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A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (DUET-CD)

Primary Purpose

Crohn's Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Golimumab
JNJ-78934804
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
  • Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
  • If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

  • Complications of CD that may be anticipated to require surgery
  • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
  • Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
  • Has a draining (example, functioning) stoma or ostomy
  • Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
  • Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer

Sites / Locations

  • University of Alabama Liver CenterRecruiting
  • Del Sol Research Management, LLCRecruiting
  • Moore Clinical Trials, LLCRecruiting
  • Om Research LLCRecruiting
  • Valley Gastroenterology Medical GroupRecruiting
  • Southern California Research CenterRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Hoag Memorial HospitalRecruiting
  • Medical Associates Research Group, Inc.Recruiting
  • University of ColoradoRecruiting
  • Medical Research Center of ConnecticutRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • Pioneer Research Solutions Inc.Recruiting
  • Homestead Associates in Research, IncRecruiting
  • Florida Research Center Inc.Recruiting
  • Gastroenterology Group Of NaplesRecruiting
  • Omega Research ConsultantsRecruiting
  • Synergy Clinical ResearchRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Gastroenterolgy Associates of Central GARecruiting
  • Gastrointestinal Specialists of GeorgiaRecruiting
  • IU Health University HospitalRecruiting
  • Gastroenterology of Southern IndianaRecruiting
  • Cotton O'Neil Digestive Health CenterRecruiting
  • Ascension via Christi ResearchRecruiting
  • Univ. of KS School of MedRecruiting
  • Tri-State Gastroenterology AssocRecruiting
  • University of KentuckyRecruiting
  • Gastroenterology Clinic of AcadianaRecruiting
  • Tandem Clinical ResearchRecruiting
  • Ochsner Medical CenterRecruiting
  • Chevy Chase Clinical ResearchRecruiting
  • Brigham & Women's HospitalRecruiting
  • FC Research, LLCRecruiting
  • Detroit Clinical Research Center
  • Gastrointestinal Associates LLPRecruiting
  • Care Access Las Vegas
  • A1 Clinical ResearchRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • Lenox Hill HospitalRecruiting
  • Mohawk Valley Endoscopy Center
  • University of North CarolinaRecruiting
  • Tryon Medical GroupRecruiting
  • PMG Research of Winston-SalemRecruiting
  • University Hospitals Case Medical CenterRecruiting
  • Northshore Gastroenterology Research, LLCRecruiting
  • The Oregon ClinicRecruiting
  • Susquehanna Gastroenterology AssociatesRecruiting
  • Medical University of South CarolinaRecruiting
  • Digestive Disease AssociatesRecruiting
  • Saint Francis HospitalRecruiting
  • Galen Medical GroupRecruiting
  • Etsu Quillen College Of MedicineRecruiting
  • Amel Med LLC. ResearchRecruiting
  • Accurate Clinical ResearchRecruiting
  • Gastroenterology Clinic Of San Antonio P ARecruiting
  • Texas Digestive Disease ConsultantsRecruiting
  • Digestive Health SpecialistsRecruiting
  • Care Access Research- Salt Lake CityRecruiting
  • University of VirginiaRecruiting
  • Hunter Holmes McGuire Veterans Affairs Medical CenterRecruiting
  • Washington Gastroenterology, PLLCRecruiting
  • Swedish Medical CenterRecruiting
  • University of Washington Digestive Disease CenterRecruiting
  • Digestive Health SpecialistsRecruiting
  • Marshall Health Clinical Research CenterRecruiting
  • Akh WienRecruiting
  • Algemeen Ziekenhuis DeltaRecruiting
  • VitazRecruiting
  • UMHAT 'Aleksandrovska' EADRecruiting
  • MHAT Tzaritza JoannaRecruiting
  • Foothills HospitalRecruiting
  • Gastroenterology and Internal Medicine Research Institute (GIRI)Recruiting
  • University of Alberta HospitalRecruiting
  • Fraser Clinical Trials Inc.Recruiting
  • GIRI Gastrointestinal Research InstituteRecruiting
  • Winnipeg Health Sciences CentreRecruiting
  • Viable Clinical ResearchRecruiting
  • Nova Scotia Health AuthorityRecruiting
  • Barrie GI AssociatesRecruiting
  • London Health Sciences CentreRecruiting
  • Toronto Immune & Digestive Health Institute Inc.Recruiting
  • CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-RosemontRecruiting
  • McGill University - Health Centre - Montreal General HospitalRecruiting
  • St. Jerome Medical ResearchRecruiting
  • CMIIM, Centre médical L'EnjeuRecruiting
  • Royal University HospitalRecruiting
  • Viable Clinical ResearchRecruiting
  • Hopital ChicoutimiRecruiting
  • China-Japan Friendship HospitalRecruiting
  • The second Xiangya Hospital of Central South UniversityRecruiting
  • Changzhou No.2 People's HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Chongqing Medical UniversityRecruiting
  • The First People's Hospital of FoshanRecruiting
  • Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal HospitalRecruiting
  • Guangzhou First Municipal People's HospitalRecruiting
  • Nanfang Hospital of Southern Medical HospitalRecruiting
  • Hainan General HospitalRecruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
  • Jinhua municipal central hospitalRecruiting
  • The First Affiliated Hospital of NanChang UniversityRecruiting
  • Zhongda Hospital,Southeast UniversityRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Shanghai East HospitalRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong UniversityRecruiting
  • The Central Hospital of WuhanRecruiting
  • Wuhan Union HospitalRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • Wuxi People's HospitalRecruiting
  • Zhongshan Hospital, Xiamen UniversityRecruiting
  • Yangzhou First People's HospitalRecruiting
  • ZhuZhou Central HospitalRecruiting
  • Opca bolnica BjelovarRecruiting
  • Vojenska nemocnice BrnoRecruiting
  • ISCARE a.s.Recruiting
  • Aarhus University HospitalRecruiting
  • Bispebjerg Og Frederiksberg HospitalRecruiting
  • Herlev Hospital, University of CopenhagenRecruiting
  • Odense UniversitetshospitalRecruiting
  • West Tallinn Central HospitalRecruiting
  • Tallinn Children's HospitalRecruiting
  • Tartu University HospitalRecruiting
  • CHU Amiens - Hopital SudRecruiting
  • Centre Hospitalier Universitaire(CHU) - Hopital Henri MondorRecruiting
  • Hopital Nord - MarseilleRecruiting
  • CHU de Nantes hotel-DieuRecruiting
  • Clinique Ambroise PareRecruiting
  • CHU de Nice Hopital de l ArchetRecruiting
  • Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude VellefauxRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Centre hospitalier universitaire de St EtienneRecruiting
  • CHU RangueilRecruiting
  • CHRU Nancy-BraboisRecruiting
  • Gastroenterologische Spezialpraxis - Berlin-KarlshorstRecruiting
  • Praxis Für GastroenteroligieRecruiting
  • Charite Campus Benjamin FranklinRecruiting
  • Medizinisches Versorgungszentrum (MVZ) DachauRecruiting
  • University Hospital DresdenRecruiting
  • Universitaetsklinik ErlangenRecruiting
  • JWG-University HospitalRecruiting
  • Martin-Luther-Universitaet Halle-Wittenberg - UniversitaetskRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. HemstädRecruiting
  • Universitätsklinikum JenaRecruiting
  • Praxisgemeinschaft JerichowRecruiting
  • Gastroenterologie OpernstrasseRecruiting
  • Evangelisches Krankenhaus KalkRecruiting
  • Eugastro GmbHRecruiting
  • Medizinische Fakultät Mannheim der Universität HeidelbergRecruiting
  • Gastroenterologische Gemeinschaftspraxis MindenRecruiting
  • Universitätsklinikum MünsterRecruiting
  • MVZ Portal 10Recruiting
  • Medius Klinik NürtingenRecruiting
  • Universitaetsmedizin RostockRecruiting
  • Universitätsklinikum TübingenRecruiting
  • Universitätsklinikum WürzburgRecruiting
  • General Hospital of Athens 'Ippokrateion'Recruiting
  • Sotiria General State Hospital of Chest DiseasesRecruiting
  • Hippokration HospitalRecruiting
  • Obudai Egeszsegugyi Centrum Kft.Recruiting
  • Semmelweis EgyetemRecruiting
  • Semmelweis Egyetem I.Belgyogyaszati KlinikaRecruiting
  • Bugat Pal KorhazRecruiting
  • Szegedi TudomanyegyetemRecruiting
  • Markusovszky Egyetemi OktatokorhazRecruiting
  • AOU Policlinico G.MartinoRecruiting
  • Ospedale Specializzato in Gastroenterologia Saverio de BellisRecruiting
  • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di NegrarRecruiting
  • Catholic University of Sacred HearthRecruiting
  • Asahikawa Medical University HospitalRecruiting
  • Tokyo Medical and Dental University HospitalRecruiting
  • Fukuoka University Chikushi HospitalRecruiting
  • Fukuoka University HospitalRecruiting
  • Tokai University Hachioji HospitalRecruiting
  • Hamamatsu University HospitalRecruiting
  • Hirosaki University HospitalRecruiting
  • Hitachi General HospitalRecruiting
  • Hospital of the University of Occupational and Environmental HealthRecruiting
  • The Hospital of Hyogo College of MedicineRecruiting
  • Kagoshima University HospitalRecruiting
  • Kagoshima IBD Gastroenterology ClinicRecruiting
  • Ofuna Chuo HospitalRecruiting
  • Tsujinaka Hospital KashiwanohaRecruiting
  • Saitama Medical University Saitama Medical CenterRecruiting
  • Kyushu Rosai HospitalRecruiting
  • Kobe University HospitalRecruiting
  • Japanese Red Cross Kumamoto HospitalRecruiting
  • Kurume University HospitalRecruiting
  • University Hospital Kyoto Perfectural University of MedicineRecruiting
  • Kyorin University HospitalRecruiting
  • Iwate Medical University HospitalRecruiting
  • Nagaoka Red Cross HospitalRecruiting
  • Nagasaki University HospitalRecruiting
  • Nagoya University HospitalRecruiting
  • Niigata University Medical & Dental HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Kinshukai Infusion ClinicRecruiting
  • Osaka City University HospitalRecruiting
  • Japan Community Health Care Organization Osaka HospitalRecruiting
  • Shiga University of Medical Science HospitalRecruiting
  • Saga University HospitalRecruiting
  • Tokitokai Tokito Clinic Coloproctology CenterRecruiting
  • Sapporo Tokushukai HospitalRecruiting
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalRecruiting
  • Sapporo Medical University HospitalRecruiting
  • Sapporo Higashi Tokushukai HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Dokkyo Medical University HospitalRecruiting
  • Jichi Medical University HospitalRecruiting
  • Tokyo Metropolitan Bokutoh HospitalRecruiting
  • Takamatsu Red Cross HospitalRecruiting
  • The Jikei University HospitalRecruiting
  • Kitasato University Kitasato Institute HospitalRecruiting
  • National Center for Global Health and MedicineRecruiting
  • Toyama Prefectural Central HospitalRecruiting
  • Ieda HospitalRecruiting
  • Mie University HospitalRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Kosin University Gospel HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Yeungnam University HospitalRecruiting
  • Dongguk University Ilsan HospitalRecruiting
  • Chosun university hospitalRecruiting
  • Hallym University Dongtan Sacred Heart HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Kyung Hee University HospitalRecruiting
  • Kangbuk Samsung HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
  • The Catholic University of Korea, Seoul St.Mary's HospitalRecruiting
  • The Catholic University of Korea, Seoul St.Mary's HospitalRecruiting
  • Ajou University HospitalRecruiting
  • Hospital Sultanah BahiyahRecruiting
  • Hospital AmpangRecruiting
  • Hospital Pulau PinangRecruiting
  • University Malaya Medical CentreRecruiting
  • Academisch Medisch Centrum Universiteit van AmsterdamRecruiting
  • Albert Schweitzer ZiekenhuisRecruiting
  • Leiden University Medical CenterRecruiting
  • Maastricht Universitair Medisch CentrumRecruiting
  • Erasmus MCRecruiting
  • UMC UtrechtRecruiting
  • Alesund sjukehusRecruiting
  • Akershus UniversitetssykehusRecruiting
  • Oslo University Hospital HF Ullevål sykehusRecruiting
  • Universitetssykehuset Nord-Norge HFRecruiting
  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w BydgoszczyRecruiting
  • Centrum Medyczne PlejadyRecruiting
  • Centrum Medyczne PromedRecruiting
  • AmiCare Centrum MedyczneRecruiting
  • Gastromed ZOZRecruiting
  • Twoja PrzychodniaRecruiting
  • Synexus Polska Sp. z o.o.Recruiting
  • Centrum Medyczne MedykRecruiting
  • Endoskopia Sp z o.o.Recruiting
  • Sonomed Sp. z o.o.Recruiting
  • GASTROMED Sp. z o.o.Recruiting
  • Centrum Zdrowia Matki, Dziecka i MłodzieżyRecruiting
  • Centralny Szpital Kliniczny MswiaRecruiting
  • Reumatika-Centrum Reumatologii, NZOZRecruiting
  • NZOZ VivamedRecruiting
  • Wojskowy Instytut MedycznyRecruiting
  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny BarskaRecruiting
  • Melita Medical Sp. z o.o.Recruiting
  • Centrum Medyczne OporowRecruiting
  • ETG ZamoscRecruiting
  • Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa MariaRecruiting
  • Centro Hospitalar Vila Nova de GaiaRecruiting
  • KL Ling Gastroenterology and Liver ClinicRecruiting
  • Splosna bolnisnica CeljeRecruiting
  • Worthwhile Clinical Trials Lakeview HospitalRecruiting
  • Inspired GI CareRecruiting
  • Clinical Research Centre University of Cape TownRecruiting
  • Groote Schur HospitalRecruiting
  • Hillcrest privateRecruiting
  • Hosp. Univ. La PazRecruiting
  • Hosp. de NavarraRecruiting
  • Hosp. MonteceloRecruiting
  • Corporacio Sanitari Parc TauliRecruiting
  • Hosp. Univ. Marques de ValdecillaRecruiting
  • Hosp. Univ. de TorrejonRecruiting
  • Universitetssjukhuset OrebroRecruiting
  • Karolinska University HospitalRecruiting
  • INSELSPITAL, Universitätsspital BernRecruiting
  • Gastroenterologische Praxis Balsiger und SeiboldRecruiting
  • Chang-Hua Christian HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Glasgow Royal InfirmaryRecruiting
  • Queen Elizabeth University HospitalRecruiting
  • Velocity Clinical ResearchRecruiting
  • Whipps Cross University HospitalRecruiting
  • St George's Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1: Placebo

Group 2: Guselkumab

Group 3: Golimumab

Group 4: JNJ-78934804 (High-dose)

Group 5: JNJ-78934804 (Mid-dose)

Group 6: JNJ-78934804 (Low-dose)

Arm Description

Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Outcomes

Primary Outcome Measures

Percentage of Participants with Clinical Remission at Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Percentage of Participants with Endoscopic Response at Week 48
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).

Secondary Outcome Measures

Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.
Percentage of Participants with Endoscopic Remission at Week 48
Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD.
Percentage of Participants with Clinical Remission at Week 24
Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Percentage of Participants with Endoscopic Response at Week 24
Percentage of participants with endoscopic response at Week 24 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Percentage of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Percentage of Participants with Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Serum Concentrations of Guselkumab Over Time
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.
Serum Concentrations of Golimumab Over Time
Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.
Percentage of Participants with Antibodies to Guselkumab
Percentage of participants with antibodies to guselkumab will be reported.
Titers of Antibodies to Guselkumab
Titers of antibodies to guselkumab will be reported.
Percentage of Participants with Antibodies to Golimumab
Percentage of participants with antibodies to golimumab will be reported.
Titers of Antibodies to Golimumab
Titers of antibodies to golimumab will be reported.
Percentage of Participants with Neutralizing Antibodies to Guselkumab.
Percentage of participants with neutralizing antibodies to guselkumab will be reported.
Percentage of Participants with Neutralizing Antibodies to Golimumab
Percentage of participants with neutralizing antibodies to golimumab will be reported.

Full Information

First Posted
February 15, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05242471
Brief Title
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
Acronym
DUET-CD
Official Title
A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
July 29, 2024 (Anticipated)
Study Completion Date
October 8, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
715 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Arm Title
Group 2: Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Arm Title
Group 3: Golimumab
Arm Type
Experimental
Arm Description
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Arm Title
Group 4: JNJ-78934804 (High-dose)
Arm Type
Experimental
Arm Description
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Arm Title
Group 5: JNJ-78934804 (Mid-dose)
Arm Type
Experimental
Arm Description
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Arm Title
Group 6: JNJ-78934804 (Low-dose)
Arm Type
Experimental
Arm Description
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Intervention Type
Biological
Intervention Name(s)
Guselkumab
Intervention Description
Guselkumab will be administered as subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Golimumab
Intervention Description
Golimumab will be administered as subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
JNJ-78934804
Intervention Description
JNJ-78934804 will be administered subcutaneously as per defined regimen.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as subcutaneous injection.
Primary Outcome Measure Information:
Title
Percentage of Participants with Clinical Remission at Week 48
Description
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Time Frame
Week 48
Title
Percentage of Participants with Endoscopic Response at Week 48
Description
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
Description
Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.
Time Frame
Week 48
Title
Percentage of Participants with Endoscopic Remission at Week 48
Description
Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD.
Time Frame
Week 48
Title
Percentage of Participants with Clinical Remission at Week 24
Description
Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Time Frame
Week 24
Title
Percentage of Participants with Endoscopic Response at Week 24
Description
Percentage of participants with endoscopic response at Week 24 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Time Frame
Week 24
Title
Percentage of Participants with Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time Frame
Up to Week 48
Title
Percentage of Participants with Serious Adverse Events (SAEs)
Description
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time Frame
Up to Week 48
Title
Serum Concentrations of Guselkumab Over Time
Description
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.
Time Frame
Up to Week 48
Title
Serum Concentrations of Golimumab Over Time
Description
Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.
Time Frame
Up to Week 48
Title
Percentage of Participants with Antibodies to Guselkumab
Description
Percentage of participants with antibodies to guselkumab will be reported.
Time Frame
Up to Week 48
Title
Titers of Antibodies to Guselkumab
Description
Titers of antibodies to guselkumab will be reported.
Time Frame
Up to Week 48
Title
Percentage of Participants with Antibodies to Golimumab
Description
Percentage of participants with antibodies to golimumab will be reported.
Time Frame
Up to Week 48
Title
Titers of Antibodies to Golimumab
Description
Titers of antibodies to golimumab will be reported.
Time Frame
Up to Week 48
Title
Percentage of Participants with Neutralizing Antibodies to Guselkumab.
Description
Percentage of participants with neutralizing antibodies to guselkumab will be reported.
Time Frame
Up to Week 48
Title
Percentage of Participants with Neutralizing Antibodies to Golimumab
Description
Percentage of participants with neutralizing antibodies to golimumab will be reported.
Time Frame
Up to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD) Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease If female and of childbearing potential, must meet the contraception and reproduction requirements Exclusion Criteria: Complications of CD that may be anticipated to require surgery Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks Has a draining (example, functioning) stoma or ostomy Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention) Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Liver Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Name
Moore Clinical Trials, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Om Research LLC
City
Apple Valley
State/Province
California
ZIP/Postal Code
92307
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Gastroenterology Medical Group
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Research Center of Connecticut
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Pioneer Research Solutions Inc.
City
Coconut Creek
State/Province
Florida
ZIP/Postal Code
33066
Country
United States
Individual Site Status
Recruiting
Facility Name
Homestead Associates in Research, Inc
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Research Center Inc.
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Group Of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Name
Synergy Clinical Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Mississippi Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterolgy Associates of Central GA
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology of Southern Indiana
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Recruiting
Facility Name
Cotton O'Neil Digestive Health Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Individual Site Status
Recruiting
Facility Name
Univ. of KS School of Med
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3124
Country
United States
Individual Site Status
Recruiting
Facility Name
Tri-State Gastroenterology Assoc
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Clinic of Acadiana
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham & Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Individual Site Status
Recruiting
Facility Name
FC Research, LLC
City
South Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Recruiting
Facility Name
Detroit Clinical Research Center
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Individual Site Status
Completed
Facility Name
Gastrointestinal Associates LLP
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Completed
Facility Name
A1 Clinical Research
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Name
Mohawk Valley Endoscopy Center
City
Utica
State/Province
New York
ZIP/Postal Code
13502-6313
Country
United States
Individual Site Status
Completed
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
Individual Site Status
Recruiting
Facility Name
Tryon Medical Group
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Individual Site Status
Recruiting
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Northshore Gastroenterology Research, LLC
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Individual Site Status
Recruiting
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220-9428
Country
United States
Individual Site Status
Recruiting
Facility Name
Susquehanna Gastroenterology Associates
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110-3673
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Disease Associates
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Francis Hospital
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Galen Medical Group
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Individual Site Status
Recruiting
Facility Name
Etsu Quillen College Of Medicine
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Individual Site Status
Recruiting
Facility Name
Amel Med LLC. Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Individual Site Status
Recruiting
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Clinic Of San Antonio P A
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Specialists
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access Research- Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
Hunter Holmes McGuire Veterans Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington Gastroenterology, PLLC
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington Digestive Disease Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Specialists
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Marshall Health Clinical Research Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Name
Akh Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Vitaz
City
Sint-Niklaas
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UMHAT 'Aleksandrovska' EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Tzaritza Joanna
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Gastroenterology and Internal Medicine Research Institute (GIRI)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Individual Site Status
Recruiting
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fraser Clinical Trials Inc.
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Individual Site Status
Recruiting
Facility Name
GIRI Gastrointestinal Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Winnipeg Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Viable Clinical Research
City
Dartmouth
State/Province
Nova Scotia
ZIP/Postal Code
B2W 6L4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Barrie GI Associates
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Immune & Digestive Health Institute Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University - Health Centre - Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Name
St. Jerome Medical Research
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Individual Site Status
Recruiting
Facility Name
CMIIM, Centre médical L'Enjeu
City
Ville Mont-Royal
State/Province
Quebec
ZIP/Postal Code
H3P-3E5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Viable Clinical Research
City
Bridgewater
ZIP/Postal Code
B4V 3N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital Chicoutimi
City
Saguenay
ZIP/Postal Code
G7H3C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
The second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou City
ZIP/Postal Code
213004
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400013
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Foshan
City
Foshan
ZIP/Postal Code
528010
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
Nanfang Hospital of Southern Medical Hospital
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Hainan General Hospital
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Jinhua municipal central hospital
City
Jinhua
ZIP/Postal Code
321000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongda Hospital,Southeast University
City
Nanjing
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
The Central Hospital of Wuhan
City
Wuhan
ZIP/Postal Code
430014
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital, Xiamen University
City
Xiamen
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Name
Yangzhou First People's Hospital
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
ZhuZhou Central Hospital
City
ZhuZhou
ZIP/Postal Code
412007
Country
China
Individual Site Status
Recruiting
Facility Name
Opca bolnica Bjelovar
City
Bjelovar
ZIP/Postal Code
43000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Vojenska nemocnice Brno
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
ISCARE a.s.
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Bispebjerg Og Frederiksberg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Herlev Hospital, University of Copenhagen
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Tallinn Children's Hospital
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Name
CHU Amiens - Hopital Sud
City
AMIENS cedex 1
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Nord - Marseille
City
Marseille
ZIP/Postal Code
13915
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Clinique Ambroise Pare
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nice Hopital de l Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Centre hospitalier universitaire de St Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Nancy-Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
City
Berlin-Karlshorst
ZIP/Postal Code
10318
Country
Germany
Individual Site Status
Recruiting
Facility Name
Praxis Für Gastroenteroligie
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinisches Versorgungszentrum (MVZ) Dachau
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinik Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
JWG-University Hospital
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
City
Halle Saale
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Name
Praxisgemeinschaft Jerichow
City
Jerichow
ZIP/Postal Code
39319
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gastroenterologie Opernstrasse
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Evangelisches Krankenhaus Kalk
City
Köln
ZIP/Postal Code
51103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Eugastro GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Fakultät Mannheim der Universität Heidelberg
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster
City
Munster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
MVZ Portal 10
City
Münster
ZIP/Postal Code
48155
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medius Klinik Nürtingen
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens 'Ippokrateion'
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Sotiria General State Hospital of Chest Diseases
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hippokration Hospital
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Individual Site Status
Recruiting
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem I.Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bugat Pal Korhaz
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Markusovszky Egyetemi Oktatokorhaz
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
AOU Policlinico G.Martino
City
Messina
ZIP/Postal Code
98125
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Specializzato in Gastroenterologia Saverio de Bellis
City
Monopoli
ZIP/Postal Code
70043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
City
Negrar ( Ve)
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Name
Catholic University of Sacred Hearth
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Asahikawa Medical University Hospital
City
Asahikawa
ZIP/Postal Code
078-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino
ZIP/Postal Code
818-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hachioji Hospital
City
Hachioji
ZIP/Postal Code
192-0032
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hirosaki University Hospital
City
Hirosaki
ZIP/Postal Code
036-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hitachi General Hospital
City
Hitachi
ZIP/Postal Code
317-0077
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Occupational and Environmental Health
City
Hukuoka
ZIP/Postal Code
807-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Hospital of Hyogo College of Medicine
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagoshima IBD Gastroenterology Clinic
City
Kagoshima
ZIP/Postal Code
892-0843
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ofuna Chuo Hospital
City
Kamakura
ZIP/Postal Code
247-0056
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tsujinaka Hospital Kashiwanoha
City
Kashiwa
ZIP/Postal Code
277-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Saitama Medical Center
City
Kawagoe
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu Rosai Hospital
City
Kitakyushu
ZIP/Postal Code
800-0296
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe University Hospital
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital Kyoto Perfectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyorin University Hospital
City
Mitaka
ZIP/Postal Code
181-8611
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Medical University Hospital
City
Morioka
ZIP/Postal Code
020-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka
ZIP/Postal Code
940-2085
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama-shi
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kinshukai Infusion Clinic
City
Osaka
ZIP/Postal Code
530-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Community Health Care Organization Osaka Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
ZIP/Postal Code
520-2192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saga University Hospital
City
Saga-shi
ZIP/Postal Code
849-0937
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokitokai Tokito Clinic Coloproctology Center
City
Saitama
ZIP/Postal Code
336-0963
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Tokushukai Hospital
City
Sapporo
ZIP/Postal Code
004-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
City
Sapporo
ZIP/Postal Code
060-0033
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Medical University Hospital
City
Sapporo
ZIP/Postal Code
060-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
ZIP/Postal Code
065-0033
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-gun
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
ZIP/Postal Code
329-0498
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Metropolitan Bokutoh Hospital
City
Sumida-ku
ZIP/Postal Code
130-8575
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takamatsu Red Cross Hospital
City
Takamatsu
ZIP/Postal Code
760-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitasato University Kitasato Institute Hospital
City
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
9308550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ieda Hospital
City
Toyota
ZIP/Postal Code
470-1219
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mie University Hospital
City
Tsu
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Dongguk University Ilsan Hospital
City
Goyang-si
ZIP/Postal Code
10326
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chosun university hospital
City
Gwangju
ZIP/Postal Code
61453
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hallym University Dongtan Sacred Heart Hospital
City
Hwaseong-si
ZIP/Postal Code
18450
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St.Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St.Mary's Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
ZIP/Postal Code
5460
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Ampang
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Academisch Medisch Centrum Universiteit van Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Alesund sjukehus
City
Alesund
ZIP/Postal Code
6010
Country
Norway
Individual Site Status
Recruiting
Facility Name
Akershus Universitetssykehus
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Name
Oslo University Hospital HF Ullevål sykehus
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Universitetssykehuset Nord-Norge HF
City
Tromso
ZIP/Postal Code
N-9038
Country
Norway
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Promed
City
Krakow
ZIP/Postal Code
31-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
AmiCare Centrum Medyczne
City
Lodz
ZIP/Postal Code
90-644
Country
Poland
Individual Site Status
Recruiting
Facility Name
Gastromed ZOZ
City
Lublin
ZIP/Postal Code
20-583
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia
City
Poznan
ZIP/Postal Code
61-293
Country
Poland
Individual Site Status
Recruiting
Facility Name
Synexus Polska Sp. z o.o.
City
Poznan
ZIP/Postal Code
61-441
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-326
Country
Poland
Individual Site Status
Recruiting
Facility Name
Endoskopia Sp z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Individual Site Status
Recruiting
Facility Name
Sonomed Sp. z o.o.
City
Szczecin
ZIP/Postal Code
71-685
Country
Poland
Individual Site Status
Recruiting
Facility Name
GASTROMED Sp. z o.o.
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Zdrowia Matki, Dziecka i Młodzieży
City
Warszawa
ZIP/Postal Code
00-632
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centralny Szpital Kliniczny Mswia
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Recruiting
Facility Name
Reumatika-Centrum Reumatologii, NZOZ
City
Warszawa
ZIP/Postal Code
02-655
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
City
Wloclawek
ZIP/Postal Code
87-800
Country
Poland
Individual Site Status
Recruiting
Facility Name
Melita Medical Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
50-449
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Oporow
City
Wrocław
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Recruiting
Facility Name
ETG Zamosc
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Vila Nova de Gaia
City
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Recruiting
Facility Name
KL Ling Gastroenterology and Liver Clinic
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Splosna bolnisnica Celje
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Worthwhile Clinical Trials Lakeview Hospital
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Inspired GI Care
City
Cape Town
ZIP/Postal Code
7800
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Clinical Research Centre University of Cape Town
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Groote Schur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hillcrest private
City
Durban
ZIP/Postal Code
3610
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Montecelo
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de Torrejon
City
Torrejón de Ardoz
ZIP/Postal Code
28850
Country
Spain
Individual Site Status
Recruiting
Facility Name
Universitetssjukhuset Orebro
City
Orebro
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska University Hospital
City
Solna
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Name
INSELSPITAL, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Gastroenterologische Praxis Balsiger und Seibold
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Chang-Hua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
High Wycombe
ZIP/Postal Code
HP112QW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Whipps Cross University Hospital
City
London
ZIP/Postal Code
E111NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St George's Healthcare NHS Trust
City
London
ZIP/Postal Code
SW19 0QT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

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