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| ID | Type | Description | Link |
|---|---|---|---|
| 77242113UCO2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-504673-20-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: JNJ-77242113 Dose-1 | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77242113 | Drug | JNJ-77242113 tablet will be administered orally. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinnova Research | Anaheim | California | 92805 | United States | ||
| Hoag Memorial Hospital |
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
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|
| Placebo | Drug | Placebo tablet will be administered orally. |
|
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 |
| 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 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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