Clinical trial NCT06141486: Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Official title: A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include:

* This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end.
* The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.


Eligibility criteria: Inclusion Criteria:

* Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
* Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
* Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
* Absence of clinical relapses for at least 24 months.
* The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

Exclusion Criteria:

* The participant has a history of infection or may be at risk for infection.
* The presence of psychiatric disturbance or substance abuse.
* History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
* History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
* A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
* The participant has sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
* The participant was previously exposed to frexalimab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period
timeFrame: Up to 36 months
Secondary outcomes:
measure: Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period
timeFrame: Up to 36 months
measure: Time to onset of individual components of the composite, confirmed over 3-months or 6 months in the double-blind treatment period
timeFrame: Up to 36 months
measure: Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period
timeFrame: Up to 36 months
measure: Number of new and/or enlarging T2hyperintense lesions per scan as detected by MRI, and number of new and/or enlarging T2-hyperintense lesions per scan as detected by MRI
timeFrame: Up to 36 months
measure: Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6
timeFrame: Up to 36 months
measure: Change in cognitive function at the end of double-blind treatment period compared to baseline as assessed by symbol digit modalities test (SDMT)
timeFrame: Baseline, Up to 36 months
measure: Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time in the double-blind treatment period
timeFrame: Baseline, Up to 36 months
measure: Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time in the double-blind treatment period
timeFrame: Baseline, Up to 36 months
measure: Annualized relapse rate during the double-blind treatment period assessed by protocol defined adjudicated relapses
timeFrame: Up to 36 months
measure: Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs)
timeFrame: Up to 36 months
measure: Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period
timeFrame: Up to 36 months
measure: Number of participants with antibody over time
timeFrame: Up to 36 months
measure: Change from baseline in serum Ig levels over time
timeFrame: Up to 36 months
measure: Change from baseline in plasma neurofilament light chain (NfL) levels over time in the double-blind treatment period
timeFrame: Up to 36 months
measure: Frexalimab plasma concentration over time in the double-blind treatment period
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Neurology Associates- Site Number : 8400115
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center- Site Number : 8400139
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Neurological Associates - Phoenix- Site Number : 8400074
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center- Site Number : 8400138
state: Arizona
city: Scottsdale
country: United States
facility: Imaging Endpoints- Site Number : 8400050
state: Arizona
city: Berkeley
country: United States
facility: Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134
state: California
city: Carlsbad
country: United States
facility: The Neurology Center of Southern California - Carlsbad- Site Number : 8400023
state: California
city: Irvine
country: United States
facility: UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400143
state: California
city: La Jolla
country: United States
facility: University of California San Diego Site Number : 8400095
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of University of Southern California- Site Number : 8400118
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian- Site Number : 8400031
state: California
city: Palo Alto
country: United States
facility: Stanford Neuroscience Health Center- Site Number : 8400120
state: California
city: West Hollywood
country: United States
facility: Private Practice - Dr. Regina Berkovich- Site Number : 8400005
state: California
city: Denver
country: United States
facility: University of Colorado- Site Number : 8400001
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurology of Colorado- Site Number : 8400148
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital- Site Number : 8400081
state: Connecticut
city: Norwich
country: United States
facility: Hartford Healthcare Medical Group- Site Number : 8400069
state: Connecticut
city: Stamford
country: United States
facility: New England Institute for Clinical Research- Site Number : 8400114
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital- Site Number : 8400044
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Neurology of Central Florida- Site Number : 8400147
state: Florida
city: Boca Raton
country: United States
facility: First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8400169
state: Florida
city: Fort Myers
country: United States
facility: Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8400041
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine- Site Number : 8400054
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital Jacksonville- Site Number : 8400093
state: Florida
city: Maitland
country: United States
facility: Neurology Associates - Maitland- Site Number : 8400010
state: Florida
city: Oldsmar
country: United States
facility: MS & Neuromuscular Center of Excellence- Site Number : 8400015
state: Florida
city: Orlando
country: United States
facility: Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida- Site Number : 8400049
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Site Number : 8400013
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Medical Group- Site Number : 8400105
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research - Savannah Neurology- Site Number : 8400061
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center- Site Number : 8400102
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Biological Science/Neurology (The) University of Chicago Medical Center)- Site Number : 8400055
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology- Site Number : 8400020
state: Illinois
city: Peoria
country: United States
facility: OSF Center for Health- Site Number : 8400030
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic 1st - 800 Building- Site Number : 8400043
state: Illinois
city: Merrillville
country: United States
facility: Neuroscience Institute Center- Site Number : 8400053
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa- Site Number : 8400029
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center- Site Number : 8400084
state: Kansas
city: Overland Park
country: United States
facility: College Park Family Care Center - Overland Park- Site Number : 8400032
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington- Site Number : 8400149
state: Kentucky
city: Alexandria
country: United States
facility: NeuroMedical Clinic of Central Louisiana- Site Number : 8400159
state: Louisiana
city: Baton Rouge
country: United States
facility: The NeuroMedical Center- Site Number : 8400182
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital- Site Number : 8400080
state: Maryland
city: Lutherville
country: United States
facility: International Neurorehabilitation Institute- Site Number : 8400089
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center- Site Number : 8400003
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials- Site Number : 8400178
state: Massachusetts
city: Foxboro
country: United States
facility: Neurology Center of New England- Site Number : 8400164
state: Massachusetts
city: Wellesley
country: United States
facility: The Elliot Lewis Center- Site Number : 8400033
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School- Site Number : 8400028
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital- Site Number : 8400091
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders- Site Number : 8400004
state: Michigan
city: Grand Rapids
country: United States
facility: Trinity Health Grand Rapids- Site Number : 8400150
state: Michigan
city: Owosso
country: United States
facility: Memorial Healthcare Institute for Neuroscience- Site Number : 8400123
state: Michigan
city: Rochester Hills
country: United States
facility: Rochester Medical Group- Site Number : 8400172
state: Michigan
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400077
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota - Department of Neurology- Site Number : 8400056
state: Minnesota
city: Plymouth
country: United States
facility: Minnesota Center for Multiple Sclerosis- Site Number : 8400073
state: Minnesota
city: Ozark
country: United States
facility: Sharlin Health & Neurology- Site Number : 8400016
state: Missouri
city: Saint Louis
country: United States
facility: Washington University- Site Number : 8400076
state: Missouri
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center- Site Number : 8400066
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center - Lebanon - 1 Medical Center Drive- Site Number : 8400098
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers University- Site Number : 8400067
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center- Site Number : 8400101
state: New Jersey
city: Albuquerque
country: United States
facility: The University of New Mexico- Site Number : 8400090
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst- Site Number : 8400129
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - New York- Site Number : 8400088
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai- Site Number : 8400011
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University- Site Number : 8400094
state: New York
city: Charlotte
country: United States
facility: Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates- Site Number : 8400014
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist - Digestive Health Services - Shepherd- Site Number : 8400040
state: North Carolina
city: Fargo
country: United States
facility: Sanford Neuroscience Clinic- Site Number : 8400085
state: North Dakota
city: Cincinnati
country: United States
facility: Riverhills Neuroscience- Site Number : 8400007
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati - Internal Medicine- Site Number : 8400117
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute- Site Number : 8400009
state: Ohio
city: Columbus
country: United States
facility: The Boster Center for Multiple Sclerosis- Site Number : 8400006
state: Ohio
city: Dayton
country: United States
facility: Medical Center at Elizabeth Place- Site Number : 8400008
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation- Site Number : 8400039
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent's Medical Center- Site Number : 8400052
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital- Site Number : 8400035
state: Pennsylvania
city: Greer
country: United States
facility: Premier Neurology- Site Number : 8400047
state: South Carolina
city: Knoxville
country: United States
facility: Hope Neurology- Site Number : 8400019
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Multiple Sclerosis Center- Site Number : 8400130
state: Tennessee
city: Dallas
country: United States
facility: Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152
state: Texas
city: Plano
country: United States
facility: North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio- Site Number : 8400099
state: Texas
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center- Site Number : 8400042
state: Vermont
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8400109
state: Virginia
city: Newport News
country: United States
facility: Riverside Neurology Specialists - Newport News- Site Number : 8400132
state: Virginia
city: Vienna
country: United States
facility: Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8400128
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center- Site Number : 8400078
state: Washington
city: Morgantown
country: United States
facility: West Virginia University School of Medicine- Site Number : 8400131
state: West Virginia
city: Milwaukee
country: United States
facility: Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038
state: Wisconsin
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 : 0320007
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Saint Leonards
country: Australia
facility: Investigational Site Number : 0360005
state: New South Wales
city: Woolloongabba
country: Australia
facility: Investigational Site Number : 0360001
state: Queensland
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360002
state: Victoria
city: Brussels
country: Belgium
facility: Investigational Site Number : 0560008
city: Kortrijk
country: Belgium
facility: Investigational Site Number : 0560007
city: Melsbroek
country: Belgium
facility: Investigational Site Number : 0560003
city: Overpelt
country: Belgium
facility: Investigational Site Number : 0560005
city: Brasília
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003
state: Distrito Federal
city: Goiânia
country: Brazil
facility: Universidade Federal de Goias- Site Number : 0760024
state: Goiás
city: Belo Horizonte
country: Brazil
facility: Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760025
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento- Site Number : 0760005
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Clínica Neurológica- Site Number : 0760007
state: Santa Catarina
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica - São Paulo- Site Number : 0760002
city: São Paulo
country: Brazil
facility: PSEG Centro de Pesquisa Clínica- Site Number : 0760021
city: São Paulo
country: Brazil
facility: Jordy Sinapse- Site Number : 0760004
city: Blagoevgrad
country: Bulgaria
facility: Investigational Site Number : 1000009
city: Panagyurishte
country: Bulgaria
facility: Investigational Site Number : 1000008
city: Pazardzhik
country: Bulgaria
facility: Investigational Site Number : 1000007
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1000002
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1000010
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000004
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 : 1000005
city: Calgary
country: Canada
facility: Investigational Site Number : 1240011
state: Alberta
city: Burnaby
country: Canada
facility: Investigational Site Number : 1240005
state: British Columbia
city: Vancouver
country: Canada
facility: Investigational Site Number : 1240010
state: British Columbia
city: North York
country: Canada
facility: Investigational Site Number : 1240015
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site Number : 1240002
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240012
state: Ontario
city: Gatineau
country: Canada
facility: Investigational Site Number : 1240001
state: Quebec
city: Lévis
country: Canada
facility: Investigational Site Number : 1240008
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number : 1240009
state: Quebec
city: Pointe-claire
country: Canada
facility: Investigational Site Number : 1240016
state: Quebec
city: Québec City
country: Canada
facility: Investigational Site Number : 1240003
state: Quebec
city: Sherbrooke
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
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 : 1560007
city: Beijing
country: China
facility: Investigational Site Number : 1560005
city: Beijing
country: China
facility: Investigational Site Number : 1560008
city: Changchun
country: China
facility: Investigational Site Number : 1560003
city: Changsha
country: China
facility: Investigational Site Number : 1560011
city: Chengdu
country: China
facility: Investigational Site Number : 1560004
city: Guangzhou
country: China
facility: Investigational Site Number : 1560002
city: Harbin
country: China
facility: Investigational Site Number : 1561027
city: Jiazhuang
country: China
facility: Investigational Site Number : 1560010
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Taiyuan
country: China
facility: Investigational Site Number : 1560006
city: Tianjin
country: China
facility: Investigational Site Number : 1560012
city: Wuhan
country: China
facility: Investigational Site Number : 1560009
city: Xi An
country: China
facility: Investigational Site Number : 1560013
city: Zhengzhou
country: China
facility: Investigational Site Number : 1560034
city: Brno
country: Czechia
facility: Investigational Site Number : 2030011
city: Brno
country: Czechia
facility: Investigational Site Number : 2030005
city: Hradec Králové
country: Czechia
facility: Investigational Site Number : 2030002
city: Jihlava
country: Czechia
facility: Investigational Site Number : 2030006
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2030007
city: Prague
country: Czechia
facility: Investigational Site Number : 2030003
city: Prague
country: Czechia
facility: Investigational Site Number : 2030004
city: Prague
country: Czechia
facility: Investigational Site Number : 2030008
city: Teplice
country: Czechia
facility: Investigational Site Number : 2030009
city: Zlín
country: Czechia
facility: Investigational Site Number : 2030001
city: Bron
country: France
facility: Investigational Site Number : 2500011
city: Créteil
country: France
facility: Investigational Site Number : 2500005
city: La Tronche
country: France
facility: Investigational Site Number : 2500006
city: Lille
country: France
facility: Investigational Site Number : 2500009
city: Montpellier
country: France
facility: Investigational Site Number : 2500015
city: Nice
country: France
facility: Investigational Site Number : 2500002
city: Paris
country: France
facility: Investigational Site Number : 2500007
city: Paris
country: France
facility: Investigational Site Number : 2500014
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: Bielefeld
country: Germany
facility: Investigational Site Number : 2760009
city: Bochum
country: Germany
facility: Investigational Site Number : 2760010
city: Düsseldorf
country: Germany
facility: Investigational Site Number : 2760002
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760003
city: Münster
country: Germany
facility: Investigational Site Number : 2760006
city: ULM
country: Germany
facility: Investigational Site Number : 2760001
city: Athens
country: Greece
facility: Investigational Site Number : 3000003
city: Athens
country: Greece
facility: Investigational Site Number : 3000005
city: Ioannina
country: Greece
facility: Investigational Site Number : 3000004
city: Larissa
country: Greece
facility: Investigational Site Number : 3000001
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480003
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480004
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480006
city: Gyor
country: Hungary
facility: Investigational Site Number : 3480002
city: Hyderabad
country: India
facility: Investigational Site Number : 3560008
city: Florence
country: Italy
facility: Investigational Site Number : 3800004
state: Firenze
city: Genoa
country: Italy
facility: Investigational Site Number : 3800011
state: Genova
city: Pozzilli
country: Italy
facility: Investigational Site Number : 3800008
state: Isernia
city: Milan
country: Italy
facility: Investigational Site Number : 3800002
state: Milano
city: Milan
country: Italy
facility: Investigational Site Number : 3800016
state: Milano
city: Naples
country: Italy
facility: Investigational Site Number : 3800010
state: Napoli
city: Cefalù
country: Italy
facility: Investigational Site Number : 3800006
state: Palermo
city: Rome
country: Italy
facility: Investigational Site Number : 3800015
state: Roma
city: Rome
country: Italy
facility: Investigational Site Number : 3800001
state: Roma
city: Rome
country: Italy
facility: Investigational Site Number : 3800013
state: Roma
city: Rome
country: Italy
facility: Investigational Site Number : 3800021
state: Roma
city: Bologna
country: Italy
facility: Investigational Site Number : 3800009
city: Chieti
country: Italy
facility: Investigational Site Number : 3800014
city: Ferrara
country: Italy
facility: Investigational Site Number : 3800025
city: Foggia
country: Italy
facility: Investigational Site Number : 3800019
city: Palermo
country: Italy
facility: Investigational Site Number : 3800017
city: Parma
country: Italy
facility: Investigational Site Number : 3800029
city: Pavia
country: Italy
facility: Investigational Site Number : 3800005
city: Ravenna
country: Italy
facility: Investigational Site Number : 3800030
city: Koriyama
country: Japan
facility: Investigational Site Number : 3920003
state: Fukushima
city: Asahikawa
country: Japan
facility: Investigational Site Number : 3920014
state: Hokkaido
city: Himeji
country: Japan
facility: Investigational Site Number : 3920007
state: Hyogo
city: Sagamihara
country: Japan
facility: Investigational Site Number : 3920010
state: Kanagawa
city: Higashimatsuyama
country: Japan
facility: Investigational Site Number : 3920015
state: Saitama
city: Kodaira
country: Japan
facility: Investigational Site Number : 3920016
state: Tokyo
city: Chiba
country: Japan
facility: Investigational Site Number : 3920002
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920001
city: Tokyo
country: Japan
facility: Investigational Site Number : 3920011
city: Tokyo
country: Japan
facility: Investigational Site Number : 3920012
city: Goyang-si
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Investigational Site Number : 4100007
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100004
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Seoul-teukbyeolsi
city: Rotterdam
country: Netherlands
facility: Investigational Site Number : 5280002
city: Sittard-geleen
country: Netherlands
facility: Investigational Site Number : 5280001
city: Krakow
country: Poland
facility: Investigational Site Number : 6160005
state: Malopolskie
city: Rzeszow
country: Poland
facility: Investigational Site Number : 6160006
state: Podkarpackie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160010
state: Slaskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160011
state: Slaskie
city: Plewiska
country: Poland
facility: Investigational Site Number : 6160002
state: Wielkopolskie
city: Poznan
country: Poland
facility: Investigational Site Number : 6160012
state: Wielkopolskie
city: Braga
country: Portugal
facility: Investigational Site Number : 6200001
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200011
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200007
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200006
city: Matosinhos
country: Portugal
facility: Investigational Site Number : 6200002
city: Guaynabo
country: Puerto Rico
facility: San Juan MS Center- Site Number : 8400106
city: Murcia
country: Spain
facility: Investigational Site Number : 7240018
state: Almería
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240016
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240010
state: Barcelona [Barcelona]
city: L'hospitalet de Llobregat
country: Spain
facility: Investigational Site Number : 7240011
state: Catalunya [Cataluña]
city: Donostia-san Sebastian
country: Spain
facility: Investigational Site Number : 7240012
state: Gipuzkoa
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigational Site Number : 7240013
state: Las Palmas
city: Lleida
country: Spain
facility: Investigational Site Number : 7240015
state: Lleida [Lérida]
city: Majadahonda
country: Spain
facility: Investigational Site Number : 7240017
state: Madrid
city: Pozuelo de Alarcón
country: Spain
facility: Investigational Site Number : 7240001
state: Madrid
city: Barakaldo
country: Spain
facility: Investigational Site Number : 7240009
state: Pais Vasco
city: Pontevedra
country: Spain
facility: Investigational Site Number : 7240014
state: Pontevedra [Pontevedra]
city: Seville
country: Spain
facility: Investigational Site Number : 7240007
state: Sevilla
city: Córdoba
country: Spain
facility: Investigational Site Number : 7240004
city: Madrid
country: Spain
facility: Investigational Site Number : 7240002
city: Madrid
country: Spain
facility: Investigational Site Number : 7240003
city: Málaga
country: Spain
facility: Investigational Site Number : 7240005
city: Valencia
country: Spain
facility: Investigational Site Number : 7240008
city: Gothenburg
country: Sweden
facility: Investigational Site Number : 7520001
city: Huddinge
country: Sweden
facility: Investigational Site Number : 7520005
city: Malmö
country: Sweden
facility: Investigational Site Number : 7520003
city: Stockholm
country: Sweden
facility: Investigational Site Number : 7520002
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7920006
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920018
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920011
city: Bursa
country: Turkey
facility: Investigational Site Number : 7920020
city: Bursa
country: Turkey
facility: Investigational Site Number : 7920013
city: Eskişehir
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920012
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920002
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920016
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920009
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920007
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920019
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920008
city: Izmit
country: Turkey
facility: Investigational Site Number : 7920001
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920014
city: Konya
country: Turkey
facility: Investigational Site Number : 7920015
city: Samsun
country: Turkey
facility: Investigational Site Number : 7920004
city: Sultangazi
country: Turkey
facility: Investigational Site Number : 7920003
city: VAN
country: Turkey
facility: Investigational Site Number : 7920017
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number : 8040001
city: Ivano-frankivsk
country: Ukraine
facility: Investigational Site Number : 8040009
city: Krykhivtsi
country: Ukraine
facility: Investigational Site Number : 8040003
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040006
city: Lutsk
country: Ukraine
facility: Investigational Site Number : 8040008
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8040004
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8040002
city: Vinnytsia
country: Ukraine
facility: Investigational Site Number : 8040005
city: Gwent
country: United Kingdom
facility: Investigational Site Number : 8260011
state: Blaenau Gwent
city: Cardiff
country: United Kingdom
facility: Investigational Site Number : 8260007
state: Cardiff [Caerdydd Gb-crd]
city: Exeter
country: United Kingdom
facility: Investigational Site Number : 8260001
state: Devon
city: London
country: United Kingdom
facility: Investigational Site Number : 8260013
state: England
city: Newcastle Upon Tyne
country: United Kingdom
facility: Investigational Site Number : 8260006
state: England
city: Canterbury
country: United Kingdom
facility: Investigational Site Number : 8260003
state: Kent
city: Salford
country: United Kingdom
facility: Investigational Site Number : 8260008
state: Manchester
city: Oxford
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Oxfordshire
city: Swansea
country: United Kingdom
facility: Investigational Site Number : 8260005
state: Swansea [Abertawe Gb-ata]
city: Inverness
country: United Kingdom
facility: Investigational Site Number : 8260010
city: Liverpool
country: United Kingdom
facility: Investigational Site Number : 8260009
Study officials:
References: