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
2 other identifiers
interventional
252
21 countries
177
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2023
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
October 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2026
CompletedApril 13, 2026
April 1, 2026
12 months
September 15, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Percentage of Participants with Clinical Remission at Week 12
Week 12
Percentage of Participants with Symptomatic Remission at Week 12
Week 12
Percentage of Participants with Endoscopic Improvement at Week 12
Week 12
Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12
Week 12
Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)
Up to Week 76
Study Arms (4)
Group 1: JNJ-77242113 Dose-1
EXPERIMENTALParticipants 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.
Group 2: JNJ-77242113 Dose-2
EXPERIMENTALParticipants 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.
Group 3: JNJ-77242113 Dose-3
EXPERIMENTALParticipants 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.
Group 4: Placebo
EXPERIMENTALParticipants 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.
Interventions
JNJ-77242113 tablet will be administered orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (177)
Clinnova Research
Anaheim, California, 92805, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
I.H.S. Health. LLC
Kissimmee, Florida, 34741, United States
Endoscopic Research Inc
Orlando, Florida, 32803-1853, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Gastroenterology of Southern Indiana
New Albany, Indiana, 47150, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606, United States
Ochsner Medical Center
Jefferson, Louisiana, 70121, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Mercy Medical Center
Baltimore, Maryland, 21202-2102, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
New York Gastroenterology Associates
New York, New York, 10075, United States
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, 11758, United States
UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, 44145, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112, United States
Gastroenterology Associates P.A.
Greenville, South Carolina, 29607, United States
DHAT Research Institute
Garland, Texas, 75044, United States
Amel Med LLC Research
Georgetown, Texas, 78628, United States
Accurate Clinical Research, Inc.
Humble, Texas, 77346, United States
Caprock Gastro Research
Lubbock, Texas, 79424, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Care Access Research, Ogden
Ogden, Utah, 84403, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Washington Gastroenterology, PLLC
Bellevue, Washington, 98004, United States
Washington Gastroenterology, PLLC 1
Tacoma, Washington, 98405, United States
Cer Instituto Medico
Buenos Aires, B1878DVB, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
Gedyt - Consultorios Gastroenterologia
Buenos Aires, C1425, Argentina
Hospital Provincial del Centenario
Rosario, S2000KDS, Argentina
Sanatorio 9 de Julio
San Miguel de Tucumán, 4000, Argentina
Sunshine Coast University Hospital
Birtinya, 4575, Australia
Blacktown Hospital
Blacktown, 2148, Australia
Concord Repatriation General Hospital
Concord, 2139, Australia
Wollongong Private Hospital
Wollongong, 2500, Australia
CHU Saint-Pierre
Brussels, 1000, Belgium
AZ Sint-Lucas
Ghent, 9000, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Vitaz
Sint-Niklaas, 9100, Belgium
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, 18618-687, Brazil
L2IP Instituto de Pesquisas Clinicas
Brasília, 70.200-730, Brazil
CDC - Centro Digestivo de Curitiba
Curitiba, 80430-180, Brazil
Hospital de Clinicas de Porto Alegre - Hospital de Clinicas
Porto Alegre, 90035 903, Brazil
Pesquisare Saude
Santo André, 09080-110, Brazil
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo, 01236030, Brazil
Instituto D Or de Pesquisa e Ensino
São Paulo, 01401 002, Brazil
INTEGRAL Pesquisa e Ensino
Votuporanga, 15501-405, Brazil
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2, Canada
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
ABP Research Services Corp.
Oakville, Ontario, L6L 5L7, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0C1, Canada
The second Xiangya Hospital of Central South University
Changsha, 410011, China
Chongqing General Hospital
Chongqing, 400014, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510060, China
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, 510655, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310000, China
Qilu Hospital of Shandong University
Jinan, 250012, China
Lanzhou University Second Hospital
Lanzhou, 730031, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Shengjing Hospital Of China Medical University
Shenyang, 110022, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022, China
Wuxi People s Hospital
Wuxi, 214023, China
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
Xi'an, 710038, China
Nemocnice Ceske Budejovice
České Budějovice, 370 01, Czechia
Gastroenterologie, s.r.o., Hradec Kralove
Hradec Kralova, 500 02, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
ISCARE a.s.
Prague, 19000, Czechia
Nemocnice Slany
Slaný, 27401, Czechia
CHRU Besancon Hopital Jean Minjoz
Besançon, 25030, France
APHP - Hopital Henri Mondor
Créteil, 94000, France
CHRU de Lille Hopital Claude Huriez
Lille, 59037, France
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200, France
CHU de Nice Hopital de l Archet
Nice, 06202, France
CHU Nimes Hopital Caremeau
Nîmes, 30900, France
APHP - Hopital Bichat - Claude Bernard
Paris, 75018, France
Hospices Civils de Lyon CHU Lyon Sud
Pierre-Bénite, 69495, France
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270, France
CHU Toulouse - Hopital de Rangueil
Toulouse, 31400, France
CHU de Nancy_ Hopital Brabois
Vandœuvre-lès-Nancy, 54500, France
Klinikum Augsburg
Augsburg, D-86158, Germany
Krankenhaus Waldfriede Mitte
Berlin, 14163, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105, Germany
Eugastro GmbH
Leipzig, 04103, Germany
Staedtisches Klinikum Lueneburg
Lüneburg, 21339, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Semmelweis Egyetem
Budapest, 1083, Hungary
Semmelweis Egyetem 1
Budapest, 1088, Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, H-1136, Hungary
Vasutegeszsegugyi Nonprofit Kozhasznu Kft
Debrecen, 4025, Hungary
Debreceni Egyetem Gasztroenterologiai Klinika
Debrecen, 4032, Hungary
Clinexpert Kft
Gyöngyös, 3200, Hungary
S. R. Kalla Memorial General Hospital
Jaipur, 302006, India
Midas Hospital
Nagpur, 441108, India
Govind Ballabh Pant Hospital
New Delhi, 110002, India
SIDS Hospital & Research Centre
Surat, 395002, India
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, 20122, Italy
Ospedale San Raffaele di Milano
Milan, 20132, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, 37024, Italy
Azienda Ospedaliera San Camillo - Roma
Roma, 00152, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013, Italy
Sai Gastroenterology Proctology
Fujiidera-shi, 583-0027, Japan
Hamamatsu University Hospital
Hamamatsu, 431 3192, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871, Japan
Aoyama Naika Clinic
Kobe, 650-0015, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
Japanese Red Cross Osaka Hospital
Osaka, 543 8555, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Sapporo Tokushukai Hospital
Sapporo, 004-0041, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
National Hospital Organization Shizuoka Medical Center
Shimizu, 411-8611, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, 130 8575, Japan
Mie University Hospital
Tsu, 514 8507, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Hospital Sultanah Aminah
Johor Bahru, 80100, Malaysia
Sultan Idris Shah Hospital
Kajang, 43000, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Centrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz, 85 229, Poland
Centrum Medyczne Lukamed Spolka z Ograniczona Odpowiedzialnoscia
Chojnice, 89-600, Poland
Centrum Medyczne Plejady
Krakow, 30 363, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
GASTROMED Sp. z o.o.
Torun, 87 100, Poland
Centralny Szpital Kliniczny Mswia
Warsaw, 02 507, Poland
Bodyclinic Sp. z o.o. sp. k
Warsaw, 03 712, Poland
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04 501, Poland
Centrum Medyczne Oporow
Wroclaw, 52 416, Poland
Melita Medical Sp. z o.o.
Wroclaw, 53 611, Poland
EMC Instytut Medyczny SA
Wroclaw, 54 144, Poland
Spital Memorial
Bucharest, 013823, Romania
S C Delta Health Care S R L
Bucharest, 014146, Romania
Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
Cluj-Napoca, 400061, Romania
Centrul Medical Valahia
Ploieşti, 100032, Romania
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Hosp. Univ. Fundacion Alcorcon
Alcorcón, 28922, Spain
Hosp. Arquitecto Marcide
Ferrol, 15405, Spain
Hosp. de Cabuenes
Gijón, 33394, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Hosp. Ntra. Sra. de Valme
Seville, 41014, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Hosp. Alvaro Cunqueiro
Vigo, 36312, Spain
Gazi University Medical Faculty
Ankara, 6500, Turkey (Türkiye)
Uludag Universitesi Tıp Fakultesi Hastanesi
Bursa, 16059, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir, 35040, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33343, Turkey (Türkiye)
Fairfield General Hospital
Bury, Greater Manchester, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Barts Health NHS Trust
London, E11 1NR, United Kingdom
Guys St Thomas Hospital
London, SE1 7EH, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
St Georges University Hospital NHS Foundation Trust
London, SW17 0RE, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU, United Kingdom
Whiston Hospital
Prescot, L35 5DR, United Kingdom
Southampton University Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2023
First Posted
September 21, 2023
Study Start
October 9, 2023
Primary Completion
September 26, 2024
Study Completion
January 5, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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