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NCT07184931PHASE3Recruiting

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Sanofi

Start Date

10/1/2025

Completion Date

5/14/2029

Summary

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Eligibility Criteria

Age Range: 16 years to 80 years

Inclusion Criteria: * Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development * Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline * Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs) Exclusion Criteria: * Participants with Ulcerative Colitis (UC) or indeterminate colitis * Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum * Prior or current high-grade gastrointestinal (GI) dysplasia * Participants on treatment with but not on stable doses of conventional therapy prior to baseline * Participants receiving prohibited medications or therapies * Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Interventions

DRUG

Duvakitug

DRUG

Placebo

Interested in This Trial?

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Conditions

Crohn's Disease

Locations

Onyx Clinical Research - Site Number:8400021

Peoria, Arizona 85381

United States

One of a Kind Clinical Research Center AZ, LLC-Site Number: 8400061

Scottsdale, Arizona 85258

United States

Scottsdale Clinical Trials-Site Number: 8400145

Scottsdale, Arizona 85260

United States

Del Sol Research Management, LLC-Site Number: 8400012

Tucson, Arizona 85715

United States

Preferred Research Partners-Site Number: 8400018

Little Rock, Arkansas 72211

United States

Alliance Research Institute-Site Number: 8400008

Canoga Park, California 91304

United States

Southern California GI & Liver Centers-Site Number: 8400062

Coronado, California 92118-1408

United States

Gastroenterology and Liver Institute - Escondido-Site Number: 8400146

Escondido, California 92025

United States

GMC Clinical Research, LLC-Site Number: 8400113

Folsom, California 95630

United States

Om Research, LLC - Lancaster-Site Number: 8400148

Lancaster, California 93534

United States

TLC Clinical Research Inc.-Site Number: 8400030

Los Angeles, California 90048

United States

GastroIntestinal Bioscience - Los Angeles-Site Number: 8400019

Los Angeles, California 90067

United States

United Medical Doctors CA-Site Number: 8400044

Murrieta, California 92563

United States

Om Research, LLC - Oxnard-Site Number: 8400150

Oxnard, California 93030

United States

Prospective Research Innovations Inc.-Site Number: 8400017

Rancho Cucamonga, California 91730

United States

UC Davis Health System-Site Number: 8400071

Sacramento, California 95817

United States

Clinical Applications Laboratories Inc-Site Number: 8400056

San Diego, California 92103

United States

Medical Associates Research Group-Site Number:8400063

San Diego, California 92123

United States

Valiance Clinical Research - Tarzana-Site Number: 8400023

Tarzana, California 91356

United States

Clinical Trials Management Services-Site Number: 8400047

Thousand Oaks, California 91360

United States

Amicis Research Center - Valencia-Site Number: 8400064

Valencia, California 91355

United States

Om Research, LLC - Victorville-Site Number: 8400022

Victorville, California 92395

United States

UCHealth Digestive Health Center - Anschutz Medical Campus-Site Number: 8400085

Aurora, Colorado 80045

United States

Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039

Colorado Springs, Colorado 80907

United States

Gastroenterology of the Rockies - Denver-Site Number: 8400122

Denver, Colorado 80218

United States

Yale University Digestive Disease-Site Number: 8400108

New Haven, Connecticut 06510

United States

Novum Research, LLC-Site Number: 8400003

Clermont, Florida 34711

United States

Sarkis Clinical Trials - Gainesville-Site Number: 8400048

Gainesville, Florida 32607

United States

Clinical Research of Osceola-Site Number: 8400013

Kissimmee, Florida 34741

United States

Columbus Clinical Services LLc-Site Number: 8400038

Miami, Florida 33125

United States

Regis Clinical Research, LLC-Site Number: 8400041

Miami, Florida 33126

United States

Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami-Site Number: 8400111

Miami, Florida 33136

United States

Medical Professional Clinical Research Center-Site Number: 8400119

Miami, Florida 33165

United States

Bioresearch Partner-Kendale Lakes-Site Number: 8400053

Miami, Florida 33175

United States

Paradisus Med Research-Site Number: 8400036

Miami, Florida 33185

United States

Correa Research Center-Site Number: 8400010

Miami, Florida 33186

United States

AdventHealth Orlando-Site Number: 8400070

Orlando, Florida 32803

United States

Orlando Health, Inc.-Site Number: 8400084

Orlando, Florida 32806

United States

Tropical Clinical Trials-Site Number: 8400082

Palmetto Bay, Florida 33176

United States

Precision Clinical Research - Sunrise-Site Number: 8400059

Sunrise, Florida 33351

United States

NMC Research LLC-Site Number: 8400033

Tampa, Florida 33607

United States

Atlanta Gastroenterology Associates-Site Number: 8400109

Atlanta, Georgia 30342

United States

M3 Wake Research - Atlanta-Site Number: 8400028

Sandy Springs, Georgia 30328

United States

EBGS Clinical Research Center, LLC-Site Number: 8400037

Snellville, Georgia 30078

United States

Atlanta Gastroenterology Specialists-Site Number: 8400149

Suwanee, Georgia 30024

United States

Grand Teton Research Group, PLLC-Site Number: 8400127

Idaho Falls, Idaho 83404

United States

Rush University Medical Center-Site Number: 8400015

Chicago, Illinois 60612

United States

Midwest Digestive Health and Nutrition-Site Number: 8400136

Des Plaines, Illinois 60016

United States

GI Alliance - Glenview-Site Number: 8400068

Glenview, Illinois 60026

United States

GI Alliance - Gurnee-Site Number: 8400049

Gurnee, Illinois 60031

United States

Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100

New Albany, Indiana 47150

United States

Heartland Medical Research, Inc.-Site Number: 8400134

Clive, Iowa 50325

United States

Digestive Health Research Center-Site Number: 8400096

Waterloo, Iowa 50701

United States

University of Kansas Medical Center-Site Number: 8400110

Kansas City, Kansas 66160

United States

University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058

Lexington, Kentucky 40536-0293

United States

GI Alliance - Baton Rouge-Site Number: 8400129

Baton Rouge, Louisiana 70809

United States

Tandem Intermediate, LLC - Houma-Site Number: 8400034

Houma, Louisiana 70360

United States

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128

Mandeville, Louisiana 70471

United States

Tandem Clinical Research - Marrero-Site Number: 8400002

Marrero, Louisiana 70072

United States

GI Alliance - Metairie-Site Number: 8400124

Metairie, Louisiana 70006

United States

Delta Research Partners-Site Number: 8400087

Monroe, Louisiana 71201

United States

Care Access - New Iberia-Site Number: 8400031

New Iberia, Louisiana 70560

United States

Mercy Medical Center, Baltimore-Site Number: 8400117

Baltimore, Maryland 21202

United States

Mid-Atlantic GI Research, LLC-Site Number: 8400106

Laurel, Maryland 20708

United States

Tufts Medical Center-Site Number: 8400126

Boston, Massachusetts 02111

United States

UMass Memorial Medical Center-Site Number: 8400121

Worcester, Massachusetts 01655

United States

Henry Ford Medical Center - Columbus-Site Number: 8400118

Novi, Michigan 48377

United States

Gastroenterology Associates of Western Michigan-Site Number: 8400060

Wyoming, Michigan 49519

United States

Allied Health Clinical Research Organization, LLC - Jackson-Site Number:8400007

Jackson, Mississippi 08527

United States

BVL Clinical Research-Site Number: 8400005

Liberty, Missouri 64068

United States

Washington University School of Medicine-Site Number: 8400075

St Louis, Missouri 63110

United States

Gateway Gastroenterology-Site Number: 8400097

St Louis, Missouri 63141

United States

Las Vegas Clinical Trials-Site Number: 8400079

Las Vegas, Nevada 89030

United States

Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123

East Orange, New Jersey 07018

United States

Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014

Freehold, New Jersey 07728

United States

Tandem-Allied Clinical Research - Somers Point-Site Number: 8400050

Somers Point, New Jersey 08244

United States

Premier Health Research, LLC-Site Number: 8400114

Sparta, New Jersey 07871

United States

MedTraits NY-Site Number: 8400045

Maspeth, New York 11378

United States

Manhattan Clinical Research, LLC-Site Number: 8400069

New York, New York 10016

United States

NYU Langone Health-Site Number: 8400091

New York, New York 10016

United States

Columbia University Medical Center-Site Number: 8400138

New York, New York 10032

United States

Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040

New York, New York 10065

United States

New York Gastroenterology Associates-Site Number: 8400009

New York, New York 10075

United States

Montefiore Medical Center - Bronx-Site Number: 8400142

The Bronx, New York 10467

United States

UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074

Chapel Hill, North Carolina 27514

United States

OnSite Clinical Solutions-Site Number: 8400051

Charlotte, North Carolina 28211

United States

Duke University Medical Center-Site Number: 8400093

Durham, North Carolina 27710

United States

Cross Creek Medical Clinic-Site Number: 8400057

Fayetteville, North Carolina 28304

United States

Monroe Biomedical Research-Site Number: 8400046

Monroe, North Carolina 28112

United States

ClinTrial Research, LLC-Site Number: 8400043

Raleigh, North Carolina 27612

United States

Plains Clinical Research Center-Site Number: 8400078

Fargo, North Dakota 58104

United States

Gastroenterology & Hepatology Specialists, Inc.-Site nUmber: 8400139

Canton, Ohio 44718

United States

University Hospitals Cleveland Medical Center-Site Number: 8400073

Cleveland, Ohio 44106-5077

United States

Ohio Gastroenterology Group Inc.-8400006

Columbus, Ohio 43202

United States

OSU Wexner Medical Center-Site Number: 8400077

Columbus, Ohio 43210

United States

DSI Research Northridge - Dayton-Site Number: 8400115

Dayton, Ohio 45414

United States

DSI Research - Springboro-Site Number: 8400105

Springboro, Ohio 45066

United States

University of Toledo Medical Center-Site Number: 8400042

Toledo, Ohio 43614

United States

North Shore Gastroenterology Research-Site Number: 8400130

Westlake, Ohio 44145

United States

Central Sooner Research-Site Number: 8400094

Norman, Oklahoma 73071

United States

Oregon Health & Science University-Site Number: 8400131

Portland, Oregon 97239

United States

Penn State Milton S. Hershey Medical Center-Site Number: 8400066

Hershey, Pennsylvania 17033-0850

United States

University of Pennsylvania School of Medicine-Site Number: 8400072

Philadelphia, Pennsylvania 19104-6243

United States

The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107

Pittsburgh, Pennsylvania 15212

United States

University Gastroenterology-Site Number: 8400103

Providence, Rhode Island 02904

United States

Johns Hopkins University Gastroenterology and Hepatology-Site Number: 8400116

Columbia, South Carolina 21045

United States

Biocentric Health Research Center-Site Number: 8400089

Columbia, South Carolina 29203

United States

Tri-Cities Gastroenterology-Site Number: 8400076

Kingsport, Tennessee 37663

United States

Inquest Clinical Research-Site Number: 8400144

Baytown, Texas 77521

United States

The University of Texas Southwestern Medical Center-Site Number: 8400098

Dallas, Texas 75390

United States

Valley Institute of Research-Site Number: 8400004

Harlingen, Texas 78550

United States

One of a Kind Clinical Research Center TX, LLC-Site Number; 8400125

Kingwood, Texas 77339

United States

Innovare Research Group-Site number: 8400067

Lake Jackson, Texas 77566

United States

GI Alliance - Lubbock-Site Number: 8400092

Lubbock, Texas 79410

United States

SMS Clinical Research-Site Number: 8400035

Mesquite, Texas 75149

United States

Gastroenterology Research of San Antonio LLC-Site Number: 8400054

San Antonio, Texas 78229

United States

Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office-Site Number: 8400101

Southlake, Texas 76092

United States

Texas Gastro Consultants-Site Number: 8400029

Tomball, Texas 77375

United States

Tyler Research Institute, LLC-Site Number: 8400095

Tyler, Texas 75701

United States

Velocity Clinical Research, Salt Lake City-Site Number: 8400147

West Jordan, Utah 84088

United States

Blue Ridge Medical Research-Site Number: 8400020

Lynchburg, Virginia 24502

United States

Clinical Research Partners-Site Number: 8400080

Richmond, Virginia 23226

United States

GI Alliance - Bellevue-Site Number: 8400143

Bellevue, Washington 98004

United States

The Vancouver Clinic Inc. P.S.-Site Number: 8400090

Vancouver, Washington 98664

United States

Froedtert Hospital and the Medical College of Wisconsin-Site Number: 8400081

Milwaukee, Wisconsin 53226

United States

Investigational Site Number : 0320002

La Plata, Buenos Aires B1900AXI

Argentina

Investigational Site Number : 0320001

Buenos Aires, City of Buenos Aires 1280AEB

Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province 2000

Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province 2000

Argentina

Investigational Site Number : 0320005

Buenos Aires, 1425

Argentina

Investigational Site Number : 0320003

Buenos Aires, 1702

Argentina

Investigational Site Number : 0360005

Birtinya, 4575

Australia

Investigational Site Number : 0360006

Nedlands, 6009

Australia

Investigational Site Number : 0360001

South Brisbane, 4101

Australia

Investigational Site Number : 0400006

Sankt Veit an der Glan, Carinthia 9300

Austria

Investigational Site Number : 0400003

Krems, Lower Austria 3500

Austria

Investigational Site Number : 0400004

Graz, Styria 8036

Austria

Investigational Site Number : 0400005

Linz, Upper Austria 4021

Austria

Investigational Site Number : 0400002

Salzburg, 5020

Austria

Investigational Site Number : 0400001

Vienna, 1090

Austria

Investigational Site Number : 0400007

Vienna, 1190

Austria

Investigational Site Number : 0560001

Genk, 3600

Belgium

Investigational Site Number : 0560004

Liège, 4000

Belgium

Investigational Site Number : 0560002

Sint-Niklaas, B-9100

Belgium

Investigational Site Number : 0560003

Yvoir, 5530

Belgium

Investigational Site Number: 0760005

Juiz de Fora, Minas Gerais 36033-318

Brazil

Investigational Site Number: 0760003

Caxias do Sul, Rio Grande do Sul 95070-560

Brazil

Investigational Site Number : 0760009

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Investigational Site Number : 0760006

São José do Rio Preto, Sao Jose Do Rio Preto, Sao Paulo 15090-000

Brazil

Investigational Site Number: 0760002

Barretos, São Paulo 14784-400

Brazil

Investigational Site Number : 0760012

Campinas, São Paulo 13092-133

Brazil

Investigational Site Number : 0760008

Aracaju, 49075-000

Brazil

Investigational Site Number : 0760010

Brasília, 72145-450

Brazil

Investigational Site Number : 0760001

Goiânia, 74535-170

Brazil

Investigational Site Number : 0760007

Porto Alegre, 90160-092

Brazil

Investigational Site Number : 0760013

Salvador, 41820-020

Brazil

Investigational Site Number : 0760014

São Paulo, 01139-000

Brazil

Investigational Site Number : 0760011

Teresina, 64049-550

Brazil

Investigational Site Number : 1000003

Gorna Oryahovitsa, Oblast Veliko Tirnovo 5100

Bulgaria

Investigational Site Number : 1000007

Rousse, 7002

Bulgaria

Investigational Site Number : 1000008

Sofia, 1343

Bulgaria

Investigational Site Number : 1000005

Sofia, 1407

Bulgaria

Investigational Site Number : 1000006

Sofia, 1407

Bulgaria

Investigational Site Number : 1000004

Sofia, 1606

Bulgaria

Investigational Site Number : 1000001

Sofia, 1618

Bulgaria

Investigational Site Number : 1000002

Sofia, 1784

Bulgaria

Investigational Site Number : 1240010

Oakville, Ontario L6L 5L7

Canada

Investigational Site Number : 1240014

Brampton, L6S 0C1

Canada

Investigational Site Number : 1240004

Edmonton, T6G 2X8

Canada

Investigational Site Number : 1240005

Greater Sudbury, P3C1X3

Canada

Investigational Site Number : 1240009

Hamilton, L8N 1Y2

Canada

Investigational Site Number : 1240011

London, N6A 5W9

Canada

Investigational Site Number : 1240013

London, N6K 1M6

Canada

Investigational Site Number : 1240002

Montreal, H2X 3E4

Canada

Investigational Site Number : 1240007

Montreal, H4J 1C5

Canada

Investigational Site Number : 1240006

New Westminster, BC V3L 3W4

Canada

Investigational Site Number : 1240003

Toronto, M6A 3B4

Canada

Investigational Site Number : 1520004

Santiago, 7550000

Chile

Investigational Site Number : 1520003

Santiago, 7770086

Chile

Investigational Site Number : 1520002

Santiago, 8320000

Chile

Investigational Site Number : 1520001

Viña del Mar, 2540488

Chile

Investigational Site Number : 1560034

Guangzhou, Guangdong 510080

China

Investigational Site Number : 1560049

Guangzhou, Guangdong 510180

China

Investigational Site Number : 1560002

Guangzhou, Guangdong 510655

China

Investigational Site Number : 1560026

Huizhou, Guangdong 516001

China

Investigational Site Number : 1560043

Shenzhen, Guangdong 518100

China

Investigational Site Number : 1560010

Wuhan, Hubei 430022

China

Investigational Site Number : 1560037

Changsha, Hunan 410011

China

Investigational Site Number : 1560025

Nanjing, Jiangsu 210006

China

Investigational Site Number : 1560004

Nanjing, Jiangsu 210009

China

Investigational Site Number : 1560018

Wuxi, Jiangsu 214023

China

Investigational Site Number : 1560001

Chengdu, Sichuan 610041

China

Investigational Site Number : 1560013

Hangzhou, Zhejiang 310003

China

Investigational Site Number : 1560029

Taizhou, Zhejiang 31800

China

Investigational Site Number : 1560016

Beijing, 100034

China

Investigational Site Number : 1560027

Beijing, 100195

China

Investigational Site Number : 1560011

Changzhou, 213004

China

Investigational Site Number : 1560061

Chengdu, 610072

China

Investigational Site Number : 1560036

Fuzhou, 350004

China

Investigational Site Number : 1560009

Guangzhou, 510420

China

Investigational Site Number : 1560005

Hangzhou, 310009

China

Investigational Site Number : 1560060

Hefei, 230022

China

Investigational Site Number : 1560008

Jinan, 250012

China

Investigational Site Number : 1560022

Jingzhou, 434099

China

Investigational Site Number : 1560030

Mianyang, 621000

China

Investigational Site Number : 1560019

Nanjing, 210000

China

Investigational Site Number : 1560024

Nanjing, 210011

China

Investigational Site Number : 1560057

Qingdao, 26000

China

Investigational Site Number : 1560059

Qingyuan, 511518

China

Investigational Site Number : 1560020

Shanghai, 200123

China

Investigational Site Number : 1560007

Wenzhou, 325027

China

Investigational Site Number : 1560050

Yangzhou, 225100

China

Investigational Site Number : 1700006

Medellín, Antioquia 50015

Colombia

Investigational Site Number : 1700002

Medellín, Antioquia 50034

Colombia

Investigational Site Number : 1700001

Armenia, Quindío Department 630004

Colombia

Investigational Site Number : 2030001

Brno, 602 00

Czechia

Investigational Site Number : 2030008

Brno, 625 00

Czechia

Investigational Site Number : 2030011

Hradec Králové, 500 12

Czechia

Investigational Site Number : 2030013

Prague, 150 00

Czechia

Investigational Site Number : 2030006

Prague, 190 00

Czechia

Investigational Site Number : 2500009

Amiens, Cedex 1 80054

France

Investigational Site Number : 2500002

Saint-Etienne, Cedex 2 42055

France

Investigational Site Number : 2500008

Besançon, 25000

France

Investigational Site Number : 2500003

Créteil, 94000

France

Investigational Site Number : 2500010

Lille, 59000

France

Investigational Site Number : 2500012

Marseille, 13015

France

Investigational Site Number : 2500007

Nantes, 44000

France

Investigational Site Number : 2500005

Nantes, 44300

France

Investigational Site Number : 2500013

Nice, 6200

France

Investigational Site Number : 2500001

Paris, 75018

France

Investigational Site Number : 2500011

Toulouse, 31400

France

Investigational Site Number : 2500006

Vandœuvre-lès-Nancy, 54500

France

Investigational Site Number : 2680007

Kutaisi, 4600

Georgia

Investigational Site Number : 2680006

Tbilisi, 102

Georgia

Investigational Site Number : 2680001

Tbilisi, 119

Georgia

Investigational Site Number : 2680008

Tbilisi, 144

Georgia

Investigational Site Number : 2680003

Tbilisi, 159

Georgia

Investigational Site Number : 2680005

Tbilisi, 160

Georgia

Investigational Site Number : 2680009

Tbilisi, 178

Georgia

Investigational Site Number : 2680002

Tbilisi, 180

Georgia

Investigational Site Number : 2680004

Tbilisi, 180

Georgia

Investigational Site Number : 2760009

Tübingen, Baden-Wurttemberg 72076

Germany

Investigational Site Number : 2760005

Ulm, Baden-Wurttemberg 89081

Germany

Investigational Site Number : 2760023

Würzburg, Bavaria 97080

Germany

Investigational Site Number : 2760013

Remscheid, North Rhine-Westphalia 42859

Germany

Investigational Site Number : 2760014

Ludwigshafen am Rhein, Rhineland-Palatinate 67067

Germany

Investigational Site Number : 2760008

Dresden, Saxony 1307

Germany

Investigational Site Number : 2760015

Leipzig, Saxony 4103

Germany

Investigational Site Number : 2760020

Leipzig, Saxony 4103

Germany

Investigational Site Number : 2760016

Jerichow, Saxony-Anhalt 39319

Germany

Investigational Site Number : 2760001

Kiel, Schleswig-Holstein 24105

Germany

Investigational Site Number : 2760006

Berlin, 12559

Germany

Investigational Site Number : 2760003

Berlin, 14163

Germany

Investigational Site Number : 2760019

Dachau, 85221

Germany

Investigational Site Number : 2760007

Duisburg, 47055

Germany

Investigational Site Number : 2760004

Hamburg, 20246

Germany

Investigational Site Number : 2760026

Herne, 44623

Germany

Investigational Site Number : 2760029

Lüneburg, 21339

Germany

Investigational Site Number : 2760010

Minden, 32423

Germany

Investigational Site Number : 3000001

