002
city: Bergen
country: Norway
facility: Investigational Site Number : 5780003
city: Tromsø
country: Norway
facility: Investigational Site Number : 5780005
city: Lima
country: Peru
facility: Investigational Site Number : 6040004
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160003
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Investigational Site Number : 6160001
state: Lódzkie
city: Warszawa
country: Poland
facility: Investigational Site Number : 6160005
state: Mazowieckie
city: Warszawa
country: Poland
facility: Investigational Site Number : 6160006
state: Mazowieckie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160007
state: Slaskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160004
state: Slaskie
city: Braga
country: Portugal
facility: Investigational Site Number : 6200001
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200007
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200012
city: Matosinhos
country: Portugal
facility: Investigational Site Number : 6200002
city: Porto
country: Portugal
facility: Investigational Site Number : 6200010
city: Santa Maria da Feira
country: Portugal
facility: Investigational Site Number : 6200004
city: Bucuresti
country: Romania
facility: Investigational Site Number : 6420008
city: Campulung Muscel
country: Romania
facility: Investigational Site Number : 6420004
city: Constanta
country: Romania
facility: Investigational Site Number : 6420003
city: Oradea
country: Romania
facility: Investigational Site Number : 6420013
city: Targu Mures
country: Romania
facility: Investigational Site Number : 6420001
city: Timișoara
country: Romania
facility: Investigational Site Number : 6420002
city: Barnaul
country: Russian Federation
facility: Investigational Site Number : 6430018
city: Ekaterinburg
country: Russian Federation
facility: Investigational Site Number : 6430022
city: Kaliningrad
country: Russian Federation
facility: Investigational Site Number : 6430023
city: Kazan
country: Russian Federation
facility: Investigational Site Number : 6430004
city: Krasnoyarsk
country: Russian Federation
facility: Investigational Site Number : 6430021
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430013
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430011
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number : 6430014
city: Pyatigorsk
country: Russian Federation
facility: Investigational Site Number : 6430008
city: Rostov-on-Don
country: Russian Federation
facility: Investigational Site Number : 6430015
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430017
city: Samara
country: Russian Federation
facility: Investigational Site Number : 6430009
city: Saransk
country: Russian Federation
facility: Investigational Site Number : 6430020
city: Tyumen
country: Russian Federation
facility: Investigational Site Number : 6430007
city: Ufa
country: Russian Federation
facility: Investigational Site Number : 6430006
city: Belgrade
country: Serbia
facility: Investigational Site Number : 6880001
city: Kragujevac
country: Serbia
facility: Investigational Site Number : 6880002
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100001
city: La Coruña
country: Spain
facility: Investigational Site Number : 7240012
state: A Coruña [La Coruña]
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number : 7240015
state: A Coruña [La Coruña]
city: Sevilla
country: Spain
facility: Investigational Site Number : 7240007
state: Andalucia
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240010
state: Barcelona [Barcelona]
city: Bilbao
country: Spain
facility: Investigational Site Number : 7240013
state: Bizkaia
city: Salt
country: Spain
facility: Investigational Site Number : 7240011
state: Girona [Gerona]
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigational Site Number : 7240016
state: Las Palmas
city: Majadahonda
country: Spain
facility: Investigational Site Number : 7240002
state: Madrid
city: Pozuelo De Alarcón
country: Spain
facility: Investigational Site Number : 7240001
state: Madrid
city: Córdoba
country: Spain
facility: Investigational Site Number : 7240004
city: Madrid
country: Spain
facility: Investigational Site Number : 7240003
city: Malaga
country: Spain
facility: Investigational Site Number : 7240005
city: Murcia
country: Spain
facility: Investigational Site Number : 7240006
city: Palma de Mallorca
country: Spain
facility: Investigational Site Number : 7240014
city: Valencia
country: Spain
facility: Investigational Site Number : 7240008
city: Göteborg
country: Sweden
facility: Investigational Site Number : 7520001
city: Motala
country: Sweden
facility: Investigational Site Number : 7520005
city: Bangkok
country: Thailand
facility: Investigational Site Number : 7640001
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920009
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920014
city: Eskisehir
country: Turkey
facility: Investigational Site Number : 7920005
city: Hatay
country: Turkey
facility: Investigational Site Number : 7920010
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920016
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920003
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920002
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920007
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920015
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920018
city: Izmit
country: Turkey
facility: Investigational Site Number : 7920001
city: Konya
country: Turkey
facility: Investigational Site Number : 7920017
city: Kutahya
country: Turkey
facility: Investigational Site Number : 7920011
city: Mersin
country: Turkey
facility: Investigational Site Number : 7920012
city: Samsun
country: Turkey
facility: Investigational Site Number : 7920013
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number : 8040020
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number : 8040012
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8040017
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8040025
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8040023
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040014
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040013
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040015
city: Lutsk
country: Ukraine
facility: Investigational Site Number : 8040011
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8040002
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8040007
city: Odesa
country: Ukraine
facility: Investigational Site Number : 8040010
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number : 8040024
city: Exeter
country: United Kingdom
facility: Investigational Site Number : 8260003
state: Devon
city: Canterbury
country: United Kingdom
facility: Investigational Site Number : 8260016
state: Kent
city: London
country: United Kingdom
facility: Investigational Site Number : 8260006
state: London, City Of
city: London
country: United Kingdom
facility: Investigational Site Number : 8260005
state: London, City Of
city: Swansea
country: United Kingdom
facility: Investigational Site Number : 8260010
state: Neath Port Talbot
city: Nottingham
country: United Kingdom
facility: Investigational Site Number : 8260012
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Investigational Site Number : 8260013
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: Investigational Site Number : 8260001
state: Vale Of Glamorgan, The
city: Bristol
country: United Kingdom
facility: Investigational Site Number : 8260009
city: Salford
country: United Kingdom
facility: Investigational Site Number : 8260019
city: Sheffield
country: United Kingdom
facility: Investigational Site Number : 8260007
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: