A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT06049017
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
252 participants
INTERVENTIONAL
2023-10-09
2026-01-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: JNJ-77242113 Dose-1
Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.
JNJ-77242113
JNJ-77242113 tablet will be administered orally.
Group 2: JNJ-77242113 Dose-2
Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
JNJ-77242113
JNJ-77242113 tablet will be administered orally.
Group 3: JNJ-77242113 Dose-3
Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
JNJ-77242113
JNJ-77242113 tablet will be administered orally.
Group 4: Placebo
Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.
JNJ-77242113
JNJ-77242113 tablet will be administered orally.
Placebo
Placebo tablet will be administered orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JNJ-77242113
JNJ-77242113 tablet will be administered orally.
Placebo
Placebo tablet will be administered orally.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Exclusion Criteria
* UC limited to rectum only or to less than (\<) 15 centimeters (cm) of colon
* Presence of a stoma
* Presence or history of fistula
* History of extensive colonic resection (example, \<30 cm of colon remaining)
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinnova Research
Anaheim, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
I.H.S. Health. LLC
Kissimmee, Florida, United States
Endoscopic Research Inc
Orlando, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastroenterology of Southern Indiana
New Albany, Indiana, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
Ochsner Medical Center
Jefferson, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
New York Gastroenterology Associates
New York, New York, United States
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, United States
University North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health
Charlotte, North Carolina, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
Gastroenterology Associates P.A.
Greenville, South Carolina, United States
DHAT Research Institute
Garland, Texas, United States
Amel Med LLC Research
Georgetown, Texas, United States
Accurate Clinical Research, Inc.
Humble, Texas, United States
Caprock Gastro Research
Lubbock, Texas, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Care Access Research, Ogden
Ogden, Utah, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Washington Gastroenterology, PLLC
Bellevue, Washington, United States
Washington Gastroenterology, PLLC
Tacoma, Washington, United States
Cer Instituto Medico
Buenos Aires, , Argentina
CIPREC
Buenos Aires, , Argentina
Gedyt - Consultorios Gastroenterologia
Buenos Aires, , Argentina
Hospital Provincial del Centenario
Rosario, , Argentina
Sanatorio 9 de Julio
San Miguel de Tucumán, , Argentina
Sunshine Coast University Hospital
Birtinya, , Australia
Blacktown Hospital
Blacktown, , Australia
Concord Repatriation General Hospital
Concord, , Australia
Wollongong Private Hospital
Wollongong, , Australia
CHU Saint-Pierre
Brussels, , Belgium
AZ Sint-Lucas
Ghent, , Belgium
Ghent University Hospital
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, , Belgium
Vitaz
Sint-Niklaas, , Belgium
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, , Brazil
L2IP Instituto de Pesquisas Clinicas
Brasília, , Brazil
CDC - Centro Digestivo de Curitiba
Curitiba, , Brazil
Hospital de Clinicas de Porto Alegre - Hospital de Clinicas
Porto Alegre, , Brazil
Pesquisare Saude
Santo André, , Brazil
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo, , Brazil
Instituto D Or de Pesquisa e Ensino
São Paulo, , Brazil
INTEGRAL Pesquisa e Ensino
Votuporanga, , Brazil
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, Canada
Barrie GI Associates
Barrie, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
ABP Research Services Corp.
Oakville, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
The second Xiangya Hospital of Central South University
Changsha, , China
Chongqing General Hospital
Chongqing, , China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, , China
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
Qilu Hospital of Shandong University
Jinan, , China
Lanzhou University Second Hospital
Lanzhou, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Shengjing Hospital Of China Medical University
Shenyang, , China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
Wuxi People s Hospital
Wuxi, , China
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
Xi'an, , China
Nemocnice Ceske Budejovice
České Budějovice, , Czechia
Gastroenterologie, s.r.o., Hradec Kralove
Hradec Kralova, , Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
ISCARE a.s.
Prague, , Czechia
Nemocnice Slany
Slaný, , Czechia
CHRU Besancon Hopital Jean Minjoz
Besançon, , France
APHP - Hopital Henri Mondor
Créteil, , France
CHRU de Lille Hopital Claude Huriez
Lille, , France
Clinique Ambroise Pare
Neuilly-sur-Seine, , France
CHU de Nice Hopital de l Archet
Nice, , France
CHU Nimes Hopital Caremeau
Nîmes, , France
APHP - Hopital Bichat - Claude Bernard
Paris, , France
Hospices Civils de Lyon CHU Lyon Sud
Pierre-Bénite, , France
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, , France
CHU Toulouse - Hopital de Rangueil
Toulouse, , France
CHU de Nancy_ Hopital Brabois
Vandœuvre-lès-Nancy, , France
Klinikum Augsburg
Augsburg, , Germany
Krankenhaus Waldfriede Mitte
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, , Germany
Eugastro GmbH
Leipzig, , Germany
Staedtisches Klinikum Lueneburg
Lüneburg, , Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, , Hungary
Vasutegeszsegugyi Nonprofit Kozhasznu Kft
Debrecen, , Hungary
Debreceni Egyetem Gasztroenterologiai Klinika
Debrecen, , Hungary
Clinexpert Kft
Gyöngyös, , Hungary
S. R. Kalla Memorial General Hospital
Jaipur, , India
Midas Hospital
Nagpur, , India
Govind Ballabh Pant Hospital
New Delhi, , India
SIDS Hospital & Research Centre
Surat, , India
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, , Italy
Ospedale San Raffaele di Milano
Milan, , Italy
Ospedale Sacro Cuore Don Calabria
Negrar, , Italy
Azienda Ospedaliera San Camillo - Roma
Roma, , Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, , Italy
Sai Gastroenterology Proctology
Fujiidera-shi, , Japan
Hamamatsu University Hospital
Hamamatsu, , Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, , Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, , Japan
Aoyama Naika Clinic
Kobe, , Japan
Kinshukai Infusion Clinic
Osaka, , Japan
Japanese Red Cross Osaka Hospital
Osaka, , Japan
Toho University Sakura Medical Center
Sakura, , Japan
Sapporo Tokushukai Hospital
Sapporo, , Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, , Japan
National Hospital Organization Shizuoka Medical Center
Shimizu, , Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, , Japan
Mie University Hospital
Tsu, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Hospital Sultanah Aminah
Johor Bahru, , Malaysia
Sultan Idris Shah Hospital
Kajang, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Centrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz, , Poland
Centrum Medyczne Lukamed Spolka z Ograniczona Odpowiedzialnoscia
Chojnice, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
Sonomed Sp. z o.o.
Szczecin, , Poland
GASTROMED Sp. z o.o.
Torun, , Poland
Centralny Szpital Kliniczny Mswia
Warsaw, , Poland
Bodyclinic Sp. z o.o. sp. k
Warsaw, , Poland
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Melita Medical Sp. z o.o.
Wroclaw, , Poland
EMC Instytut Medyczny SA
Wroclaw, , Poland
Spital Memorial
Bucharest, , Romania
S C Delta Health Care S R L
Bucharest, , Romania
Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
Cluj-Napoca, , Romania
Centrul Medical Valahia
Ploieşti, , Romania
Inje University Haeundae Paik Hospital
Busan, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic university of Korea, St. Vincent's Hospital
Suwon, , South Korea
Hosp. Univ. Fundacion Alcorcon
Alcorcón, , Spain
Hosp. Arquitecto Marcide
Ferrol, , Spain
Hosp. de Cabuenes
Gijón, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Hosp. Ntra. Sra. de Valme
Seville, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Hosp. Alvaro Cunqueiro
Vigo, , Spain
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Uludag Universitesi Tıp Fakultesi Hastanesi
Bursa, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir, , Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, , Turkey (Türkiye)
Fairfield General Hospital
Bury, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Guys St Thomas Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
St Georges University Hospital NHS Foundation Trust
London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Whiston Hospital
Prescot, , United Kingdom
Southampton University Hospital
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
77242113UCO2001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504673-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
77242113UCO2001
Identifier Type: -
Identifier Source: org_study_id