Heraklion, Crete 715 00

Greece

Investigational Site Number : 3000003

Larissa, Thessaly 41110

Greece

Investigational Site Number : 3000002

Athens, 11527

Greece

Investigational Site Number : 3480004

Budapest, 1066

Hungary

Investigational Site Number : 3480002

Budapest, H-1036

Hungary

Investigational Site Number : 3480003

Tatabánya, H-2800

Hungary

Investigational Site Number : 3480001

Veszprém, 8200

Hungary

Investigational Site Number : 3760004

Afula, 1834111

Israel

Investigational Site Number : 3760006

Ashkelon, 7830604

Israel

Investigational Site Number : 3760003

Beersheba, 8410101

Israel

Investigational Site Number : 3760001

Jerusalem, 91004

Israel

Investigational Site Number : 3760005

Nahariya, 2210001

Israel

Investigational Site Number : 3760007

Petah Tikva, 49100

Israel

Investigational Site Number : 3760002

Tel Aviv, 6423906

Israel

Investigational Site Number : 3800009

Rome, 152

Italy

Investigational Site Number : 3800003

Rozzano, 20089

Italy

Investigational Site Number : 3800005

Turin, 10128

Italy

Investigational Site Number : 3920046

Shizuoka, Hamamatsu 431-3192

Japan

Investigational Site Number : 3920005

Asahikawa, 078-8510

Japan

Investigational Site Number : 3920012

Bunkyō City, 113-8519

Japan

Investigational Site Number : 3920059

Bunkyō City, 113-8655

Japan

Investigational Site Number : 3920039

Chikushino-shi, 818-8502

Japan

Investigational Site Number : 3920045

Fukuoka, 810-0001

Japan

Investigational Site Number : 3920063

Fukuoka, 814-0180

Japan

Investigational Site Number : 3920027

Fukuoka, 815-8555

Japan

Investigational Site Number : 3920031

Hachiōji, 192-0032

Japan

Investigational Site Number : 3920065

Isehara, 259-1193

Japan

Investigational Site Number : 3920028

Isesaki, 372-0817

Japan

Investigational Site Number : 3920049

Kagoshima, 892-0843

Japan

Investigational Site Number : 3920030

Kamakura, 247-0056

Japan

Investigational Site Number : 3920018

Kashiwa, 277-0871

Japan

Investigational Site Number : 3920054

Kitakyushu, 806-8501

Japan

Investigational Site Number : 3920019

Kobe, 650-0015

Japan

Investigational Site Number : 3920060

Kobe, 650-0017

Japan

Investigational Site Number : 3920033

Kōriyama, 963-8563

Japan

Investigational Site Number : 3920036

Kumamoto, 862-0971

Japan

Investigational Site Number : 3920061

Kurume, 830-0011

Japan

Investigational Site Number : 3920052

Maebashi, 371-8511

Japan

Investigational Site Number : 3920058

Minato, 105-8471

Japan

Investigational Site Number : 3920024

Mitaka, 181-8611

Japan

Investigational Site Number : 3920062

Nagakute, 480-1195

Japan

Investigational Site Number : 3920026

Nagoya, 457-8511

Japan

Investigational Site Number : 3920057

Nagoya, 466-8560

Japan

Investigational Site Number : 3920013

Nishinomiya, 663-8501

Japan

Investigational Site Number : 3920025

Okayama, 700-8558

Japan

Investigational Site Number : 3920050

Osaka, 532-0003

Japan

Investigational Site Number : 3920002

Osaka, 540-0006

Japan

Investigational Site Number : 3920022

Osaka, 545-8586

Japan

Investigational Site Number : 3920001

Saga, 840-8571

Japan

Investigational Site Number : 3920014

Saga, 849-8501

Japan

Investigational Site Number : 3920064

Sagamihara, 252-0375

Japan

Investigational Site Number : 3920023

Sakura, 285-8741

Japan

Investigational Site Number : 3920029

Sapporo, 004-0041

Japan

Investigational Site Number : 3920042

Sapporo, 065-0033

Japan

Investigational Site Number : 3920048

Sendai, 980-8574

Japan

Investigational Site Number : 3920004

Sendai, 981-3213

Japan

Investigational Site Number : 3920003

Sendai, 983-8520

Japan

Investigational Site Number : 3920047

Shimotsuga-gun, 321-0293

Japan

Investigational Site Number : 3920034

Shinjuku, 162-8666

Japan

Investigational Site Number : 3920006

Shinjuku, 169-0073

Japan

Investigational Site Number : 3920020

Shiwa-gun, 028-3695

Japan

Investigational Site Number : 3920032

Toyama, 930-0194

Japan

Investigational Site Number : 3920037

Toyama, 930-8550

Japan

Investigational Site Number : 3920015

Toyohashi, 441-8570

Japan

Investigational Site Number : 3920009

Tsu, 514-8507

Japan

Investigational Site Number : 3920035

Yokohama, 232-0024

Japan

Investigational Site Number : 4400001

Kaunas, LT-50161

Lithuania

Investigational Site Number : 4400002

Panevezys, 35144

Lithuania

Investigational Site Number : 4840001

Jalisco, 45640

Mexico

Investigational Site Number : 4980001

Chisinau, MD-2025

Moldova

Investigational Site Number : 4980002

Chisinau, MD-2025

Moldova

Investigational Site Number : 4980003

Chisinau, MD-2025

Moldova

Investigational Site Number : 4980004

Chisinau, MD-2068

Moldova

Investigational Site Number : 5280002

Amsterdam, 1081 HZ

Netherlands

Investigational Site Number : 5540001

Christchurch, 8011

Netherlands

Investigational Site Number : 5540003

Lower Hutt, 5010

Netherlands

Investigational Site Number : 5540002

Tauranga, 3112

Netherlands

Investigational Site Number : 5280003

Tilburg, 5022 GC

Netherlands

Investigational Site Number : 5540005

Wellington, 6021

Netherlands

Investigational Site Number : 5780001

Lorenskog, 1478

Norway

Investigational Site Number : 5780002

Tromsø, 9038

Norway

Investigational Site Number : 6160026

Bydgoszcz, 85-229

Poland

Investigational Site Number : 6160019

Bydgoszcz, 85-794

Poland

Investigational Site Number : 6160013

Elblag, 82-300

Poland

Investigational Site Number : 6160035

Katowice, 40-040

Poland

Investigational Site Number : 6160014

Katowice, 40-748

Poland

Investigational Site Number : 6160022

Krakow, 31-506

Poland

Investigational Site Number : 6160030

Kłodzko, 57-300

Poland

Investigational Site Number : 6160016

Lodz, 90-752

Poland

Investigational Site Number : 6160011

Lodz, 91-034

Poland

Investigational Site Number : 6160034

Lublin, 20-049

Poland

Investigational Site Number : 6160027

Nowy Targ, 34-400

Poland

Investigational Site Number : 6160032

Olsztyn, 10-684

Poland

Investigational Site Number : 6160010

Opole, 45-819

Poland

Investigational Site Number : 6160018

Poznan, 60-309

Poland

Investigational Site Number : 6160001

Poznan, 60-702

Poland

Investigational Site Number : 6160025

Rzeszów, 35-326

Poland

Investigational Site Number : 6160029

Siedlce, 08-110

Poland

Investigational Site Number : 6160004

Sopot, 81-756

Poland

Investigational Site Number : 6160007

Staszów, 28-200

Poland

Investigational Site Number : 6160002

Szczecin, 71-434

Poland

Investigational Site Number : 6160020

Szczecin, 71-685

Poland

Investigational Site Number : 6160023

Torun, 87-100

Poland

Investigational Site Number : 6160015

Tychy, 43-100

Poland

Investigational Site Number : 6160012

Wadowice, 34-100

Poland

Investigational Site Number : 6160005

Warsaw, 00-189

Poland

Investigational Site Number : 6160031

Warsaw, 01-595

Poland

Investigational Site Number : 6160009

Warsaw, 02-786

Poland

Investigational Site Number : 6160003

Warsaw, 03-712

Poland

Investigational Site Number : 6160008

Warsaw, 04-501

Poland

Investigational Site Number : 6160006

Wroclaw, 52-416

Poland

Investigational Site Number : 6160028

Wroclaw, 53-611

Poland

Investigational Site Number : 6160017

Wroclaw, 54-239

Poland

Puerto Rico Health and Wellness Institute-Site Number: 8400104

Dorado, 646

Puerto Rico

Wellness Clinical Research - Vega Baja-Site Number: 8400099

Vega Baja, 693

Puerto Rico

Investigational Site Number : 6880001

Belgrade, 11 000

Serbia

Investigational Site Number : 6880002

Belgrade, 11 080

Serbia

Investigational Site Number : 6880006

Belgrade, 11000

Serbia

Investigational Site Number : 6880007

Belgrade, 11000

Serbia

Investigational Site Number : 6880003

Belgrade, 11080

Serbia

Investigational Site Number : 6880004

Niš, 18 000

Serbia

Investigational Site Number : 7030001

Bratislava, 811 09

Slovakia

Investigational Site Number : 7030003

Košice, 040 13

Slovakia

Investigational Site Number : 7030002

Prešov, 080 01

Slovakia

Investigational Site Number : 7030004

Prešov, 080 01

Slovakia

Investigational Site Number : 7100002

Cape Town, 7405

South Africa

Investigational Site Number : 7100005

Claremont, 7708

South Africa

Investigational Site Number : 7100004

Durban, 3610

South Africa

Investigational Site Number : 7100003

East London, 5219

South Africa

Investigational Site Number : 7100001

Kempton Park, 1619

South Africa

Investigational Site Number : 7100006

KwaZulu-Natal, 4449

South Africa

Investigational Site Number : 4100010

Ansan-si, 15355

South Korea

Investigational Site Number : 4100008

Busan, 48108

South Korea

Investigational Site Number : 4100009

Busan, 49241

South Korea

Investigational Site Number : 4100004

Daegu, 42415

South Korea

Investigational Site Number : 4100003

Daejeon, 34943

South Korea

Investigational Site Number : 4100007

Gwangju, 61453

South Korea

Investigational Site Number : 4100006

Seoul, 6351

South Korea

Investigational Site Number : 4100001

Seoul, 6591

South Korea

Investigational Site Number : 4100002

Seoul, 6973

South Korea

Investigational Site Number : 4100005

Suwon, 16247

South Korea

Investigational Site Number : 7240006

Ourense, Galicia 32005

Spain

Investigational Site Number : 7240005

Gijón, 33394

Spain

Investigational Site Number : 7240002

Huelva, 21005

Spain

Investigational Site Number : 7240004

Madrid, 28041

Spain

Investigational Site Number : 7560002

Basel, CH-4058

Switzerland

Investigational Site Number : 7560001

Bern, 3012

Switzerland

Investigational Site Number : 1580005

Changhua County, 500209

Taiwan

Investigational Site Number : 1580003

Chiayi City, 60002

Taiwan

Investigational Site Number : 1580010

Kaohsiung City, 81362

Taiwan

Investigational Site Number : 1580006

Kaohsiung City, 833401

Taiwan

Investigational Site Number : 1580009

New Taipei City, 23561

Taiwan

Investigational Site Number : 1580008

Tainan, 709

Taiwan

Investigational Site Number : 1580007

Tainan, 71004

Taiwan

Investigational Site Number : 1580002

Taipei, 100225

Taiwan

Investigational Site Number : 1580001

Taoyuan City, 333

Taiwan

Investigational Site Number : 8040003

Chernivtsi, 58001

Ukraine

Investigational Site Number : 8040001

Kyiv, 2002

Ukraine

Investigational Site Number : 8040013

Kyiv, 2091

Ukraine

Investigational Site Number : 8040002

Kyiv, 3037

Ukraine

Investigational Site Number : 8040004

Lviv, 79000

Ukraine

Investigational Site Number : 8040011

Lviv, 79010

Ukraine

Investigational Site Number : 8040005

Lviv, 79019

Ukraine

Investigational Site Number : 8040006

Uzhhorod, 88018

Ukraine

Investigational Site Number : 8040010

Vinnytsia, 21013

Ukraine

Investigational Site Number : 8040009

Vinnytsia, 21028

Ukraine

Investigational Site Number : 8040008

Vinnytsia, 21029

Ukraine

Investigational Site Number : 8260008

Cottingham, Hull HU16 5JQ

United Kingdom

Investigational Site Number : 8260005

Cambridge, CB2 0QQ

United Kingdom

Investigational Site Number : 8260007

London, NW3 2QG

United Kingdom

Investigational Site Number : 8260001

London, SE1 9RT

United Kingdom

Investigational Site Number : 8260004

Norwich, NR4 7UY

United Kingdom

Investigational Site Number : 8260003

Rochdale, BL9 7TD

United Kingdom