Clinical trial NCT06049017: A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Clinical Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Symptomatic Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Endoscopic Improvement at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)
timeFrame: Up to Week 76
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Clinnova Research
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Kissimmee
country: United States
facility: I.H.S. Health. LLC
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research Inc
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: New Albany
country: United States
facility: Gastroenterology of Southern Indiana
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Digestive Health Center
state: Kansas
city: Jefferson
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: New York Gastroenterology Associates
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Institute for Medical Education & Research
state: New York
city: Chapel Hill
country: United States
facility: University North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, PLLC
state: North Carolina
city: Westlake
country: United States
facility: Northshore Gastroenterology Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
city: Greenville
country: United States
facility: Gastroenterology Associates P.A.
state: South Carolina
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Georgetown
country: United States
facility: Amel Med LLC Research
state: Texas
city: Humble
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Lubbock
country: United States
facility: Caprock Gastro Research
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Ogden
country: United States
facility: Care Access Research, Ogden
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology, PLLC
state: Washington
city: Tacoma
country: United States
facility: Washington Gastroenterology, PLLC
state: Washington
city: Buenos Aires
country: Argentina
facility: Cer Instituto Medico
city: Buenos Aires
country: Argentina
facility: Gedyt - Consultorios Gastroenterologia
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: San Miguel de Tucuman
country: Argentina
facility: Sanatorio 9 de Julio
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
city: Blacktown
country: Australia
facility: Blacktown Hospital
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Wollongong
country: Australia
facility: Wollongong Private Hospital
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
city: Brasília
country: Brazil
facility: L2IP Instituto de Pesquisas Clinicas
city: Curitiba
country: Brazil
facility: CDC - Centro Digestivo de Curitiba
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre - Hospital de Clinicas
city: Santo Andre
country: Brazil
facility: Pesquisare Saude
city: Sao Paulo
country: Brazil
facility: BR TRIALS Ensaios Clinicos e Consultoria Ltda
city: Sao Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino
city: Votuporanga
country: Brazil
facility: INTEGRAL Pesquisa e Ensino
city: Edmonton
country: Canada
facility: Gastroenterology and Internal Medicine Research Institute (GIRI)
state: Alberta
city: Barrie
country: Canada
facility: Barrie GI Associates
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Oakville
country: Canada
facility: ABP Research Services Corp.
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: Chongqing General Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat sen University
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital Sun Yat sen University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Lan Zhou
country: China
facility: Lanzhou University Second Hospital
city: Nan Jing Shi
country: China
facility: Nanjing Drum Tower Hospital
city: Shen Yang Shi
country: China
facility: Shengjing Hospital Of China Medical University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Xi'An
country: China
facility: The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice
city: Hradec Kralova
country: Czechia
facility: Gastroenterologie, s.r.o., Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Hepato-gastroenterologie HK, s.r.o.
city: Praha
country: Czechia
facility: ISCARE a.s.
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Besancon Cedex
country: France
facility: CHRU Besancon Hopital Jean Minjoz
city: Creteil
country: France
facility: APHP - Hopital Henri Mondor
city: Lille
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Pare
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Nimes Cedex
country: France
facility: CHU Nimes Hopital Caremeau
city: Paris
country: France
facility: APHP - Hopital Bichat - Claude Bernard
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon CHU Lyon Sud
city: Saint Priest en Jarez
country: France
facility: CHU Saint Etienne Hopital Nord
city: Toulouse
country: France
facility: CHU Toulouse - Hopital de Rangueil
city: Vandœuvre-les-Nancy
country: France
facility: CHU de Nancy_ Hopital Brabois
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede Mitte
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein Kiel
city: Leipzig
country: Germany
facility: Eugastro GmbH
city: Lueneburg
country: Germany
facility: Staedtisches Klinikum Lueneburg
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Debrecen
country: Hungary
facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Gasztroenterologiai Klinika
city: Gyongyos
country: Hungary
facility: Clinexpert Kft
city: Jaipur
country: India
facility: S. R. Kalla Memorial General Hospital
city: Nagpur
country: India
facility: Midas Hospital
city: New Delhi
country: India
facility: Govind Ballabh Pant Hospital
city: Surat
country: India
facility: SIDS Hospital & Research Centre
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
city: Milano
country: Italy
facility: Ospedale San Raffaele di Milano
city: Negrar Di Valpolicella
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo - Roma
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli IRCCS
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo Della Sofferenza IRCCS
city: Fujiidera-shi
country: Japan
facility: Sai Gastroenterology Proctology
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Kobe
country: Japan
facility: Aoyama Naika Clinic
city: Osaka
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo
country: Japan
facility: Sapporo Tokushukai Hospital
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Shimizu
country: Japan
facility: National Hospital Organization Shizuoka Medical Center
city: Sumida ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Suwon si
country: Korea, Republic of
facility: The Catholic university of Korea, St. Vincent's Hospital
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
city: Kajang
country: Malaysia
facility: Sultan Idris Shah Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Medis ManerMed Sp Z O O
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Torun
country: Poland
facility: GASTROMED Sp. z o.o.
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Mswia
city: Warszawa
country: Poland
facility: Bodyclinic Sp. z o.o. sp. k
city: Warszawa
country: Poland
facility: Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Wroclaw
country: Poland
facility: Melita Medical Sp. z o.o.
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny SA
city: Bucuresti
country: Romania
facility: Spital Memorial
city: Bucuresti
country: Romania
facility: S C Delta Health Care S R L
city: Cluj-Napoca
country: Romania
facility: Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
city: Ploiesti
country: Romania
facility: Centrul Medical Valahia
city: Alcorcon
country: Spain
facility: Hosp. Univ. Fundacion Alcorcon
city: Ferrol
country: Spain
facility: Hosp. Arquitecto Marcide
city: Gijon
country: Spain
facility: Hosp. de Cabuenes
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Majadahonda
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Sevilla
country: Spain
facility: Hosp. Ntra. Sra. de Valme
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Bursa
country: Turkey
facility: Uludag Universitesi Tıp Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Bury
country: United Kingdom
facility: Fairfield General Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Guys St Thomas Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: St George's University Hospital NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Prescot
country: United Kingdom
facility: Whiston Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: