Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466411
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Guselkumab Dose 3 Drug: Guselkumab Dose 4 Drug: Guselkumab Dose 5 Drug: Guselkumab Drug: Ustekinumab Drug: Placebo Phase 2 Phase 3

Detailed Description:
This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : June 3, 2022
Estimated Study Completion Date : October 23, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Phase 2 (GALAXI 1): Group 1 (Guselkumab)
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 1
Guselkumab will be administered by IV infusion.

Drug: Guselkumab Dose 2
Guselkumab will be administered by SC injection.

Experimental: Phase 2 (GALAXI 1): Group 2 (Guselkumab)
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 2
Guselkumab will be administered by SC injection.

Drug: Guselkumab Dose 3
Guselkumab will be administered by IV infusion.

Experimental: Phase 2 (GALAXI 1): Group 3 (Guselkumab)
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 4
Guselkumab will be administered by IV infusion.

Drug: Guselkumab Dose 5
Guselkumab will be by SC injection.

Active Comparator: Phase 2 (GALAXI 1): Group 4 (Ustekinumab)
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
Ustekinumab will be administered by IV infusion and SC injection.

Experimental: Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
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: Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.

Drug: Placebo
Placebo will be administered as IV infusion.

Experimental: Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
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
Guselkumab will be administered by IV infusion and SC injection.

Active Comparator: Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)
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
Ustekinumab will be administered by IV infusion and SC injection.

Experimental: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
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: Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.

Drug: Placebo
Placebo will be administered as IV infusion.




Primary Outcome Measures :
  1. Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity.

  2. Phase 3: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission is defined as CDAI score less than (<) 150 points.


Secondary Outcome Measures :
  1. Phase 2: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission is defined as CDAI score <150.

  2. Phase 2: Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score <150.

  3. Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12 [ Time Frame: Week 12 ]
    PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.

  4. Phase 2: Clinical-Biomarker Response at Week 12 [ Time Frame: Week 12 ]
    Clinical-biomarker response is defined using clinical response based on the CDAI score and reduction from baseline in C-reactive protein (CRP) or fecal calprotectin.

  5. Phase 2 and Phase 3: Endoscopic Response at Week 12 [ Time Frame: Week 12 ]
    Endoscopic Response is measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD is based on the evaluation of 4 endoscopic components across 5 ileocolonic segments, with a total score ranging from 0 to 56.

  6. Phase 3: Clinical Remission at Week 48 [ Time Frame: Week 48 ]
    Clinical remission is defined as CDAI score <150.

  7. Phase 3: Durable Clinical Remission at Week 48 [ Time Frame: Week 48 ]
    Durable clinical remission is defined as CDAI<150 for most of all visits between Week 12 and Week 48.

  8. Phase 3: Corticosteroid-Free Clinical Remission at Week 48 [ Time Frame: Week 48 ]
    Corticosteroid-free clinical remission is defined as CDAI score <150 at Week 48 and not receiving corticosteroids at Week 48.

  9. Phase 3: PRO-2 Remission at Week 48 [ Time Frame: Week 48 ]
    PRO-2 remission is defined based on average daily stool frequency (SF) and average daily abdominal pain (AP) score.

  10. Phase 3: Fatigue Response at Week 12 [ Time Frame: Week 12 ]
    Fatigue response will be based on the Patient-Reported Outcomes Measurement Information System (PROMIS). Fatigue Short Form 7a contains 7 items that evaluate the severity of fatigue, with higher scores indicating greater fatigue.

  11. Phase 3: Endoscopic Response at Week 48 [ Time Frame: Week 48 ]
    Endoscopic response is measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Prior exposure to p40 inhibitors or p19 inhibitors
  • Any medical contraindications preventing study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466411


Contacts
Layout table for location contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
United States, California
Advanced Research Center Inc Recruiting
Anaheim, California, United States, 92805
University Of California San Diego Not yet recruiting
La Jolla, California, United States, 92093
Om Research LLC Recruiting
Lancaster, California, United States, 93534
Inland Empire Liver Foundation Recruiting
Rialto, California, United States, 91106
United States, Florida
InvesClinic, LLC Recruiting
Fort Lauderdale, Florida, United States, 33308
Harmony Medical Research Institute, Inc. Recruiting
Hialeah, Florida, United States, 33016
Elite Research Network - Nature Coast Clinical Research, LLC Recruiting
Inverness, Florida, United States, 34452
SIH Research Recruiting
Kissimmee, Florida, United States, 34759
Visionary Investigators Network Recruiting
Miami, Florida, United States, 33180
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Theia Clincial Research, LLC Recruiting
Pinellas Park, Florida, United States, 33781
Clinical Research of West Florida Recruiting
Tampa, Florida, United States, 33603
Florida Hospital Tampa Recruiting
Tampa, Florida, United States, 33613
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
United States, Georgia
Atlanta Gastroenterology Associates Recruiting
Atlanta, Georgia, United States, 30342
Atlanta Center For Gastroenterology Recruiting
Decatur, Georgia, United States, 30033
Gastrointestinal Specialists of Georgia Withdrawn
Marietta, Georgia, United States, 30060
United States, Illinois
Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
IU Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Health Science Research Center Recruiting
Pratt, Kansas, United States, 67124
United States, Louisiana
Gastroenterology Associates Recruiting
Baton Rouge, Louisiana, United States, 70809
Gastroenterology Clinic of Acadiana Recruiting
Lafayette, Louisiana, United States, 70503
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
DelRicht Research Recruiting
New Orleans, Louisiana, United States, 70124
Louisiana Research Center, LLC Recruiting
Shreveport, Louisiana, United States, 71105
United States, Massachusetts
Harvard Medical School-Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Clinical Research Institute of Michigan, LLC Recruiting
Chesterfield, Michigan, United States, 48047
Associated cardiology Withdrawn
Saginaw, Michigan, United States, 48603
Huron Gastroenterology Associates Center for Digestive Care Recruiting
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minnesota Gastroenterology, P.A Withdrawn
Minneapolis, Minnesota, United States, 55446
United States, New Jersey
Atlantic Digestive Health Institute/ Atlantic IBD Center Recruiting
Morristown, New Jersey, United States, 07960
United States, New York
A1 Clinical Research Recruiting
Jackson Heights, New York, United States, 11372
NYU Langone Medical Center Recruiting
New York, New York, United States, 11021
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Syracuse VA Medical Center Not yet recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville Gastroenterology Associates Recruiting
Asheville, North Carolina, United States, 28801
University North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Cumberland Research Associates Recruiting
Fayetteville, North Carolina, United States, 28304
Carolina Research Not yet recruiting
Greenville, North Carolina, United States, 27834
PMG Research of Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Wexner Medical Center at the Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Integris Baptist Office Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Drexel University College of Medicine Suspended
Philadelphia, Pennsylvania, United States, 19107
Guthrie Medical Group, PC Withdrawn
Sayre, Pennsylvania, United States, 18840
United States, Rhode Island
LifeSpan Hospital System Withdrawn
Providence, Rhode Island, United States, 02903
United States, South Carolina
Clinical Trials of South Carolina Withdrawn
Charleston, South Carolina, United States, 29406
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212-1610
United States, Texas
Aztec Clinical Research, Inc. Recruiting
Channelview, Texas, United States, 77530
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Houston Methodist Hospital Not yet recruiting
Houston, Texas, United States, 77030
Memorial Hermann Hospital - TMC Withdrawn
Houston, Texas, United States, 77030
Biopharma Informatic Research Center Not yet recruiting
Houston, Texas, United States, 77043
CliniCore Houston Recruiting
Houston, Texas, United States, 77079
BI Research Center Not yet recruiting
Houston, Texas, United States, 77084
DHAT Research Institute Recruiting
Richardson, Texas, United States, 75082
Gastroenterology Research of America, LLC Recruiting
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
Baylor Scott & White Research Institute Recruiting
Temple, Texas, United States, 76508
Tyler Research Institute, LLC Recruiting
Tyler, Texas, United States, 75701
Victoria Gastroenterology Suspended
Victoria, Texas, United States, 77904
United States, Utah
Val Hansen Not yet recruiting
Bountiful, Utah, United States, 84010
United States, Virginia
University of Virginia Withdrawn
Charlottesville, Virginia, United States, 22908
Gastroenterology Associates of Tidewater Recruiting
Chesapeake, Virginia, United States, 23320
Center for Gastrointestinal Health Recruiting
Petersburg, Virginia, United States, 23805
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Australia
Monash Health, Monash Medical Centre Recruiting
Clayton, Australia, 3168
Concord Hospital Not yet recruiting
Concord, Australia, 2139
Austin Hospital Recruiting
Heidelberg, Australia, 3084
Royal Brisbane and Women's Hospital Withdrawn
Herston, Australia, 4029
Sir Charles Gairdner Hospital Recruiting
Nedlands, Australia, 6009
Royal Adelaide Hospital Recruiting
North Terrace, Australia, 5000
Royal Melbourne Hospital Recruiting
Parkville, Australia, 3050
Nepean Hospital Recruiting
Penrith, Australia, 2751
The Alfred Hospital Recruiting
Prahran, Australia, 3004
Mater Hospital Brisbane Recruiting
South Brisbane, Australia, 4101
Princess Alexandra Hospital Recruiting
Woolloongabba, Australia, 4102
Austria
Krankenhaus der Elisabethinen Linz Withdrawn
Linz, Austria, A-4020
Universitätsklinikum Salzburg - Landeskrankenhaus Recruiting
Salzburg, Austria, 5020
Akh Wien Not yet recruiting
Wien, Austria, 1090
Belarus
Gomel Regional Clinical Hospital Recruiting
Gomel, Belarus, 246029
Republican Research Centre of Radiation Medicine and Human E Recruiting
Gomel, Belarus, 246040
Grodno Regional Clinical Hospital Recruiting
Grodno, Belarus, 230017
BelMAPE Withdrawn
Minsk, Belarus, 220014
City Clinical Hospital #9 Recruiting
Minsk, Belarus, 220116
Vitebsk Regional Clinical Hospital Recruiting
Vitebsk, Belarus, 210037
Belgium
GZA Ziekenhuizen Withdrawn
Antwerpen, Belgium, 2018
CHU Saint-Pierre Recruiting
Bruxelles, Belgium, 1000
Az Groeninge Recruiting
Kortrijk, Belgium, 8500
CHwapi Recruiting
Tournai, Belgium, 7500
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska Recruiting
Banja Luka, Bosnia and Herzegovina, 78000
Clinical hospital Mostar Recruiting
Mostar, Bosnia and Herzegovina, 88000
Clinical Center University of Sarajevo Not yet recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Polyclinic Dr. Al-Tawil Recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Kantonalna bolnica Zenica Recruiting
Zenica, Bosnia and Herzegovina, 72000
Brazil
MK Blumenau Pesquisa Clínica Not yet recruiting
Blumenau, Brazil, 89010-506
Universidade Estadual Paulista 'Julio De Mesquita Filho' Not yet recruiting
Botucatu, Brazil, 18618-970
L2IP - Instituto de Pesquisas Clínicas Not yet recruiting
Brasília, Brazil, 70200-730
Hospital Nossa Senhora Das Gracas Not yet recruiting
Curitiba, Brazil, 80810-040
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Not yet recruiting
Goiania, Brazil, 74535-170
Hospital Universitrio Santa Terezinha Not yet recruiting
Joaaba, Brazil, 89600-000
Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS Recruiting
Porto Alegre, Brazil, 90035-903
Hospital Ernesto Dornelles Withdrawn
Porto Alegre, Brazil, 90160-093
UFRJ-Hospital Universitário Clementino Fraga Filho Not yet recruiting
Rio de Janeiro, Brazil, 21941-913
Bioclinica Inc. Research Network Withdrawn
Rio de Janeiro, Brazil, 22271-100
Pesquisare Saude Not yet recruiting
Santo Andre, Brazil, 09080-110
CEMEC - Centro Multidisciplinar de Estudos Clínicos Not yet recruiting
Santo André, Brazil, 09190-510
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto Recruiting
Sao Jose do Rio Preto, Brazil, 15090-000
Hemomed Not yet recruiting
Sao Paulo, Brazil, 01236-030
CEP - Hospital das Clinicas da FMUSP Not yet recruiting
Sao Paulo, Brazil, 05403000
Hospital Israelita Albert Einstein Withdrawn
São Paulo, Brazil, 05652-900
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N4Z6
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A1R9
Canada, Nova Scotia
QEII Health Sciences Centre Withdrawn
Helifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Toronto Digestive Disease Associates Inc Withdrawn
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
MUHC Center for Applied Ethics Recruiting
Montreal, Quebec, Canada, H3H2R9
Canada
GI Research Institute (G.I.R.I.) Withdrawn
Edmonton, Canada, T5H4B9
University of Alberta- Ziedler Ledcor Centre Not yet recruiting
Edmonton, Canada, T6G 2X8
Chile
Instituto Oncologico Viña del Mar Withdrawn
Viña del Mar, Chile, 2540364
China
Peking University First Hospital Not yet recruiting
Beijing, China, 100034
Peking University People's Hospital Not yet recruiting
Beijing, China, 100044
Beijing Friendship Hospital Not yet recruiting
Beijing, China, 100050
Peking University Third Hospital Not yet recruiting
Beijing, China, 100191
The Military General Hospital of Beijing PLA Not yet recruiting
Beijing, China, 100700
The second Xiangya Hospital of Central South University Not yet recruiting
Changsha, China, 200120
West China Hospital, Sichuan University Not yet recruiting
Chengdu, China, 610041
The Second Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, China, 400010
Chongqing Qijiang People Hospital Not yet recruiting
Guangzhou, China, 510080
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Not yet recruiting
Guangzhou, China, 510235
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital Not yet recruiting
Guangzhou, China, 510610
The Second Affiliated Hospital of Zhejiang University Not yet recruiting
Hangzhou, China, 310003
Sir Run Run Shaw Hospital, Zhejiang University Not yet recruiting
Hangzhou, China, 310016
The 1st affiliated hospital of Anhui Medical University Not yet recruiting
Hefei, China, 230022
First Affiliated Hospital of Kunming Medical Unversity Withdrawn
Kunming, China, 650032
The First Affiliated Hospital of NanChang University Not yet recruiting
Nanchang, China, 330006
Nanjing Drum Tower Hospital Not yet recruiting
Nanjing, China, 210008
Zhongda Hospital,Southeast University Not yet recruiting
Nanjing, China, 210009
Shanghai 10th Peoples Hospital Withdrawn
Shanghai, China, 200072
Shanghai General Hospital Not yet recruiting
Shanghai, China, 200080
Shanghai East Hospital Not yet recruiting
Shanghai, China, 200120
Shanghai Renji Hospital Not yet recruiting
Shanghai, China, 200127
Second Military Medical University (SMMU) Not yet recruiting
Shanghai, China, 200433
Tongji Hospital of Tongji University Not yet recruiting
Shanghai, China, 430030
Ruijin Hospital, Shanghai Jiao Tong University Not yet recruiting
Shanghai, China
The first hospital of China medical university Withdrawn
Shenyang, China, 110001
University of Hong Kong-Shenzhen Hospital Not yet recruiting
Shenzhen, China, 518053
The first affiliated hospital of suzhou University Not yet recruiting
Suzhou, China
The First Affiliated Hospital of Wenzhou Medical University Not yet recruiting
Wenzhou, China, 325003
Wuhan Union Hospital Not yet recruiting
Wuhan, China, 430022
Zhongshan Hospital, Xiamen University Withdrawn
Xiamen, China, 361004
Zhangzhou Municipal Hospital of Fujian Province Not yet recruiting
Zhangzhou, China, 363000
Colombia
Endocare Ltda. Recruiting
Bogota, Colombia, 111111
Centro Médico Imbanaco Recruiting
Cali, Colombia, 760042
Hospital Pablo Tobón Uribe Withdrawn
Medellin, Colombia
Instituto De Coloproctologia Ico S.A.S Withdrawn
Medellin, Colombia
Croatia
Klinički bolnički centar Osijek Withdrawn
Osijek, Croatia, 31000
Opca bolnica Zadar Recruiting
Zadar, Croatia, 23000
CH Sestre Milosrdnice Recruiting
Zagreb, Croatia, 10000
University Hospital Center Zagreb Terminated
Zagreb, Croatia, 10000
University Hospital Dubrava Recruiting
Zagreb, Croatia, 10000
Czechia
NH Hospital, a.s. Recruiting
Horovice, Czechia, 268 31
FN Hradec Kralove Withdrawn
Hradec Kralove, Czechia, 500 05
Hepato-gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czechia, 500 12
Fakultni nemocnice Ostrava Withdrawn
Ostrava - Poruba, Czechia, 70852
Fakultni nemocnice Kralovske Vinohrady Recruiting
Praha 10, Czechia, 100 34
ISCARE I.V.F. a.s. Recruiting
Praha 7, Czechia, 170 00
France
CHU Amiens Recruiting
Amiens, France, 80054
Hôpital Besançon Recruiting
Besançon, France, 25030
Centre Hospitalier Universitaire (CHU) de Caen Withdrawn
Caen, France, 14033
CHRU de Tours - Hopital Trousseau Recruiting
Chambray Les Tours Centre, France, 37170
CHU Clermont-Ferrant-Hopital Hotel Dieu Withdrawn
Clermont-Ferrand Cedex 3, France, 63000
Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon Withdrawn
Clichy-Sous-Bois, France, 92110
Hopital Louis Mourier Not yet recruiting
Colombes Cedex, France, 92701
CHRU de Lille - Hôpital Claude Huriez Recruiting
Lille, France, 59037
Aphm - Hopital Nord Recruiting
Marseille, France, 13015
CHRU Montpellier - Hopital Saint-Eloi Recruiting
Montpellier Cedex 5, France, 34295
CHU de Nantes hôtel-Dieu Recruiting
Nantes, France, 44093
CHU de Nice Hopital de l Archet Recruiting
Nice cedex 03, France, 06202
Hôpital Saint Louis Withdrawn
Paris, France, 75475
Groupement Hospitalier Universitaire Ouest Recruiting
Paris, France, 75908
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Hôpital Robert Debré Recruiting
Reims, Cedex, France, 51092
CHU Saint-etienne Recruiting
Saint Etienne, France, 42055
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Recruiting
Strasbourg CEDEX, France, 67098
CHU Rangueil Recruiting
Toulouse, France, 31059
Hopital Purpan Recruiting
Toulouse, France, 31059
Georgia
LTD 'Aversi Clinic' Recruiting
T'bilisi, Georgia, 0160
Israel Georgian medical research clinic Helsicore Recruiting
Tbilisi, Georgia, 0112
TSMU The First University Clinic Recruiting
Tbilisi, Georgia, 0141
Institute of Clinical Cardiology, Ltd. Recruiting
Tbilisi, Georgia, 0159
LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital' Recruiting
Tbilisi, Georgia, 0159
LTD Unimed Kakheti- Telavi Referral Hospital Recruiting
Telavi, Georgia, 2200
Germany
Gastroenterologische Spezialpraxis - Berlin-Karlshorst Recruiting
Berlin-Karlshorst, Germany, 10318
Charité - Campus Mitte Recruiting
Berlin, Germany, 10117
Universitaetsklinikum Charite, Campus Virchow Klinikum Recruiting
Berlin, Germany, 13353
Vivantes Klinikum Spandau Not yet recruiting
Berlin, Germany, 13585
Krankenhaus Waldfriede Mitte Recruiting
Berlin, Germany, 14163
Universitatsklinikum Bonn Withdrawn
Bonn, Germany, 53105
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus Recruiting
Frankfurt/Main, Germany, 60431
JWG-University Hospital Recruiting
Frankfurt, Germany, 69590
Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk Withdrawn
Halle, Germany, 06120
Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie Recruiting
Hamburg, Germany, 20246
Asklepios Westklinikum Completed
Hamburg, Germany, 22559
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Universitaetsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Universitatsklinikum Schleswig-Holstein - Kiel Recruiting
Kiel, Germany, 24105
Gemeinschaftspraxis Germania-Campus Recruiting
Münster, Germany, 48159
Praxiszentrum Alte Mälzerei Recruiting
Regensburg, Germany, 93053
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Greece
Laiko General Hospital of Athens Recruiting
Athens, Greece, 11527
University Hospital of Heraklion Recruiting
Heraklion, Greece, 71110
University General Hospital of Ioannina Withdrawn
Ioannina, Greece, 45100
Hungary
Obudai Egeszsegugyi Centrum Kft. Not yet recruiting
Budapest, Hungary, 1036
Szent János Kórház és Észak-budai Egyesített Kórházak Withdrawn
Budapest, Hungary, 1125
Meddica Centre Hungarian Defence Froces Not yet recruiting
Budapest, Hungary, H-1062
Semmelweis Egyetem Not yet recruiting
Budapest, Hungary, H-1088
Réthy Pál Kórház - Rendelőintézet Not yet recruiting
Békéscsaba, Hungary, 5600
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Withdrawn
Gyula, Hungary, 5701
Kaposi Mór Oktató Kórház, Kardiológiai Részleg Withdrawn
Kaposvár, Hungary, 7400
Karolina Hospital Not yet recruiting
Mosonmagyarovár, Hungary, H-9200
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp. Withdrawn
Szeged, Hungary, 6720
India
Kaizen Hospital Withdrawn
Ahmedabad, India, 380052
Bangalore Medical College and Research Institute Withdrawn
Bangalore, India, 560002
Postgraduate Institute of Medical Education and Research Withdrawn
Chandigarh, India, 160012
Citizen Hospital Withdrawn
Hyderabad, India, 500019
Asian Institute Of Gastroenterology Withdrawn
Hyderabad, India, 500082
SMS Hospital Withdrawn
Jaipur, India, 302004
Baba Farid University of Health Sciences - Christian Medical Withdrawn
Ludhiana, India, 141008
P.D. Hinduja National Hospital and - Medical Research Center Withdrawn
Mumbai, India, 400016
Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute Withdrawn
Nashik, India, 422005
All India Institute of Medical Sciences Withdrawn
New Delhi, India, 110029
Nirmal Hospital Pvt. Ltd. Withdrawn
Surat, India, 395002
Surat Institute of Digestive Sciences Hospitals Withdrawn
Surat, India, 395002
Samvedana Hospital Withdrawn
Varanasi, India, 221005
Andhra Hospitals Withdrawn
Vijayawada, India, 520 002
Government Siddhartha Medical College Withdrawn
Vijayawada, India, 520008
Israel
Ha'Emek Medical Center Recruiting
Afula, Israel, 1834111
Barzilai Medical Center Recruiting
Ashkelon, Israel, 78278
Hillel Yaffe Medical Center Withdrawn
Hadera, Israel, 38100
Bnai Zion Medical Center Recruiting
Haifa, Israel, 3339419
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Hadassah Medical Organization Ein Kerem Withdrawn
Jerusalem, Israel, 91120
Meir Medical Center Recruiting
Kfar Saba, Israel, 4428164
Galilee Medical Center Withdrawn
Nahariya, Israel, 2210001
Rabin Med Ctr Beilinson Hosp Recruiting
Petah Tikva, Israel, 4941492
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 5262000
Tel Aviv Sourasky Medical Center Withdrawn
Tel Aviv, Israel, 6423906
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Italy
Policlinico S.Orsola Malpighi, AOU di Bologna Not yet recruiting
Bologna, Italy, 40138
Ospedale Santissima Annunziata Not yet recruiting
Cento, Italy, 44042
AOU Careggi Not yet recruiting
Firenze, Italy, 50134
AOU Policlinico G.Martino Recruiting
Messina, Italy, 98125
Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura Recruiting
Milano, Italy, 20097
AOU Policlinico di Modena Withdrawn
Modena, Italy, 41124
Università Campus Biomedico di Roma Recruiting
Roma, Italy, 00128
IBD Unit- Sandro Pertini Hospital Not yet recruiting
Roma, Italy, 00157
Catholic University of Sacred Hearth Recruiting
Roma, Italy, 00168
Complesso Integrato Columbus Recruiting
Rome, Italy, 00168
Istituto Clinico Humanitas Rozzano, IRCCS Recruiting
Rozzano, Italy, 20089
Ospedale Molinette, AO Città della Salute e della Scienza di Withdrawn
Torino, Italy, 10126
S.C. Gastroenterologia Not yet recruiting
Torino, Italy, 10128
Azienda Ospedaliero Universitaria S.Maria Della Misericordia Not yet recruiting
Udine, Italy, 33100
Policlinico G.B.Rossi Recruiting
Verona, Italy, 37134
Japan
Asahikawa City Hospital Recruiting
Asahikawa, Japan, 070-8610
Juntendo University Hospital Recruiting
Bunkyo-ku, Japan, 113-8431
Chiba University Hospital Recruiting
Chiba, Japan, 260-8677
Fukuoka University Chikushi Hospital Recruiting
Chikushino, Japan, 818-8502
Saiseikai Fukuoka General Hospital Recruiting
Fukuoka-shi, Japan, 810-0001
Fukuoka University Hospital Recruiting
Fukuoka-shi, Japan, 814-0180
Gifu University Hospital Recruiting
Gifu, Japan, 501-1194
Matsuda Hospital Recruiting
Hamamatsu-shi, Japan, 432-8061
Mito Medical Center Recruiting
Higashiibaraki-gun, Japan, 311-3193
Hirosaki National Hospital Recruiting
Hirosaki, Japan, 036-8545
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Izumiotsu Municipal Hospital Recruiting
Izumiotsu, Japan, 595-0027
Shimane University Hospital Recruiting
Izumo, Japan, 693-8501
Sameshima Hospital Recruiting
Kagoshima, Japan, 892-0846
Aoyama Naika Clinic Recruiting
Kobe, Japan, 650-0015
Kobe University Hospital Recruiting
Kobe, Japan, 650-0017
Kochi National Hospital Recruiting
Kochi, Japan, 780-8077
Yamanashi Prefectural Central Hospital Recruiting
Kofu, Japan, 400-8506
Kurume University Hospital Recruiting
Kurume, Japan, 830-0011
Kyoto Prefectural University of Medicine Hospital Recruiting
Kyoto, Japan, 602-8566
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Kitasato Institute Hospital Biomedical Research Center, Clinical Trial Unit Recruiting
Minato-ku, Japan, 108-8642
Kyorin University Hospital Suspended
Mitaka, Japan, 181-8611
Iwate Medical University Hospital Recruiting
Morioka, Japan, 020-8505
Aichi Medical University Hospital Recruiting
Nagakute, Japan, 480-1195
Nagasaki University Hospital Recruiting
Nagasaki, Japan, 852-8501
Nagoya City University Hospital Recruiting
Nagoya, Japan, 467-8602
Niigata University Medical & Dental Hospital Withdrawn
Niigata, Japan, 951-8520
Hyogo College of Medicine Hospital Recruiting
Nishinomiya, Japan, 663-8501
Oita Red Cross Hospital Recruiting
Oita, Japan, 870-0033
Keiaikai Chibana Clinic Recruiting
Okinawa, Japan, 904-2143
Kinshu-kai Infusion Clinic Recruiting
Osaka, Japan, 530-0011
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Osaka University Hospital Recruiting
Osaka, Japan, 565-0871
National Hospital Organization Higashi Ohmi General Medical Center Recruiting
Otsu-shi, Japan, 527-8505
Shiga University of Medical Science Hospital Recruiting
Otsu, Japan, 520-2192
Saitama Medical Center Not yet recruiting
Saitama, Japan, 330-0074
Toho University Sakura Medical Center Recruiting
Sakura, Japan, 285-8741
Hokkaido University Hospital Recruiting
Sapporo-shi, Japan, 060-8648
Sapporo-Kosei General Hospital Recruiting
Sapporo, Japan, 060-0033
Sapporo East tokusyu-kai Hospital Recruiting
Sapporo, Japan, 065-0033
Keio University Hospital Recruiting
Shinjuku-ku, Japan, 160-8582
Tokyo Yamate Medical Center Recruiting
Shinjuku-ku, Japan, 169-0073
Takamatsu Red Cross Hospital Not yet recruiting
Takamatsu, Japan, 760-0017
Kagawa Prefectural Central Hospital Recruiting
Takamatsu, Japan, 760-8557
The Jikei University Hospital Not yet recruiting
Tokyo, Japan, 105-8471
Yuaikai Tomishiro Central Hospital Not yet recruiting
Tomishiro, Japan, 901-0243
Toyama City Hospital Not yet recruiting
Toyama-shi, Japan, 939-8511
Fujita Health University Hospital Recruiting
Toyoake, Japan, 470-1192
Mie University Hospital Recruiting
Tsu, Japan, 514-8507
Wakayama Medical University Hospital Recruiting
Wakayama, Japan, 641-8509
Jordan
Khalidi Hospital and Medical Center Recruiting
Amman, Jordan, 11183
Prince Hamza Hospital Withdrawn
Amman, Jordan, 11731
Jordan University Hospital Not yet recruiting
Amman, Jordan, 11942
King Abdullah University Hospital Recruiting
Irbid, Jordan, 22110
Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan-si, Korea, Republic of, 15355
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 48108
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 602-812
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
CHA Bundang Medical center, CHA University Recruiting
Seongnam, Korea, Republic of, 13496
Kyung Hee University Medical Center Withdrawn
Seoul, Korea, Republic of, 02447
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 03181
Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 6973
The Catholic University of Korea St. Vincent's Hospital Recruiting
Suwon-si, Korea, Republic of, 16247
Ewha Womans University Mokdong Hospital Recruiting
YangCheon-Gu, Korea, Republic of, 07985
Latvia
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia, LV-1002
Riga East Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1038
Alda Pukisa arsta prakse Not yet recruiting
Riga, Latvia, LV-1046
Lebanon
American Universitty of Beirut Medical Center Recruiting
Beirut, Lebanon, 110 72020
St Georges Hospital university medical centre Withdrawn
Beirut, Lebanon, 166378
Hotel Dieu de France Hospital Recruiting
Beirut, Lebanon, 166830
Bellevue Medical Center Recruiting
Beirut, Lebanon
Mount Lebanon Hospital Recruiting
Beirut, Lebanon
Rafik Hariri University Hospital Recruiting
Beirut, Lebanon
Notre Dame De Secours Withdrawn
Jbeil, Lebanon
