NCT03466411

Brief Summary

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,409

participants targeted

Target at P75+ for phase_2

Timeline
21mo left

Started Apr 2018

Longer than P75 for phase_2

Geographic Reach
40 countries

563 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Apr 2018Jan 2028

First Submitted

Initial submission to the registry

March 8, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

April 13, 2018

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 7, 2025

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2028

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.5 years

First QC Date

March 8, 2018

Results QC Date

April 17, 2025

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (9)

  • GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12

    The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.

    Baseline and Week 12

  • Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

    Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (\>=) 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Weeks 48

  • Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

    CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

    Weeks 48

  • Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

    Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Weeks 48

  • Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

    CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

    Weeks 48

  • Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12

    Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Week 12

  • Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12

    Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

    Week 12

  • Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12

    Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Week 12

  • Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12

    Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

    Week 12

Secondary Outcomes (29)

  • GALAXI 1: Percentage of Participants With Clinical Remission at Week 12

    At Week 12

  • GALAXI 1: Percentage of Participants With Clinical Response at Week 12

    At Week 12

  • GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12

    At Week 12

  • GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12

    At Week 12

  • GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12

    At Week 12

  • +24 more secondary outcomes

Study Arms (8)

Phase 2 (GALAXI 1): Group 1 (Guselkumab)

EXPERIMENTAL

Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.

Drug: Guselkumab Dose 1Drug: Guselkumab Dose 2

Phase 2 (GALAXI 1): Group 2 (Guselkumab)

EXPERIMENTAL

Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Drug: Guselkumab Dose 2Drug: Guselkumab Dose 3

Phase 2 (GALAXI 1): Group 3 (Guselkumab)

EXPERIMENTAL

Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Drug: Guselkumab Dose 4Drug: Guselkumab Dose 5

Phase 2 (GALAXI 1): Group 4 (Ustekinumab)

ACTIVE COMPARATOR

Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab.

Drug: Ustekinumab

Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)

EXPERIMENTAL

Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

Drug: UstekinumabDrug: Placebo

Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)

EXPERIMENTAL

Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Drug: Guselkumab

Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)

ACTIVE COMPARATOR

Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab.

Drug: Ustekinumab

Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)

EXPERIMENTAL

Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

Drug: UstekinumabDrug: Placebo

Interventions

Guselkumab will be administered by SC injection.

Phase 2 (GALAXI 1): Group 1 (Guselkumab)Phase 2 (GALAXI 1): Group 2 (Guselkumab)

Ustekinumab will be administered by IV infusion and SC injection.

Phase 2 (GALAXI 1): Group 4 (Ustekinumab)Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)

Placebo will be administered as IV infusion.

Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)

Guselkumab will be administered by IV infusion.

Phase 2 (GALAXI 1): Group 1 (Guselkumab)

Guselkumab will be administered by IV infusion.

Phase 2 (GALAXI 1): Group 2 (Guselkumab)

Guselkumab will be administered by IV infusion.

Phase 2 (GALAXI 1): Group 3 (Guselkumab)

Guselkumab will be by SC injection.

Phase 2 (GALAXI 1): Group 3 (Guselkumab)

Guselkumab will be administered by IV infusion and SC injection.

Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
  • Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Have screening laboratory test results within the protocol specified parameters
  • A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
  • Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

You may not qualify if:

  • Current diagnosis of ulcerative colitis or indeterminate colitis
  • Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
  • Unstable doses of concomitant Crohn's disease therapy
  • Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
  • Any medical contraindications preventing study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (577)

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Internal Medicine Center

Mobile, Alabama, 36693, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Advanced Research Center Inc

Anaheim, California, 92805, United States

Location

Paul Wallace MD

Beverly Hills, California, 90211, United States

Location

University Of California San Diego

La Jolla, California, 92093, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

Allameh Medical Corp

Mission Viejo, California, 92691, United States

Location

United Gastroenterologists

Murrieta, California, 92563, United States

Location

Clinnova Research

Orange, California, 92868, United States

Location

Inland Empire Liver Foundation

Rialto, California, 91106, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Clinical Applications Laboratories, Inc

San Diego, California, 91941, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80920, United States

Location

Pioneer Research Solutions Inc.

Coconut Creek, Florida, 33066, United States

Location

InvesClinic, LLC

Fort Lauderdale, Florida, 33308, United States

Location

Harmony Medical Research Institute, Inc.

Hialeah, Florida, 33016, United States

Location

Elite Research Network - Nature Coast Clinical Research, LLC

Inverness, Florida, 34452, United States

Location

SIH Research

Kissimmee, Florida, 34759, United States

Location

Auzmer Research

Lakeland, Florida, 33813, United States

Location

Florida Research Center Inc.

Lakewood Rch, Florida, 34211, United States

Location

Homestead Associates in Research Inc

Miami, Florida, 33032, United States

Location

Community Research Foundation, Inc.

Miami, Florida, 33155, United States

Location

Sanchez Clinical Research, Inc

Miami, Florida, 33157-6575, United States

Location

Visionary Investigators Network

Miami, Florida, 33180, United States

Location

Gastroenterology Group Of Naples

Naples, Florida, 34102, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Omega Research Consultants

Orlando, Florida, 32808, United States

Location

Care Access Research, Orlando

Orlando, Florida, 32825, United States

Location

Synexus Clinical Research US Inc 1

Pinellas Park, Florida, 33781, United States

Location

Central Florida Internists

Saint Cloud, Florida, 34769, United States

Location

Synergy Clinical Research

St. Petersburg, Florida, 33705, United States

Location

Theia Clincial Research, LLC

St. Petersburg, Florida, 33709, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33603, United States

Location

GCP Clinical Research

Tampa, Florida, 33609, United States

Location

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

Alliance Clinical Research

Tampa, Florida, 33615, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30224, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Atlanta Center For Gastroenterology

Decatur, Georgia, 30033, United States

Location

Gastroenterology Consultants

Roswell, Georgia, 30076, United States

Location

Atlanta Gastroenterology Specialists PC

Suwanee, Georgia, 30024, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

BVL Clinical Research

Leawood, Kansas, 66211, United States

Location

Health Science Research Center

Pratt, Kansas, 67124, United States

Location

Cotton O'Neil Digestive Health Center

Topeka, Kansas, 66606, United States

Location

Gastroenterology Associates

Baton Rouge, Louisiana, 70809, United States

Location

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, 70503, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

DelRicht Research

New Orleans, Louisiana, 70124, United States

Location

LSUHSC Shreveport Feist-Weiller Cancer Center

Shreveport, Louisiana, 71103, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Woodholme Gastroenterology Associates

Baltimore, Maryland, 21208, United States

Location

Digestive Health Specialists PC

Chelmsford, Massachusetts, 01824, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Huron Gastroenterology Associates Center for Digestive Care

Ypsilanti, Michigan, 48197, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

Atlantic Digestive Health Institute/ Atlantic IBD Center

Morristown, New Jersey, 07960, United States

Location

A1 Clinical Research

Jackson Heights, New York, 11372, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

New York Gastroenterology Associates

New York, New York, 10028, United States

Location

Care Access Research

New York, New York, 10065, United States

Location

NYU Langone Medical Center

New York, New York, 11021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Syracuse VA Medical Center

Syracuse, New York, 13210, United States

Location

Asheville Gastroenterology Associates

Asheville, North Carolina, 28801, United States

Location

University North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Charlotte Gastroenterology and Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Onsite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Cumberland Research Associates

Fayetteville, North Carolina, 28304, United States

Location

Care Access Research, Kinston

Kinston, North Carolina, 28501, United States

Location

Clinical Trials of America

Mount Airy, North Carolina, 27030, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Clinical Inquest Center, LTD

Beavercreek, Ohio, 45432, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Synexus Clinical Research US Inc 2

Columbus, Ohio, 43212, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Southwoods Health

Poland, Ohio, 44514, United States

Location

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145, United States

Location

Integris Baptist Office

Oklahoma City, Oklahoma, 73112, United States

Location

US Digestive Health

Wyomissing, Pennsylvania, 19610, United States

Location

Synexus Clinical Research US Inc

Anderson, South Carolina, 29621-2062, United States

Location

Gastroenterology Associates P.A.

Greenville, South Carolina, 29615, United States

Location

Memorial Health Care System

Chattanooga, Tennessee, 37404, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Tennessee State University

Johnson, Tennessee, 37614-1700, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-1610, United States

Location

DHAT Research Institute

Garland, Texas, 75044, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Houston Digestive Diseases Consultants

Houston, Texas, 77074, United States

Location

CliniCore Houston

Houston, Texas, 77079, United States

Location

Caprock Gastro Research

Lubbock, Texas, 79424, United States

Location

Gastroenterology Clinic Of San Antonio P A

San Antonio, Texas, 78229, United States

Location

Gastroenterology Research of America, LLC

San Antonio, Texas, 78229, United States

Location

UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Texas Gastroenterology Associates - Research

Spring, Texas, 77386, United States

Location

Baylor Scott and White Research Institute

Temple, Texas, 76508, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Center for Gastrointestinal Health

Petersburg, Virginia, 23805, United States

Location

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia, 24014-1372, United States

Location

Northwest Gastroenterology Associates - USA

Bellevue, Washington, 98004, United States

Location

Washington Gastroenterology, PLLC

Tacoma, Washington, 98405, United States

Location

The Queen Elizabeth Hospital

Adelaide, 5011, Australia

Location

Monash Health, Monash Medical Centre

Clayton, 3168, Australia

Location

Concord Hospital

Concord, 2139, Australia

Location

Austin Hospital

Heidelberg, 3084, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, 6009, Australia

Location

Royal Adelaide Hospital

North Terrace, 5000, Australia

Location

Royal Melbourne Hospital

Parkville, 3050, Australia

Location

Nepean Hospital

Penrith, 2751, Australia

Location

The Alfred Hospital

Prahran, 3004, Australia

Location

Mater Hospital Brisbane

South Brisbane, 4101, Australia

Location

Princess Alexandra Hospital

Woolloongabba, 4102, Australia

Location

Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, 5020, Austria

Location

Akh Wien

Vienna, 1090, Austria

Location

Grodno University Hospital

Grodno, 230017, Belarus

Location

Gomel Regional Clinical Hospital

Homyel, 246029, Belarus

Location

Republican Research Centre of Radiation Medicine and Human E

Homyel, 246040, Belarus

Location

Healthcare Institution,Minsk Scientific center for surgery,

Minsk, 220116, Belarus

Location

Vitebsk Regional Clinical Hospital

Vitebsk, 210037, Belarus

Location

AZ Klina

Brasschaat, 2930, Belgium

Location

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

Hopital Erasme

Brussels, 1070, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Az Groeninge

Kortrijk, 8500, Belgium

Location

Algemeen Ziekenhuis Delta

Roeselare, 8800, Belgium

Location

CHwapi

Tournai, 7500, Belgium

Location

University Clinical Centre of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Clinical hospital Mostar

Mostar, 88000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Polyclinic Dr. Al-Tawil

Sarajevo, 71000, Bosnia and Herzegovina

Location

Cantonal Hospital Zenica

Zenica, 72000, Bosnia and Herzegovina

Location

MK Blumenau Pesquisa Clínica

Blumenau, 89010-506, Brazil

Location

Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, 18618-970, Brazil

Location

L2IP Instituto de Pesquisas Clinicas

Brasília, 70200 730, Brazil

Location

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, 13060-904, Brazil

Location

Hospital Nossa Senhora Das Gracas

Curitiba, 80810-040, Brazil

Location

Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro

Goiânia, 74535-170, Brazil

Location

Centro de Estudos Clínicos do Interior Paulista - CECIP

Jaú, 17201-130, Brazil

Location

CMIP - Centro Mineiro de Pesquisa Ltda

Juiz de Fora, 36010 570, Brazil

Location

Complexo Hospitalar de Niteroi

Niterói, 24020-096, Brazil

Location

Instituto Mederi de Pesquisa e Saude

Passo Fundo, 99010-120, Brazil

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

Instituto do Aparelho Digestivo

Porto Alegre, 90560-002, Brazil

Location

Universidade Federal do Rio de Janeiro - Faculdade de Medicina

Rio de Janeiro, 21941-913, Brazil

Location

Hospital Santa Izabel

Salvador, 40050-410, Brazil

Location

Pesquisare Saude

Santo André, 09080-110, Brazil

Location

Praxis pesquisa médica

Santo André, 09090-790, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos

Santo André, 09190-510, Brazil

Location

Irmandade da Santa Casa da Misericórdia de Santos

Santos São Paulo, 11075-101, Brazil

Location

Kaiser Hospta

São José do Rio Preto, 15015-110, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, 15090-000, Brazil

Location

CPCLIN - Centro de Pesquisas Clínicas

São Paulo, 01228-200, Brazil

Location

Hemomed

São Paulo, 01236-030, Brazil

Location

BR Trials

São Paulo, 03325-050, Brazil

Location

Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

Teresina, 64049-550, Brazil

Location

University of Calgary

Calgary, Alberta, T2N4Z6, Canada

Location

Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, Alberta, T5R 1W2, Canada

Location

University of Alberta- Ziedler Ledcor Centre

Edmonton, Alberta, T6G 2X8, Canada

Location

Columbia Gastroenterology

New Westminster, British Columbia, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

Barrie GI Associates

Barrie, Ontario, L4M 7G1, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Mount Sinai Hospital-Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Pharmaceutical Integrated Research Company

Waterloo, Ontario, N2J 1C4, Canada

Location

MUHC Montreal General Hospital

Montreal, Quebec, H3H2R9, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Friendship Hospital

Beijing, 100050, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

The Military General Hospital of Beijing PLA

Beijing, 100700, China

Location

The second Xiangya Hospital of Central South University

Changsha, 200120, China

Location

Changzhou No 2 Peoples Hospital

Changzhou, 213004, China

Location

West China Hospital Sichuan University

Chengdu, 610041, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, 400010, China

Location

First Affiliated Hospital of Gannan Medical University

Ganzhou, 341000, China

Location

The First Affiliated Hospital Sun Yat-Sen University

Guangzhou, 510080, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, 510235, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, 510280, China

Location

Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

Guangzhou, 510610, China

Location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

Location

Huai'an 1st Hospital

Huai'an, China

Location

The First Affiliated Hospital of NanChang University

Nanchang, 330006, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Zhongda Hospital Southeast University

Nanjing, 210009, China

Location

Shanghai Ninth Peoples Hospital

Shanghai, 200011, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

Second Military Medical University (SMMU)

Shanghai, 200433, China

Location

Tongji Hospital of Tongji University

Shanghai, 430030, China

Location

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110004, China

Location

Peking University Shenzhen Hospital

Shenzhen, 518036, China

Location

The first affiliated hospital of suzhou University

Suzhou, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325003, China

Location

Wuhan Union Hospital

Wuhan, 430022, China

Location

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

Wuxi People s Hospital

Wuxi, 214023, China

Location

Zhongshan Hospital, Xiamen University

Xiamen, 361004, China

Location

Yangzhou First People's Hospital

Yangzhou, 225001, China

Location

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, 363000, China

Location

Medplus Medicina Prepagada S.A.

Bogotá, 110111, Colombia

Location

Clinica de la Mujer

Bogotá, 110221, Colombia

Location

Endocare Ltda.

