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RECRUITING

NCT06141473

PHASE3

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Sponsor: Sanofi

View on ClinicalTrials.gov

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 depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * 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.

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2023-12-13

Completion Date

2027-05-06

Last Updated

2026-03-05

Healthy Volunteers

Conditions

Multiple Sclerosis

Interventions

DRUG

Frexalimab

SAR441344 Solution for IV infusion

DRUG

Teriflunomide

Aubagio oral tablet

DRUG

Placebo infusion

Solution for IV infusion

DRUG

Placebo tablet

Oral tablet

DRUG

MRI contrast-enhancing agents

IV, as per respective label

DRUG

Cholestyramine

oral, 8 g 3 times daily for 11 days for accelerated elimination procedure (4 g 3 times daily for 11 days in case of intolerance). The teriflunomide local label should be followed.

DRUG

Activated charcoal

oral, 50 g every 12 hours for 11 days for accelerated elimination procedure. The teriflunomide local label should be followed.

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. * Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia. * 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.

Locations (386)

University of Alabama at Birmingham- Site Number : 8401135

Birmingham, Alabama, United States

North Central Neurology Associates- Site Number : 8401100

Cullman, Alabama, United States

Alabama Neurology Associates- Site Number : 8400115

Homewood, Alabama, United States

St. Joseph's Hospital and Medical Center- Site Number : 8401139

Phoenix, Arizona, United States

Perseverance Research Center- Site Number : 8401138

Scottsdale, Arizona, United States

Clinical Endpoints- Site Number : 8400050

Scottsdale, Arizona, United States

The Neurology Center of Southern California - Carlsbad- Site Number : 8400023

Carlsbad, California, United States

University of California Irvine - School of Medicine- Site Number : 8401143

Irvine, California, United States

Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122

Laguna Hills, California, United States

Chemidox Clinical Trials- Site Number : 8401157

Lancaster, California, United States

Hoag Memorial Hospital Presbyterian- Site Number : 8401031

Newport Beach, California, United States

Private Practice - Dr. Regina Berkovich- Site Number : 8400005

West Hollywood, California, United States

University of Colorado - Anschutz Medical Campus- Site Number : 8401001

Aurora, Colorado, United States

Advanced Neurology of Colorado- Site Number : 8401148

Fort Collins, Colorado, United States

Hartford Healthcare Medical Group- Site Number : 8401069

Norwich, Connecticut, United States

New England Institute for Clinical Research- Site Number : 8400114

Stamford, Connecticut, United States

MedStar Georgetown University Hospital- Site Number : 8400044

Washington D.C., District of Columbia, United States

Neurology of Central Florida- Site Number : 8401147

Altamonte Springs, Florida, United States

Neurology Offices of South Florida - Boca Raton- Site Number : 8401169

Boca Raton, Florida, United States

First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8401071

Boca Raton, Florida, United States

Nova Clinical Research - Bradenton- Site Number : 8400189

Bradenton, Florida, United States

Mayo Clinic in Florida- Site Number : 8401093

Jacksonville, Florida, United States

Neurology Associates - Maitland- Site Number : 8400010

Maitland, Florida, United States

University of Miami Hospital- Site Number : 8401177

Miami, Florida, United States

Design Neuroscience Center- Site Number : 8401191

Miami Lakes, Florida, United States

Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060

Orlando, Florida, United States

Axiom Clinical Research of Florida- Site Number : 8400049

Tampa, Florida, United States

University of South Florida- Site Number : 8400013

Tampa, Florida, United States

Palm Beach Neurology- Site Number : 8401105

West Palm Beach, Florida, United States

Velocity Clinical Research - Savannah Neurology- Site Number : 8400061

Savannah, Georgia, United States

Joi Life Wellness Group LLC- Site Number : 8401192

Smyrna, Georgia, United States

NorthShore Medical Group - Evanston- Site Number : 8401111

Evanston, Illinois, United States

Consultants in Neurology- Site Number : 8401020

Northbrook, Illinois, United States

Springfield Clinic 1st - 900 Building- Site Number : 8400043

Springfield, Illinois, United States

IU Health Physicians - Fort Wayne - Hope Drive- Site Number : 8400058

Fort Wayne, Indiana, United States

Neuroscience Institute Center- Site Number : 8400053

Merrillville, Indiana, United States

University of Iowa- Site Number : 8400029

Iowa City, Iowa, United States

University of Kansas Medical Center- Site Number : 8400084

Kansas City, Kansas, United States

KC Research Center- Site Number : 8400032

Roeland Park, Kansas, United States

Baptist Health Lexington- Site Number : 8401149

Lexington, Kentucky, United States

Norton Neurology Services- Site Number : 8401103

Louisville, Kentucky, United States

NeuroMedical Clinic of Central Louisiana- Site Number : 8401159

Alexandria, Louisiana, United States

The NeuroMedical Center- Site Number : 8401182

Baton Rouge, Louisiana, United States

Ochsner Medical Center - Jefferson Highway- Site Number : 8400027

New Orleans, Louisiana, United States

International Neurorehabilitation Institute- Site Number : 8400089

Lutherville, Maryland, United States

Boston Clinical Trials- Site Number : 8401178

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center - Boston- Site Number : 8401041

Boston, Massachusetts, United States

Neurology Center of New England- Site Number : 8401164

Foxborough, Massachusetts, United States

Henry Ford Hospital- Site Number : 8401091

Detroit, Michigan, United States

Michigan Institute for Neurological Disorders- Site Number : 8400004

Farmington Hills, Michigan, United States

Memorial Healthcare Institute for Neuroscience- Site Number : 8400123

Owosso, Michigan, United States

Rochester Medical Group- Site Number : 8401172

Rochester Hills, Michigan, United States

M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056

Minneapolis, Minnesota, United States

Minnesota Center for Multiple Sclerosis- Site Number : 8400073

Plymouth, Minnesota, United States

Sharlin Health and Neurology- Site Number : 8400016

Ozark, Missouri, United States

Washington University- Site Number : 8400076

St Louis, Missouri, United States

The MS Center for Innovations in Care- Site Number : 8401141

St Louis, Missouri, United States

Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045

Las Vegas, Nevada, United States

Renown Regional Medical Center- Site Number : 8400066

Reno, Nevada, United States

Rutgers University- Site Number : 8401067

New Brunswick, New Jersey, United States

The University of New Mexico- Site Number : 8401090

Albuquerque, New Mexico, United States

South Shore Neurologic Associates - Patchogue- Site Number : 8400063

Patchogue, New York, United States

Montefiore Medical Center - Einstein Campus- Site Number : 8401145

The Bronx, New York, United States

The Neurological Institute- Site Number : 8401166

Charlotte, North Carolina, United States

Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

Charlotte, North Carolina, United States

Raleigh Neurology Associates- Site Number : 8400014

Raleigh, North Carolina, United States

Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040

Winston-Salem, North Carolina, United States

Sanford Brain and Spine Center- Site Number : 8401085

Fargo, North Dakota, United States

Dayton Center for Neurological Disorders- Site Number : 8400079

Centerville, Ohio, United States

University of Cincinnati Medical Center- Site Number : 8401117

Cincinnati, Ohio, United States

The Ohio State University- Site Number : 8401009

Columbus, Ohio, United States

OhioHealth Riverside Methodist Hospital- Site Number : 8401092

Columbus, Ohio, United States

The Boster Center for Multiple Sclerosis- Site Number : 8400006

Columbus, Ohio, United States

UC Health - Elizabeth Place- Site Number : 8401008

Dayton, Ohio, United States

Oklahoma Medical Research Foundation- Site Number : 8400039

Oklahoma City, Oklahoma, United States

Providence St. Vincent's Medical Center- Site Number : 8400052

Portland, Oregon, United States

Oregon Neurology Associates- Site Number : 8400188

Springfield, Oregon, United States

Abington Neurological Associates- Site Number : 8401065

Abington, Pennsylvania, United States

Penn State Health Milton South Hershey Medical Center- Site Number : 8401176

Hershey, Pennsylvania, United States

Thomas Jefferson University Hospital- Site Number : 8400035

Philadelphia, Pennsylvania, United States

Allegheny General Hospital- Site Number : 8401173

Pittsburgh, Pennsylvania, United States

UPMC Magee-Womens Hospital- Site Number : 8401133

Pittsburgh, Pennsylvania, United States

Premier Neurology- Site Number : 8401047

Greer, South Carolina, United States

Hope Neurology- Site Number : 8400019

Knoxville, Tennessee, United States

Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152

Dallas, Texas, United States

ANESC Research- Site Number : 8400187

El Paso, Texas, United States

Baylor College of Medicine Medical Center- Site Number : 8401170

Houston, Texas, United States

North Texas Institute of Neurology & Headache - Plano- Site Number : 8401083

Plano, Texas, United States

UT Health - San Antonio- Site Number : 8401167

San Antonio, Texas, United States

Neurology Center of San Antonio- Site Number : 8400099

San Antonio, Texas, United States

Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018

Sherman, Texas, United States

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8401109

Fairfax, Virginia, United States

Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8401128

Vienna, Virginia, United States

Sentara Family Medicine Physicians - Virginia Beach - Glenn Mitchell Drive- Site Number : 8401168

Virginia Beach, Virginia, United States

Swedish Medical Center - Seattle- Site Number : 8400078

Seattle, Washington, United States

University of Washington Medical Center - Northwest- Site Number : 8401146

Seattle, Washington, United States

MultiCare Tacoma General Hospital- Site Number : 8401140

Tacoma, Washington, United States

Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034

Milwaukee, Wisconsin, United States

Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038

Milwaukee, Wisconsin, United States

Investigational Site Number : 0320003

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320008

Buenos Aires, Argentina

Investigational Site Number : 0321010

Buenos Aires, Argentina

Investigational Site Number : 0320009

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0321011

Córdoba, Argentina

Investigational Site Number : 0400001

Innsbruck, Austria

Investigational Site Number : 0401002

Linz, Austria

Investigational Site Number : 0401003

Vienna, Austria

Investigational Site Number : 0560006

Ghent, Belgium

Investigational Site Number : 0560005

Overpelt, Belgium

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0761029

Vitória, Espírito Santo, Brazil

Centro de Pesquisas da Clínica IBIS- Site Number : 0761030

Salvador, Estado de Bahia, Brazil

Clinica AMO- Site Number : 0761017

Salvador, Estado de Bahia, Brazil

L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003

Brasília, Federal District, Brazil

Universidade Federal de Goias- Site Number : 0761024

Goiânia, Goiás, Brazil

Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0761025

Belo Horizonte, Minas Gerais, Brazil

Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0761001

Curitiba, Paraná, Brazil

Hospital Moinhos de Vento- Site Number : 0761005

Porto Alegre, Rio Grande do Sul, Brazil

IMV Pesquisa Neurológica- Site Number : 0761031

Porto Alegre, Rio Grande do Sul, Brazil

Instituto Ceos- Site Number : 0761028

Porto Alegre, Rio Grande do Sul, Brazil

InsCer - Instituto do Cérebro da PUCRS- Site Number : 0761009

Porto Alegre, Rio Grande do Sul, Brazil

Clínica Neurológica- Site Number : 0761007

Joinville, Santa Catarina, Brazil

Hospital E Maternidade Christovão Da Gama- Site Number : 0761022

Santo André, São Paulo, Brazil

CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0761002

São Paulo, Brazil

Centro de Pesquisas Clínicas - São Paulo- Site Number : 0761027

São Paulo, Brazil

PSEG Centro de Pesquisa Clínica- Site Number : 0761021

São Paulo, Brazil

Jordy Sinapse- Site Number : 0761004

São Paulo, Brazil

Investigational Site Number : 1000009

Blagoevgrad, Bulgaria

Investigational Site Number : 1001008

Panagyurishte, Bulgaria

Investigational Site Number : 1000007

Pazardzhik, Bulgaria

Investigational Site Number : 1000002

Pleven, Bulgaria

Investigational Site Number : 1001010

Pleven, Bulgaria

Investigational Site Number : 1000004

Sofia, Bulgaria

Investigational Site Number : 1001001

Sofia, Bulgaria

Investigational Site Number : 1001006

Sofia, Bulgaria

Investigational Site Number : 1000005

Sofia, Bulgaria

Investigational Site Number : 1000012

Sofia, Bulgaria

Investigational Site Number : 1240017

Edmonton, Alberta, Canada

Investigational Site Number : 1240010

Vancouver, British Columbia, Canada

Investigational Site Number : 1240014

London, Ontario, Canada

Investigational Site Number : 1240002

Ottawa, Ontario, Canada

Investigational Site Number : 1240001

Gatineau, Quebec, Canada

Investigational Site Number : 1240004

Granby, Quebec, Canada

Investigational Site Number : 1240008

Lévis, Quebec, Canada

Investigational Site Number : 1240003

Québec, Quebec, Canada

Investigational Site Number : 1521005

Las Condes, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1521001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1521003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560007

Beijing, China

Investigational Site Number : 1560005

Beijing, China

Investigational Site Number : 1560008

Beijing, China

Investigational Site Number : 1560003

Changchun, China

Investigational Site Number : 1560011

Changsha, China

Investigational Site Number : 1560004

Chengdu, China

Investigational Site Number : 1561029

Chengdu, China

Investigational Site Number : 1560015

Chongqing, China

Investigational Site Number : 1560020

Dongguan, China

Investigational Site Number : 1561028

Fuzhou, China

Investigational Site Number : 1561026

Guangzhou, China

Investigational Site Number : 1560002

Guangzhou, China

Investigational Site Number : 1561023

Hangzhou, China

Investigational Site Number : 1561027

Harbin, China

Investigational Site Number : 1560019

Hohhot, China

Investigational Site Number : 1560040

Hohhot, China

Investigational Site Number : 1560010

Jiazhuang, China

Investigational Site Number : 1561025

Jinan, China

Investigational Site Number : 1560018

Nanjing, China

Investigational Site Number : 1560001

Shanghai, China

Investigational Site Number : 1560043

Shanghai, China

Investigational Site Number : 1560014

Shenyang, China

Investigational Site Number : 1560030

Suzhou, China

Investigational Site Number : 1560006

Taiyuan, China

Investigational Site Number : 1560012

Tianjin, China

Investigational Site Number : 1560016

Wenzhou, China

Investigational Site Number : 1560009

Wuhan, China

Investigational Site Number : 1560013

Xi'an, China

Investigational Site Number : 1560021

Yinchuan, China

Investigational Site Number : 1911001

Zagreb, Croatia

Investigational Site Number : 2031011

Brno, Czechia

Investigational Site Number : 2030005

Brno, Czechia

Investigational Site Number : 2030002

Hradec Králové, Czechia

Investigational Site Number : 2030006

Jihlava, Czechia

Investigational Site Number : 2031007

Ostrava, Czechia

Investigational Site Number : 2030010

Pardubice, Czechia

Investigational Site Number : 2031003

Prague, Czechia

Investigational Site Number : 2031004

Prague, Czechia

Investigational Site Number : 2031008

Prague, Czechia

Investigational Site Number : 2031009

Teplice, Czechia

Investigational Site Number : 2030001

Zlín, Czechia

Investigational Site Number : 2081002

Esbjerg, Denmark

Investigational Site Number : 2081001

Glostrup Municipality, Denmark

Investigational Site Number : 2501017

Calais, France

Investigational Site Number : 2501018

Colmar, France

Investigational Site Number : 2501006

La Tronche, France

Investigational Site Number : 2501009

Lille, France

Investigational Site Number : 2501002

Nice, France

Investigational Site Number : 2501010

Saint-Herblain, France

Investigational Site Number : 2761009

Bielefeld, Germany

Investigational Site Number : 2760010

Bochum, Germany

Investigational Site Number : 2761016

Böblingen, Germany

Investigational Site Number : 2760012

Dresden, Germany

Investigational Site Number : 2760002

Düsseldorf, Germany

Investigational Site Number : 2761013

Erbach im Odenwald, Germany

Investigational Site Number : 2761011

Essen, Germany

Investigational Site Number : 2761017

Giessen, Germany

Investigational Site Number : 2761014

Heidelberg, Germany

Investigational Site Number : 2761007

Jena, Germany

Investigational Site Number : 2760003

Leipzig, Germany

Investigational Site Number : 2761008

Marburg, Germany

Investigational Site Number : 2761006

Münster, Germany

Investigational Site Number : 2760001

Ulm, Germany

Investigational Site Number : 3001005

Athens, Greece

Investigational Site Number : 3000004

Ioannina, Greece

Investigational Site Number : 3001001

Larissa, Greece

Investigational Site Number : 3000002

Thessaloniki, Greece

Investigational Site Number : 3001006

Thessaloniki, Greece

Investigational Site Number : 3441001

Shatin, Hong Kong

Investigational Site Number : 3481003

Budapest, Hungary

Investigational Site Number : 3481004

Budapest, Hungary

Investigational Site Number : 3480002

Győr, Hungary

Investigational Site Number : 3480001

Kaposvár, Hungary

Investigational Site Number : 3481005

Pécs, Hungary

Investigational Site Number : 3561024

Bengaluru, India

Investigational Site Number : 3560002

Chandigarh, India

Investigational Site Number : 3561008

Hyderabad, India

Investigational Site Number : 3560020

Kochi, India

Investigational Site Number : 3560010

Nagpur, India

Investigational Site Number : 3561005

Nashik, India

Investigational Site Number : 3560017

New Delhi, India

Investigational Site Number : 3561023

New Delhi, India

Investigational Site Number : 3561006

Shimla, India

Investigational Site Number : 3561004

Thiruvananthapuram, India

Investigational Site Number : 3760001

Haifa, Israel

Investigational Site Number : 3760003

Ramat Gan, Israel

Investigational Site Number : 3760002

Safed, Israel

Centro Sclerosi Multipla UO Neurologia Universitaria, Dipartimento di Neuroscienze, AOU S.Anna-Site Number : 3801025

Cona, Ferrara, Italy

AOU CAREGGI-Site Number : 3800004

Florence, Firenze, Italy

Investigational Site Number : 3801011

Genoa, Genova, Italy

Investigational Site Number : 3800002

Milan, Milano, Italy

Investigational Site Number : 3800016

Milan, Milano, Italy

Investigational Site Number : 3800032

Monza, Monza E Brianza, Italy

A.O.U. Università degli studi della Campania Luigi Vanvitelli, II Clinica Neurologica-Site Number : 3801010

Naples, Napoli, Italy

Investigational Site Number : 3800015

Rome, Roma, Italy

Investigational Site Number : 3800001

Rome, Roma, Italy

Investigational Site Number : 3801013

Rome, Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800021

Rome, Roma, Italy

AOU S. Luigi Gonzaga-Site Number : 3801024

Orbassano, Torino, Italy

Investigational Site Number : 3801012

Catania, Italy

Investigational Site Number : 3800014

Chieti, Italy

Ospedale Valduce-Site Number : 3800033

Como, Italy

Policlinico "Riuniti" di Foggia-Site Number : 3800019

Foggia, Italy

A.O.U di Modena - Centro Sclerosi Multipla, Ospedale Civile di Baggiovara-Site Number : 3801028

Modena, Italy

AOU maggiore della carità di Novara-Site Number : 3801026

Novara, Italy

Investigational Site Number : 3801022

Palermo, Italy

Policlinico "P.Giaccone"U.O.C. di Neurologia - Centro Sclerosi Multipla-Site Number : 3800017

Palermo, Italy

Investigational Site Number : 3801029

Parma, Italy

Investigational Site Number : 3801005

Pavia, Italy

Investigational Site Number : 3801030

Ravenna, Italy

Investigational Site Number : 3801031

Udine, Italy

Investigational Site Number : 3800020

Verona, Italy

Investigational Site Number : 3920003

Kōriyama, Fukushima, Japan

Investigational Site Number : 3920014

Asahikawa, Hokkaido, Japan

Investigational Site Number : 3920006

Asahikawa, Hokkaido, Japan

Investigational Site Number : 3920017

Sapporo, Hokkaido, Japan

Investigational Site Number : 3800008

Joyo-Shi, Isernia, Japan

Investigational Site Number : 3920008

Yahaba, Iwate, Japan

Investigational Site Number : 3920010

Sagamihara, Kanagawa, Japan

Investigational Site Number : 3920015

Higashi-Matsuyama, Saitama, Japan

Investigational Site Number : 3920016

Kodaira, Tokyo, Japan

Investigational Site Number : 3920009

Tachikawa, Tokyo, Japan

Investigational Site Number : 3920002

Chiba, Japan

Investigational Site Number : 3920013

Fukuoka, Japan

Investigational Site Number : 3920001

Kyoto, Japan

Investigational Site Number : 3920011

Tokyo, Japan

Investigational Site Number : 3920004

Tokyo, Japan

Investigational Site Number : 3920012

Tokyo, Japan

Investigational Site Number : 4401001

Vilnius, Lithuania

Investigational Site Number : 4581001

Kuala Lumpur, Malaysia

Investigational Site Number : 4841007

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4841009

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840002

Monterrey, Nuevo León, Mexico

Investigational Site Number : 4841005

Culiacán, Sinaloa, Mexico

Investigational Site Number : 4840011

Mérida, Yucatán, Mexico

Investigational Site Number : 4841003

Tlalnepantla, Mexico

Investigational Site Number : 4840001

Veracruz, Mexico

Investigational Site Number : 6160002

Plewiska, Greater Poland Voivodeship, Poland

Investigational Site Number : 6160018

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Investigational Site Number : 6161005

Krakow, Lesser Poland Voivodeship, Poland

Investigational Site Number : 6161017

Lublin, Lublin Voivodeship, Poland

Investigational Site Number : 6161008

Lodz, Lódzkie, Poland

Investigational Site Number : 6161016

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160006

Rzeszów, Podkarpackie Voivodeship, Poland

Investigational Site Number : 6161010

Katowice, Silesian Voivodeship, Poland

Investigational Site Number : 6160019

Katowice, Silesian Voivodeship, Poland

Investigational Site Number : 6161011

Katowice, Silesian Voivodeship, Poland

Investigational Site Number : 6160004

Zabrze, Silesian Voivodeship, Poland

Investigational Site Number : 6160020

Żory, Silesian Voivodeship, Poland

Investigational Site Number : 6161014

Krakow, Poland

Investigational Site Number : 6161015

Kielce, Świętokrzyskie Voivodeship, Poland

Investigational Site Number : 6200001

Braga, Portugal

Investigational Site Number : 6201005

Coimbra, Portugal

Investigational Site Number : 6200009

Guimarães, Portugal

Investigational Site Number : 6201011

Lisbon, Portugal

Investigational Site Number : 6201012

Lisbon, Portugal

Investigational Site Number : 6200002

Matosinhos Municipality, Portugal

San Juan MS Center- Site Number : 8401106

Guaynabo, Puerto Rico

Investigational Site Number : 6421004

Bucharest, Romania

Investigational Site Number : 6420002

Campulung Muscel, Romania

Investigational Site Number : 6421001

Constanța, Romania

Investigational Site Number : 6820001

Riyadh, Saudi Arabia

Investigational Site Number : 6820002

Riyadh, Saudi Arabia

Investigational Site Number : 7021001

Singapore, Singapore

Investigational Site Number : 7031001

Bratislava, Slovakia

Investigational Site Number : 7030007

Martin, Slovakia

Investigational Site Number : 7030004

Nitra, Slovakia

Investigational Site Number : 7030003

Trnava, Slovakia

Investigational Site Number : 7101002

Cape Town, South Africa

Investigational Site Number : 7101001

Pretoria, South Africa

Investigational Site Number : 4100001

Goyang-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100007

Seongnam-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100006