Clinical trial NCT06372145: A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Participants with relapsing MS from the Phase 2b LTS16004 parent study will continue open-label (OL) tolebrutinib.

All participants from the Phase 3 parent studies (EFC16033, EFC16034, EFC16645, and EFC16035) will learn which treatment they received in the parent study:

* If from one of the Phase 3 relapsing MS studies and on teriflunomide, an accelerated elimination procedure or a 3-month washout period is required prior to starting OL tolebrutinib. If on teriflunomide, and benefiting and recommended by the Investigator, the participant may opt to continue teriflunomide outside of the LTS17043 study, if clinically appropriate. If on tolebrutinib, the participant will continue tolebrutinib.
* All participants from one of the Phase 3 progressive MS studies will start OL tolebrutinib.
* If a participant already started OL tolebrutinib in the Phase 3 parent study this will be continued.
* 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.

The treatment duration per participant will be approximately 3 years of OL tolebrutinib.

Eligibility criteria: Inclusion Criteria:

- 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.

OR

- 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.

ToleDYNAMIC Substudy: Inclusion criteria are those of the main study

Exclusion Criteria:

* 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.

ToleDYNAMIC Substudy: Exclusion criteria are those of the main study

Primary outcomes:
measure: 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
timeFrame: From baseline until the End of study approximately 3 years per participant
measure: Number of Participants with Potentially clinically significant abnormalities (PCSAs)
timeFrame: From baseline until the End of study approximately 3 years per participant
Secondary outcomes:
measure: 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
timeFrame: From baseline until the End of study approximately 3 years per participant
measure: Annualized Relapse Rate (ARR) for RMS only
timeFrame: From baseline until the End of study approximately 3 years per participant
measure: Number of new and/or enlarging T2-hyperintense lesions per year
timeFrame: From baseline until the End of study approximately 3 years per participant
measure: Change from baseline in total volume of T2-hyperintense lesions
timeFrame: From baseline until the End of study approximately 3 years per participant
measure: ToleDYNAMIC substudy Change from baseline in biomarkers
timeFrame: From baseline until 12 months per participant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham- Site Number : 8400013
state: Alabama
city: Cullman
country: United States
facility: North Central Neurology Associates- Site Number : 8400009
state: Alabama
city: Phoenix
country: United States
facility: Center for Neurology and Spine - Phoenix - North 32nd Street- Site Number : 8400089
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego - La Jolla- 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: Keck School of Medicine of University of Southern California- Site Number : 8400143
state: California
city: West Hollywood
country: United States
facility: Private Practice - Dr. Regina Berkovich- Site Number : 8400059
state: California
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus- Site Number : 8400012
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurology of Colorado- Site Number : 8400025
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown University Hospital- Site Number : 8400119
state: District of Columbia
city: Boca Raton
country: United States
facility: SFM Clinical Research- Site Number : 8400029
state: Florida
city: Maitland
country: United States
facility: Neurology Associates - Maitland- Site Number : 8409902
state: Florida
city: Miami
country: United States
facility: University of Miami- Site Number : 8400063
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research- Site Number : 8400027
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida- Site Number : 8400001
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Site Number : 8409905
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research - Savannah Neurology- Site Number : 8409903
state: Georgia
city: Northbrook
country: United States
facility: Consultants in Neurology- Site Number : 8409906
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic 1st - 800 Building- Site Number : 8400071
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center - North- Site Number : 8400039
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center- Site Number : 8400023
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute - St. Matthews- Site Number : 8400127
state: Kentucky
city: Baton Rouge
country: United States
facility: The NeuroMedical Center- Site Number : 8400057
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center- Site Number : 8400072
state: Massachusetts
city: Detroit
country: United States
facility: Harper University Hospital- Site Number : 8400046
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders- Site Number : 8400058
state: Michigan
city: Owosso
country: United States
facility: Memorial Healthcare Institute for Neuroscience- Site Number : 8400033
state: Michigan
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400051
state: Minnesota
city: Ozark
country: United States
facility: Sharlin Health & Neurology- Site Number : 8400093
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center- Site Number : 8400019
state: Missouri
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400117
state: Nevada
city: Albuquerque
country: United States
facility: The University of New Mexico- Site Number : 8400032
state: New Mexico
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai- Site Number : 8400038
state: New York
city: Patchogue
country: United States
facility: South Shore Neurologic Associates - Patchogue- Site Number : 8400100
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University- Site Number : 8400042
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400116
state: North Carolina
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders- Site Number : 8400081
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic - Cleveland- Site Number : 8400125
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University- Site Number : 8400150
state: Ohio
city: Columbus
country: United States
facility: The Boster Center for Multiple Sclerosis- Site Number : 8400147
state: Ohio
city: Dayton
country: United States
facility: Medical Center at Elizabeth Place- Site Number : 8409901
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent's Medical Center- Site Number : 8400020
state: Oregon
city: Greer
country: United States
facility: Premier Neurology- Site Number : 8400069
state: South Carolina
city: Knoxville
country: United States
facility: Hope Neurology- Site Number : 8409904
state: Tennessee
city: San Antonio
country: United States
facility: Neurology Center of San Antonio- Site Number : 8400036
state: Texas
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders - Sherman- Site Number : 8400151
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center- Site Number : 8400130
state: Vermont
city: Richmond
country: United States
facility: Neurological Associates - Richmond- Site Number : 8400097
state: Virginia
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320007
state: Ciudad De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
state: Ciudad De Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0329901
state: Ciudad De Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320003
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Córdoba
country: Argentina
facility: Investigational Site Number : 0320006
city: San Miguel de Tucuman
country: Argentina
facility: Investigational Site Number : 0320005
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320005
city: Saint Leonards
country: Australia
facility: Investigational Site Number : 0360001
state: New South Wales
city: Kent Town
country: Australia
facility: Investigational Site Number : 0360006
state: South Australia
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360007
state: Victoria
city: Innsbruck
country: Austria
facility: Investigational Site Number : 0400003
city: Linz
country: Austria
facility: Investigational Site Number : 0400004
city: Vienna
country: Austria
facility: Investigational Site Number : 0400002
city: Bruges
country: Belgium
facility: Investigational Site Number : 0560005
city: Brussels
country: Belgium
facility: Investigational Site Number : 0560007
city: Gent
country: Belgium
facility: Investigational Site Number : 0560004
city: Leuven
country: Belgium
facility: Investigational Site Number : 0560006
city: Liège
country: Belgium
facility: Investigational Site Number : 0560008
city: Overpelt
country: Belgium
facility: Investigational Site Number : 0560001
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760002
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica - São Paulo- Site Number : 0760007
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1000002
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number : 1000005
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 : 1000006
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000009
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240002
state: Alberta
city: Burnaby
country: Canada
facility: Investigational Site Number : 1240017
state: British Columbia
city: Vancouver
country: Canada
facility: Investigational Site Number : 1249901
state: British Columbia
city: Halifax
country: Canada
facility: Investigational Site Number : 1240011
state: Nova Scotia
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240012
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site Number : 1240003
state: Ontario
city: Gatineau
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
city: Lévis
country: Canada
facility: Investigational Site Number : 1240021
state: Quebec
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: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
city: Beijing
country: China
facility: Investigational Site Number : 1560009
city: Beijing
country: China
facility: Investigational Site Number : 1560006
city: Beijing
country: China
facility: Investigational Site Number : 1560023
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: Chongqing
country: China
facility: Investigational Site Number : 1560019
city: Fuzhou
country: China
facility: Investigational Site Number : 1560035
city: Guangzhou
country: China
facility: Investigational Site Number : 1569903
city: Hohhot
country: China
facility: Investigational Site Number : 1560027
city: Jiazhuang
country: China
facility: Investigational Site Number : 1560014
city: Nanjing
country: China
facility: Investigational Site Number : 1560044
city: Nanjing
country: China
facility: Investigational Site Number : 1560042
city: Shanghai
country: China
facility: Investigational Site Number : 1569901
city: Shenyang
country: China
facility: Investigational Site Number : 1560018
city: Taiyuan
country: China
facility: Investigational Site Number : 1560008
city: Tianjin
country: China
facility: Investigational Site Number : 1560020
city: Wuhan
country: China
facility: Investigational Site Number : 1560011
city: Xi An
country: China
facility: Investigational Site Number : 1560017
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 : 2039907
city: Brno
country: Czechia
facility: Investigational Site Number : 2030002
city: Hradec Králové
country: Czechia
facility: Investigational Site Number : 2039903
city: Jihlava
country: Czechia
facility: Investigational Site Number : 2039901
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2039902
city: Pardubice
country: Czechia
facility: Investigational Site Number : 2039904
city: Prague
country: Czechia
facility: Investigational Site Number : 2030008
city: Prague
country: Czechia
facility: Investigational Site Number : 2039906
city: Prague
country: Czechia
facility: Investigational Site Number : 2039905
city: Teplice
country: Czechia
facility: Investigational Site Number : 2030003
city: Zlín
country: Czechia
facility: Investigational Site Number : 2030007
city: Esbjerg
country: Denmark
facility: Investigational Site Number : 2080001
city: Holstebro
country: Denmark
facility: Investigational Site Number : 2080005
city: Odense
country: Denmark
facility: Investigational Site Number : 2080004
city: Tallinn
country: Estonia
facility: Investigational Site Number : 2330001
city: Tampere
country: Finland
facility: Investigational Site Number : 2460001
city: Turku
country: Finland
facility: Investigational Site Number : 2460002
city: Besançon
country: France
facility: Investigational Site Number : 2500019
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: Nice
country: France
facility: Investigational Site Number : 2500002
city: Nîmes
country: France
facility: Investigational Site Number : 2500017
city: Paris
country: France
facility: Investigational Site Number : 2500007
city: Paris
country: France
facility: Investigational Site Number : 2500014
city: Poissy
country: France
facility: Investigational Site Number : 2500004
city: Rennes
country: France
facility: Investigational Site Number : 2500003
city: Saint-herblain
country: France
facility: Investigational Site Number : 2500010
city: Strasbourg
country: France
facility: Investigational Site Number : 2500001
city: Toulouse
country: France
facility: Investigational Site Number : 2500012
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: Berlin
country: Germany
facility: Investigational Site Number : 2760014
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 : 2769901
city: Essen
country: Germany
facility: Investigational Site Number : 2760012
city: Giessen
country: Germany
facility: Investigational Site Number : 2760002
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760016
city: Münster
country: Germany
facility: Investigational Site Number : 2760008
city: ULM
country: Germany
facility: Investigational Site Number : 2760011
city: Wã¼rzburg
country: Germany
facility: Investigational Site Number : 2760003
city: Athens
country: Greece
facility: Investigational Site Number : 3000006
city: Athens
country: Greece
facility: Investigational Site Number : 3000001
city: Athens
country: Greece
facility: Investigational Site Number : 3000002
city: Athens
country: Greece
facility: Investigational Site Number : 3000007
city: Larissa
country: Greece
facility: Investigational Site Number : 3000004
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000003
city: Sha Tin
country: Hong Kong
facility: Investigational Site Number : 3440001
city: Budapest
country: Hungary
facility: Investigational Site Number : 3489901
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480007
city: Budapest
country: Hungary
facility: Investigational Site Number : 3489903
city: Pécs
country: Hungary
facility: Investigational Site Number : 3480002
city: Chandigarh
country: India
facility: Investigational Site Number : 3569904
city: Gurugram
country: India
facility: Investigational Site Number : 3560007
city: Gurugram
country: India
facility: Investigational Site Number : 3569903
city: Mangaluru
country: India
facility: Investigational Site Number : 3569901
city: Nagpur
country: India
facility: Investigational Site Number : 3560009
city: New Delhi
country: India
facility: Investigational Site Number : 3569902
city: New Delhi
country: India
facility: Investigational Site Number : 3560002
city: Thiruvananthapuram
country: India
facility: Investigational Site Number : 3560004
city: Haifa
country: Israel
facility: Investigational Site Number : 3760003
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760001
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760006
city: Safed
country: Israel
facility: Investigational Site Number : 3760004
city: Florence
country: Italy
facility: Investigational Site Number : 3800016
state: Firenze
city: Milan
country: Italy
facility: Investigational Site Number : 3800010
state: Lombardia
city: Rome
country: Italy
facility: Investigational Site Number : 3800009
state: Roma
city: Rome
country: Italy
facility: Investigational Site Number : 3800013
state: Roma
city: Florence
country: Italy
facility: Investigational Site Number : 3800012
state: Toscana
city: Bergamo
country: Italy
facility: Investigational Site Number : 3800011
city: Cagliari
country: Italy
facility: Investigational Site Number : 3800007
city: Catania
country: Italy
facility: Investigational Site Number : 3800015
city: Genoa
country: Italy
facility: Investigational Site Number : 3800014
city: Milan
country: Italy
facility: Investigational Site Number : 3800001
city: Naples
country: Italy
facility: Investigational Site Number : 3800006
city: Pavia
country: Italy
facility: Investigational Site Number : 3800008
city: Pozzilli
country: Italy
facility: Investigational Site Number : 3800002
city: Roma
country: Italy
facility: Investigational Site Number : 3800009
city: Rome
country: Italy
facility: Investigational Site Number : 3800005
city: Morioka
country: Japan
facility: Investigational Site Number : 3920022
state: Iwate
city: Sagamihara
country: Japan
facility: Investigational Site Number : 3920023
state: Kanagawa
city: Kawagoe
country: Japan
facility: Investigational Site Number : 3920018
state: Saitama
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920011
city: Osaka
country: Japan
facility: Investigational Site Number : 3920001
city: Osaka
country: Japan
facility: Investigational Site Number : 3920004
city: Tokyo
country: Japan
facility: Investigational Site Number : 3920010
city: Goyang-si
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Seoul-teukbyeolsi
city: Riga
country: Latvia
facility: Investigational Site Number : 4280002
city: Riga
country: Latvia
facility: Investigational Site Number : 4280003
city: Kaunas
country: Lithuania
facility: Investigational Site Number : 4400003
city: Siauliai
country: Lithuania
facility: Investigational Site Number : 4400004
city: Vilnius
country: Lithuania
facility: Investigational Site Number : 4400001
city: Mexico City
country: Mexico
facility: Investigational Site Number : 4840002
state: Ciudad De Mexico
city: Mexico City
country: Mexico
facility: Investigational Site Number : 4840001
state: Ciudad De Mexico
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840003
city: Amsterdam
country: Netherlands
facility: Investigational Site Number : 5280001
city: Heerlen
country: Netherlands
facility: Investigational Site Number : 5280002
city: Bergen
country: Norway
facility: Investigational Site Number : 5780003
city: Oslo
country: Norway
facility: Investigational Site Number : 5780001
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160003
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Investigational Site Number : 6160001
state: Lódzkie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160005
state: Mazowieckie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160006
state: Mazowieckie
city: Glogow
country: Poland
facility: Investigational Site Number : 6160009
state: Podkarpackie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160004
state: Slaskie
city: Plewiska
country: Poland
facility: Investigational Site Number : 6160008
state: Wielkopolskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160002
city: Lublin
country: Poland
facility: Investigational Site Number : 6160012
city: Zabrze
country: Poland
facility: Investigational Site Number : 6160011
city: Braga
country: Portugal
facility: Investigational Site Number : 6200001
city: Coimbra
country: Portugal
facility: Investigational Site Number : 6200005
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200011
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200006
city: Santa Maria Da Feira
country: Portugal
facility: Investigational Site Number : 6200004
city: Guaynabo
country: Puerto Rico
facility: San Juan MS Center- Site Number : 8400015
city: Brașov
country: Romania
facility: Investigational Site Number : 6420015
city: Bucharest
country: Romania
facility: Investigational Site Number : 6420008
city: Cluj-napoca
country: Romania
facility: Investigational Site Number : 6420006
city: Constanta
country: Romania
facility: Investigational Site Number : 6420003
city: Câmpulung
country: Romania
facility: Investigational Site Number : 6420004
city: Oradea
country: Romania
facility: Investigational Site Number : 6420013
city: Sibiu
country: Romania
facility: Investigational Site Number : 6420005
city: Timișoara
country: Romania
facility: Investigational Site Number : 6420002
city: Belgrade
country: Serbia
facility: Investigational Site Number : 6880001
city: Belgrade
country: Serbia
facility: Investigational Site Number : 6880003
city: Belgrade
country: Serbia
facility: Investigational Site Number : 6880006
city: Kragujevac
country: Serbia
facility: Investigational Site Number : 6880002
city: Novi Sad
country: Serbia
facility: Investigational Site Number : 6880005
city: Bratislava
country: Slovakia
facility: Investigational Site Number : 7030001
city: Martin
country: Slovakia
facility: Investigational Site Number : 7030002
city: Nitra
country: Slovakia
facility: Investigational Site Number : 7030004
city: A Coruña
country: Spain
facility: Investigational Site Number : 7249908
state: A Coruña [La Coruña]
city: Seville
country: Spain
facility: Investigational Site Number : 7249907
state: Andalucia
city: Barcelona
country: Spain
facility: Investigational Site Number : 7249906
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7249912
state: Barcelona [Barcelona]
city: L'hospitalet de Llobregat
country: Spain
facility: Investigational Site Number : 7249919
state: Barcelona [Barcelona]
city: Barakaldo
country: Spain
facility: Investigational Site Number : 7249913
state: Bizkaia
city: Donostia-san Sebastian
country: Spain
facility: Investigational Site Number : 7249918
state: Gipuzkoa
city: Girona
country: Spain
facility: Investigational Site Number : 7249911
state: Girona [Gerona]
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigational Site Number : 7249904
state: Las Palmas
city: Lleida
country: Spain
facility: Investigational Site Number : 7249902
state: Lleida [Lérida]
city: Madrid
country: Spain
facility: Investigational Site Number : 7249909
state: Madrid, Comunidad De
city: Majadahonda
country: Spain
facility: Investigational Site Number : 7249901
state: Madrid
city: Pozuelo de Alarcón
country: Spain
facility: Investigational Site Number : 7249905
state: Madrid
city: Córdoba
country: Spain
facility: Investigational Site Number : 7249914
city: Madrid
country: Spain
facility: Investigational Site Number : 7249903
city: Madrid
country: Spain
facility: Investigational Site Number : 7249910
city: Murcia
country: Spain
facility: Investigational Site Number : 7249916
city: Málaga
country: Spain
facility: Investigational Site Number : 7249915
city: Valencia
country: Spain
facility: Investigational Site Number : 7249917
city: Gothenburg
country: Sweden
facility: Investigational Site Number : 7520001
city: Stockholm
country: Sweden
facility: Investigational Site Number : 7520002
city: Bern
country: Switzerland
facility: Investigational Site Number : 7560002
city: Hsinchu
country: Taiwan
facility: Investigational Site Number : 1580007
city: Taipei City
country: Taiwan
facility: Investigational Site Number : 1580002
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7929902
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920006
city: Eskişehir
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920002
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920009
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920007
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920003
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920010
city: Izmit
country: Turkey
facility: Investigational Site Number : 7920001
city: Kütahya
country: Turkey
facility: Investigational Site Number : 7929901
city: Samsun
country: Turkey
facility: Investigational Site Number : 7929903
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number : 8040020
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number : 8049912
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number : 8049904
city: Dnipro
country: Ukraine
facility: Investigational Site Number : 8049905
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8040025
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8049903
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8040018
city: Krykhivtsi
country: Ukraine
facility: Investigational Site Number : 8049908
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8049902
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8049911
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8049901
city: Lutsk
country: Ukraine
facility: Investigational Site Number : 8049914
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8049909
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8049906
city: Odesa
country: Ukraine
facility: Investigational Site Number : 8049913
city: Vinnytsia
country: Ukraine
facility: Investigational Site Number : 8040024
city: Vinnytsia
country: Ukraine
facility: Investigational Site Number : 8049910
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 : 8260005
state: London, City Of
city: Salford
country: United Kingdom
facility: Investigational Site Number : 8260019
state: Manchester
city: Oxford
country: United Kingdom
facility: Investigational Site Number : 8260013
state: Oxfordshire
city: Bristol
country: United Kingdom
facility: Investigational Site Number : 8260009
city: Newcastle Upon Tyne
country: United Kingdom
facility: Investigational Site Number : 8260014
Study officials:
References: