A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (DUET-UC)
Colitis, Ulcerative
About this trial
This is an interventional treatment trial for Colitis, Ulcerative
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)
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
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
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)
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.