A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Interventions
- Drug: Placebo
- Registration Number
- NCT06049017
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 252
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: JNJ-77242113 Dose-1 JNJ-77242113 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. Group 2: JNJ-77242113 Dose-2 JNJ-77242113 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. Group 3: JNJ-77242113 Dose-3 JNJ-77242113 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. Group 4: Placebo 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. Group 4: Placebo JNJ-77242113 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Clinical Response at Week 12 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Clinical Remission at Week 12 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.
Percentage of Participants with Symptomatic Remission at Week 12 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.
Percentage of Participants with Endoscopic Improvement at Week 12 Week 12 Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12 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.
Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs) Up to Week 76 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.
Trial Locations
- Locations (175)
Clinnova Research
🇺🇸Anaheim, California, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
I.H.S. Health. LLC
🇺🇸Kissimmee, Florida, United States
Endoscopic Research Inc
🇺🇸Orlando, Florida, United States
GCP Clinical Research
🇺🇸Tampa, Florida, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Cotton O'Neil Digestive Health Center
🇺🇸Topeka, Kansas, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
Gastroenterology of Southern Indiana
🇺🇸New Albany, Indiana, United States
Ochsner Medical Center
🇺🇸Jefferson, Louisiana, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
New York Gastroenterology Associates
🇺🇸New York, New York, United States
DiGiovanna Institute for Medical Education & Research
🇺🇸North Massapequa, New York, United States
Northshore Gastroenterology Research, LLC
🇺🇸Westlake, Ohio, United States
Digestive Disease Specialists Inc
🇺🇸Oklahoma City, Oklahoma, 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 P.A.
🇺🇸Greenville, South Carolina, United States
DHAT Research Institute
🇺🇸Garland, Texas, United States
Southern Star Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States
Sunshine Coast University Hospital
🇦🇺Birtinya, Australia
Amel Med LLC Research
🇺🇸Georgetown, Texas, United States
Washington Gastroenterology, PLLC
🇺🇸Tacoma, Washington, United States
Hospital Provincial del Centenario
🇦🇷Rosario, Argentina
CHU Saint-Pierre
🇧🇪Brussels, Belgium
AZ Sint-Lucas
🇧🇪Gent, Belgium
Vitaz
🇧🇪Sint Niklaas, Belgium
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
🇧🇷Botucatu, Brazil
Pesquisare Saude
🇧🇷Santo Andre, Brazil
Accurate Clinical Research, Inc.
🇺🇸Humble, Texas, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
CIPREC
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Concord Repatriation General Hospital
🇦🇺Concord, Australia
Wollongong Private Hospital
🇦🇺Wollongong, Australia
Caprock Gastro Research
🇺🇸Lubbock, Texas, United States
Cer Instituto Medico
🇦🇷Buenos Aires, Argentina
Sanatorio 9 de Julio
🇦🇷San Miguel de Tucuman, Argentina
Ghent University Hospital
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
L2IP Instituto de Pesquisas Clinicas
🇧🇷BrasÃlia, Brazil
Care Access Research, Ogden
🇺🇸Ogden, Utah, United States
Gedyt - Consultorios Gastroenterologia
🇦🇷Buenos Aires, Argentina
Blacktown Hospital
🇦🇺Blacktown, Australia
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Instituto D Or de Pesquisa e Ensino
🇧🇷Sao Paulo, Brazil
CDC - Centro Digestivo de Curitiba
🇧🇷Curitiba, Brazil
Hospital de Clinicas de Porto Alegre - Hospital de Clinicas
🇧🇷Porto Alegre, Brazil
BR TRIALS Ensaios Clinicos e Consultoria Ltda
🇧🇷Sao Paulo, Brazil
INTEGRAL Pesquisa e Ensino
🇧🇷Votuporanga, Brazil
Gastroenterology and Internal Medicine Research Institute (GIRI)
🇨🇦Edmonton, Alberta, Canada
Barrie GI Associates
🇨🇦Barrie, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
ABP Research Services Corp.
🇨🇦Oakville, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montréal, Quebec, Canada
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
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
🇨🇳Xi'An, China
Nemocnice Ceske Budejovice
🇨🇿Ceske Budejovice, Czechia
Hepato-gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
ISCARE a.s.
🇨🇿Praha, Czechia
CHRU de Lille Hopital Claude Huriez
🇫🇷Lille, France
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
Gastroenterologie, s.r.o., Hradec Kralove
🇨🇿Hradec Kralova, Czechia
Nemocnice Slany
🇨🇿Slany, Czechia
CHRU Besancon Hopital Jean Minjoz
🇫🇷Besancon Cedex, France
CHU de Nice Hopital de l Archet
🇫🇷Nice, France
Hospices Civils de Lyon CHU Lyon Sud
🇫🇷Pierre Benite, France
APHP - Hopital Henri Mondor
🇫🇷Creteil, France
Clinique Ambroise Pare
🇫🇷Neuilly-sur-Seine, France
CHU Nimes Hopital Caremeau
🇫🇷Nimes Cedex, France
CHU de Nancy_ Hopital Brabois
🇫🇷Vandœuvre-les-Nancy, France
APHP - Hopital Bichat - Claude Bernard
🇫🇷Paris, France
CHU Toulouse - Hopital de Rangueil
🇫🇷Toulouse, France
Krankenhaus Waldfriede Mitte
🇩🇪Berlin, Germany
CHU Saint Etienne Hopital Nord
🇫🇷Saint Priest en Jarez, France
Klinikum Augsburg
🇩🇪Augsburg, Germany
Staedtisches Klinikum Lueneburg
🇩🇪Lueneburg, Germany
Gastroenterologische Gemeinschaftspraxis Minden
🇩🇪Minden, Germany
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
Pannónia Magánorvosi Centrum Kft
ðŸ‡ðŸ‡ºBudapest, Hungary
Vasutegeszsegugyi Nonprofit Kozhasznu Kft
ðŸ‡ðŸ‡ºDebrecen, Hungary
Debreceni Egyetem Gasztroenterologiai Klinika
ðŸ‡ðŸ‡ºDebrecen, Hungary
Clinexpert Kft
ðŸ‡ðŸ‡ºGyongyos, Hungary
Universitaetsklinikum Carl Gustav Carus TU Dresden
🇩🇪Dresden, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitatsklinikum Schleswig Holstein Kiel
🇩🇪Kiel, Germany
Eugastro GmbH
🇩🇪Leipzig, Germany
S. R. Kalla Memorial General Hospital
🇮🇳Jaipur, India
Midas Hospital
🇮🇳Nagpur, India
Govind Ballabh Pant Hospital
🇮🇳New Delhi, India
SIDS Hospital & Research Centre
🇮🇳Surat, India
Fondazione IRCCS Ca Granda Ospedale Policlinico 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
Hamamatsu University Hospital
🇯🇵Hamamatsu, Japan
Sapporo Higashi Tokushukai Hospital
🇯🇵Sapporo, Japan
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Sumida ku, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Sultanah Aminah
🇲🇾Johor Bahru, Malaysia
Sultan Idris Shah Hospital
🇲🇾Kajang, Malaysia
Centrum Medyczne Lukamed
🇵🇱Chojnice, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Melita Medical Sp. z o.o.
🇵🇱Wroclaw, Poland
Ospedale San Raffaele di Milano
🇮🇹Milano, Italy
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Centrum Medyczne Medyk
🇵🇱Rzeszow, Poland
Sonomed Sp. z o.o.
🇵🇱Szczecin, Poland
Casa Sollievo Della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo, Italy
Kagoshima IBD Gastroenterology Clinic
🇯🇵Kagoshima, Japan
Kinshukai Infusion Clinic
🇯🇵Osaka, Japan
Toho University Sakura Medical Center
🇯🇵Sakura, Japan
Sapporo Tokushukai Hospital
🇯🇵Sapporo, Japan
Centralny Szpital Kliniczny Mswia
🇵🇱Warszawa, Poland
Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
🇷🇴Cluj-Napoca, Romania
Centrul Medical Valahia
🇷🇴Ploiesti, Romania
Hosp. Univ. Fundacion Alcorcon
🇪🇸Alcorcon, Spain
Hosp. Arquitecto Marcide
🇪🇸Ferrol, 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. Virgen Macarena
🇪🇸Sevilla, Spain
Hosp. Ntra. Sra. de Valme
🇪🇸Sevilla, Spain
Hosp. Clinico Univ. de Valencia
🇪🇸Valencia, Spain
Hosp. Univ. I Politecni La Fe
🇪🇸Valencia, Spain
Hosp. Alvaro Cunqueiro
🇪🇸Vigo, Spain
Sai Gastroenterology Proctology
🇯🇵Fujiidera-shi, Japan
Aoyama Naika Clinic
🇯🇵Kobe, Japan
Japanese Red Cross Osaka Hospital
🇯🇵Osaka, Japan
National Hospital Organization Shizuoka Medical Center
🇯🇵Shimizu, Japan
Mie University Hospital
🇯🇵Tsu, Japan
Centrum Medyczne Medis ManerMed Sp Z O O
🇵🇱Bydgoszcz, Poland
Bodyclinic Sp. z o.o. sp. k
🇵🇱Warszawa, Poland
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warszawa, Poland
EMC Instytut Medyczny SA
🇵🇱Wroclaw, Poland
Spital Memorial
🇷🇴Bucuresti, Romania
S C Delta Health Care S R L
🇷🇴Bucuresti, Romania
Tsujinaka Hospital Kashiwanoha
🇯🇵Kashiwa, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Japan
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
The Catholic university of Korea, St. Vincent's Hospital
🇰🇷Suwon si, Korea, Republic of
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
GASTROMED Sp. z o.o.
🇵🇱Torun, Poland
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Uludag Universitesi Tıp Fakultesi Hastanesi
🇹🇷Bursa, Turkey
Ege Universitesi Tip Fakultesi
🇹🇷Izmir, Turkey
Mersin University Medical Faculty
🇹🇷Mersin, Turkey
Fairfield General Hospital
🇬🇧Bury, United Kingdom
Guys St Thomas Hospital
🇬🇧London, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Barts Health NHS Trust
🇬🇧London, United Kingdom
Kings College Hospital
🇬🇧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 Kingdom
Southampton University Hospital
🇬🇧Southampton, United Kingdom