A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified April 2026 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT05197049
Other Study ID Numbers:
CR109125
First Submitted
January 16, 2022
First Posted
January 18, 2022
Results First Posted
January 15, 2025
Last Update Posted
May 7, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Crohn Disease
Drug: Guselkumab Dose 1Drug: Guselkumab Dose 1Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment350 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Study Start DateJanuary 18, 2022
Actual Primary Completion DateJuly 3, 2023
Actual Study Completion Date2yrs 4mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.
Drug: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.
Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.
Drug: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.
Group 3: Placebo
Participants will receive placebo injection subcutaneously.
Drug: Placebo
Placebo will be administered by SC injection.

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants Who Achieved Clinical Remission at Week 12
    Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
  2. Percentage of Participants Who Achieved Endoscopic Response at Week 12
    Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
Secondary Outcome Measures
  1. Percentage of Participants Who Achieved Clinical Remission at Week 24
    Percentage of participants who achieved clinical remission at Week 24 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
  2. Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12
    Percentage of participants who achieved PRO-2 remission at Week 12 were reported. PRO-2 remission was defined as an abdominal pain (AP) mean daily score \<=1, and stool frequency (SF) mean daily score \<=3, and no worsening of AP or SF from baseline. Mean daily AP score based on the CDAI was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score based on the CDAI was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease.
  3. Percentage of Participants Who Achieved Clinical Response at Week 12
    Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \< 150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
  4. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48
    Percentage of participants with TEAEs through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent.
  5. Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 48
    Percentage of participants with TESAEs through Week 48 were reported. An SAE was any untoward medical occurrence in a clinical study participant resulting in any of the following outcomes or was deemed significant for any other reason: death, life-threatening (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. An AE does not necessarily have a causal relationship with the study drug. Any SAE that occurred at or after the initial administration of study drug (Week 0) through the data cutoff of Week 48 was considered treatment-emergent.
  6. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through Week 48
    Percentage of participants with TEAEs leading to discontinuation of study drug through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Diagnosis of Crohn's disease (CD) of at least 3 months in duration
Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion Criteria
Current diagnosis of ulcerative colitis or indeterminate colitis
Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
Unstable doses of concomitant Crohn's disease therapy

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
Digestive Health Specialists of the Southeast | Dothan Alabama, United States, 36305Advanced Gastro P.C | Chandler Arizona, United States, 85224-1636Reliance Research | Scottsdale Arizona, United States, 85260Moore Clinical Trials, LLC | Little Rock Arkansas, United States, 72205-6414Central Arkansas Veterans Healthcare System | Little Rock Arkansas, United States, 72223Om Research LLC 1 | Lancaster California, United States, 93534Om Research LLC | Lancaster California, United States, 93534United Gastroenterologists | Los Alamitos California, United States, 90720Paul Wallace MD | Los Angeles California, United States, 90048Clinnova Research | Orange California, United States, 92868Digestive System Healthcare | Pasadena California, United States, 77505-3950Northshore Gastroenterology Research, LLC | San Diego California, United States, 92103-2120Clinical Applications Laboratories, Inc | San Diego California, United States, 92103Santa Maria Gastroenterology | Santa Maria California, United States, 93454Clinical Research of California | Walnut Creek California, United States, 94598Amel Med LLC Research | Grand Junction Colorado, United States, 81505-1027Western Connecticut Health Network/Danbury Hospital | Danbury Connecticut, United States, 06810Gastroenterology Associates of SW Florida | Clearwater Florida, United States, 33762-5323Pioneer Research Solutions Inc. | Coconut Creek Florida, United States, 33066Omega Research Consultants | DeBary Florida, United States, 32713Harmony Medical Research Institute, Inc. | Hialeah Florida, United States, 33016Central Florida Gastro Research | Kissimmee Florida, United States, 34741Community Research Foundation, Inc. | Miami Florida, United States, 33155Gastroenterology Group Of Naples | Naples Florida, United States, 34102Center for Digestive Health | Orlando Florida, United States, 32803-1853Central Florida Internists | Orlando Florida, United States, 32819Synergy Clinical Research | St. Petersburg Florida, United States, 33705Atlanta Gastroenterology Specialists, PC | Atlanta Georgia, United States, 30224Agile Clinical Research Trials, LLC | Atlanta Georgia, United States, 30328Atlanta Center For Gastroenterology | Decatur Georgia, United States, 30033Gastroenterolgy Associates of Central GA | Macon Georgia, United States, 31201Gastroenterology Consultants | Roswell Georgia, United States, 30076-4943USF Asthma, Allergy, Immunology Clinical Research Unit | Boise Idaho, United States, 83706Grand Teton Research Group, PLLC | Idaho Falls Idaho, United States, 83404Lemah Creek Clinical Research | Oakbrook Terrace Illinois, United States, 60618University of Kansas Medical Center | Kansas City Kansas, United States, 66103-2937BVL Clinical Research | Leawood Kansas, United States, 66211Cotton O'Neil Digestive Health Center | Topeka Kansas, United States, 66606Tri-State Gastroenterology Assoc | Crestview Hills Kentucky, United States, 41017Tandem Clinical Research | Marrero Louisiana, United States, 70072Institute for Digestive Health and Liver Disease | Baltimore Maryland, United States, 21202-2102Woodholme Gastroenterology Associates | Glen Burnie Maryland, United States, 21061Digestive Health Specialists PC | Chelmsford Massachusetts, United States, 01824FC Research, LLC | South Dartmouth Massachusetts, United States, 02747Clinical Research Institute of Michigan, LLC | Chesterfield Michigan, United States, 48047Detroit Clinical Research Center | Livonia Michigan, United States, 48152University of Mississippi Medical Center | Jackson Mississippi, United States, 39216SUNY Downstate Medical Center | Brooklyn New York, United States, 11203Smart Medical Research | Jackson Heights New York, United States, 11372Crystal Run Healthcare LLP | Middletown New York, United States, 10941New York Gastroenterology Associates | New York New York, United States, 10075DiGiovanna Institute for Medical Education & Research | North Massapequa New York, United States, 11758A1 Clinical Network | Queens New York, United States, 11375Carolinas Medical Center | Charlotte North Carolina, United States, 28207Onsite Clinical Solutions | Charlotte North Carolina, United States, 28277Carolina Research | Greenville North Carolina, United States, 27834Gastroenterology Associates of the Piedmont, P.A. | Winston-Salem North Carolina, United States, 27103Central Ohio Endoscopy Center LLC | Columbus Ohio, United States, 43214Dayton Gastroenterology, Inc | Dayton Ohio, United States, 45440Great Lakes Gastroenterology | Mentor Ohio, United States, 44060Oklahoma University Health Science Center | Oklahoma City Oklahoma, United States, 73104Integris Baptist Office | Oklahoma City Oklahoma, United States, 73112Central Sooner Research | Oklahoma City Oklahoma, United States, 73120Essential Medical Research | Tulsa Oklahoma, United States, 74137-7061The Oregon Clinic | Portland Oregon, United States, 97220-9428Frontier Clinical Research | Smithfield Pennsylvania, United States, 15478Gastroenterology Associates P.A. | Greenville South Carolina, United States, 29615Carolina Health Specialists | Myrtle Beach South Carolina, United States, 29572West Texas Clinical Research | Lubbock Texas, United States, 79424Victoria Gastroenterology | Richmond Texas, United States, 77407Gastroenterology Clinic Of San Antonio P A | San Antonio Texas, United States, 78229Wellness Clinical Research | San Antonio Texas, United States, 78232Texas Digestive Disease Consultants | Southlake Texas, United States, 76092Digestive Health Specialists of Tyler | Tyler Texas, United States, 75701Care Access Research- Salt Lake City | Salt Lake City Utah, United States, 84124Burke Internal Medicine and Research | Burke Virginia, United States, 22015Gastroenterology Associates of Tidewater | Chesapeake Virginia, United States, 23320Monash Health, Monash Medical Centre | Clayton , Australia, 3168Coral Sea Clinical Research Institute | North Mackay , Australia, 4740OLV Ziekenhuis Aalst | Aalst , Belgium, 9300CHU Saint-Pierre | Brussels , Belgium, 1000Hopital Erasme | Brussels , Belgium, 1070Universitair Ziekenhuis Gent | Ghent , Belgium, 9000Algemeen Ziekenhuis Delta | Roeselare , Belgium, 8800University hospital Clinical centre Banja Luka | Banja Luka , Bosnia and Herzegovina, 78000Clinical Center University of Sarajevo | Sarajevo , Bosnia and Herzegovina, 71000Polyclinic Dr. Al-Tawil | Sarajevo , Bosnia and Herzegovina, 71000General Hospital Tesanj | Tešanj , Bosnia and Herzegovina, 74260Plava poliklinika Tuzla | Tuzla , Bosnia and Herzegovina, 75000Cantonal Hospital Zenica | Zenica , Bosnia and Herzegovina, 72000Universidade Estadual Paulista 'Julio De Mesquita Filho' | Botucatu , Brazil, 18608-025CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia | Brasília , Brazil, 70200-730Chronos Clinica Medica Ltda | Brasília , Brazil, 72145 450Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro | Campinas , Brazil, 13060-904CDC - Centro Digestivo de Curitiba | Curitiba , Brazil, 80430-180Universidade Federal Do Ceara | Fortaleza , Brazil, 60430-370Centro de Estudos Clínicos do Interior Paulista - CECIP | Jaú , Brazil, 17201-130Cliged | Macaé , Brazil, 27910-020Liga Norte Riograndense Contra O Cancer | Natal , Brazil, 59062 000Instituto Mederi de Pesquisa e Saude | Passo Fundo , Brazil, 99010-120Associacao Hospitalar Moinhos de Vento | Porto Alegre , Brazil, 90035-001Hospital das Clinicas de Porto Alegre | Porto Alegre , Brazil, 90035-003Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles | Porto Alegre , Brazil, 90160-092NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre , Brazil, 90430-001Hospital das Clinicas - Universidade Federal de Pernambuco | Recife , Brazil, 51011040Universidade Federal da Bahia - Hospital Professor Edgard Santos | Salvador , Brazil, 40110-060SER - Servicos Especializados em Reumatologia da Bahia | Salvador , Brazil, 40150150Pesquisare Saude | Santo André , Brazil, 09080-110Irmandade da Santa Casa da Misericórdia de Santos | Santos , Brazil, 11075-101CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo , Brazil, 09715-090Kaiser Hospta | São José do Rio Preto , Brazil, 15015-110Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base | São José do Rio Preto , Brazil, 15090-000BR TRIALS Ensaios Clinicos e Consultoria Ltda | São Paulo , Brazil, 03325-050Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE | São Paulo , Brazil, 04039-004Instituto D Or de Pesquisa e Ensino IDOR | São Paulo , Brazil, 04543-000Hepatogastro | São Paulo , Brazil, 04543-011Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui | Teresina , Brazil, 64049-550Integral Centro de Pesquisas Clinicas | Votuporanga , Brazil, 15501 405London Health Sciences Centre | London Ontario, Canada, N6A 5A5North Bay Dermatology Centre | North Bay Ontario, Canada, P1B 2H3The Affiliated Hospital of Bengbu Medical College | Bengbu , China, 233004Xiangya Hospital Central South University | Changsha , China, 410008The second Xiangya Hospital of Central South University | Changsha , China, 410011Changzhou No 2 Peoples Hospital | Changzhou , China, 213004West China Hospital Sichuan University | Chengdu , China, 610041Chongqing Medical University | Chongqing , China, 400013The First People's Hospital of Foshan | Foshan , China, The First Affiliated Hospital of Fujian Medical University | Fuzhou , China, 350005First Affiliated Hospital of Gannan Medical University | Ganzhou , China, 341000Guangdong Provincial People's Hospital | Guangzhou , China, 510080Guangzhou First Municipal People's Hospital | Guangzhou , China, 510180Guangzhou Medical University | Guangzhou , China, 510260Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine | Hangzhou , China, 310006Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou , China, 310016The First Affiliated Hospital of Anhui Medical University | Hefei , China, 230022The First Affiliated Hospital of NanChang University | Nanchang , China, 330006Nanjing 1st Hospital | Nanjing , China, 210006Nanjing Drum Tower Hospital | Nanjing , China, 210008The First Hospital of Quanzhou | Quanzhou , China, 362002Huashan Hospital Fudan University | Shanghai , China, 200040Shanghai East Hospital | Shanghai , China, 200120Shengjing Hospital Of China Medical University | Shenyang , China, 110022The first affiliated hospital of suzhou University | Suzhou , China, Wuxi People s Hospital | Wuxi , China, 214023Yangzhou First People's Hospital | Yangzhou , China, 225001ZhuZhou Central Hospital | Zhuzhou , China, 412007Opca bolnica Bjelovar | Bjelovar , Croatia, 43000University Hospital Center Split | Split , Croatia, 21000Opca bolnica Zadar | Zadar , Croatia, 23000Poliklinika Solmed | Zagreb , Croatia, 10000Fakultni nemocnice Brno | Brno , Czechia, 636 00Fakultni nemocnice Hradec Kralove | Hradec Králové , Czechia, 500 05Oblastni nemocnice Kladno a.s. | Kladno , Czechia, 27259Fakultni nemocnice Kralovske Vinohrady | Prague , Czechia, 100 34Nemocnice Slany | Slaný , Czechia, 274 01Sydvestjysk Sygehus | Esbjerg , Denmark, 6700Nordsjaellands Hospital - Hillerod | Hilleroed , Denmark, 3400Centre Hospitalier de la Cote Basque | Bayonne , France, 64100CHRU Besancon Hopital Jean Minjoz | Besançon , France, 25000Hopital Louis Mourier | Colombes , France, 92701CHU de Nantes hotel Dieu | Nantes , France, 44093CHU de Nice Hopital de l Archet | Nice , France, 06202Hôpital Bichat | Paris , France, 75877Hospices Civils de Lyon HCL | Pierre-Bénite , France, 69495Hôpital Robert Debré | Reims , France, 51092CHU Saint Etienne Hopital Nord | Saint-Priest-en-Jarez , France, 42270CHRU Strasbourg | Strasbourg , France, 67098CHU Rangueil | Toulouse , France, 31059Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center | Berlin , Germany, 10117DRK Kliniken Westend | Berlin , Germany, 14050Krankenhaus Waldfriede Mitte | Berlin , Germany, 14163Staedtisches Klinikum Braunschweig | Braunschweig , Germany, 38126Evangelisches Krankenhaus Kalk | Cologne , Germany, 51103Medizinisches Versorgungszentrum (MVZ) Dachau | Dachau , Germany, 85221MVZ Sanaklinikum Duisburg | Duisburg , Germany, 47055BSF Studiengesellschaft | Halle , Germany, 6108Medizinische Hochschule Hannover | Hanover , Germany, 30625Praxisgemeinschaft Jerichow | Jerichow , Germany, 39319Gastroenterologische Spezialpraxis - Berlin-Karlshorst | Karlshorst , Germany, 10318Universitaetsklinikum Mannheim | Mannheim , Germany, 68167Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum | Nordhausen , Germany, 99734Obudai Egeszsegugyi Centrum Kft | Budapest , Hungary, 1036Egyesített Szent István és Szent László Kórház | Budapest , Hungary, 1097Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu | Budapest , Hungary, 1125Mh Egészségügyi Központ | Budapest , Hungary, 1126Semmelweis Egyetem | Budapest , Hungary, H-1088Pannónia Magánorvosi Centrum Kft | Budapest , Hungary, H-1136Pest Megyei Flor Ferenc Korhaz | Kistarcsa , Hungary, 2143Mohacsi Korhaz | Mohács , Hungary, 7700Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika | Pécs , Hungary, 7624Markusovszky Egyetemi Oktatokorhaz | Szombathely , Hungary, H-9700Haemek Medical Center | Afula , Israel, 1834111Soroka University Medical Center | Beersheba , Israel, 84101The Chaim Sheba Medical Center | Ramat Gan , Israel, 5265601Kaplan Medical Center | Rehovot , Israel, 76100Assaf Harofeh Medical Center | Tzrifin , Israel, 70300Policlinico Sant'Orsola Malpighi | Bologna , Italy, 40138Istituto Clinico Humanitas Rozzano, IRCCS | Milan , Italy, 20132Università Campus Biomedico di Roma | Roma , Italy, 00128Policlinico Universitario Agostino Gemelli | Roma , Italy, 168Juntendo University Hospital | Bunkyō City , Japan, 113-8431Ginza central clinic | Chūōku , Japan, 1040061Fukui Prefectural Hospital | Fukui-ken , Japan, 910-8526Fukuoka University Hospital | Fukuoka , Japan, 814-0180Japanese Red Cross Fukuoka Hospital | Fukuoka , Japan, 815-8555National Hospital Organization Fukuyama Medical Center | Fukuyama , Japan, 720-8520Gamagori City Hospital | Gamagōri , Japan, 443-8501Gunma University Hospital | Gunma , Japan, 371-0034Hachinohe City Hospital | Hachinohe , Japan, 031-8555Hamamatsu University Hospital | Hamamatsu , Japan, 431 3192Matsuda Hospital | Hamamatsu , Japan, 432-8061National Hospital Organization Mito Medical Center | Higashi-Ibaraki , Japan, 311-3193Kure Kyosai Hospital | Hiroshima , Japan, 737-8505National Hospital Organization Shikoku Cancer Center | Iizuka-shi , Japan, 820-8505Kagoshima University Hospital | Kagoshima , Japan, 890-8520Kagoshima IBD Gastroenterology Clinic | Kagoshima , Japan, 892-0843Tsujinaka Hospital Kashiwanoha | Kashiwa , Japan, 277-0871Kyushu Rosai Hospital | Kitakyushu , Japan, 800-0229Kobe University Hospital | Kobe , Japan, 650 0017Yamanashi Prefectural Central Hospital | Kofu , Japan, 400-8506Dokkyo Medical University Saitama Medical Center | Koshigaya , Japan, 343-8555Hidaka Coloproctologic Clinic | Kurume , Japan, 839-0809Japanese Red Cross Kyoto Daini Hospital | Kyoto , Japan, 602-8026University Hospital Kyoto Prefectural University of Medicine | Kyoto , Japan, 602-8566Iwate Medical University Hospital | Morioka , Japan, 020-8505Nagasaki University Hospital | Nagasaki , Japan, 852-8501Yokoyama IBD Clinic | Nagoya , Japan, 460-0022University of the Ryukyus Hospital | Nakagami-gun , Japan, 901-2132Niigata University Medical And Dental Hospital | Niigata , Japan, 951 8520Nishinomiya Municipal Central Hospital | Nishinomiya , Japan, 663-8014Kinshukai Infusion Clinic | Osaka , Japan, 530-0011National Hospital Organization Osaka National Hospital | Osaka , Japan, 540-0006Japanese Red Cross Osaka Hospital | Osaka , Japan, 543-8555Osaka General Medical Center | Osaka , Japan, 558-8558Oita Red Cross Hospital | Ōita , Japan, 870-0033Shiga University of Medical Science Hospital | Ōtsu , Japan, 520-2192Sapporo Higashi Tokushukai Hospital | Sapporo , Japan, 065-0033Takagi Clinic | Sendai , Japan, 981-3213National Hospital Organization Shizuoka Medical Center | Sunto-gun , Japan, 411-8611Tokyo Medical University Hospital | Tokyo , Japan, 160-0023Toyota Kosei Hospital | Toyota , Japan, 470-0396Yokohama City University Medical Center | Yokohama , Japan, 232 0024Khalidi Hospital and Medical Center | Amman , Jordan, 11183The Speciality Hospital (TSH) / Advanced Clinical Center | Amman , Jordan, 11194Istiklal Hospital | Amman , Jordan, 11196Abdali Hospital | Amman , Jordan, 1184Irbid Specialty Hospital | Irbid , Jordan, 21110King Abdullah University Hospital | Irbid , Jordan, 22110Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik | Kaunas , Lithuania, 44307Vilnius University Hospital Santaros Klinikos, Public Institution | Vilnius , Lithuania, LT-08661Hospital Sultanah Aminah | Johor Bharu , Malaysia, 80100Hospital University Sains Malaysia | Kota Bharu , Malaysia, 16150Hospital Raja Permaisuri Bainun | Kota Kinabalu , Malaysia, 88586University Malaya Medical Centre | Kuala Lumpur , Malaysia, 59100Hospital Tengku Ampuan Afzan | Kuantan , Malaysia, 25100Onze Lieve Vrouwe Gasthuis | Amsterdam , Netherlands, 1091 ACSint Franciscus Gasthuis | Rotterdam , Netherlands, 3045 PMElisabeth-TweeSteden Ziekenhuis | Tilburg , Netherlands, 5022 GCChristchurch Hospital | Christchurch , New Zealand, 8011Dunedin Hospital | Dunedin , New Zealand, 9016Gastromed Kralisz Romatowski Stachurska Sp. j. | Bialystok , Poland, 15-32210 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ | Bydgoszcz , Poland, 85-681Centrum Medyczne Lukamed | Chojnice , Poland, 89-600Sahlgrenska University Hospital | Chrzanów , Poland, 32-500Private Practice - Dr. Krzysztof Cymerman | Gdynia , Poland, 81-157Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j. | Grudziądz , Poland, 86-300Malopolskie Centrum Kliniczne | Krakow , Poland, 30 149Centrum Medyczne Plejady | Krakow , Poland, 30 363Centrum Medyczne ProMiMed | Krakow , Poland, 31 637AmiCare Centrum Medyczne | Lodz , Poland, 90-644IP Clinic Sp. z o.o. | Lodz , Poland, 90-752Centrum Medyczne Med Gastr | Lodz , Poland, 91 034ETG Lublin | Lublin , Poland, 20-412Niepubliczny Zaklad Opieki Zdrowotnej | Lublin , Poland, 20-582Allmedica | Nowy Targ , Poland, 34 400Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn , Poland, 10 561Twoja Przychodnia 1 | Opole , Poland, 45-819Centrum Medyczne | Piotrkow Trybunalski , Poland, 97 300EMC Instytut Medyczny SA PL CERTUS | Poznan , Poland, 60 309Synexus Polska Sp z o o | Poznan , Poland, 61 441Twoja Przychodnia | Poznan , Poland, 61-293Centrum Medyczne Medyk | Rzeszów , Poland, 35-326Centrum Medyczne Promed | Skorzewo , Poland, 60-185Endoskopia Sp z o.o. | Sopot , Poland, 81-756Kiepury Clinic | Sosnowiec , Poland, 41-200KO Med Centrum Medyczne | Straszów , Poland, 28 200Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin , Poland, 71-434Sonomed Sp. z o.o. | Szczecin , Poland, 71-685GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii | Torun , Poland, 87 100H-T Centrum Medyczne Endoterapia | Tychy , Poland, 43-100Centrum Zdrowia Matki Dziecka i Mlodziezy | Warsaw , Poland, 00 632Endoterapia | Warsaw , Poland, 02 653Medical Concierge Centrum Medyczne | Warsaw , Poland, 02 798Centralny Szpital Kliniczny MSWiA w Warszawie | Warsaw , Poland, 02-507NZOZ Vivamed | Warsaw , Poland, 03 580Gabinety Lekarskie Bodyclinic | Warsaw , Poland, 03-712IBD Point Profesor Kierkus | Warsaw , Poland, 04-501Centrum Zdrowia Tuchow | Wierzchosławice , Poland, 33-122Melita Medical Sp. z o.o. | Wroclaw , Poland, 50 449Centrum Medyczne Melita Medical | Wroclaw , Poland, 50-449Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego | Wroclaw , Poland, 50-556Przychodnia Vistamed | Wroclaw , Poland, 53 149Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska | Włocławek , Poland, 87-800ETG Zamosc | Zamość , Poland, 22-400FNsP F.D.R. Banska Bystrica | Banská Bystrica , Slovakia, 974 01ENDOMED s.r.o | Košice , Slovakia, 040 13GASTRO I. s.r.o. | Prešov , Slovakia, 080 01Kyungpook National University Chilgok Hospital | Busan , South Korea, 41404Inje University Haeundae Paik Hospital | Busan , South Korea, 48108Kosin University Gospel Hospital | Busan , South Korea, 49267DongA Medical Center | Busan , South Korea, 602739Yeungnam University Medical Center | Daegu , South Korea, 42415The Catholic University of Korea Seoul St.Mary's Hospital | Daejeon , South Korea, 34943Kyung Hee University Hospital | Dongdaemun-gu , South Korea, 02447Dongguk University Ilsan Hospital | Goyang-si , South Korea, 10326Chonnam National University Hospital | Gwangju , South Korea, 61469CHA Bundang Medical Center, CHA University | Gyeonggi-do , South Korea, 13496The Catholic university of Korea, St. Vincent's Hospital | Gyeonggi-do , South Korea, 16247Kangbuk Samsung Hospital | Seoul , South Korea, 03181Yonsei University College of Medicine | Seoul , South Korea, 03722Samsung Medical Center | Seoul , South Korea, 06351The Catholic University of Korea Seoul St Mary s Hospital | Seoul , South Korea, 06591Ajou University Hospital | Suwon , South Korea, 16499Wonju Christian Hospital | Wŏnju , South Korea, 26426Ewha Womans University Mokdong Hospital | Yangch’ŏn-gu , South Korea, 07985Hosp. de Cabuenes | Gijón , Spain, 33394Hosp. Gral. Juan Ramon Jimenez 1 | Huelva , Spain, 21002Hosp. Gral. Juan Ramon Jimenez | Huelva , Spain, 21005Hosp. Univ. Infanta Leonor | Madrid , Spain, 28031Hosp. Virgen Macarena | Seville , Spain, 41009Hosp. Alvaro Cunqueiro | Vigo , Spain, 36213Hosp. de La Marina Baixa | Villajoyosa , Spain, 03570Kaohsiung Medical University Chung Ho Memorial Hospital | Kaoshiung , Taiwan, 80756China Medical University Hospital | Taichung , Taiwan, 40447National Taiwan University Hospital, Division of Infectious Diseases | Taipei , Taiwan, 100Taipei Medical University | Taipei , Taiwan, 110301Linkou Chang Gung Memorial Hospital | Taoyuan , Taiwan, 33305Ankara Numune Egitim ve Arastirma Hastanesi | Ankara , Turkey (Türkiye), 06100Hacettepe University Hospital | Ankara , Turkey (Türkiye), 06230Gazi University Medical Faculty | Ankara , Turkey (Türkiye), 06560Acibadem Fulya Hospital | Istanbul , Turkey (Türkiye), 34349Ege Universitesi Tip Fakultesi | Izmir , Turkey (Türkiye), 35040Mersin University Medical Faculty | Mersin , Turkey (Türkiye), 33343Ondokuz Mayis University | Samsun , Turkey (Türkiye), 55420Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi | Zonguldak , Turkey (Türkiye), 67000
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full Text)
Documents provided by Janssen Research & Development, LLC: Study Protocol  October 3, 2024Documents provided by Janssen Research & Development, LLC: Statistical Analysis Plan  October 1, 2023