Bogotá, 111111, Colombia

Location

Centro Médico Imbanaco

Cali, 760042, Colombia

Location

Corporacion para Estudios en Salud Clinica CES - Gastroenterology

Medellín, 50012, Colombia

Location

Opca bolnica Bjelovar

Bjelovar, 43000, Croatia

Location

Opca bolnica Zadar

Zadar, 23000, Croatia

Location

CH Sestre Milosrdnice

Zagreb, 10000, Croatia

Location

Poliklinika Solmed

Zagreb, 10000, Croatia

Location

University Hospital Center Zagreb

Zagreb, 10000, Croatia

Location

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Nemocnice Ceske Budejovice

České Budějovice, 370 01, Czechia

Location

NH Hospital, a.s.

Hořovice, 268 31, Czechia

Location

Hepato-gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Synexus Czech s.r.o.

Prague, 120 00, Czechia

Location

ISCARE a.s.

Prague, 190 00, Czechia

Location

CHU Amiens

Amiens, 80054, France

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

Location

CHRU Besancon Hopital Jean Minjoz

Besançon, 25000, France

Location

Centre Hospitalier Universitaire (CHU) de Caen

Caen, 14033, France

Location

CHRU de Tours - Hopital Trousseau

Chambray Les Tours Centre, 37170, France

Location

Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

Créteil, 94010, France

Location

CHU Grenoble

Grenoble, 38700, France

Location

CHRU de Lille Hopital Claude Huriez

Lille, 59037, France

Location

Hopital Nord Marseille

Marseille, 13915, France

Location

CHRU Montpellier - Hopital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nantes hotel Dieu

Nantes, 44093, France

Location

CHU de Nice Hopital de l Archet

Nice, 06202, France

Location

CHU Nimes Hopital Caremeau

Nîmes, 30029, France

Location

Hôpital Bichat

Paris, 75877, France

Location

Groupement Hospitalier Universitaire Ouest

Paris, 75908, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

Reims, 51092, France

Location

CHU Saint Etienne

Saint-Etienne, 42270, France

Location

Hopital D'Instruction Des Armees

Saint-Mandé, 94160, France

Location

CHRU de Strasbourg - Hopital de Hautepierre

Strasbourg, 67098, France

Location

CHU Toulouse - Hopital de Rangueil

Toulouse, 31059, France

Location

Hopital Rangueil

Toulouse, 50032, France

Location

CHU de Nancy_ Hopital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

TSMU The First University Clinic

Tbilisi, 0141, Georgia

Location

Institute of Clinical Cardiology, Ltd.

Tbilisi, 0159, Georgia

Location

LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital'

Tbilisi, 0159, Georgia

Location

LTD 'Aversi Clinic'

Tbilisi, 0160, Georgia

Location

LTD Helsicore

Tbilisi, 112, Georgia

Location

LTD Unimed Kakheti- Telavi Referral Hospital

Telavi, 2200, Georgia

Location

Klinikum Augsburg

Augsburg, D-86158, Germany

Location

Charite - Campus Mitte

Berlin, 10117, Germany

Location

Synexus Berlin Research Center

Berlin, 12627, Germany

Location

Universitaetsklinikum Charite, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Krankenhaus Waldfriede Mitte

Berlin, 14163, Germany

Location

Klinikum Dresden

Dresden, 1307, Germany

Location

Synexus Clinical Research GmbH

Frankfurt, 60313, Germany

Location

JWG-University Hospital

Frankfurt, 69590, Germany

Location

Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

Frankfurt am Main, 60431, Germany

Location

Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

Hamburg, 20246, Germany

Location

Asklepios Westklinikum

Hamburg, 22559, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Gastroenterologische Spezialpraxis - Berlin-Karlshorst

Karlshorst, 10318, Germany

Location

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105, Germany

Location

Eugastro GmbH

Leipzig, 04103, Germany

Location

Gastroenterologie und Hepatologie am Johannisplatz

Leipzig, 04103, Germany

Location

Staedtisches Klinikum Lueneburg

Lüneburg, 21339, Germany

Location

Universitaetsklinikum Mannheim

Mannheim, 68167, Germany

Location

Gemeinschaftspraxis Germania-Campus

Münster, 48159, Germany

Location

Praxiszentrum Alte Mälzerei

Regensburg, 93053, Germany

Location

Zentrum für Gastroenterologie Saar MVZ GmbH

Saarbrücken, 66111, Germany

Location

Universitatsklinikum Ulm

Ulm, 89081, Germany

Location

Laiko General Hospital of Athens

Athens, 11527, Greece

Location

University Hospital of Heraklion

Heraklion, 71110, Greece

Location

Réthy Pál Kórház - Rendelőintézet

Békéscsaba, 5600, Hungary

Location

Synexus Magyarorszag Kft

Budapest, 1036, Hungary

Location

Péterfy Sándor utcai Kórház

Budapest, 1076, Hungary

Location

Meddica Centre Hungarian Defence Froces

Budapest, H-1062, Hungary

Location

Semmelweis Egyetem

Budapest, H-1088, Hungary

Location

Synexus Magyarorszag Kft

Gyula, 5700, Hungary

Location

Tolna Megyei Balassa Janos Korhaz

Szekszárd, 7100, Hungary

Location

Apex Hospitals Ltd

Jaipur, 302017, India

Location

Fortis Hospital 1

New Delhi, 110088, India

Location

Fortis Hospital

Noida, 201301, India

Location

Shree Giriraj Multispeciality Hospital

Rajkot, 360005, India

Location

Nirmal Hospital Pvt. Ltd.

Surat, 395002, India

Location

Surat Institute of Digestive Sciences Hospitals

Surat, 395002, India

Location

BAPS Pramukhswami Hospital

Surat, 395009, India

Location

Unity Hospital

Surat, 395010, India

Location

Ha'Emek Medical Center

Afula, 1834111, Israel

Location

Barzilai Medical Center

Ashkelon, 78278, Israel

Location

Soroka Medical Center

Bear Sheva, 84100, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Bnai Zion Medical Center

Haifa, 3339419, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin Med Ctr Beilinson Hosp

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Assaf Harofeh Medical Center

Tzrifin, 70300, Israel

Location

Policlinico S.Orsola Malpighi, AOU di Bologna

Bologna, 40138, Italy

Location

Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

Cagliari, 09042, Italy

Location

Ospedale Santissima Annunziata

Cento, 44042, Italy

Location

AOU Policlinico G.Martino

Messina, 98125, Italy

Location

Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura

Milan, 20097, Italy

Location

Universita degli Studi di Padova - Azienda Ospedaliera di Padova

Padova, 35128, Italy

Location

Università Campus Biomedico di Roma

Roma, 00128, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Complesso Integrato Columbus

Rome, 00168, Italy

Location

IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali

Rozzano, 20089, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

S.C. Gastroenterologia

Torino, 10128, Italy

Location

Azienda Ospedaliero Universitaria S.Maria Della Misericordia

Udine, 33100, Italy

Location

Policlinico G.B.Rossi

Verona, 37134, Italy

Location

Asahikawa City Hospital

Asahikawa, 087-8686, Japan

Location

Tokyo Medical and Dental University Hospital

Bunkyō City, 113 8519, Japan

Location

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

Location

Juntendo University Hospital 1

Bunkyō City, 279-0021, Japan

Location

Chiba University Hospital

Chiba, 260-8677, Japan

Location

Fukuoka University Chikushi Hospital

Chikushino-shi, 818-8502, Japan

Location

Saiseikai Fukuoka General Hospital

Fukuoka, 810-0001, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Gifu University Hospital

Gifu, 501-1194, Japan

Location

Tokai University Hachioji Hospital

Hachiōji, 192-0032, Japan

Location

Matsuda Hospital

Hamamatsu, 432-8061, Japan

Location

Mito Medical Center - Digestive Organs

Higashiibaraki-gun, 311-3193, Japan

Location

National Hospital Organization Hirosaki General Medical Center

Hirosaki, 036-8174, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

National Hospital Organization Kanazawa Medical Center

Ishikawa, 920 8650, Japan

Location

Izumiotsu Municipal Hospital

Izumiōtsu, 595-0027, Japan

Location

Shimane University Hospital

Izumo, 693-8501, Japan

Location

Kagoshima IBD Gastroenterology Clinic

Kagoshima, 892-0843, Japan

Location

Sameshima Hospital

Kagoshima, 892-0846, Japan

Location

Nanpuh Hospital

Kagoshima, 892-8512, Japan

Location

Kanazawa University Hospital

Kanazawa, 9208651, Japan

Location

Nara Medical University Hospital

Kashihara, 634-8522, Japan

Location

Tsujinaka Hospital Kashiwanoha

Kashiwa, 277-0871, Japan

Location

The Jikei University Hospital 1

Kashiwa, 277-8567, Japan

Location

Aoyama Naika Clinic

Kobe, 650-0015, Japan

Location

Kobe University Hospital

Kobe, 650-0017, Japan

Location

National Hospital Organization Kochi National Hospital

Kochi, 780-8077, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, 400-8506, Japan

Location

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Kure, 736-0023, Japan

Location

Kurume University Hospital

Kurume, 830-0011, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

JRC Kyoto Daiichi Hospital

Kyoto, 605-0981, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto, 612-8555, Japan

Location

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642, Japan

Location

Kyorin University Hospital

Mitaka, 181-8611, Japan

Location

Iwate Medical University Hospital

Morioka, 020-8505, Japan

Location

Aichi Medical University Hospital

Nagakute, 480-1195, Japan

Location

Nagaoka Red Cross Hospital

Nagaoka, 940-2085, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Nagoya University Hospital

Nagoya, 466-8560, Japan

Location

Nagoya City University Hospital

Nagoya, 467-8602, Japan

Location

The Hospital of Hyogo College of Medicine

Nishinomiya, 663-8501, Japan

Location

JA Obihiro Kosei Hospital

Obihiro, 080-0024, Japan

Location

Okayama Saiseikai General Hospital

Okayama, 700-8511, Japan

Location

Nakagami Hospital

Okinawa, 904-2195, Japan

Location

Kinshukai Infusion Clinic

Osaka, 530-0011, Japan

Location

Kitano Hospital

Osaka, 530-8480, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Japanese Red Cross Osaka Hospital

Osaka, 543 8555, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

Oita Red Cross Hospital

Ōita, 870-0033, Japan

Location

Kindai University Hospital

Ōsaka-sayama, 589-8511, Japan

Location

Osaki Citizen Hospital

Ōsaki, 989-6183, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, 520-2192, Japan

Location

National Hospital Organization Higashi Ohmi General Medical Center

Ōtsu, 527-8505, Japan

Location

Japan Community Health Care Organization Saitama Medical Center

Saitama, 330-0074, Japan

Location

Tokitokai Tokito Clinic Coloproctology Center

Saitama, 336-0963, Japan

Location

Saitama Medical University Hospital

Saitama, 350-0495, Japan

Location

Toho University Sakura Medical Center

Sakura, 285-8741, Japan

Location

JA Sapporo-Kosei General Hospital - 1st Digestive Organs

Sapporo, 060-0033, Japan

Location

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033, Japan

Location

Sapporo IBD Clinic

Sapporo Chuo-ku, 064-0919, Japan

Location

Tokyo Yamate Medical Center

Shinjuku-ku, 169-0073, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

Takamatsu Red Cross Hospital

Takamatsu, 760-0017, Japan

Location

Kagawa Prefectural Central Hospital

Takamatsu, 760-85557, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

The Jikei University Hospital

Tokyo, 105 8471, Japan

Location

Yuaikai Tomishiro Central Hospital

Tomishiro, 901-0243, Japan

Location

Toyama City Hospital

Toyama, 939 8511, Japan

Location

Fujita Health University Hospital

Toyoake, 470-1192, Japan

Location

Ehime University Hospital

Tōon, 791-0295, Japan

Location

Mie University Hospital

Tsu, 514-8507, Japan

Location

Wakayama Medical University Hospital

Wakayama, 641-8509, Japan

Location

Yokohama City University Medical Center

Yokohama, 232 0024, Japan

Location

Khalidi Hospital and Medical Center

Amman, 11183, Jordan

Location

Jordan University Hospital

Amman, 11942, Jordan

Location

Irbid Specialty Hospital

Irbid, 21110, Jordan

Location

King Abdullah University Hospital

Irbid, 22110, Jordan

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Alda Pukisa arsta prakse

Riga, LV-1046, Latvia

Location

Ain Wazein Hospital

Ain Wazein, Lebanon

Location

American Universitty of Beirut Medical Center

Beirut, 110 72020, Lebanon

Location

St Georges Hospital university medical centre

Beirut, 166378, Lebanon

Location

Hotel Dieu de France Hospital

Beirut, 166830, Lebanon

Location

Bellevue Medical Center

Beirut, Lebanon

Location

Mount Lebanon Hospital

Beirut, Lebanon

Location

Rafik Hariri University Hospital

Beirut, Lebanon

Location

Nini Hospital

Tripoli, NAP, Lebanon

Location

Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

Kaunas, LT-50161, Lithuania

Location

Vilnius University Hospital Santaros Klinikos, Public Institution

Vilnius, LT-08661, Lithuania

Location

Hospital Ampang

Ampang, 68000, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, 30990, Malaysia

Location

Hospital Sultanah Aminah

Johor Bharu, 80100, Malaysia

Location

Hospital Raja Perempuan Zainab Ii

Kota Bharu, 15160, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

Location

Amsterdam UMC locatie VUMC

Amsterdam, 7057-1007 MB, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6229 HX, Netherlands

Location

Stichting Zuyderland Medisch Centrum

Sittard-Geleen, 6130 MB, Netherlands

Location

Auckland City Hospital

Auckland, 1142, New Zealand

Location

Christchurch Hospital

Christchurch, 8140, New Zealand

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

General City Hospital 8mi Septemvri

Skopje, 1000, North Macedonia

Location

University Clinic of Gastroenterohepatology 1

Skopje, 1000, North Macedonia

Location

University Clinic of Gastroenterohepatology

Skopje, 1000, North Macedonia

Location

NZOZ Centrum Medyczne KERmed

Bydgoszcz, 85 681, Poland

Location

Centrum Medyczne Lukamed

Chojnice, 89-600, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Częstochowa, 42-202, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, 80 382, Poland

Location

Synexus Scm Sp Z o o Oddzial Gdynia

Gdynia, 81 537, Poland

Location

Prywatna Praktyka Lekarska

Jelenia Góra, 8 500, Poland

Location

Synexus Polska Sp z o o Oddzial w Katowicach

Katowice, 40 040, Poland

Location

Malopolskie Centrum Kliniczne

Krakow, 30 149, Poland

Location

Centrum Medyczne Plejady

Krakow, 30 363, Poland

Location

Centrum Medyczne Promed

Krakow, 31-411, Poland

Location

Centrum Opieki Zdrowotnej Orkan Med Stec Michalska sj

Ksawerów, 95-054, Poland

Location

Synexus Polska Sp z o o

Lodz, 90 127, Poland

Location

AmiCare Centrum Medyczne

Lodz, 90-644, Poland

Location

1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ W Lublinie

Lublin, 20 049, Poland

Location

Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.

Lublin, 20-582, Poland

Location

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 10 561, Poland

Location

Twoja Przychodnia 1

Opole, 45-819, Poland

Location

Oswiecimskie Centrum Badan Klinicznych

Oświęcim, 32 600, Poland

Location

EMC Instytut Medyczny SA

Poznan, 60 309, Poland

Location

Solumed S C

Poznan, 60 529, Poland

Location

Synexus Polska Sp. z.o.o. Oddzial w Poznaniu

Poznan, 60-702, Poland

Location

Twoja Przychodnia

Poznan, 61-293, Poland

Location

Centrum Medyczne 'Medyk' Sp. z o.o. K.

Rzeszów, 35-055, Poland

Location

Endoskopia Sp z o.o.

Sopot, 81-756, Poland

Location

Kiepury Clinic

Sosnowiec, 41-209, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej

Szczecin, 71-685, Poland

Location

GASTROMED Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie

Torun, 87 100, Poland

Location

H-T Centrum Medyczne Endoterapia

Tychy, 43-100, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 00 141, Poland

Location

Centrum Medyczne

Warsaw, 02 676, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, 02-507, Poland

Location

Centrum Badawcze Wspolczesnej Terapii

Warsaw, 02-679, Poland

Location

NZOZ Vivamed Zespol Lekarzy Specjalistow

Warsaw, 03-580, Poland

Location

Szpital Pomnik Centrum Zdrowia Dziecka

Warsaw, 04-730, Poland

Location

Synexus Polska Sp z o o Oddzial w Warszawie

Warsaw, 623832, Poland

Location

Centrum Zdrowia Tuchow

Wierzchosławice, 33-122, Poland

Location

Synexus Polska Sp z o o Oddzial we Wroclawiu

Wroclaw, 50 381, Poland

Location

Przychodnia Vistamed

Wroclaw, 50 449, Poland

Location

Futuremeds sp. z o.o.

Wroclaw, 50-088, Poland

Location

Melita Medical Sp. z o.o.

Wroclaw, 50-449, Poland

Location

ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c.

Wroclaw, 53-333, Poland

Location

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, 54 144, Poland

Location

Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

Włocławek, 87-800, Poland

Location

ETG Zamosc

Zamość, 22-400, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, 3000-075, Portugal

Location

Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

Guimarães, 4835-044, Portugal

Location

Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

Portimão, 8500-338, Portugal

Location

H. Santo António - Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

Centro Hospitalar de Entre o Douro e Vouga, E.P.E

Santa Maria da Feira, 4520-211, Portugal

Location

San Juan Bautista School of Medicine

Caguas, 00726, Puerto Rico

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

KGBUZ 'Regional Clinical Hospital'

Krasnoyarsk, 660022, Russia

Location

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

Novgorod Regional Clinical Hospital n.a. N.A. Semashko

Nizhny Novgorod, 603126, Russia

Location

City Clinical Hospital #12

Novosibirsk, 630091, Russia

Location

FSBI 'Scientific Research Institute of Clinical and Experimental Lymphology' of Siberian Branch

Novosibirsk, 630117, Russia

Location

Clinical Diagnostic Center 'Ultramed'

Omsk, 644024, Russia

Location

GBUZ of Moscow Region City Clinical Hospital #3

Podolsk, 142105, Russia

Location

GBOU VPO Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

City Hospital #20

Rostov-on-Don, 344091, Russia

Location

Clinical Hospital #122 n.a. after L.G. Sokolov

Saint Petersburg, 194291, Russia

Location

City Hospital named after St. Martyr Elizabeth

Saint Petersburg, 195257, Russia

Location

The Limited Liability Company Research center Eco-safety

Saint Petersburg, 196143, Russia

Location

St.Petersburg State Medical University n.a.Pavlov

Saint Petersburg, 197022, Russia

Location

City Clinical Hospital #31

Saint Petersburg, 197110, Russia

Location

Medical University Reaviz

Samara, 443001, Russia

Location

NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'

Samara, 443041, Russia

Location

Saratov City Hospital #5

Saratov, 410071, Russia

Location

Tomsk Regional Clinical Hospital

Tomsk, 634063, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432063, Russia

Location

GUZ Novgorod Regional Clinical Hospital

Veliky Novgorod, 173008, Russia

Location

King Abdullah Medical City in Holy Capital

Mecca, 21955, Saudi Arabia

Location

King Abdul Aziz Medical City for National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

Location

Special hospital for Internal diseases, Oncomed system

Belgrade, 11000, Serbia

Location

University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Zvezdara University Medical Center

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11080, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

General Hospital 'Djordje Joanovic'

Zrenjanin, 23000, Serbia

Location

FNsP F.D.R. Banska Bystrica

Banská Bystrica, 975 17, Slovakia

Location

ENDOMED s.r.o

Košice, 040 13, Slovakia

Location

GASTRO I. s.r.o.

Prešov, 080 01, Slovakia

Location

Korea University Ansan Hospital

Ansan-si, 15355, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Kyongpook national university Medical center

Daegu, 41404, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

The Catholic university of Korea, St. Vincent's Hospital

Gyeonggi-do, 16247, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, 18450, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam, 13496, South Korea

Location

The Catholic Univ of Korea DaeJeon St Mary s Hospital

Seongnam, 13620, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Wonju Christian Hospital

Wŏnju, 26426, South Korea

Location

Ewha Womans University Mokdong Hospital

Yangch’ŏn-gu, 07985, South Korea

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Complejo Hosp Univ. de Ferrol

Ferrol, 15405, Spain

Location

Hosp. Univ. Dr. Josep Trueta

Girona, 17007, Spain

Location

Hosp. Gral. Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp. Univ. Central de Asturias

Oviedo, 33011, Spain

Location

Hosp. Provincial de Pontevedra

Pontevedra, 36071, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

Hosp. Univ. de Torrejon

Torrejón de Ardoz, 28850, Spain

Location

Hosp. Alvaro Cunqueiro

Vigo, 36312, Spain

Location

Hosp. Univ. Miguel Servet

Zaragoza, 50009, Spain

Location

Chang-Hua Christian Hospital

Changhua, 500, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang-Gung Memorial Hospital-Linkou

Taoyuan District, 33305, Taiwan

Location

Hopital Regional Mohamed Tahar El Maamouri

Nabeul, 8000, Tunisia

Location

Hopital Universitaire Sahloul

Sousse, 4051, Tunisia

Location

Hopital Habib Thameur

Tunis, 1008, Tunisia

Location

Military Hospital of Instruction of Tunis

Tunis, Tunisia

Location

Hospital La Rabta

Tunis Jebbari, 1007, Tunisia

Location

Hacettepe University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Gulhane Egitim ve Arastirma Hastanesi

Ankara, 6010, Turkey (Türkiye)

Location

Firat University Hospital

Elâzığ, 23200, Turkey (Türkiye)

Location

Mustafa Kemal University Research and Practise Hospital

Hatay, 31001, Turkey (Türkiye)

Location

Acibadem Fulya Hospital

Istanbul, 34349, Turkey (Türkiye)

Location

Sisli Etfal Egitim ve Arastirma Hospital

Istanbul, 34360, Turkey (Türkiye)

Location

BAU Medical Park Goztepe Hospital

Istanbul, 34732, Turkey (Türkiye)

Location

Marmara University Medical Faculty

Istanbul, 34899, Turkey (Türkiye)

Location

Dokuz Eylul University Medical Faculty

Izmir, 35340, Turkey (Türkiye)

Location

MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council

Kharkiv, 61037, Ukraine

Location

SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'

Kharkiv, 61039, Ukraine

Location

KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha

Kherson, 73000, Ukraine

Location

KNP Kyivska miska klinichna likarnia №18 vykonavchoho orhanu KMR (KMDA)

Kyiv, 01030, Ukraine

Location

LLC Treatment and Diagnostic Center Adonis Plus

Kyiv, 02002, Ukraine

Location

Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

Kyiv, 03037, Ukraine

Location

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Kyiv, 03049, Ukraine

Location

Kyiv Regional Clinical Hospital

Kyiv, 4107, Ukraine

Location

Odeska oblasna klinichna likarnia

Odesa, 65025, Ukraine

Location

Ternopil municipal hospital #1

Ternopil, 46000, Ukraine

Location

MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

Uzhhorod, 88018, Ukraine

Location

Health Clinic Limited Liability Company

Vinnytsia, 21009, Ukraine

Location

KU 6 miska klinichna likarnia ZMR

Zaporizhzhya, 69035, Ukraine

Location

Barnsley District General Hospital

Barnsley, S75 2EP, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

St Georges Healthcare NHS Trust

London, SW17 0QT, United Kingdom

Location

Related Publications (4)

  • Panaccione R, Feagan BG, Afzali A, Rubin DT, Reinisch W, Panes J, Danese S, Hisamatsu T, Terry NA, Salese L, Van Rampelbergh R, Sahoo A, Vetter ML, Yee J, Han C, Frustaci ME, Wan KYY, Yang Z, Johanns J, Andrews JM, D'Haens GR, Sands BE; GALAXI 2 & 3 Study Group. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025 Jul 26;406(10501):358-375. doi: 10.1016/S0140-6736(25)00681-6. Epub 2025 Jul 17.

  • Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.

  • Danese S, Panaccione R, Feagan BG, Afzali A, Rubin DT, Sands BE, Reinisch W, Panes J, Sahoo A, Terry NA, Chan D, Han C, Frustaci ME, Yang Z, Sandborn WJ, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI-1 Study Group. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):133-146. doi: 10.1016/S2468-1253(23)00318-7. Epub 2023 Dec 14.

  • Sandborn WJ, D'Haens GR, Reinisch W, Panes J, Chan D, Gonzalez S, Weisel K, Germinaro M, Frustaci ME, Yang Z, Adedokun OJ, Han C, Panaccione R, Hisamatsu T, Danese S, Rubin DT, Sands BE, Afzali A, Andrews JM, Feagan BG; GALAXI-1 Investigators. Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study. Gastroenterology. 2022 May;162(6):1650-1664.e8. doi: 10.1053/j.gastro.2022.01.047. Epub 2022 Feb 5.

MeSH Terms

Conditions

Crohn Disease

Interventions

guselkumabUstekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Senior Medical Leader PEDIATRICS IMM
Organization
J&J Innovative Medicine

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 15, 2018

Study Start

April 13, 2018

Primary Completion

October 20, 2023

Study Completion (Estimated)

January 28, 2028

Last Updated

April 13, 2026

Results First Posted

May 7, 2025

Record last verified: 2026-04

Locations