Hammoud Hospital Withdrawn
Saida, Lebanon
Lithuania
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik Recruiting
Kaunas, Lithuania, LT-50009
Vilniaus Universiteto Ligonines Santariskiu Klinikos Recruiting
Vilnius, Lithuania, LT-08661
Malaysia
Hospital Ampang Recruiting
Ampang, Malaysia, 68000
Hospital Raja Perempuan Zainab Ii Recruiting
Kota Bahru, Malaysia, 15160
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59120
Netherlands
Academisch Medisch Centrum Universiteit van Amsterdam Recruiting
Amsterdam, Netherlands, 1105 AZ
Academisch Ziekenhuis Maastricht Recruiting
Maastricht, Netherlands, 6229 HX
Stichting Zuyderland Medisch Centrum Recruiting
Sittard-Geleen, Netherlands, 6130 MB
New Zealand
Auckland City Hospital Not yet recruiting
Auckland, New Zealand, 1142
Dunedin Hospital Recruiting
Dunedin, New Zealand, 9016
Waikato Hospital Recruiting
Hamilton, New Zealand, 3240
North Macedonia
General City Hospital 8mi Septemvri Recruiting
Skopje, North Macedonia, 1000
University Clinic of Gastroenterohepatology Recruiting
Skopje, North Macedonia, 1000
Poland
Centrum medyczne plejady Recruiting
Krakow, Poland, 30-363
Centrum Medyczne Pratia Krakow Withdrawn
Krakow, Poland, 31-002
Centrum Medyczne Promed Recruiting
Krakow, Poland, 31-513
Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K. Recruiting
Lublin, Poland, 20-582
Wojewodzki Szpital Specjalistyczny w Olsztynie Recruiting
Olsztyn, Poland, 10-561
Centrum Medyczne 'Medyk' Sp. z o.o. K. Recruiting
Rzeszow, Poland, 35-055
Endoskopia Sp z o.o. Recruiting
Sopot, Poland, 81-756
Twoja Przychodnia - Szczecinskie Centrum Medyczne Recruiting
Szczecin, Poland, 71-270
Toruńskie Centrum Gastrologiczne Recruiting
Toruń, Poland, 87-100
H-T Centrum Medyczne Endoterapia Recruiting
Tychy, Poland, 43-100
NZOZ Vivamed Zespol Lekarzy Specjalistow Recruiting
Warsaw, Poland, 03-580
Wojskowy Instytut Medyczny Recruiting
Warszawa, Poland, 00-141
Centrum Medyczne Pratia Warszawa Withdrawn
Warszawa, Poland, 01-868
Centrum Badawcze Wspolczesnej Terapii Recruiting
Warszawa, Poland, 02-679
Centrum Zdrowia Tuchow Recruiting
Wierzchoslawice, Poland, 33-122
Melita Medical Sp. z o.o. Recruiting
Wroclaw, Poland, 50-449
Przychodnia Vistamed Recruiting
Wroclaw, Poland, 53-149
ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c. Recruiting
Wroclaw, Poland, 53-333
ETG Zamosc Recruiting
Zamosc, Poland, 22-400
Portugal
Hospital da Senhora da Oliveira Recruiting
Guimarães, Portugal, 4835-044
Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente Not yet recruiting
Lisbon, Portugal, 2720-276
H. Santo António - Centro Hospitalar do Porto Not yet recruiting
Porto, Portugal, 4099-001
Centro Hospitalar de Entre o Douro e Vouga, E.P.E Recruiting
Santa Maria da Feira, Portugal, 4520-211
Puerto Rico
San Juan Bautista School of Medicine Recruiting
Caguas, Puerto Rico, 00726
Hopital San Cristobal Not yet recruiting
Ponce, Puerto Rico, 00795
Russian Federation
Kazan State Medical University Recruiting
Kazan, Russian Federation, 420012
KGBUZ 'Regional Clinical Hospital' Recruiting
Krasnoyarsk, Russian Federation, 660022
State Scientific Centre of Coloproctology Withdrawn
Moscow, Russian Federation, 123423
Novgorod Regional Clinical Hospital n.a. N.A. Semashko Recruiting
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk Region Clinical Hospital Withdrawn
Novosibirsk, Russian Federation, 630087
Federal State Budgetary Institution 'Scientific Research In Withdrawn
Novosibirsk, Russian Federation, 630117
Clinical Diagnostic Center 'Ultramed' Recruiting
Omsk, Russian Federation, 644024
GBUZ of Moscow Region City Clinical Hospital #3 Recruiting
Podolsk, Russian Federation, 142105
GBOU VPO Rostov State Medical University Recruiting
Rostov-na-Donu, Russian Federation, 344022
City Hospital #20 Recruiting
Rostov-on-Don, Russian Federation, 344091
Clinical Hospital #122 n.a. after L.G. Sokolov Recruiting
Saint Petersburg, Russian Federation, 194291
City Hospital #9 Withdrawn
Saint Petersburg, Russian Federation, 197110
City Hospital named after St. Martyr Elizabeth Recruiting
Saint-Petersburg, Russian Federation, 195257
City Clinical Hospital # 26 Recruiting
Saint-Petersburg, Russian Federation, 196247
Medical University Reaviz Recruiting
Samara, Russian Federation, 443001
NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways' Recruiting
Samara, Russian Federation, 443041
City Hospital# 40 Withdrawn
Sestroretsk, Russian Federation, 197706
St.Petersburg State Medical University n.a.Pavlov Recruiting
St Petersburg, Russian Federation, 197022
City Clinical Hospital #31 Recruiting
St. Petersburg, Russian Federation, 197110
LLC PoliClinic EXPERT Withdrawn
St. Petersburg, Russian Federation, 197110
Tomsk Regional Clinical Hospital Recruiting
Tomsk, Russian Federation, 634063
Ulyanovsk Regional Clinical Hospital Recruiting
Ulyanovsk, Russian Federation, 432063
GUZ Novgorod Regional Clinical Hospital Recruiting
Velikiy Novgorod, Russian Federation, 173008
Saudi Arabia
King Abdullah Medical City in Holy Capital Recruiting
Makkah, Saudi Arabia, 21955
King Abdul Aziz Medical City for National Guard Health Affairs Not yet recruiting
Riyadh, Saudi Arabia, 11426
King Khalid Hospital Withdrawn
Riyadh, Saudi Arabia, 12372
Serbia
Clinical Center of Serbia Recruiting
Belgrade, Serbia, 11000
Special hospital for Internal diseases, Oncomed system Recruiting
Belgrade, Serbia, 11000
Zvezdara University Medical Center Recruiting
Belgrade, Serbia, 11000
Clinical Hospital Center Bezanijska Kosa Recruiting
Belgrade, Serbia, 11080
Clinical Center Kragujevac Recruiting
Kragujevac, Serbia, 34000
Slovakia
FNsP F.D.R. Banska Bystrica Recruiting
Banska Bystrica, Slovakia, 975 17
ENDOMED s.r.o Recruiting
Kosice, Slovakia, 040 13
GASTRO I. s.r.o. Recruiting
Presov, Slovakia, 080 01
Spain
Complejo Hosp Univ. de Ferrol Recruiting
Ferrol, Spain, 15405
Hosp. Univ. Fuenlabrada Withdrawn
Fuenlabrada, Spain, 28942
Hosp. Univ. Dr. Josep Trueta Recruiting
Girona, Spain, 17007
Hosp. Gral. Juan Ramon Jimenez Not yet recruiting
Huelva, Spain, 21005
Hosp. Univ. Ramon Y Cajal Withdrawn
Madrid, Spain, 28034
Hosp. Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hosp. Univ. Pta. de Hierro Majadahonda Not yet recruiting
Majadahonda, Spain, 28222
Hosp. Univ. Central de Asturias Recruiting
Oviedo, Spain, 33011
Hosp. Univ. de Torrejon Recruiting
Torrejón de Ardoz, Spain, 28850
Hosp. Alvaro Cunqueiro Recruiting
Vigo, Spain, 36312
Switzerland
Gastroenterologische Praxis Balsiger und Seibold Withdrawn
Bern, Switzerland, 3012
Taiwan
Chang-Hua Christian Hospital Recruiting
Changhua, Taiwan, 500
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Chang-Gung Memorial Hospital-Linkou Not yet recruiting
Taoyuan, Taiwan, 33305
Tunisia
Hopital Regional Mohamed Tahar El Maamouri Not yet recruiting
Nabul, Tunisia, 8000
Hopital Universitaire Sahloul Not yet recruiting
Sousse, Tunisia, 4051
Hospital La Rabta Not yet recruiting
Tunis Jebbari, Tunisia, 1007
Hopital Habib Thameur Not yet recruiting
Tunis, Tunisia, 1008
Military Hospital of Instruction of Tunis Not yet recruiting
Tunis, Tunisia
Turkey
Cukurova University Medical Faculty Balcali Hospital Withdrawn
Adana, Turkey, 00133
Hacettepe University Medical Faculty Recruiting
Ankara, Turkey, 06100
Gulhane Egitim ve Arastirma Hastanesi Terminated
Ankara, Turkey, 6010
Ankara University Medical Faculty Suspended
Ankara, Turkey, 6100
Acibadem Fulya Hospital Recruiting
D:14/4 Nisantasi, Turkey, 34340
Firat University Hospital Recruiting
Elazig, Turkey, 23200
Gaziantep University School of Medicine Withdrawn
Gaziantep, Turkey, 27310
Mustafa Kemal University Research and Practise Hospital Recruiting
Hatay, Turkey, 31001
Bezmialem University Medical Faculty Withdrawn
İstanbul, Turkey, 34093
Sisli Etfal Egitim ve Arastirma Hospital Recruiting
Istanbul, Turkey, 34360
Marmara University Medical Faculty Recruiting
Istanbul, Turkey, 34899
Dokuz Eylul Universitesi Tip Fakultesi Recruiting
Izmir, Turkey, 35210
Istanbul Medeniyet University Goztepe Training and Research Hospital Withdrawn
Kadikoy, Turkey, 34722
Kocaeli University Medical Faculty Recruiting
Kocaeli, Turkey, 41380
Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari Suspended
Malatya, Turkey, 44280
Mersin University Medical Faculty Withdrawn
Mersin, Turkey, 33343
Ukraine
Kharkiv City Clinical Hospital Recruiting
Kharkiv, Ukraine, 61037
KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha Recruiting
Kherson, Ukraine, 73000
O.O.Bogomolets National Medical University, Kyiv City Clinical Hospital #18, Recruiting
Kyiv, Ukraine, 01030
Kyiv Regional Clinical Hospital Recruiting
Kyiv, Ukraine, 4107
Odeska oblasna klinichna likarnia Recruiting
Odesa, Ukraine, 65025
Sumska oblasna klinichna likarnia Withdrawn
Sumy, Ukraine, 40022
Ternopil municipal hospital #1 Recruiting
Ternopil, Ukraine, 46000
Transcarpathian Regional Clinical Hospital Recruiting
Uzhgorod, Ukraine, 88000
Medical Clinical Investigational Center of Medical Center 'Health Clinic' Recruiting
Vinnytsia, Ukraine, 21009
Komunalna ustanova 'Miska likarnia №1' Withdrawn
Zaporizhzhia, Ukraine, 69104
Zaporizka oblasna klinichna likarnia Suspended
Zaporizhzhia, Ukraine, 69600
KU 6 miska klinichna likarnia ZMR Recruiting
Zaporozhye, Ukraine, 69035
United Kingdom
Barnsley District General Hospital Not yet recruiting
Barnsley, United Kingdom, S75 2EP
Addenbrooke's Hospital Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Leighton Hospital Suspended
Crewe, United Kingdom, CW1 4QJ
Whipps Cross University Hospital Withdrawn
London, United Kingdom, E111NR
St George's Healthcare NHS Trust Not yet recruiting
London, United Kingdom, SW17 0QT
Nottingham University Hospitals NHS Trust Withdrawn
Nottingham, United Kingdom, NG7 2UH
Sandwell & West Birmingham Hospitals NHS Trust/Sandwell Gene Not yet recruiting
West Bromwich, United Kingdom, B71 4HJ
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03466411     History of Changes
Other Study ID Numbers: CR108387
2017-002195-13 ( EudraCT Number )
CNTO1959CRD3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs