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A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (DUET-UC)

Primary Purpose

Colitis, Ulcerative

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 Colitis, Ulcerative

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
  • Moderately to severely active UC as assessed by the modified Mayo Score
  • Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
  • If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

  • Has severe extensive colitis as defined in the protocol
  • Extent of inflammatory disease limited to the rectum
  • Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
  • 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
  • Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Sites / Locations

  • Valley Gastroenterology Medical GroupRecruiting
  • Southern California Research CenterRecruiting
  • Om Research LLCRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • University of ColoradoRecruiting
  • Peak Gastroenterology AssociatesRecruiting
  • Medical Research Center of ConnecticutRecruiting
  • Yale UniversityRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • Pioneer Research Solutions Inc.Recruiting
  • Digestive and Liver Disease Institute
  • Florida Research Center Inc.Recruiting
  • Gastroenterology Group Of NaplesRecruiting
  • Omega Research ConsultantsRecruiting
  • Synergy Clinical ResearchRecruiting
  • Gastroenterolgy Associates of Central GARecruiting
  • Atlanta Gastroenterology AssociatesRecruiting
  • Gastrointestinal Specialists of GeorgiaRecruiting
  • Gastroenterology ConsultantsRecruiting
  • Grand Teton Gastroenterology
  • IU Health University HospitalRecruiting
  • Gastroenterology of Southern IndianaRecruiting
  • Tri-State Gastroenterology AssocRecruiting
  • University of Kentucky Chandler Medical CenterRecruiting
  • Jewish HospitalRecruiting
  • Chevy Chase Clinical ResearchRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Care Access Las Vegas
  • Weill Cornell Medical CollegeRecruiting
  • Lenox Hill HospitalRecruiting
  • Mohawk Valley Endoscopy Center
  • University North Carolina at Chapel HillRecruiting
  • Tryon Medical GroupRecruiting
  • Onsite Clinical Solutions
  • Care Access Research, KinstonRecruiting
  • Great Lakes Gastroenterology Research, LLCRecruiting
  • Medical University of South CarolinaRecruiting
  • Digestive Disease AssociatesRecruiting
  • Gastro OneRecruiting
  • Etsu Quillen College Of MedicineRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • UT Southwestern Medical CenterRecruiting
  • GI Specialists of HoustonRecruiting
  • Gastroenterology Clinic Of San Antonio P ARecruiting
  • Texas Digestive Disease ConsultantsRecruiting
  • Tyler Research Institute, LLCRecruiting
  • Medical College Of Virginia HospitalRecruiting
  • Washington Gastroenterology, PLLCRecruiting
  • Swedish Medical CenterRecruiting
  • Virginia Mason Medical CenterRecruiting
  • Digestive Health SpecialistsRecruiting
  • Medical College Of WisconsinRecruiting
  • Medizinische Universität WienRecruiting
  • UZ GentRecruiting
  • Medical Centre HipocratRecruiting
  • Diagnostic - Consulting Center I-SlivenRecruiting
  • University Hospital Alexandrovska - Clinic of NephrologyRecruiting
  • UMHAT 'Tsaritsa Yoanna'Recruiting
  • Medical Center -Medika PlusRecruiting
  • Multriprofile Hospital for Active Treatment Hristo BotevRecruiting
  • Foothills HospitalRecruiting
  • Gastroenterology and Internal Medicine Research Institute (GIRI)Recruiting
  • Covenant Health/Grey Nuns hospitalRecruiting
  • Columbia GastroenterologyRecruiting
  • Health Sciences CentreRecruiting
  • Viable Clinical ResearchRecruiting
  • Nova Scotia Health AuthorityRecruiting
  • London Health Sciences Centre - University CampusRecruiting
  • Toronto Immune & Digestive Health Institute Inc.Recruiting
  • St. Jerome Medical ResearchRecruiting
  • Viable Clinical ResearchRecruiting
  • Hopital ChicoutimiRecruiting
  • Opca bolnica BjelovarRecruiting
  • Vojenska nemocnice BrnoRecruiting
