A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC)

A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis

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.

Study Overview

• Status: Completed
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: JNJ-77242113; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1878DVB
    • Cer Instituto Medico
  • Buenos Aires, Argentina, C1425
    • Gedyt - Consultorios Gastroenterologia
  • Buenos Aires, Argentina, C1061AAS
    • CIPREC
  • Rosario, Argentina, S2000KDS
    • Hospital Provincial del Centenario
  • San Miguel de Tucumán, Argentina, 4000
    • Sanatorio 9 de Julio
• Australia
  • Birtinya, Australia, 4575
    • Sunshine Coast University Hospital
  • Blacktown, Australia, 2148
    • Blacktown Hospital
  • Concord, Australia, 2139
    • Concord Repatriation General Hospital
  • Wollongong, Australia, 2500
    • Wollongong Private Hospital
• Belgium
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Ghent, Belgium, 9000
    • AZ Sint-Lucas
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • Sint-Niklaas, Belgium, 9100
    • Vitaz
• Brazil
  • Botucatu, Brazil, 18618-687
    • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  • Brasília, Brazil, 70.200-730
    • L2IP Instituto de Pesquisas Clinicas
  • Curitiba, Brazil, 80430-180
    • CDC - Centro Digestivo de Curitiba
  • Porto Alegre, Brazil, 90035 903
    • Hospital de Clinicas de Porto Alegre - Hospital de Clinicas
  • Santo André, Brazil, 09080-110
    • Pesquisare Saude
  • São Paulo, Brazil, 01236030
    • BR TRIALS Ensaios Clinicos e Consultoria Ltda
  • São Paulo, Brazil, 01401 002
    • Instituto D Or de Pesquisa e Ensino
  • Votuporanga, Brazil, 15501-405
    • Integral Pesquisa e Ensino
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5R 1W2
      • Gastroenterology and Internal Medicine Research Institute (GIRI)
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Barrie GI Associates
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Oakville, Ontario, Canada, L6L 5L7
      • ABP Research Services Corp.
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Centre hospitalier de l'Université de Montréal
• China
  • Changsha, China, 410011
    • The Second Xiangya Hospital of Central South University
  • Chongqing, China, 400014
    • Chongqing General Hospital
  • Guangzhou, China, 510060
    • The First Affiliated Hospital Sun Yat sen University
  • Guangzhou, China, 510655
    • The Sixth Affiliated Hospital Sun Yat sen University
  • Hangzhou, China, 310000
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Jinan, China, 250012
    • Qilu Hospital of Shandong University
  • Lanzhou, China, 730031
    • Lanzhou university second hospital
  • Nanjing, China, 210008
    • NanJing Drum Tower Hospital
  • Shenyang, China, 110022
    • Shengjing Hospital of China Medical University
  • Wuhan, China, 430022
    • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Wuxi, China, 214023
    • Wuxi People s Hospital
  • Xi'an, China, 710038
    • The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
• Czechia
  • Hradec Kralova, Czechia, 500 02
    • Gastroenterologie, s.r.o., Hradec Kralove
  • Hradec Králové, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.
  • Prague, Czechia, 19000
    • ISCARE a.s.
  • Slaný, Czechia, 27401
    • Nemocnice Slany
  • České Budějovice, Czechia, 370 01
    • Nemocnice Ceske Budejovice
• France
  • Besançon, France, 25030
    • CHRU Besancon Hopital Jean Minjoz
  • Créteil, France, 94000
    • Aphp - Hopital Henri Mondor
  • Lille, France, 59037
    • CHRU de Lille Hopital Claude Huriez
  • Neuilly-sur-Seine, France, 92200
    • Clinique Ambroise Pare
  • Nice, France, 06202
    • CHU de Nice Hopital de l Archet
  • Nîmes, France, 30900
    • CHU Nimes Hopital Caremeau
  • Paris, France, 75018
    • APHP - Hopital Bichat - Claude Bernard
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon CHU Lyon Sud
  • Saint-Priest-en-Jarez, France, 42270
    • CHU Saint Etienne Hopital Nord
  • Toulouse, France, 31400
    • CHU Toulouse - Hopital de Rangueil
  • Vandœuvre-lès-Nancy, France, 54500
    • CHU de Nancy_ Hopital Brabois
• Germany
  • Augsburg, Germany, D-86158
    • Klinikum Augsburg
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede Mitte
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig Holstein Kiel
  • Leipzig, Germany, 04103
    • EUGASTRO GmbH
  • Lüneburg, Germany, 21339
    • Staedtisches Klinikum Lueneburg
  • Minden, Germany, 32423
    • Gastroenterologische Gemeinschaftspraxis Minden
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, H-1136
    • Pannónia Magánorvosi Centrum Kft
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem 1
  • Debrecen, Hungary, 4025
    • Vasutegeszsegugyi Nonprofit Kozhasznu Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Gasztroenterologiai Klinika
  • Gyöngyös, Hungary, 3200
    • Clinexpert Kft
• India
  • Jaipur, India, 302006
    • S. R. Kalla Memorial General Hospital
  • Nagpur, India, 441108
    • Midas Hospital
  • New Delhi, India, 110002
    • Govind Ballabh Pant Hospital
  • Surat, India, 395002
    • Sids Hospital & Research Centre
• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
  • Milan, Italy, 20132
    • Ospedale San Raffaele di Milano
  • Negrar, Italy, 37024
    • Ospedale Sacro Cuore Don Calabria
  • Roma, Italy, 00152
    • Azienda Ospedaliera San Camillo - Roma
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
  • San Giovanni Rotondo, Italy, 71013
    • Casa Sollievo Della Sofferenza IRCCS
• Japan
  • Fujiidera-shi, Japan, 583-0027
    • Sai Gastroenterology Proctology
  • Hamamatsu, Japan, 431 3192
    • Hamamatsu University Hospital
  • Kagoshima, Japan, 892-0843
    • Kagoshima IBD Gastroenterology Clinic
  • Kashiwa, Japan, 277-0871
    • Tsujinaka Hospital Kashiwanoha
  • Kobe, Japan, 650-0015
    • Aoyama Naika Clinic
  • Osaka, Japan, 530-0011
    • Kinshukai Infusion Clinic
  • Osaka, Japan, 543 8555
    • Japanese Red Cross Osaka Hospital
  • Sakura, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Sapporo, Japan, 065-0033
    • Sapporo Higashi Tokushukai Hospital
  • Sapporo, Japan, 004-0041
    • Sapporo Tokushukai Hospital
  • Shimizu, Japan, 411-8611
    • National Hospital Organization Shizuoka Medical Center
  • Sumida Ku, Japan, 130 8575
    • Tokyo Metropolitan Bokutoh Hospital
  • Tsu, Japan, 514 8507
    • Mie University Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
• Malaysia
  • Johor Bahru, Malaysia, 80100
    • Hospital Sultanah Aminah
  • Kajang, Malaysia, 43000
    • Sultan Idris Shah Hospital
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
• Poland
  • Bydgoszcz, Poland, 85 229
    • Centrum Medyczne Medis ManerMed Sp Z O O
  • Chojnice, Poland, 89-600
    • Centrum Medyczne Lukamed Spolka z Ograniczona Odpowiedzialnoscia
  • Krakow, Poland, 30 363
    • Centrum Medyczne Plejady
  • Rzeszów, Poland, 35-326
    • Centrum Medyczne MEDYK
  • Szczecin, Poland, 71-685
    • Sonomed Sp. z o.o.
  • Torun, Poland, 87 100
    • GASTROMED Sp. z o.o.
  • Warsaw, Poland, 02 507
    • Centralny Szpital Kliniczny Mswia
  • Warsaw, Poland, 03 712
    • Bodyclinic Sp. z o.o. sp. k
  • Warsaw, Poland, 04 501
    • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
  • Wroclaw, Poland, 52 416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 54 144
    • EMC Instytut Medyczny SA
  • Wroclaw, Poland, 53 611
    • Melita Medical Sp. z o.o.
• Romania
  • Bucharest, Romania, 013823
    • Spital Memorial
  • Bucharest, Romania, 014146
    • S C Delta Health Care S R L
  • Cluj-Napoca, Romania, 400061
    • Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
  • Ploieşti, Romania, 100032
    • Centrul Medical Valahia
• South Korea
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Daegu, South Korea, 42415
    • Yeungnam University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Suwon, South Korea, 16247
    • The Catholic University of Korea, St. Vincent's Hospital
• Spain
  • Alcorcón, Spain, 28922
    • Hosp. Univ. Fundacion Alcorcon
  • Ferrol, Spain, 15405
    • Hosp. Arquitecto Marcide
  • Gijón, Spain, 33394
    • Hosp. de Cabuenes
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Majadahonda, Spain, 28222
    • Hosp. Univ. Pta. de Hierro Majadahonda
  • Santiago de Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
  • Seville, Spain, 41009
    • Hosp. Virgen Macarena
  • Seville, Spain, 41014
    • Hosp. Ntra. Sra. de Valme
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
  • Vigo, Spain, 36312
    • Hosp. Alvaro Cunqueiro
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 6500
    • Gazi University Medical Faculty
  • Bursa, Turkey (Türkiye), 16059
    • Uludag Universitesi Tıp Fakultesi Hastanesi
  • Izmir, Turkey (Türkiye), 35040
    • Ege Universitesi Tip Fakultesi
  • Mersin, Turkey (Türkiye), 33343
    • Mersin University Medical Faculty
• United Kingdom
  • Bury, United Kingdom, Greater Manchester
    • Fairfield General Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom, E11 1NR
    • Barts Health NHS Trust
  • London, United Kingdom, SE1 7EH
    • Guys St Thomas Hospital
  • London, United Kingdom, SW17 0RE
    • St Georges University Hospital NHS Foundation Trust
  • Oxford, United Kingdom, OX3 9DU
    • Oxford University Hospitals NHS Foundation Trust
  • Prescot, United Kingdom, L35 5DR
    • Whiston Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospital
• United States
  • California
    • Anaheim, California, United States, 92805
      • Clinnova Research
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital
    • San Diego, California, United States, 92123
      • Medical Associates Research Group, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
  • Florida
    • Kissimmee, Florida, United States, 34741
      • I.H.S. Health. LLC
    • Orlando, Florida, United States, 32803-1853
      • Endoscopic Research Inc
    • Tampa, Florida, United States, 33609
      • GCP Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Gastroenterology of Southern Indiana
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Digestive Health Center
  • Louisiana
    • Jefferson, Louisiana, United States, 70121
      • Ochsner Medical Center
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21202-2102
      • Mercy Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • New York
    • New York, New York, United States, 10075
      • New York Gastroenterology Associates
    • North Massapequa, New York, United States, 11758
      • DiGiovanna Institute for Medical Education & Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology and Hepatology, PLLC
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health
  • Ohio
    • Westlake, Ohio, United States, 44145
      • Northshore Gastroenterology Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists Inc
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Gastroenterology Associates P.A.
  • Texas
    • Garland, Texas, United States, 75044
      • DHAT Research Institute
    • Georgetown, Texas, United States, 78628
      • Amel Med LLC Research
    • Humble, Texas, United States, 77346
      • Accurate Clinical Research, Inc.
    • Lubbock, Texas, United States, 79424
      • Caprock Gastro Research
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute, LLC
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Utah
    • Ogden, Utah, United States, 84403
      • Care Access Research, Ogden
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
  • Washington
    • Bellevue, Washington, United States, 98004
      • Washington Gastroenterology, PLLC
    • Tacoma, Washington, United States, 98405
      • Washington Gastroenterology, PLLC 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed informed consent form 18 years of age or older
• 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.
Experimental: 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.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.
Experimental: 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.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.
Experimental: 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.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.; Drug: Placebo; Placebo tablet will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Clinical Response at Week 12	Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Clinical Remission at Week 12	Clinical remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.	Week 12
Percentage of Participants with Symptomatic Remission at Week 12	Symptomatic remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0.	Week 12
Percentage of Participants with Endoscopic Improvement at Week 12	Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.	Week 12
Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12	Histologic-endoscopic mucosal improvement is defined as a combination of histologic remission and endoscopic improvement. Histologic remission and endoscopic improvement are based on the histologic grading and the Mayo endoscopy subscore.	Week 12
Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)	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. 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.	Up to Week 76

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): January 5, 2026

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 77242113UCO2001 (Other Identifier: Janssen Research & Development, LLC); 2023-504673-20-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No