A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

JNJ-77242113

Placebo

Clinical Study ID

NCT06049017
77242113UCO2001
2023-504673-20-00
77242113UCO2001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent form 18 years of age or older

  • Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior toscreening

  • Moderately to severely active UC as per the modified Mayo score

  • Demonstrated inadequate response to or intolerance of conventional therapy and/oradvanced therapy as defined in the protocol

Exclusion

Exclusion Criteria:

  • Participants with current or prior diagnosis of fulminant colitis and/or toxicmegacolon

  • 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'scolitis or clinical findings suggestive of Crohn's disease

Study Design

Total Participants: 252
Treatment Group(s): 2
Primary Treatment: JNJ-77242113
Phase: 2
Study Start date:
October 09, 2023
Estimated Completion Date:
January 16, 2026

Connect with a study center

  • Cer Instituto Medico

    Buenos Aires, B1878DVB
    Argentina

    Site Not Available

  • Gedyt - Consultorios Gastroenterologia

    Buenos Aires, C1425
    Argentina

    Site Not Available

  • CIPREC

    Ciudad Autonoma de Buenos Aires, C1061AAS
    Argentina

    Site Not Available

  • Hospital Provincial del Centenario

    Rosario, S2000KDS
    Argentina

    Site Not Available

  • Sanatorio 9 de Julio

    San Miguel de Tucuman, 4000
    Argentina

    Site Not Available

  • Sunshine Coast University Hospital

    Birtinya, 4575
    Australia

    Site Not Available

  • Blacktown Hospital

    Blacktown, 2148
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, 2139
    Australia

    Site Not Available

  • Wollongong Private Hospital

    Wollongong, 2500
    Australia

    Site Not Available

  • CHU Saint-Pierre

    Brussels, 1000
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Gent, 9000
    Belgium

    Site Not Available

  • Ghent University Hospital

    Gent, 9000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Vitaz

    Sint Niklaas, 9100
    Belgium

    Site Not Available

  • Vitaz

    Sint-Niklaas, 9100
    Belgium

    Site Not Available

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, 18618-687
    Brazil

    Site Not Available

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70.200-730
    Brazil

    Site Not Available

  • CDC - Centro Digestivo de Curitiba

    Curitiba, 80430-180
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre - Hospital de Clinicas

    Porto Alegre, 90035 903
    Brazil

    Site Not Available

  • Pesquisare Saude

    Santo Andre, 09080-110
    Brazil

    Site Not Available

  • BR TRIALS Ensaios Clinicos e Consultoria Ltda

    Sao Paulo, 01236030
    Brazil

    Site Not Available

  • BR TRIALS-Ensaios Clinicos e Consultoria Ltda

    Sao Paulo, 01236030
    Brazil

    Site Not Available

  • Instituto D Or de Pesquisa e Ensino

    Sao Paulo, 01401 002
    Brazil

    Site Not Available

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 15501-405
    Brazil

    Site Not Available

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta T5R 1W2
    Canada

    Site Not Available

  • Barrie GI Associates

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • ABP Research Services Corp.

    Oakville, Ontario L6L 5L7
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite de Montreal

    Montréal, Quebec H2X 0C1
    Canada

    Site Not Available

  • The second Xiangya Hospital of Central South University

    Changsha, 410011
    China

    Site Not Available

  • Chongqing General Hospital

    Chongqing, 400014
    China

    Site Not Available

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510060
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510060
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital Sun Yat sen University

    Guangzhou, 510655
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310000
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, 250012
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lan Zhou, 730031
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nan Jing Shi, 210008
    China

    Site Not Available

  • Shengjing Hospital Of China Medical University

    Shen Yang Shi, 110022
    China

    Site Not Available

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022
    China

    Site Not Available

  • Wuxi People s Hospital

    Wuxi, 214023
    China

    Site Not Available

  • The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital

    Xi'An, 710038
    China

    Site Not Available

  • Nemocnice Ceske Budejovice

    Ceske Budejovice, 370 01
    Czechia

    Site Not Available

  • Gastroenterologie, s.r.o., Hradec Kralove

    Hradec Kralova, 500 02
    Czechia

    Site Not Available

  • Hepato-gastroenterologie HK, s.r.o.

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • ISCARE a.s.

    Praha, 19000
    Czechia

    Site Not Available

  • Nemocnice Slany

    Slany, 27401
    Czechia

    Site Not Available

  • CHRU Besancon Hopital Jean Minjoz

    Besancon Cedex, 25030
    France

    Site Not Available

  • APHP - Hopital Henri Mondor

    Creteil, 94000
    France

    Site Not Available

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037
    France

    Active - Recruiting

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • CHU de Nice Hopital de l Archet

    Nice, 06202
    France

    Site Not Available

  • CHU Nimes Hopital Caremeau

    Nimes Cedex, 30900
    France

    Site Not Available

  • APHP - Hopital Bichat - Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Hospices Civils de Lyon CHU Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • CHU Saint Etienne Hopital Nord

    Saint Priest en Jarez, 42270
    France

    Site Not Available

  • CHU Saint-Etienne - Hopital Nord

    Saint Priest en Jarez, 42270
    France

    Active - Recruiting

  • CHU Toulouse - Hopital de Rangueil

    Toulouse, 31400
    France

    Site Not Available

  • CHU de Nancy_ Hopital Brabois

    Vandœuvre-les-Nancy, 54500
    France

    Site Not Available

  • Klinikum Augsburg

    Augsburg, D-86158
    Germany

    Site Not Available

  • Krankenhaus Waldfriede Mitte

    Berlin, 14163
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Eugastro GmbH

    Leipzig, 04103
    Germany

    Site Not Available

  • Staedtisches Klinikum Lueneburg

    Lueneburg, 21339
    Germany

    Site Not Available

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423
    Germany

    Site Not Available

  • Pannónia Magánorvosi Centrum Kft

    Budapest, H-1136
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1083
    Hungary

    Site Not Available

  • Debreceni Egyetem Gasztroenterologiai Klinika

    Debrecen, 4032
    Hungary

    Site Not Available

  • Vasutegeszsegugyi Nonprofit Kozhasznu Kft

    Debrecen, 4025
    Hungary

    Site Not Available

  • Vasutegeszsegugyi Nonprofit Kozhasznu Kft.

    Debrecen, 4025
    Hungary

    Active - Recruiting

  • Clinexpert Kft

    Gyongyos, 3200
    Hungary

    Site Not Available

  • S. R. Kalla Memorial General Hospital

    Jaipur, 302006
    India

    Site Not Available

  • Midas Hospital

    Nagpur, 441108
    India

    Site Not Available

  • Midas Multispeciality Hospital

    Nagpur, 440010
    India

    Active - Recruiting

  • Govind Ballabh Pant Hospital

    New Delhi, 110002
    India

    Site Not Available

  • SIDS Hospital & Research Centre

    Surat, 395002
    India

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    Milano, 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda, Ospedale Policlinico di Milano

    Milano, 20122
    Italy

    Active - Recruiting

  • Ospedale San Raffaele di Milano

    Milano, 20132
    Italy

    Site Not Available

  • Ospedale Sacro Cuore Don Calabria

    Negrar Di Valpolicella, 37024
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo - Roma

    Roma, 00152
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Casa Sollievo della Sofferenza, IRCCS

    San Giovanni Rotondo, 71013
    Italy

    Active - Recruiting

  • Sai Clinic, Gastrointestinal and Protology Divisions

    Fujiidera-shi, 583-0027
    Japan

    Active - Recruiting

  • Sai Gastroenterology Proctology

    Fujiidera-shi, 583-0027
    Japan

    Site Not Available

  • Hamamatsu University Hospital

    Hamamatsu, 431 3192
    Japan

    Site Not Available

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843
    Japan

    Site Not Available

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871
    Japan

    Site Not Available

  • Aoyama Naika Clinic

    Kobe, 650-0015
    Japan

    Site Not Available

  • Japanese Red Cross Osaka Hospital

    Osaka, 543 8555
    Japan

    Site Not Available

  • Kinshukai Infusion Clinic

    Osaka, 530-0011
    Japan

    Site Not Available

  • Toho University Sakura Medical Center

    Sakura, 285-8741
    Japan

    Site Not Available

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033
    Japan

    Site Not Available

  • Sapporo Tokushukai Hospital

    Sapporo, 004-0041
    Japan

    Site Not Available

  • National Hospital Organization Shizuoka Medical Center

    Shimizu, 411-8611
    Japan

    Site Not Available

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida ku, 130 8575
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu, 514 8507
    Japan

    Site Not Available

  • Yokohama City University Medical Center

    Yokohama, 232 0024
    Japan

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Yeungnam University Hospital

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • The Catholic university of Korea, St. Vincent's Hospital

    Suwon si, 16247
    Korea, Republic of

    Site Not Available

  • The Catholic university of Korea, St. Vincent's Hospital

    Suwon-si, 16247
    Korea, Republic of

    Site Not Available

  • Hospital Sultanah Aminah

    Johor Bahru, 80100
    Malaysia

    Site Not Available

  • Sultan Idris Shah Hospital

    Kajang, 43000
    Malaysia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Centrum Medyczne Medis ManerMed Sp Z O O

    Bydgoszcz, 85 229
    Poland

    Site Not Available

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Centrum Medyczne Lukamed

    Chojnice, 89-600
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, 30 363
    Poland

    Site Not Available

  • Centrum Medyczne Medyk

    Rzeszow, 35-326
    Poland

    Site Not Available

  • Sonomed Sp. z o.o.

    Szczecin, 71-685
    Poland

    Site Not Available

  • GASTROMED Sp. z o.o.

    Torun, 87 100
    Poland

    Site Not Available

  • Bodyclinic Sp. z o.o. sp. k

    Warszawa, 03 712
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny Mswia

    Warszawa, 02 507
    Poland

    Site Not Available

  • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 04 501
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 04-501
    Poland

    Active - Recruiting

  • Centrum Medyczne Oporow

    Wroclaw, 52 416
    Poland

    Site Not Available

  • EMC Instytut Medyczny SA

    Wroclaw, 54 144
    Poland

    Site Not Available

  • Melita Medical Sp. z o.o.

    Wroclaw, 53 611
    Poland

    Site Not Available

  • S C Delta Health Care S R L

    Bucuresti, 014146
    Romania

    Site Not Available

  • S.C Delta Health Care S.R.L

    Bucuresti, 014146
    Romania

    Active - Recruiting

  • Spital Memorial

    Bucuresti, 013823
    Romania

    Site Not Available

  • Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva

    Cluj-Napoca, 400061
    Romania

    Site Not Available

  • Centrul Medical Valahia

    Ploiesti, 100032
    Romania

    Site Not Available

  • Hosp. Univ. Fundacion Alcorcon

    Alcorcon, 28922
    Spain

    Site Not Available

  • Hosp. Arquitecto Marcide

    Ferrol, 15405
    Spain

    Site Not Available

  • Hosp. de Cabuenes

    Gijon, 33394
    Spain

    Site Not Available

  • Hosp. Univ. La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hosp. Ntra. Sra. de Valme

    Sevilla, 41014
    Spain

    Site Not Available

  • Hosp. Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312
    Spain

    Site Not Available

  • Gazi University Medical Faculty

    Ankara, 6500
    Turkey

    Site Not Available

  • Uludag Universitesi Tıp Fakultesi Hastanesi

    Bursa, 16059
    Turkey

    Site Not Available

  • Ege Universitesi Tip Fakultesi

    Izmir, 35040
    Turkey

    Site Not Available

  • Mersin University Medical Faculty

    Mersin, 33343
    Turkey

    Site Not Available

  • Fairfield General Hospital

    Bury, Greater Manchester
    United Kingdom

    Site Not Available

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust

    London, E11 1NR
    United Kingdom

    Site Not Available

  • Guys St Thomas Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • King s College Hospital

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • St George's University Hospital NHS Foundation Trust

    London, SW17 0RE
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Whiston Hospital

    Prescot, L35 5DR
    United Kingdom

    Site Not Available

  • Southampton University Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Clinnova Research

    Anaheim, California 92805
    United States

    Site Not Available

  • Hoag Memorial Hospital

    Newport Beach, California 92663
    United States

    Site Not Available

  • Clinnova Research

    Orange, California 92868
    United States

    Site Not Available

  • Medical Associates Research Group, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • I.H.S. Health. LLC

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Endoscopic Research Inc

    Orlando, Florida 32803-1853
    United States

    Site Not Available

  • GCP Clinical Research

    Tampa, Florida 33609
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Gastroenterology of Southern Indiana

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Ochsner Medical Center

    Jefferson, Louisiana 70121
    United States

    Site Not Available

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Mercy Medical Center

    Baltimore, Maryland 21202-2102
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • New York Gastroenterology Associates

    New York, New York 10075
    United States

    Site Not Available

  • DiGiovanna Institute for Medical Education & Research

    North Massapequa, New York 11758
    United States

    Site Not Available

  • University North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Charlotte Gastroenterology and Hepatology, PLLC

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Gastroenterology Associates P.A.

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Amel Med LLC. Research

    Austin, Texas 78705
    United States

    Site Not Available

  • DHAT Research Institute

    Garland, Texas 75044
    United States

    Site Not Available

  • Amel Med LLC Research

    Georgetown, Texas 78628
    United States

    Site Not Available

  • Accurate Clinical Research, Inc.

    Humble, Texas 77346
    United States

    Site Not Available

  • Caprock Gastro Research

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Southern Star Research Institute, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Site Not Available

  • Care Access Research, Ogden

    Ogden, Utah 84403
    United States

    Site Not Available

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • Washington Gastroenterology, PLLC

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Washington Gastroenterology, PLLC

    Tacoma, Washington 98405
    United States

    Site Not Available

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