  • ISCARE a.s.Recruiting
  • Aalborg HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • Bispebjerg Og Frederiksberg HospitalRecruiting
  • Herlev Hospital, University of CopenhagenRecruiting
  • Odense UniversitetshospitalRecruiting
  • East Tallinn Central HospitalRecruiting
  • West Tallinn Central HospitalRecruiting
  • Tartu University HospitalRecruiting
  • CHU Amiens - Hopital SudRecruiting
  • Hopital Louis MourierRecruiting
  • Centre Hospitalier Universitaire(CHU) - Hopital Henri MondorRecruiting
  • CHU GrenobleRecruiting
  • Centre Hospitalier Départemental VENDEERecruiting
  • Hopital Nord - MarseilleRecruiting
  • Clinique Ambroise PareRecruiting
  • CHU de Nice Hopital de l ArchetRecruiting
  • CHU Nimes - Hôpital CarémeauRecruiting
  • Hospices Civils de Lyon HCLRecruiting
  • CHU Saint-etienneRecruiting
  • Hopital de RangueilRecruiting
  • CHRU Nancy-BraboisRecruiting
  • Gastroenterologische Spezialpraxis - Berlin-KarlshorstRecruiting
  • Praxis Für GastroenteroligieRecruiting
  • Charite - Universitatsmedizin Berlin (CCM)Recruiting
  • Krankenhaus Waldfriede MitteRecruiting
  • University Hospital DresdenRecruiting
  • Universitaetsklinik ErlangenRecruiting
  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus KrankenhausRecruiting
  • Martin-Luther-Universitaet Halle-Wittenberg - UniversitaetskRecruiting
  • BSF StudiengesellschaftRecruiting
  • Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. HemstädRecruiting
  • Universitätsklinikum JenaRecruiting
  • Eugastro GmbHRecruiting
  • Universitaetsklinikum MannheimRecruiting
  • Gastroenterologische Gemeinschaftspraxis MindenRecruiting
  • Praxis fur Innere Medizin und GastroenterologieRecruiting
  • MVZ Portal 10Recruiting
  • Medius Klinik NürtingenRecruiting
  • Siloah St. Trudpert KlinikumRecruiting
  • Zentrum für Gastroenterologie Saar MVZ GmbHRecruiting
  • Universitaetsklinik TuebingenRecruiting
  • Universitätsklinikum WürzburgRecruiting
  • Sotiria General State Hospital of Chest DiseasesRecruiting
  • Nikaia General HospitalRecruiting
  • Hippokration HospitalRecruiting
  • Obudai Egeszsegugyi Centrum Kft.Recruiting
  • Magyar Honvedseg Egeszsegugyi KozpontRecruiting
  • Semmelweis EgyetemRecruiting
  • Pannónia Magánorvosi Centrum KftRecruiting
  • Bugat Pal KorhazRecruiting
  • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp.Recruiting
  • Markusovszky Egyetemi OktatokorhazRecruiting
  • AOU Policlinico G.MartinoRecruiting
  • Ospedale Sacro Cuore Don CalabriaRecruiting
  • Università Campus Biomedico di RomaRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • Casa Sollievo della SofferenzaRecruiting
  • Asahikawa Medical University HospitalRecruiting
  • Fukuoka University Chikushi HospitalRecruiting
  • Kitakyushu Municipal Medical CenterRecruiting
  • Gifu Prefectural General Medical CenterRecruiting
  • Tokai University Hachioji HospitalRecruiting
  • Hamamatsu University HospitalRecruiting
  • National Hospital Organization Hirosaki General Medical CenterRecruiting
  • Hirosaki University HospitalRecruiting
  • Tokai University HospitalRecruiting
  • Kagoshima University HospitalRecruiting
  • Kagoshima IBD Gastroenterology ClinicRecruiting
  • Ofuna Chuo HospitalRecruiting
  • Matsushima ClinicRecruiting
  • Nara Medical University HospitalRecruiting
  • Tsujinaka Hospital KashiwanohaRecruiting
  • Kobe University HospitalRecruiting
  • Yamanashi Prefectural Central HospitalRecruiting
  • Kumamoto University HospitalRecruiting
  • Kurume University HospitalRecruiting
  • University Hospital Kyoto Perfectural University of MedicineRecruiting
  • Gunma University HospitalRecruiting
  • Kitasato University Kitasato Institute HospitalRecruiting
  • Kyorin University HospitalRecruiting
  • Iwate Medical University HospitalRecruiting
  • Nagoya University HospitalRecruiting
  • Nagoya City University HospitalRecruiting
  • The Hospital of Hyogo College of MedicineRecruiting
  • Ogaki Municipal HospitalRecruiting
  • Oita Red Cross HospitalRecruiting
  • National Hospital Organization Osaka National HospitalRecruiting
  • Kinshukai Infusion ClinicRecruiting
  • Osaka City University HospitalRecruiting
  • Japan Community Health Care Organization Osaka HospitalRecruiting
  • Toho University Sakura Medical CenterRecruiting
  • Sapporo IBD ClinicRecruiting
  • Sapporo Tokushukai HospitalRecruiting
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalRecruiting
  • Sapporo Higashi Tokushukai HospitalRecruiting
  • Tokyo Metropolitan Bokutoh HospitalRecruiting
  • The Jikei University HospitalRecruiting
  • Tokyo Saiseikai Central HospitalRecruiting
  • National Hospital Organization Tokyo Medical CenterRecruiting
  • Tokyo Medical University HospitalRecruiting
  • Oji General HospitalRecruiting
  • Toyama Prefectural Central HospitalRecruiting
  • Toyota Kosei HospitalRecruiting
  • Mie University HospitalRecruiting
  • Wakayama Medical University HospitalRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Kosin University Gospel HospitalRecruiting
  • Yeungnam University HospitalRecruiting
  • Chosun university hospitalRecruiting
  • The Catholic university of Korea, St. Vincent's HospitalRecruiting
  • Hallym University Dongtan Sacred Heart HospitalRecruiting
  • Kyung Hee University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • The Catholic University of Korea, Seoul St.Mary's HospitalRecruiting
  • The Catholic University of Korea, Seoul St.Mary's HospitalRecruiting
  • Ajou University HospitalRecruiting
  • Yonsei University Wonju Severance Christian HospitalRecruiting
  • Academisch Medisch Centrum Universiteit van AmsterdamRecruiting
  • Albert Schweitzer ZiekenhuisRecruiting
  • Maastricht University Medical CentreRecruiting
  • Erasmus Medisch CentrumRecruiting
  • UMC UtrechtRecruiting
  • Alesund sjukehusRecruiting
  • Vestre Viken HF Baerum SykehusRecruiting
  • Akershus UniversitetssykehusRecruiting
  • Oslo University Hospital HF Ullevål sykehusRecruiting
  • Universitetssykehuset Nord-Norge HFRecruiting
  • Szpital Uniwersytecki No2Recruiting
  • Centrum Medyczne PlejadyRecruiting
  • Centrum Medyczne PromedRecruiting
  • AmiCare Centrum MedyczneRecruiting
  • ETG LublinRecruiting
  • Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.Recruiting
  • AllmedicaRecruiting
  • Wojewodzki Szpital Specjalistyczny w OlsztynieRecruiting
  • Twoja PrzychodniaRecruiting
  • Synexus Polska Sp. z o.o.Recruiting
  • Centrum Medyczne MedykRecruiting
  • Endoskopia Sp z o.o.Recruiting
  • Twoja Przychodnia - Szczecinskie Centrum MedyczneRecruiting
  • 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
  • Przychodnia VistamedRecruiting
  • EuroMediCare Szpital Specjalistyczny z PrzychodniaRecruiting
  • Centrum Medyczne OporowRecruiting
  • ETG ZamoscRecruiting
  • Centro Hospitalar de Lisboa Norte - Hospital Santa MariaRecruiting
  • Hospital Beatriz AngeloRecruiting
  • Chvng - Unidade IRecruiting
  • FNsP F.D.R. Banska BystricaRecruiting
  • Cliniq s.r.o.Recruiting
  • GASTRO I. s.r.o.Recruiting
  • Gastroenterology Department ENDOMED, s.r.o.Recruiting
  • Splosna bolnisnica CeljeRecruiting
  • Worthwhile Clinical Trials Lakeview HospitalRecruiting
  • Groote Schur HospitalRecruiting
  • Practice Dr Naeem MoosaRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Hosp. Univ. La PazRecruiting
  • Hosp. de NavarraRecruiting
  • Corporacio Sanitari Parc TauliRecruiting
  • Hosp. Univ. Marques de ValdecillaRecruiting
  • Hosp. Univ. de TorrejonRecruiting
  • Hosp. Alvaro CunqueiroRecruiting
  • Karolinska Universitetssjukhuset SolnaRecruiting
  • INSELSPITAL, Universitätsspital BernRecruiting
  • China Medical University HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University Hospital, Division of Infectious DiseasesRecruiting
  • Queen Elizabeth University HospitalRecruiting
  • Velocity Clinical ResearchRecruiting
  • Chelsea And Westminster HospitalRecruiting
  • St George's University Hospital NHS Foundation 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 based on the modified Mayo subscores.

Secondary Outcome Measures

Percentage of Participants with Endoscopic Improvement at Week 48
Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.
Percentage of Participants with Symptomatic Remission at Week 48
Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.
Percentage of Participants with Clinical Remission at Week 24
Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission based on the modified Mayo subscores
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 concentration 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
NCT05242484
Brief Title
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Acronym
DUET-UC
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 Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
August 28, 2024 (Anticipated)
Study Completion Date
October 12, 2033 (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 and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
550 (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 based on the modified Mayo subscores.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants with Endoscopic Improvement at Week 48
Description
Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.
Time Frame
Week 48
Title
Percentage of Participants with Symptomatic Remission at Week 48
Description
Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.
Time Frame
Week 48
Title
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
Description
Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.
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 based on the modified Mayo subscores
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 concentration 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: Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline Moderately to severely active UC as assessed by the modified Mayo Score Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity If female and of childbearing potential, must meet the contraception and reproduction requirements Exclusion Criteria: Has severe extensive colitis as defined in the protocol Extent of inflammatory disease limited to the rectum Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD) 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 Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
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
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
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
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
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
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
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
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
Digestive and Liver Disease Institute
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Completed
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
Gastroenterolgy Associates of Central GA
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Gastroenterology Associates
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
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
Gastroenterology Consultants
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Recruiting
Facility Name
Grand Teton Gastroenterology
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Completed
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
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 Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815-7313
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
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
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 North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
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
Onsite Clinical Solutions
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Completed
Facility Name
Care Access Research, Kinston
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
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
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
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
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Specialists of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77346
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
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College Of Virginia Hospital
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
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
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
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Medical Centre Hipocrat
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Diagnostic - Consulting Center I-Sliven
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Hospital Alexandrovska - Clinic of Nephrology
City
Sofia-Grad
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT 'Tsaritsa Yoanna'
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center -Medika Plus
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multriprofile Hospital for Active Treatment Hristo Botev
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
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
Covenant Health/Grey Nuns hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6K3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Columbia Gastroenterology
City
New Westminster
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Name
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
London Health Sciences Centre - University Campus
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
St. Jerome Medical Research
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
V8R 4R2
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
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
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
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
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Individual Site Status
Recruiting
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
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
Hopital Louis Mourier
City
Colombes Cedex
ZIP/Postal Code
92701
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
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Départemental VENDEE
City
La Roche sur Yon
ZIP/Postal Code
85925
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
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 cedex 03
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nimes - Hôpital Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Hospices Civils de Lyon HCL
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Saint-etienne
City
Saint Etienne
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de Rangueil
City
Toulouse cedex 09
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 - Universitatsmedizin Berlin (CCM)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Waldfriede Mitte
City
Berlin
ZIP/Postal Code
14163
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
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
City
Frankfurt/Main
ZIP/Postal Code
60431
Country
Germany
Individual Site Status
Recruiting
Facility Name
Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
City
Halle (Saale)
ZIP/Postal Code
06097
Country
Germany
Individual Site Status
Recruiting
Facility Name
BSF Studiengesellschaft
City
Halle
ZIP/Postal Code
06108
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
Eugastro GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Mannheim
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
Praxis fur Innere Medizin und Gastroenterologie
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
Siloah St. Trudpert Klinikum
City
Pforzheim
ZIP/Postal Code
75179
Country
Germany
Individual Site Status
Recruiting
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH
City
Saarbrücken
ZIP/Postal Code
66111
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinik Tuebingen
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
Sotiria General State Hospital of Chest Diseases
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Nikaia General Hospital
City
Piraievs
ZIP/Postal Code
184 54
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
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
H-1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pannónia Magánorvosi Centrum Kft
City
Budapest
ZIP/Postal Code
H-1136
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 Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp.
City
Szeged
ZIP/Postal Code
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 Sacro Cuore Don Calabria
City
Negrar Di Valpolicella
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Name
Università Campus Biomedico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
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
Fukuoka University Chikushi Hospital
City
Chikushino
ZIP/Postal Code
818-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitakyushu Municipal Medical Center
City
Fukuoka-ken
ZIP/Postal Code
802-0077
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
ZIP/Postal Code
500-8717
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
National Hospital Organization Hirosaki General Medical Center
City
Hirosaki
ZIP/Postal Code
036-8545
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
Tokai University Hospital
City
Isehara
ZIP/Postal Code
259-1193
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
Matsushima Clinic
City
Kanagawa
ZIP/Postal Code
220-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nara Medical University Hospital
City
Kashihara
ZIP/Postal Code
634-8522
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
Kobe University Hospital
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu-Shi
ZIP/Postal Code
400-0027
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
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
Gunma University Hospital
City
Maebashi
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
ZIP/Postal Code
108-8642
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
112-0015
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
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ogaki Municipal Hospital
City
Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
Oita Red Cross Hospital
City
Oita
ZIP/Postal Code
870-0033
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka-shi
ZIP/Postal Code
540-0006
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
Toho University Sakura Medical Center
City
Sakura
ZIP/Postal Code
285-8741
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo IBD Clinic
City
Sapporo Chuo-ku
ZIP/Postal Code
064-0919
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 Higashi Tokushukai Hospital
City
Sapporo
ZIP/Postal Code
065-0033
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
The Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Saiseikai Central Hospital
City
Tokyo
ZIP/Postal Code
108-0073
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Tokyo Medical Center
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Oji General Hospital
City
Tomakomai
ZIP/Postal Code
053-8506
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyota Kosei Hospital
City
Toyota
ZIP/Postal Code
470-0396
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
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
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
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
49267
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
Chosun university hospital
City
Gwangju
ZIP/Postal Code
61453
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic university of Korea, St. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
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
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
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
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
Yonsei University Wonju Severance Christian Hospital
City
Wonju, Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Academisch Medisch Centrum Universiteit van Amsterdam
City
Amsterdam
ZIP/Postal Code
105 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
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Alesund sjukehus
City
Alesund
ZIP/Postal Code
6010
Country
Norway
Individual Site Status
Recruiting
Facility Name
Vestre Viken HF Baerum Sykehus
City
Gjettum
ZIP/Postal Code
1346
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 No2
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
ETG Lublin
City
Lublin
ZIP/Postal Code
20-412
Country
Poland
Individual Site Status
Recruiting
Facility Name
Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Allmedica
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-561
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
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
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
Przychodnia Vistamed
City
Wroclaw
ZIP/Postal Code
53-149
Country
Poland
Individual Site Status
Recruiting
Facility Name
EuroMediCare Szpital Specjalistyczny z Przychodnia
City
Wroclaw
ZIP/Postal Code
54-144
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Oporow
City
Wrocław
ZIP/Postal Code
52-415
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 de Lisboa Norte - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Beatriz Angelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Chvng - Unidade I
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Recruiting
Facility Name
FNsP F.D.R. Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Cliniq s.r.o.
City
Bratislava
ZIP/Postal Code
811 09
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
GASTRO I. s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Gastroenterology Department ENDOMED, s.r.o.
City
Vranov nad Toplou
ZIP/Postal Code
093 01
Country
Slovakia
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
Groote Schur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Practice Dr Naeem Moosa
City
Johannesburg
ZIP/Postal Code
1827
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
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
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
Hosp. Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36213
Country
Spain
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset Solna
City
Solna
ZIP/Postal Code
171 76
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
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407204
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, Division of Infectious Diseases
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
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
Chelsea And Westminster Hospital
City
London
ZIP/Postal Code
SW109NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St George's University Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 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 Ulcerative Colitis

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