Clinical trial NCT06141473: Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Official title: Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of 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: 1400
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: The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis 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 have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized.
* The study intervention duration will vary ranging from approximately 12 to 40 months.
* The assessment of scheduled visits will include 1 common end of study \[EOS\] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.


Eligibility criteria: Inclusion Criteria:

* The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
* The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)
* The participant must have at least 1 of the following prior to screening:

  * ≥1 documented relapse within the previous year OR
  * ≥2 documented relapses within the previous 2 years, OR
  * ≥1 documented Gd enhancing lesion on an MRI scan within the previous year.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic 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 had a relapse in the 30 days prior to randomization.
* The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.

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

Primary outcomes:
measure: Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses
timeFrame: Until Week 156
Secondary outcomes:
measure: Time to onset of composite confirmed disability worsening (cCDW)
timeFrame: Until Week 156
measure: Time to onset of cCDW, confirmed over 3 months
timeFrame: Until Week 156
measure: Time to onset of individual components of the composite, confirmed over 3-months or 6-months
timeFrame: Until Week 156
measure: Time to onset of confirmed disability improvement (CDI)
timeFrame: Until Week 156
measure: Progression independent of relapse activity defined as the time to onset of 6-month cCDW
timeFrame: Until Week 156
measure: Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI
timeFrame: Until Week 156
measure: Total number of new Gd-enhancing T1hyperintense lesions per scan as detected by MRI
timeFrame: Until Week 156
measure: Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6
timeFrame: From Week 24 to Week 156
measure: Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT)
timeFrame: From baseline to Week 156
measure: Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time
timeFrame: From baseline to Week 156
measure: Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time
timeFrame: Until Week 156
measure: Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs and safety scales during the study period
timeFrame: Until Week 168
measure: Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period
timeFrame: Until Week 168
measure: Number of participants with antidrug (ADAs) over time
timeFrame: Until Week 156
measure: Change from baseline in plasma neurofilament light chain (NfL) levels over time
timeFrame: Until Week 144
measure: Frexalimab plasma concentration over time
timeFrame: Until Week 144
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Neurology Associates- Site Number : 8400115
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham- Site Number : 8401135
state: Alabama
city: Cullman
country: United States
facility: North Central Neurology Associates- Site Number : 8401100
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center- Site Number : 8401139
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center- Site Number : 8401138
state: Arizona
city: Scottsdale
country: United States
facility: Clinical Endpoints- Site Number : 8400050
state: Arizona
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 : 8401143
state: California
city: Laguna Hills
country: United States
facility: Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122
state: California
city: Lancaster
country: United States
facility: Chemidox Clinical Trials- Site Number : 8401157
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 : 8401001
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurology of Colorado- Site Number : 8401148
state: Colorado
city: Norwich
country: United States
facility: Hartford Healthcare Medical Group- Site Number : 8401069
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 : 8401147
state: Florida
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida - Boca Raton- Site Number : 8401169
state: Florida
city: Boca Raton
country: United States
facility: First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital Jacksonville- Site Number : 8401093
state: Florida
city: Maitland
country: United States
facility: Neurology Associates - Maitland- Site Number : 8400010
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 : 8401105
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research - Savannah Neurology- Site Number : 8400061
state: Georgia
city: Evanston
country: United States
facility: NorthShore Medical Group - Evanston- Site Number : 8401111
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology- Site Number : 8401020
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic 1st - 800 Building- Site Number : 8400043
state: Illinois
city: Fort Wayne
country: United States
facility: IU Health Physicians - Fort Wayne - Hope Drive- Site Number : 8400058
state: Indiana
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: Roeland Park
country: United States
facility: KC Research Center- Site Number : 8400032
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington- Site Number : 8401149
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute - St. Matthews- Site Number : 8401103
state: Kentucky
city: Alexandria
country: United States
facility: NeuroMedical Clinic of Central Louisiana- Site Number : 8401159
state: Louisiana
city: Baton Rouge
country: United States
facility: The NeuroMedical Center- Site Number : 8401182
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center - Jefferson Highway- Site Number : 8400027
state: Louisiana
city: Lutherville
country: United States
facility: International Neurorehabilitation Institute- Site Number : 8400089
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials- Site Number : 8401178
state: Massachusetts
city: Foxboro
country: United States
facility: Neurology Center of New England- Site Number : 8401164
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital- Site Number : 8401091
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 : 8401172
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - East Bank- 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: Saint Louis
country: United States
facility: The MS Center for Innovations in Care- Site Number : 8401141
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: New Brunswick
country: United States
facility: Rutgers University- Site Number : 8401067
state: New Jersey
city: Albuquerque
country: United States
facility: The University of New Mexico- Site Number : 8401090
state: New Mexico
city: Patchogue
country: United States
facility: South Shore Neurologic Associates - Patchogue- Site Number : 8400063
state: New York
city: Charlotte
country: United States
facility: The Neurological Institute- Site Number : 8401166
state: North Carolina
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 : 8401085
state: North Dakota
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders- Site Number : 8400079
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati - Internal Medicine- Site Number : 8401117
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 : 8401009
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital- Site Number : 8401092
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: University of Cincinnati- Site Number : 8401008
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: Abington
country: United States
facility: Abington Neurological Associates- Site Number : 8401065
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital- Site Number : 8400035
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital- Site Number : 8401173
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Magee - Womens Hospital- Site Number : 8401133
state: Pennsylvania
city: Greer
country: United States
facility: Premier Neurology- Site Number : 8401047
state: South Carolina
city: Knoxville
country: United States
facility: Hope Neurology- Site Number : 8400019
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 : 8401083
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: Fairfax
country: United States
facility: Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8401109
state: Virginia
city: Vienna
country: United States
facility: Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8401128
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center - Seattle- Site Number : 8400078
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center - Northwest- Site Number : 8401146
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation- Site Number : 8401140
state: Washington
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: Ciudad de Córdoba
country: Argentina
facility: Investigational Site Number : 0321011
state: Córdoba
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 : 0320008
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0321010
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320009
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Innsbruck
country: Austria
facility: Investigational Site Number : 0400001
city: Linz
country: Austria
facility: Investigational Site Number : 0401002
city: Vienna
country: Austria
facility: Investigational Site Number : 0401003
city: Gent
country: Belgium
facility: Investigational Site Number : 0560006
city: Overpelt
country: Belgium
facility: Investigational Site Number : 0560005
city: Salvador
country: Brazil
facility: Clinica AMO- Site Number : 0761017
state: Bahia
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 : 0761024
state: Goiás
city: Belo Horizonte
country: Brazil
facility: Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0761025
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0761001
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento- Site Number : 0761005
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: InsCer - Instituto do Cérebro da PUCRS- Site Number : 0761009
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Clínica Neurológica- Site Number : 0761007
state: Santa Catarina
city: Santo André
country: Brazil
facility: Hospital E Maternidade Christovão Da Gama- Site Number : 0761022
state: São Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica - São Paulo- Site Number : 0761002
city: São Paulo
country: Brazil
facility: PSEG Centro de Pesquisa Clínica- Site Number : 0761021
city: São Paulo
country: Brazil
facility: Jordy Sinapse- Site Number : 0761004
city: Blagoevgrad
country: Bulgaria
facility: Investigational Site Number : 1000009
city: Panagyurishte
country: Bulgaria
facility: Investigational Site Number : 1001008
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 : 1001010
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000004
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1001001
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1001006
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000005
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240017
state: Alberta
city: Vancouver
country: Canada
facility: Investigational Site Number : 1240010
state: British Columbia
city: St. Johns
country: Canada
facility: Investigational Site Number : 1240007
state: Newfoundland and Labrador
city: London
country: Canada
facility: Investigational Site Number : 1240014
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site Number : 1240002
state: Ontario
city: Gatineau
country: Canada
facility: Investigational Site Number : 1240001
state: Quebec
city: Granby
country: Canada
facility: Investigational Site Number : 1240004
state: Quebec
city: Lévis
country: Canada
facility: Investigational Site Number : 1240008
state: Quebec
city: Québec City
country: Canada
facility: Investigational Site Number : 1240003
state: Quebec
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1521001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1521003
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: Beijing
country: China
facility: Investigational Site Number : 1561024
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: Chengdu
country: China
facility: Investigational Site Number : 1561029
city: Chongqing
country: China
facility: Investigational Site Number : 1560015
city: Dongguan
country: China
facility: Investigational Site Number : 1560020
city: Fuzhou
country: China
facility: Investigational Site Number : 1561028
city: Guangzhou
country: China
facility: Investigational Site Number : 1561026
city: Guangzhou
country: China
facility: Investigational Site Number : 1560002
city: Hangzhou
country: China
facility: Investigational Site Number : 1561023
city: Harbin
country: China
facility: Investigational Site Number : 1561027
city: Hohhot
country: China
facility: Investigational Site Number : 1560019
city: Hohhot
country: China
facility: Investigational Site Number : 1560040
city: Jiazhuang
country: China
facility: Investigational Site Number : 1560010
city: Jinan
country: China
facility: Investigational Site Number : 1561025
city: Nanjing
country: China
facility: Investigational Site Number : 1560018
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Shenyang
country: China
facility: Investigational Site Number : 1560014
city: Suzhou
country: China
facility: Investigational Site Number : 1560030
city: Taiyuan
country: China
facility: Investigational Site Number : 1560006
city: Tianjin
country: China
facility: Investigational Site Number : 1560012
city: Wenzhou
country: China
facility: Investigational Site Number : 1560016
city: Wuhan
country: China
facility: Investigational Site Number : 1560009
city: Xi An
country: China
facility: Investigational Site Number : 1560013
city: Yinchuan
country: China
facility: Investigational Site Number : 1560021
city: Brno
country: Czechia
facility: Investigational Site Number : 2031011
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 : 2031007
city: Pardubice
country: Czechia
facility: Investigational Site Number : 2030010
city: Prague
country: Czechia
facility: Investigational Site Number : 2031003
city: Prague
country: Czechia
facility: Investigational Site Number : 2031004
city: Prague
country: Czechia
facility: Investigational Site Number : 2031008
city: Teplice
country: Czechia
facility: Investigational Site Number : 2031009
city: Zlín
country: Czechia
facility: Investigational Site Number : 2030001
city: Esbjerg
country: Denmark
facility: Investigational Site Number : 2081002
city: Glostrup
country: Denmark
facility: Investigational Site Number : 2081001
city: La Tronche
country: France
facility: Investigational Site Number : 2501006
city: Lille
country: France
facility: Investigational Site Number : 2501009
city: Nice
country: France
facility: Investigational Site Number : 2501002
city: Saint-herblain
country: France
facility: Investigational Site Number : 2501010
city: Bielefeld
country: Germany
facility: Investigational Site Number : 2761009
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 : 2761006
city: ULM
country: Germany
facility: Investigational Site Number : 2760001
city: Athens
country: Greece
facility: Investigational Site Number : 3001005
city: Ioannina
country: Greece
facility: Investigational Site Number : 3000004
city: Larissa
country: Greece
facility: Investigational Site Number : 3001001
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3001006
city: Budapest
country: Hungary
facility: Investigational Site Number : 3481003
city: Budapest
country: Hungary
facility: Investigational Site Number : 3481004
city: Győr
country: Hungary
facility: Investigational Site Number : 3480002
city: Kaposvár
country: Hungary
facility: Investigational Site Number : 3480001
city: Pécs
country: Hungary
facility: Investigational Site Number : 3481005
city: Hyderabad
country: India
facility: Investigational Site Number : 3561008
city: Haifa
country: Israel
facility: Investigational Site Number : 3760001
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760003
city: Safed
country: Israel
facility: Investigational Site Number : 3760002
city: Genoa
country: Italy
facility: Investigational Site Number : 3801011
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: 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 : 3801013
state: Roma
city: Rome
country: Italy
facility: Investigational Site Number : 3800021
state: Roma
city: Orbassano
country: Italy
facility: AOU S. Luigi Gonzaga-Site Number : 3801024
state: Torino
city: Catania
country: Italy
facility: Investigational Site Number : 3801012
city: Chieti
country: Italy
facility: Investigational Site Number : 3800014
city: Como
country: Italy
facility: Ospedale Valduce-Site Number : 3800033
city: Cuneo
country: Italy
facility: Investigational Site Number : 3801027
city: Ferrara
country: Italy
facility: Centro Sclerosi Multipla UO Neurologia Universitaria, Dipartimento di Neuroscienze, AOU S.Anna-Site Number : 3801025
city: Firenze
country: Italy
facility: AOU CAREGGI-Site Number : 3800004
city: Foggia
country: Italy
facility: Policlinico "Riuniti" di Foggia-Site Number : 3800019
city: Modena
country: Italy
facility: Investigational Site Number : 3801028
city: Napoli
country: Italy
facility: A.O.U. Università degli studi della Campania Luigi Vanvitelli, II Clinica Neurologica-Site Number : 3801010
city: Palermo
country: Italy
facility: Investigational Site Number : 3801022
city: Palermo
country: Italy
facility: Policlinico "P.Giaccone"U.O.C. di Neurologia - Centro Sclerosi Multipla-Site Number : 3800017
city: Parma
country: Italy
facility: Investigational Site Number : 3801029
city: Pavia
country: Italy
facility: Investigational Site Number : 3801005
city: Ravenna
country: Italy
facility: Investigational Site Number : 3801030
city: Udine
country: Italy
facility: Investigational Site Number : 3801031
city: Verona
country: Italy
facility: Investigational Site Number : 3800020
city: Koriyama
country: Japan
facility: Investigational Site Number : 3920003
state: Fukushima
city: Asahikawa
country: Japan
facility: Investigational Site Number : 3920014
state: Hokkaido
city: Asahikawa
country: Japan
facility: Investigational Site Number : 3920006
state: Hokkaido
city: Sapporo
country: Japan
facility: Investigational Site Number : 3920017
state: Hokkaido
city: Morioka
country: Japan
facility: Investigational Site Number : 3920008
state: Iwate
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: Tachikawa
country: Japan
facility: Investigational Site Number : 3920009
state: Tokyo
city: Chiba
country: Japan
facility: Investigational Site Number : 3920002
city: Fukuoka
country: Japan
facility: Investigational Site Number : 3920013
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 : 3920004
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 : 4100006
state: Seoul-teukbyeolsi
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: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100008
state: Seoul-teukbyeolsi
city: Vilnius
country: Lithuania
facility: Investigational Site Number : 4401001
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4841007
state: Jalisco
city: Culiacan
country: Mexico
facility: Investigational Site Number : 4841005
state: Sinaloa
city: Tlalnepantla de Baz
country: Mexico
facility: Investigational Site Number : 4841003
city: Heerlen
country: Netherlands
facility: Investigational Site Number : 5280001
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160018
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Investigational Site Number : 6161008
state: Lódzkie
city: Krakow
country: Poland
facility: Investigational Site Number : 6161005
state: Malopolskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6161010
state: Slaskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6161011
state: Slaskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160019
state: Slaskie
city: Zabrze
country: Poland
facility: Investigational Site Number : 6160004
state: Slaskie
city: Zory
country: Poland
facility: Investigational Site Number : 6160020
state: Slaskie
city: Kielce
country: Poland
facility: Investigational Site Number : 6161015
state: Swietokrzyskie
city: Plewiska
country: Poland
facility: Investigational Site Number : 6160002
state: Wielkopolskie
city: Krakow
country: Poland
facility: Investigational Site Number : 6161014
city: Lublin
country: Poland
facility: Investigational Site Number : 6161017
city: Warszawa
country: Poland
facility: Investigational Site Number : 6161016
city: Braga
country: Portugal
facility: Investigational Site Number : 6200001
city: Coimbra
country: Portugal
facility: Investigational Site Number : 6201005
city: Guimaraes
country: Portugal
facility: Investigational Site Number : 6200009
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6201011
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6201012
city: Matosinhos
country: Portugal
facility: Investigational Site Number : 6200002
city: Guaynabo
country: Puerto Rico
facility: San Juan MS Center- Site Number : 8401106
city: Bucharest
country: Romania
facility: Investigational Site Number : 6421004
city: Constanta
country: Romania
facility: Investigational Site Number : 6421001
city: Câmpulung
country: Romania
facility: Investigational Site Number : 6420002
city: Martin
country: Slovakia
facility: Investigational Site Number : 7030007
city: Nitra
country: Slovakia
facility: Investigational Site Number : 7030004
city: Trnava
country: Slovakia
facility: Investigational Site Number : 7030003
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7101002
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7101001
city: Murcia
country: Spain
facility: Investigational Site Number : 7240018
state: Almería
city: Barcelona
country: Spain
facility: Investigational Site Number : 7241016
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240010
state: Barcelona [Barcelona]
city: Donostia-san Sebastian
country: Spain
facility: Investigational Site Number : 7241012
state: Gipuzkoa
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigational Site Number : 7240013
state: Las Palmas
city: Pozuelo de Alarcón
country: Spain
facility: Investigational Site Number : 7240001
state: Madrid
city: Barakaldo
country: Spain
facility: Investigational Site Number : 7241009
state: Pais Vasco
city: Pontevedra
country: Spain
facility: Investigational Site Number : 7241014
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 : 7240006
city: Madrid
country: Spain
facility: Investigational Site Number : 7241023
city: Madrid
country: Spain
facility: Investigational Site Number : 7240002
city: Madrid
country: Spain
facility: Investigational Site Number : 7240003
city: Madrid
country: Spain
facility: Investigational Site Number : 7241022
city: Málaga
country: Spain
facility: Investigational Site Number : 7240005
city: Valencia
country: Spain
facility: Investigational Site Number : 7241008
city: Valladolid
country: Spain
facility: Investigational Site Number : 7240011
city: Bern
country: Switzerland
facility: Investigational Site Number : 7561001
city: Kaohsiung City
country: Taiwan
facility: Investigational Site Number : 1581001
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7921006
city: Ankara
country: Turkey
facility: Investigational Site Number : 7921018
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920011
city: Bursa
country: Turkey
facility: Investigational Site Number : 7921020
city: Bursa
country: Turkey
facility: Investigational Site Number : 7921013
city: Eskişehir
country: Turkey
facility: Investigational Site Number : 7921005
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 : 7921016
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7921009
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920007
city: Izmir
country: Turkey
facility: Investigational Site Number : 7921019
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 : 7921014
city: Konya
country: Turkey
facility: Investigational Site Number : 7920015
city: Samsun
country: Turkey
facility: Investigational Site Number : 7921004
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 : 8040007
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 : 8041003
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8041006
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 : 8041002
city: Vinnytsia
country: Ukraine
facility: Investigational Site Number : 8041005
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: Canterbury
country: United Kingdom
facility: Investigational Site Number : 8261003
state: Kent
city: Salford
country: United Kingdom
facility: Investigational Site Number : 8261008
state: Manchester
city: Inverness
country: United Kingdom
facility: Investigational Site Number : 8260010
Study officials:
References: