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

Colitis, Ulcerative Clinical Trial

— ANTHEM-UC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049017
• Other study ID #: 77242113UCO2001
• Secondary ID: 77242113UCO20012
• Status: Recruiting
• Phase: Phase 2
• Start date: October 9, 2023
• Est. completion date: October 6, 2026

Study information

• Verified date: March 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 6, 2026
• Est. primary completion date: May 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• JNJ-77242113
JNJ-77242113 tablet will be administered orally.
• Placebo
Placebo tablet will be administered orally.

Locations

Country	Name	City	State
Argentina	Cer Instituto Medico	Buenos Aires
Argentina	Gedyt - Consultorios Gastroenterologia	Buenos Aires
Argentina	CIPREC	Ciudad Autonoma de Buenos Aires
Argentina	Hospital Provincial del Centenario	Rosario
Argentina	Sanatorio 9 de Julio	San Miguel de Tucuman
Australia	Sunshine Coast University Hospital	Birtinya
Australia	Blacktown Hospital	Blacktown
Australia	Concord Repatriation General Hospital	Concord
Australia	Wollongong Private Hospital	Wollongong
Belgium	CHU Saint-Pierre	Brussels
Belgium	AZ Sint-Lucas	Gent
Belgium	Ghent University Hospital	Gent
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman	Liege
Belgium	Vitaz	Sint-Niklaas
Brazil	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	Pesquisare Saude	Santo Andre
Brazil	BR TRIALS-Ensaios Clinicos e Consultoria Ltda	Sao Paulo
Brazil	Instituto D Or de Pesquisa e Ensino	Sao Paulo
Brazil	INTEGRAL Pesquisa e Ensino	Votuporanga
Canada	Barrie GI Associates	Barrie	Ontario
Canada	Gastroenterology and Internal Medicine Research Institute (GIRI)	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	ABP Research Services Corp.	Oakville	Ontario
China	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	Lan Zhou
China	Nanjing Drum Tower Hospital	Nan Jing Shi
China	Shengjing Hospital of China Medical University	Shen Yang Shi
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
Czechia	Nemocnice Ceske Budejovice	Ceske Budejovice
Czechia	Gastroenterologie, s.r.o., Hradec Kralove	Hradec Kralova
Czechia	Hepato-gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	ISCARE a.s.	Praha
Czechia	Nemocnice Slany	Slany
France	CHRU Besancon Hopital Jean Minjoz	Besancon Cedex
France	APHP - Hopital Henri Mondor	Creteil
France	CHRU de Lille - Hopital Claude Huriez	Lille
France	CHU de Nice Hopital de l Archet	Nice
France	CHU Nimes Hopital Caremeau	Nimes Cedex
France	APHP - Hopital Bichat - Claude Bernard	Paris
France	Hospices Civils de Lyon CHU Lyon Sud	Pierre Benite
France	CHU Saint-Etienne - Hopital Nord	Saint Priest en Jarez
France	CHU Toulouse - Hopital de Rangueil	Toulouse
France	CHU de Nancy_ Hopital Brabois	Vandœuvre-les-Nancy
Germany	Klinikum Augsburg	Augsburg
Germany	Krankenhaus Waldfriede Mitte	Berlin
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	Universitatsklinikum Schleswig Holstein Kiel	Kiel
Germany	Eugastro GmbH	Leipzig
Germany	Staedtisches Klinikum Lueneburg	Lueneburg
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Hungary	Pannónia Magánorvosi Centrum Kft	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Gasztroenterologiai Klinika	Debrecen
Hungary	Vasutegeszsegugyi Nonprofit Kozhasznu Kft.	Debrecen
Hungary	Clinexpert Kft	Gyongyos
India	S. R. Kalla Memorial General Hospital	Jaipur
India	SIDS Hospital & Research Centre	Surat
Italy	Fondazione IRCCS Ca Granda, Ospedale Policlinico di Milano	Milano
Italy	Ospedale San Raffaele di Milano	Milano
Italy	Ospedale Sacro Cuore Don Calabria	Negrar Di Valpolicella
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
Japan	Sai Clinic, Gastrointestinal and Protology Divisions	Fujiidera-shi
Japan	Hamamatsu University Hospital	Hamamatsu
Japan	Kagoshima IBD Gastroenterology Clinic	Kagoshima
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa
Japan	Aoyama Naika Clinic	Kobe
Japan	Japanese Red Cross Osaka Hospital	Osaka
Japan	Kinshukai Infusion Clinic	Osaka
Japan	Toho University Sakura Medical Center	Sakura
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo
Japan	Sapporo Tokushukai Hospital	Sapporo
Japan	National Hospital Organization Shizuoka Medical Center	Shimizu
Japan	Mie University Hospital	Tsu
Japan	Yokohama City University Medical Center	Yokohama
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic university of Korea, St. Vincent's Hospital	Suwon-si
Malaysia	Hospital Sultanah Aminah	Johor Bahru
Malaysia	Sultan Idris Shah Hospital	Kajang
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Poland	Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Centrum Medyczne Lukamed	Chojnice
Poland	Centrum Medyczne Plejady	Krakow
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	Sonomed Sp. z o.o.	Szczecin
Poland	GASTROMED Sp. z o.o.	Torun
Poland	Bodyclinic Sp. z o.o. sp. k	Warszawa
Poland	Centralny Szpital Kliniczny Mswia	Warszawa
Poland	Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	EMC Instytut Medyczny SA	Wroclaw
Poland	Melita Medical Sp. z o.o.	Wroclaw
Romania	S C Delta Health Care S R L	Bucuresti
Romania	Spital Memorial	Bucuresti
Romania	Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva	Cluj-Napoca
Romania	Centrul Medical Valahia	Ploiesti
Spain	Hosp. Univ. Fundacion Alcorcon	Alcorcon
Spain	Hosp. de Cabuenes	Gijon
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. Ntra. Sra. de Valme	Sevilla
Spain	Hosp. Virgen Macarena	Sevilla
Spain	Hosp. Clinico Univ. de Valencia	Valencia
Spain	Hosp. Univ. I Politecni La Fe	Valencia
Spain	Hosp. Alvaro Cunqueiro	Vigo
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Uludag Universitesi Tip Fakultesi Hastanesi	Bursa
Turkey	Ege Universitesi Tip Fakultesi	Izmir
Turkey	Mersin University Medical Faculty	Mersin
United Kingdom	Fairfield General Hospital	Bury
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Barts Health NHS Trust	London
United Kingdom	St George's University Hospital NHS Foundation Trust	London
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	Whiston Hospital	Prescot
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Amel Med LLC. Research	Austin	Texas
United States	Mercy Medical Center	Baltimore	Maryland
United States	Washington Gastroenterology, PLLC	Bellevue	Washington
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	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Accurate Clinical Research, Inc.	Humble	Texas
United States	I.H.S. Health. LLC	Kissimmee	Florida
United States	Caprock Gastro Research	Lubbock	Texas
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Gastroenterology of Southern Indiana	New Albany	Indiana
United States	New York Gastroenterology Associates	New York	New York
United States	DiGiovanna Institute for Medical Education & Research	North Massapequa	New York
United States	Care Access Research, Ogden	Ogden	Utah
United States	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma
United States	Clinnova Research	Orange	California
United States	Endoscopic Research Inc	Orlando	Florida
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	Medical Associates Research Group, Inc.	San Diego	California
United States	Washington Gastroenterology, PLLC	Tacoma	Washington
United States	Cotton O'Neil Digestive Health Center	Topeka	Kansas
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Northshore Gastroenterology Research, LLC	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Poland,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage of Participants with Endoscopic Improvement at Week 12	Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.	Week 12
Secondary	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
Secondary	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