A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Description

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Interventions

• JNJ-78934804 (Drug)
  JNJ-78934804 will be administered subcutaneously.
• Guselkumab (Drug)
  Guselkumab will be administered subcutaneously.

Eligibility criteria

Conditions

Locations

• Clinnova Research — Anaheim, California, United States
• Gastro SB Clinic — Chula Vista, California, United States
• United Medical Doctors — Los Alamitos, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Florida Research Center Inc. — Lakewood Rch, Florida, United States
• Sanchez Clinical Research, Inc — Miami, Florida, United States
• GCP Clinical Research — Tampa, Florida, United States
• Atlanta Gastroenterology Specialists — Suwanee, Georgia, United States
• Tri-State Gastroenterology Assoc — Crestview Hills, Kentucky, United States
• Gastroenterology Clinic of Acadiana — Lafayette, Louisiana, United States
• GIA Metairie — Metairie, Louisiana, United States
• Michigan Center of Medical Research — Farmington Hills, Michigan, United States
• GIA Kansas City — Lee's Summit, Missouri, United States
• New York Gastroenterology Associates — New York, New York, United States
• University of North Carolina Hospital — Chapel Hill, North Carolina, United States
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States
• Digestive Disease Specialists Inc — Oklahoma City, Oklahoma, United States
• The Oregon Clinic — Portland, Oregon, United States
• Frontier Clinical Research — Uniontown, Pennsylvania, United States
• Gastro One — Cordova, Tennessee, United States
• Southern Star Research Institute, LLC — San Antonio, Texas, United States
• Tyler Research Institute, LLC — Tyler, Texas, United States
• GI Alliance Tacoma — Tacoma, Washington, United States
• GEDYT — AAI, Argentina
• Instituto Medico De Alta Complejidad (IMAC) — Buenos Aires, Argentina
• Globalpsy — La Plata, Argentina
• HIGEA — Mendoza, Argentina
• Instituto de Investigaciones Clinicas Quilmes — Quilmes, Argentina
• Hospital Provincial del Centenario — Rosario, Argentina
• MR Medicina Reumatologica — San Fernando, Argentina
• Banksia Trials SA — Adelaide, Australia
• Royal Prince Alfred Hospital — Camperdown, Australia
• Monash Medical Centre — Clayton, Australia
• The Melbourne Gut Clinic Epworth Hospital — East Melbourne, Australia
• SA Gastrointestinal Services — Kurralta Park, Australia
• Macquarie University — Macquarie University, Australia
• Fiona Stanley Hospital — Murdoch, Australia
• John Hunter Hospital — New Lambton Heights, Australia
• Mater Misericordiae Hospital — South Brisbane, Australia
• Kepler Universitatsklinikum GmbH — Linz, Austria
• Krankenhaus der Barmherzigen Brüder — Vienna, Austria
• Klinikum Wels Grieskirchen — Wels, Austria
• Imelda Bonheiden — Bonheiden, Belgium
• AZ Sint-Lucas — Bruges, Belgium
• ULB Erasme Ziekenhuis — Brussels, Belgium
• UZ Brussel — Brussels, Belgium
• Cliniques Universitaires Saint Luc — Brussels, Belgium
• AZ Maria Middelares — Ghent, Belgium
• Ghent University Hospital — Ghent, Belgium
• Universitair Ziekenhuis Leuven — Leuven, Belgium
• CHC MontLegia — Liège, Belgium
• CDC - Centro Digestivo de Curitiba — Curitiba, Brazil
• CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda — Jaú, Brazil
• Complexo Hospitalar de Niteroi — Niterói, Brazil
• Hospital De Clinicas De Porto Alegre — Porto Alegre, Brazil
• Hospital Ernesto Dornelles — Porto Alegre, Brazil
• Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto — Ribeirão Preto, Brazil
• Pesquisare Saude — Santo André, Brazil
• BR Trials — São Paulo, Brazil
• Solare Trials — São Paulo, Brazil
• Rocco And Nazato Servicos Medicos Ltda — São Paulo, Brazil
• INTEGRAL Pesquisa e Ensino — Votuporanga, Brazil
• MHAT Sv. Karidad EAD — Plovdiv, Bulgaria
• Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia' — Sofia, Bulgaria
• Diagnostic Consultative Center Neoclinic EAD — Sofia, Bulgaria
• St Ivan Rilski University Multiprofile Hospital For Active Treatment — Sofia, Bulgaria
• DCC Convex EOOD — Sofia, Bulgaria
• Acibadem City Clinic - Oncology Center — Sofia, Bulgaria
• Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD — Varna, Bulgaria
• South Edmonton Gastroenterology Research Clinic — Edmonton, Alberta, Canada
• Gastroenterology and Internal Medicine Research Institute (GIRI) — Edmonton, Alberta, Canada
• GI Research Institute (G.I.R.I.) — Vancouver, British Columbia, Canada
• Viable Clinical Research — Kentville, Nova Scotia, Canada
• Barrie GI Associates — Barrie, Ontario, Canada
• Charlton Digestive Disease Centre — Hamilton, Ontario, Canada
• London Digestive Disease Institute — London, Ontario, Canada
• Toronto Immune and Digestive Health Institute Inc — Toronto, Ontario, Canada
• CHUM - Centre hospitalier universitaire de Montreal — Montreal, Quebec, Canada
• Clinique IMD — Montreal, Quebec, Canada
• China Japan Friendship Hospital — Beijing, China
• Beijing Friendship Hospital Capital Medical University — Beijing, China
• Peking University Third Hospital — Beijing, China
• Changzhou No 2 Peoples Hospital — Changzhou, China
• Chongqing General Hospital — Chongqing, China
• The First People's Hospital of Foshan — Foshan, China
• The First Affiliated Hospital Sun Yat sen University — Guangzhou, China
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, China
• Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital — Guangzhou, China
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China
• The First Affiliated Hospital of Anhui Medical University — Hefei, China
• Huai'an 1st Hospital — Huai'an, China
• Jinhua municipal central hospital — Jinhua, China
• Lanzhou University Second Hospital — Lanzhou, China
• Ningbo medical center lihuili hospital — Ningbo, China
• The Second Hospital of Hebei Medical University — Shijiazhuang, China
• Taihe Hospital — Shiyan, China
• Second Affiliated Hospital, SooChow University — Suzhou, China
• Zhongshan Hospital, Xiamen University — Xiamen, China
• The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, China
• ZhuZhou Central Hospital — Zhuzhou, China
• Affiliated Hospital of Zunyi Medical University — Zunyi, China
• Nemocnice Ceske Budejovice a s — České Budějovice, Czechia
• Gastroenterologie, s.r.o., Hradec Kralove — Hradec Kralova, Czechia
• Hepato-gastroenterologie HK, s.r.o. — Hradec Králové, Czechia
• Oblastni nemocnice Kladno a.s. — Kladno, Czechia
• Fakultni Nemocnice Ostrava — Ostrava, Czechia
• Fakultni Thomayerova nemocnice — Prague, Czechia
• ISCARE a.s. — Prague, Czechia
• Herlev Hospital — Herlev, Denmark
• Hvidovre Hospital — Hvidovre, Denmark
• Odense University Hospital — Odense, Denmark
• CHU Amiens — Amiens, France
• Hopital Jean Minjoz — Besançon, France
• Hopital Beaujon — Clichy, France
• Hopital de Bicetre — Le Kremlin-Bicêtre, France
• CHU de Lille Hopital Claude Huriez — Lille, France
• CHU de Montpellier Hopital Saint Eloi — Montpellier, France
• CHU de Nantes hotel Dieu — Nantes, France
• CHU de Nice Hopital de l Archet 2 — Nice, France
• Hopital Haut Leveque CHU de Bordeaux — Pessac, France
• CHU de Reims — Reims, France
• CHU Saint Etienne Hopital Nord — Saint-Priest-en-Jarez, France
• CHU Toulouse — Toulouse, France
• CHRU de Nancy - Hopitaux de Brabois — Vandœuvre-lès-Nancy, France
• Praxis Fur Gastroenteroligie — Berlin, Germany
• Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF) — Berlin, Germany
• Krankenhaus Waldfriede Mitte — Berlin, Germany
• Medizinisches Versorgungszentrum (MVZ) Dachau — Dachau, Germany
• Universitatsklinikum Carl Gustav Carus Dresden — Dresden, Germany
• Universitaetsklinik Erlangen — Erlangen, Germany
• Studiengesellschaft Mitteldeutschland GmbH — Halle, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Universitatsklinikum Jena — Jena, Germany
• Gastroenterologische Spezialpraxis - Berlin-Karlshorst — Karlshorst, Germany
• Universitatsklinikum Schleswig Holstein Kiel — Kiel, Germany
• Eugastro GmbH — Leipzig, Germany
• Universitaetsklinikum Mannheim — Mannheim, Germany
• Klinik und Poliklinik für Innere Medizin II Klinikum rechts an der Isar der TU Muenchen — München, Germany
• Universitaetsmedizin Rostock — Rostock, Germany
• General Hospital of Athens Evaggelismos — Athens, Greece
• General Hospital Of Athens Korgialenio Benakio H R C — Athens, Greece
• Thoracic General Hospital Of Athens I Sotiria — Athens, Greece
• Geniko Nosokomeio Peiraia Tzaneio — Piraeus, Greece
• Obudai Egeszsegugyi Centrum Kft — Budapest, Hungary
• Semmelweis Egyetem 1 — Budapest, Hungary
• Semmelweis Egyetem — Budapest, Hungary
• Semmelweis Egyetem 2 — Budapest, Hungary
• Pannónia Magánorvosi Centrum Kft — Budapest, Hungary
• Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont — Szeged, Hungary
• Sushruta Multispecialty Hospital and Research Centre — Hubballi, India
• Asian Institute Of Gastroenterology — Hyderabad, India
• S. R. Kalla Memorial General Hospital — Jaipur, India
• Lisie Hospital — Kochi, India
• P D Hinduja National Hospital and Medical Research Center — Mumbai, India
• Yashoda Super Speciality Hospitals — Secunderabad, India
• SIDS Hospital & Research Centre — Surat, India
• Gujarat Gastro and Vascular Hospital — Surat, India
• Assuta Medical center — Ashdod, Israel
• Rambam Medical Center — Haifa, Israel
• Bnai Zion Medical Center — Haifa, Israel
• Wolfson Medical Center — Holon, Israel
• Shaare Zedek Medical Center — Jerusalem, Israel
• Meir Medical Center — Kfar Saba, Israel
• Galilee Medical Center — Nahariya, Israel
• Rabin Medical Center — Petah Tikva, Israel
• Sheba Medical Center — Ramat Gan, Israel
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
• Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano — Milan, Italy
• Ospedale San Raffaele di Milano — Milan, Italy
• Ospedale Sacro Cuore Negrar-Verona — Negrar Verona, Italy
• Azienda Ospedaliera San Camillo-Forlanini — Roma, Italy
• Fondazione Policlinico Universitario A Gemelli IRCCS — Roma, Italy
• Fatebenefratelli Isola Tiberina - Gemelli Isola — Roma, Italy
• Istituto Clinico Humanitas — Rozzano, Italy
• Institute of Science Tokyo Hospital — Bunkyō City, Japan
• Hamamatsu University Hospital — Hamamatsu, Japan
• Matsuda Hospital — Hamamatsu, Japan
• National Hospital Organization Mito Medical Center — Higashi-Ibaraki, Japan
• Kagoshima IBD Gastroenterology Clinic — Kagoshima, Japan
• Tsujinaka Hospital Kashiwanoha — Kashiwa, Japan
• Kumamoto University Hospital — Kumamoto, Japan
• Takano Hospital — Kumamoto, Japan
• Kitasato University Kitasato Institute Hospital — Minatoku, Japan
• Kyorin University Hospital — Mitaka, Japan
• Aichi Medical University Hospital — Nagakute, Japan
• Hyogo Medical University Hospital — Nishinomiya Shi, Japan
• National Hospital Organization Osaka National Hospital — Osaka, Japan
• Osaka Metropolitan University Hospital — Osaka, Japan
• Oita Red Cross Hospital — Ōita, Japan
• Saga University Hospital — Saga, Japan
• Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital — Sapporo, Japan
• Sapporo Medical University Hospital — Sapporo, Japan
• Sapporo Higashi Tokushukai Hospital — Sapporo, Japan
• National Hospital Organization Shizuoka Medical Center — Shimizu, Japan
• Center Hospital of the National Center for Global Health and Medicine — Shinjuku Ku, Japan
• Tokyo Metropolitan Bokutoh Hospital — Sumida Ku, Japan
• The Jikei University Hospital — Tokyo, Japan
• Yamanashi Prefectural Central Hospital — Yamanashi, Japan
• Hospital Ampang — Ampang, Malaysia
• Sultan Idris Shah Hospital — Kajang, Malaysia
• Hospital Kuala Lumpur — Kuala Lumpur, Malaysia
• University Malaya Medical Centre — Kuala Lumpur, Malaysia
• Hospital Sultanah Nur Zahirah — Kuala Terengganu, Malaysia
• Vrije Universiteit Medisch Centrum — Amsterdam, Netherlands
• Radboud Umcn — Nijmegen, Netherlands
• St. Elisabeth Ziekenhuis — Tilburg, Netherlands
• UMC Utrecht — Utrecht, Netherlands
• Alesund sjukehus — Ålesund, Norway
• Sykehuset Innlandet HF Gjøvik — Gjøvik, Norway
• Akershus Universitetssykehus — Lorenskog, Norway
• Sykehuset Ostfold — Moss, Norway
• Universitetssykehuset Nord-Norge HF — Tromsø, Norway
• St. Olavs Hospital — Trondheim, Norway
• Centrum Medyczne Medis ManerMed Sp Z O O — Bydgoszcz, Poland
• Centrum Medyczne Plejady — Krakow, Poland
• Centrum Medyczne Promed — Krakow, Poland
• Medrise Sp. z o.o. — Lublin, Poland
• Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie — Lublin, Poland
• Medicus Zaniewski i Bilski — Olsztyn, Poland
• Twoja Przychodnia Opolskie Centrum Medyczne — Opole, Poland
• Centrum Medyczne Medyk — Rzeszów, Poland
• Twoja Przychodnia - Szczecinskie Centrum Medyczne — Szczecin, Poland
• Sonomed Sp. z o.o. — Szczecin, Poland
• GASTROMED Sp. z o.o. — Torun, Poland
• H-T Centrum Medyczne — Tychy, Poland
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland
• Centrum Medyczne Oporow — Wroclaw, Poland
• EMC Instytut Medyczny S A Penta Hospitals Przychodnie — Wroclaw, Poland
• ETG Zamosc — Zamość, Poland
• Uls Braga - Hosp. Braga — Braga, Portugal
• Hosp. Da Luz Lisboa — Lisbon, Portugal
• Uls Santa Maria - Hosp. Santa Maria — Lisbon, Portugal
• Uls Algarve Hosp Portimao — Portimão, Portugal
• Uls Arrabida - Hosp. Sao Bernardo — Setúbal, Portugal
• Baneasa Tumor Center Hospital — Bucharest, Romania
• Spitalul Clinic Colentina — Bucharest, Romania
• Institutul Clinic Fundeni — Bucharest, Romania
• Gastro Med S R L — Cluj-Napoca, Romania
• Oncohelp Medical Center — Timișoara, Romania
• FNsP F. D. Roosevelta Banska Bystrica — Banská Bystrica, Slovakia
• Cliniq s.r.o. — Bratislava, Slovakia
• ENDOMED s.r.o — Košice, Slovakia
• KM Management spol. s r.o. — Nitra, Slovakia
• GASTRO I. s.r.o. — Prešov, Slovakia
• Gastro LM s.r.o. — Prešov, Slovakia
• Ustredna Vojenska Nemocnica SNP Ruzomberok- Fakultna Nemocnica — Ružomberok, Slovakia
• Korea University Ansan Hospital — Ansan-si, South Korea
• Inje University Haeundae Paik Hospital — Busan, South Korea
• The Catholic University of Korea Daejeon St Mary's Hospital — Daejeon, South Korea
• Kyung Hee University Hospital — Dongdaemun-gu, South Korea
• Samsung Medical Center — Gangnam Gu, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Hosp. Gral. Univ. Dr. Balmis — Alicante, Spain
• Hosp. Univ. Infanta Leonor — Madrid, Spain
• Hosp. Clinico Univ. de Santiago — Santiago de Compostela, Spain
• Hosp. Virgen Macarena — Seville, Spain
• Hosp. Alvaro Cunqueiro — Vigo, Spain
• Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern — Bern, Switzerland
• Taichung Veterans General Hospital — Taichung, Taiwan
• National Cheng Kung University Hospital — Tainan, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan
• Taipei Mackay Memorial Hospital — Taipei, Taiwan
• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
• Antalya Training And Research Hospital — Antalya, Turkey (Türkiye)
• Sanko Universitesi Hastanesi — Gaziantep, Turkey (Türkiye)
• Bezmialem University Medical Faculty — Istanbul, Turkey (Türkiye)
• Istanbul University Cerrahpasa Medical Faculty — Istanbul, Turkey (Türkiye)
• Izmir Sehir Hastanesi — Izmir, Turkey (Türkiye)
• Kocaeli University Medical Faculty — Kocaeli, Turkey (Türkiye)
• Mersin University Medical Faculty — Mersin, Turkey (Türkiye)
• Addenbrookes Hospital — Cambridge, United Kingdom
• Cardiff and Vale UHB - University Hospital of Wales — Cardiff, United Kingdom
• Ninewells Hospital — Dundee, United Kingdom
• Whipps Cross University Hospital — Leytonstone, United Kingdom
• Kings College Hospital — London, United Kingdom
• St Georges Healthcare NHS Trust — London, United Kingdom
• Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom