GRAVITI: A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05197049
Collaborator
(none)
318
384
3
36.7
0.8
0
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Crohn's disease is a chronic, progressive and potentially life-threatening disorder which may affect any part of the gastrointestinal (GI) tract. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to human interleukin (IL)-23, thereby blocking the binding of extracellular IL-23 to the cell surface IL-23 receptor. This binding results in inhibition of IL-23 mediated intracellular signaling, activation and cytokine production. The purpose of the study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease. The overall study duration is up to 109 weeks.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
318 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 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
Actual Study Start Date
:
Jan 19, 2022
Anticipated Primary Completion Date
:
Jul 6, 2023
Anticipated Study Completion Date
:
Feb 10, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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.
Drug: Guselkumab Dose 2
Guselkumab (Dose 2) will be administered by SC injection.
|
| Experimental: 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.
Drug: Guselkumab Dose 3
Guselkumab (Dose 3) will be administered by SC injection.
|
| Placebo Comparator: Group 3: Placebo Participants will receive placebo injection subcutaneously. |
Drug: Placebo
Placebo will be administered by SC injection.
|
Outcome Measures
Primary Outcome Measures
- Clinical Remission at Week 12 [Week 12]
Clinical Remission is based on Crohn's Disease Activity Index (CDAI).
- Endoscopic Response at Week 12 [Week 12]
Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Secondary Outcome Measures
- Clinical Remission at Week 24 [Week 24]
Clinical Remission is based in CDAI.
- Patient-reported Outcome (PRO)-2 Remission at Week 12 [Week 12]
PRO-2 remission is based on abdominal pain (AP) and stool frequency (SF) score.
- Clinical Response at Week 12 [Week 12]
Clinical response is based on change from baseline in CDAI.
- Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention [Up to 109 Weeks]
Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Advanced Gastro P.C | Chandler | Arizona | United States | 85224-1636 |
| 2 | Om Research LLC | Lancaster | California | United States | 93534 |
| 3 | Om Research LLC | Lancaster | California | United States | 93534 |
| 4 | Digestive Health Research of Southern California, LLC | Long Beach | California | United States | 90808 |
| 5 | United Gastroenterologists | Los Alamitos | California | United States | 90720 |
| 6 | University of Southern California, Keck School of Medicine | Los Angeles | California | United States | 90033-5310 |
| 7 | Paul Wallace MD | Los Angeles | California | United States | 90048 |
| 8 | Digestive System Healthcare | Pasadena | California | United States | 77505-3950 |
| 9 | Northshore Gastroenterology Research, LLC | San Diego | California | United States | 92103-2120 |
| 10 | Clinical Applications Laboratories, Inc | San Diego | California | United States | 92103 |
| 11 | Precision Research Institute | San Diego | California | United States | 92114 |
| 12 | Clearview Medical Research, LLC | Santa Clarita | California | United States | 91350 |
| 13 | Western Connecticut Health Network/Danbury Hospital | Danbury | Connecticut | United States | 06810 |
| 14 | Gastroenterology Associates of SW Florida | Clearwater | Florida | United States | 33762-5323 |
| 15 | Pioneer Research Solutions Inc. | Coconut Creek | Florida | United States | 33066 |
| 16 | Omega Research Consultants | DeBary | Florida | United States | 32713 |
| 17 | Harmony Medical Research Institute, Inc. | Hialeah | Florida | United States | 33016 |
| 18 | Osceola Mental Health D/B/A Park Place Behavioral Health Care | Kissimmee | Florida | United States | 34741 |
| 19 | Community Research Foundation, Inc. | Miami | Florida | United States | 33155 |
| 20 | Gastroenterology Group Of Naples | Naples | Florida | United States | 34102 |
| 21 | Center for Digestive Health | Orlando | Florida | United States | 32803-1853 |
| 22 | Florida Hospital | Orlando | Florida | United States | 32803 |
| 23 | Central Florida Internists | Orlando | Florida | United States | 32819 |
| 24 | Synexus Clinical Research US, Inc | Pinellas Park | Florida | United States | 33781 |
| 25 | Synergy Clinical Research | Saint Petersburg | Florida | United States | 33705 |
| 26 | Gastroenterolgy Associates of Central GA | Macon | Georgia | United States | 31201 |
| 27 | USF Asthma, Allergy, Immunology Clinical Research Unit | Boise | Idaho | United States | 83706 |
| 28 | Digestive Research Alliance of Michiana, LLC | South Bend | Indiana | United States | 46635 |
| 29 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66103-2937 |
| 30 | Cotton O'Neil Digestive Health Center | Topeka | Kansas | United States | 66606 |
| 31 | Tri-State Gastroenterology Assoc | Crestview Hills | Kentucky | United States | 41017 |
| 32 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 33 | Tandem Clinical Research | Marrero | Louisiana | United States | 70072 |
| 34 | Woodholme Gastroenterology Associates | Glen Burnie | Maryland | United States | 21061 |
| 35 | Digestive Health Specialists PC | Chelmsford | Massachusetts | United States | 01824 |
| 36 | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | United States | 48047 |
| 37 | Michigan Center of Medical Research | Farmington Hills | Michigan | United States | 48334 |
| 38 | Detroit Clinical Research Center | Livonia | Michigan | United States | 48152 |
| 39 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 40 | Excel Clinical Research | Las Vegas | Nevada | United States | 89109 |
| 41 | AGA Clinical Research Associates, L.L.C. | Egg Harbor Township | New Jersey | United States | 08234 |
| 42 | Penn Medicine - Princeton Health | Plainsboro | New Jersey | United States | 08536 |
| 43 | SUNY Downstate Medical Center | Brooklyn | New York | United States | 11203 |
| 44 | Drug Trials America - Hartsdale | Hartsdale | New York | United States | 10530 |
| 45 | Smart Medical Research | Jackson Heights | New York | United States | 11372 |
| 46 | Crystal Run Healthcare LLP | Middletown | New York | United States | 10941 |
| 47 | DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | United States | 11758 |
| 48 | A1 Clinical Network | Queens | New York | United States | 11375 |
| 49 | University of Rochester | Rochester | New York | United States | 14642 |
| 50 | Onsite Clinical Solutions | Charlotte | North Carolina | United States | 28277 |
| 51 | PMG Research of Charlotte | Concord | North Carolina | United States | 28226-5305 |
| 52 | Dayton Gastroenterology, Inc | Dayton | Ohio | United States | 45440 |
| 53 | Great Lakes Gastroenterology | Mentor | Ohio | United States | 44060 |
| 54 | Oklahoma University Health Science Center | Oklahoma City | Oklahoma | United States | 73104 |
| 55 | Integris Baptist Office | Oklahoma City | Oklahoma | United States | 73112 |
| 56 | Central Sooner Research | Oklahoma City | Oklahoma | United States | 73120 |
| 57 | Essential Medical Research | Tulsa | Oklahoma | United States | 74137-7061 |
| 58 | The Oregon Clinic | Portland | Oregon | United States | 97220-9428 |
| 59 | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 60 | Care Access Research | Scranton | Pennsylvania | United States | 18508 |
| 61 | Frontier Clinical Research | Smithfield | Pennsylvania | United States | 15478 |
| 62 | Synexus Clinical Research US, Inc | Anderson | South Carolina | United States | 29621-2062 |
| 63 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 64 | Gastroenterology Associates P.A. | Greenville | South Carolina | United States | 29615 |
| 65 | Texas Tech | El Paso | Texas | United States | 79936 |
| 66 | Baylor College Of Medicine - Dept Of Dermatology | Houston | Texas | United States | 77030 |
| 67 | Texas Gastroenterology Associates - Research | Houston | Texas | United States | 77070 |
| 68 | GI Specialists of Houston | Houston | Texas | United States | 77346 |
| 69 | Sun Research Institute | San Antonio | Texas | United States | 78215 |
| 70 | Gastroenterology Clinic Of San Antonio P A | San Antonio | Texas | United States | 78229 |
| 71 | Wellness Clinical Research | San Antonio | Texas | United States | 78232 |
| 72 | Texas Digestive Disease Consultants | Southlake | Texas | United States | 76092 |
| 73 | Gulf Coast Medical Research LLC | Sugar Land | Texas | United States | 77478 |
| 74 | Digestive Health Specialists of Tyler | Tyler | Texas | United States | 75701 |
| 75 | Digestive Health Research of North Texas, LLC | Wichita Falls | Texas | United States | 76301 |
| 76 | Care Access Research- Salt Lake City | Salt Lake City | Utah | United States | 84124 |
| 77 | Burke Internal Medicine & REsearch | Burke | Virginia | United States | 22015 |
| 78 | Richmond Gastroenterology Associates | Richmond | Virginia | United States | 23235 |
| 79 | Monash Health, Monash Medical Centre | Clayton | Australia | 3168 | |
| 80 | Coral Sea Clinical Research Institute | North Mackay | Australia | 4740 | |
| 81 | Medizinische Universität Innsbruck | Innsbruck | Austria | 6020 | |
| 82 | Krankenhaus der Barmherzigen Brüder | Wien | Austria | 1020 | |
| 83 | OLV Ziekenhuis Aalst | Aalst | Belgium | 9300 | |
| 84 | GZA Ziekenhuizen | Antwerpen | Belgium | 2018 | |
| 85 | Imelda Ziekenhuis | Bonheiden | Belgium | 2820 | |
| 86 | CHU Saint-Pierre | Bruxelles | Belgium | 1000 | |
| 87 | Hopital Erasme | Bruxelles | Belgium | 1070 | |
| 88 | AZ Maria Middelares | Gent | Belgium | 9000 | |
| 89 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 90 | Algemeen Ziekenhuis Delta | Roeselare | Belgium | 8800 | |
| 91 | University hospital Clinical centre Banja Luka | Banja Luka | Bosnia and Herzegovina | 78000 | |
| 92 | Polyclinic Dr. Al-Tawil | Sarajevo | Bosnia and Herzegovina | 71000 | |
| 93 | Kantonalna bolnica Zenica | Zenica | Bosnia and Herzegovina | 72000 | |
| 94 | Hospital Das Clinicas Da Ufmg | Belo Horizonte | Brazil | 30130-100 | |
| 95 | CCBR Brasilia | Brasilia | Brazil | 70200-730 | |
| 96 | Chronos Clínica Médica Ltda | Brasilia | Brazil | 72145-450 | |
| 97 | Hospital Brasília | Brasã-Lia | Brazil | 71635-200 | |
| 98 | UNICAMP | Campinas | Brazil | 13083-878 | |
| 99 | Hospital e Maternidade Celso Pierro | Campinas | Brazil | 13590-900 | |
| 100 | Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica | Curitiba | Brazil | 80430-180 | |
| 101 | Universidade Federal Do Ceara | Fortaleza | Brazil | 60430-370 | |
| 102 | Centro de Estudos Clínicos do Interior Paulista - CECIP | Jau | Brazil | 17201-130 | |
| 103 | Cliged | Macae | Brazil | 27910-020 | |
| 104 | Liga Norte Riograndense Contra O Cancer | Natal | Brazil | 59062000 | |
| 105 | Instituto Mederi de Pesquisa e Saude | Passo Fundo | Brazil | 99010-120 | |
| 106 | Hospital de Clínicas de Porto Alegre | Porto Alegre | Brazil | 90035-003 | |
| 107 | Hospital Moinhos de Vento | Porto Alegre | Brazil | 90035-901 | |
| 108 | Hospital de Clínicas de Porto Alegre | Porto Alegre | Brazil | 90035-903 | |
| 109 | Hospital Ernesto Dornelles | Porto Alegre | Brazil | 90160-092 | |
| 110 | Hospital das Clinicas - Universidade Federal de Pernambuco | Recife | Brazil | 51011040 | |
| 111 | UFRJ-Hospital Universitário Clementino Fraga Filho | Rio de Janeiro | Brazil | 21941-913 | |
| 112 | Universidade Federal da Bahia (UFBA) - Complexo Hospitalar U | Salvador | Brazil | 40110-060 | |
| 113 | SER - Serviços Especializados em Reumatologia da Bahia | Salvador | Brazil | 40150150 | |
| 114 | Pesquisare Saude | Santo Andre | Brazil | 09080-110 | |
| 115 | Praxis pesquisa médica | Santo André | Brazil | 09090-790 | |
| 116 | Irmandade da Santa Casa da Misericórdia de Santos | Santos | Brazil | 11075-101 | |
| 117 | Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto | Sao Jose do Rio Preto | Brazil | 15090-000 | |
| 118 | Hepatogastro | Sao Paulo | Brazil | 04543-011 | |
| 119 | CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo | Brazil | 09715-090 | |
| 120 | Kaiser Hospta | São José Do Rio Preto | Brazil | 15015-110 | |
| 121 | FMUSP - ICHC - Centro de Pesquisas Clínicas | São Paulo | Brazil | 01246-000 | |
| 122 | Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo | São Paulo | Brazil | 01246-900 | |
| 123 | BR Trials | São Paulo | Brazil | 03325-050 | |
| 124 | Hospital do Servidor Público Estadual Francisco Morato de Oliveira | São Paulo | Brazil | 04039 | |
| 125 | Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo | Brazil | 04543-000 | |
| 126 | Universidade Federal Do Piaui - Campos Universitario | Teresina | Brazil | 64049-550 | |
| 127 | Instituto D'Or de Pesquisa e Ensino (IDOR) | Votuporanga | Brazil | 15501-405 | |
| 128 | University Hospital Alexandrovska - Clinic of Nephrology | Sofia N/a | Bulgaria | 1303 | |
| 129 | Gastroenterology and Internal Medicine Research Institute (GIRI) | Edmonton | Alberta | Canada | T5R 1W2 |
| 130 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2X8 |
| 131 | London Health Sciences Centre | London | Ontario | Canada | N6A 5A5 |
| 132 | Mount Sinai Hospital-Toronto | Toronto | Ontario | Canada | M5G 1X5 |
| 133 | Hopital Maisonneuve-Rosemont | Montréal | Quebec | Canada | H1T 2M4 |
| 134 | St. Jerome Medical Research | Saint-Jerome | Quebec | Canada | J7Z 5T3 |
| 135 | Royal University Hospital | Saskatoon | Saskatchewan | Canada | S7N 0W8 |
| 136 | South Edmonton Gastroenterology | Edmonton | Canada | T6K 4B2 | |
| 137 | PerCuro Clinical Research Ltd. | Victoria | Canada | V8P 2P5 | |
| 138 | Hospital Barros Luco Trudeau | Santiago Rm | Chile | ||
| 139 | Complejo Asistencial Hospital Dr. Sótero del Río | Santiago | Chile | 8207257 | |
| 140 | The Affiliated Hospital of Bengbu Medical College | Bengbu | China | 233004 | |
| 141 | Xiangya Hospital Central South University | Changsha | China | 410008 | |
| 142 | The second Xiangya Hospital of Central South University | Changsha | China | 410011 | |
| 143 | The First People's Hospital Of Changzhou | Changzhou | China | 213003 | |
| 144 | West China Hospital, Sichuan University | Chengdu | China | 610041 | |
| 145 | The First People's Hospital of Foshan | China | China | ||
| 146 | Chongqing Medical University | Chongqing | China | 400013 | |
| 147 | First Affiliated Hospital of Gannan Medical University | Ganzhou | China | 341000 | |
| 148 | Guangdong Provincial People's Hospital | Guangzhou | China | 510080 | |
| 149 | Guangzhou First Municipal People's Hospital | GuangZhou | China | 510180 | |
| 150 | Guangzhou Medical University | Guangzhou | China | 510260 | |
| 151 | Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine | Hangzhou | China | 310006 | |
| 152 | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | China | 310016 | |
| 153 | The 1st affiliated hospital of Anhui Medical University | Hefei | China | 230022 | |
| 154 | The First Affiliated Hospital of NanChang University | Nanchang | China | 330006 | |
| 155 | Nanjing 1st Hospital | Nanjing | China | 210006 | |
| 156 | Nanjing Drum Tower Hospital | Nanjing | China | 210008 | |
| 157 | Huashan Hospital Fudan University | Shanghai | China | 200040 | |
| 158 | ShangHai Huadong Hospital | Shanghai | China | 200040 | |
| 159 | Shengjing Hospital of China Medical University | Shenyang | China | 110022 | |
| 160 | The first affiliated hospital of suzhou University | Suzhou | China | ||
| 161 | Shaanxi Provincial People's Hospital | Taiyuan | China | 30002 | |
| 162 | Wuxi People's Hospital | Wuxi | China | 214023 | |
| 163 | Opca bolnica Bjelovar | Bjelovar | Croatia | 43000 | |
| 164 | Klinički bolnički centar Osijek | Osijek | Croatia | 31000 | |
| 165 | University Hospital Center Split | Split | Croatia | 21000 | |
| 166 | Opca bolnica Zadar | Zadar | Croatia | 23000 | |
| 167 | Fakultni nemocnice Brno | Brno | Czechia | 636 00 | |
| 168 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | 500 05 | |
| 169 | Oblastni nemocnice Kladno a.s. | Kladno | Czechia | 27259 | |
| 170 | Synexus Czech s.r.o. | Prague 2 | Czechia | 120 00 | |
| 171 | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Czechia | 100 34 | |
| 172 | Nemocnice Slany | Slany | Czechia | 274 01 | |
| 173 | Krajska nemocnice T. Bati, a.s. | Zlin | Czechia | 76275 | |
| 174 | Bispebjerg Og Frederiksberg Hospital | Copenhagen | Denmark | 2400 | |
| 175 | Sydvestjysk Sygehus | Esbjerg | Denmark | 6700 | |
| 176 | Nykøbing F. Sygehus | Nykøbing Falster | Denmark | 4800 | |
| 177 | Silkeborg Hospital | Silkeborg | Denmark | 8600 | |
| 178 | West Tallinn Central Hospital | Tallinn | Estonia | 10617 | |
| 179 | Turku University Hospital | Turku | Finland | 20521 | |
| 180 | Hopital Louis Mourier | Colombes Cedex | France | 92701 | |
| 181 | CHU de Nice Hopital de l Archet | Nice | France | 06202 | |
| 182 | Hôpital Bichat | Paris | France | 75877 | |
| 183 | Hospices Civils de Lyon HCL | Pierre Bénite | France | 69495 | |
| 184 | Hôpital Robert Debré | Reims | France | 51092 | |
| 185 | CHU Saint-Etienne - Hôpital Nord | Saint-Priest en Jarez | France | 42270 | |
| 186 | CHU Rangueil | Toulouse | France | 31059 | |
| 187 | Gastroenterologische Spezialpraxis - Berlin-Karlshorst | Berlin-Karlshorst | Germany | 10318 | |
| 188 | Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center | Berlin | Germany | 10117 | |
| 189 | Praxis Für Gastroenteroligie | Berlin | Germany | 10825 | |
| 190 | DRK Kliniken Westend | Berlin | Germany | 14050 | |
| 191 | Krankenhaus Waldfriede Mitte | Berlin | Germany | 14163 | |
| 192 | Sana Klinikum Biberach | Biberach | Germany | 88400 | |
| 193 | Staedtisches Klinikum Braunschweig | Braunschweig | Germany | 38126 | |
| 194 | Medizinisches Versorgungszentrum (MVZ) Dachau | Dachau | Germany | 85221 | |
| 195 | MVZ Sanaklinikum Duisburg | Duisburg | Germany | 47055 | |
| 196 | Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt/Main | Germany | 69590 | |
| 197 | Synexus Clinical Research GmbH | Frankfurt | Germany | 60313 | |
| 198 | Curiositas ad Sanum Studien und Beratungs GmBH | Haag | Germany | 83527 | |
| 199 | BSF Studiengesellschaft | Halle | Germany | 6108 | |
| 200 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 201 | Gastroenterologische Gemeinschaftspraxis Herne | Herne | Germany | 44623 | |
| 202 | Praxisgemeinschaft Jerichow | Jerichow | Germany | 39319 | |
| 203 | Gastroenterologische Fachartzpraxis | Kassel | Germany | 34127 | |
| 204 | Evangelisches Krankenhaus Kalk | Köln | Germany | 51103 | |
| 205 | Synexus Clinical Research GmbH | Leipzig | Germany | 04103 | |
| 206 | Siloah St. Trudpert Klinikum | Pforzheim | Germany | 75179 | |
| 207 | Universitaetsmedizin Rostock | Rostock | Germany | 18057 | |
| 208 | Internistische Praxisgemeinschaft Weyhe | Weyhe | Germany | 28844 | |
| 209 | Obudai Egeszsegugyi Centrum Kft. | Budapest | Hungary | 1036 | |
| 210 | Péterfy Sándor utcai Kórház | Budapest | Hungary | 1076 | |
| 211 | Egyesített Szent István és Szent László Kórház | Budapest | Hungary | 1097 | |
| 212 | Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú | Budapest | Hungary | 1125 | |
| 213 | Mh Egészségügyi Központ | Budapest | Hungary | 1126 | |
| 214 | Semmelweis Egyetem | Budapest | Hungary | H-1088 | |
| 215 | Pannónia Magánorvosi Centrum Kft | Budapest | Hungary | H-1136 | |
| 216 | Pest Megyei Flor Ferenc Korhaz | Kistarcsa | Hungary | 2143 | |
| 217 | Mohacsi Korhaz | Mohacs | Hungary | 7700 | |
| 218 | Markusovszky Egyetemi Oktatokorhaz | Szombathely | Hungary | H-9700 | |
| 219 | Soroka University Medical Center | Beer-Sheva | Israel | 84101 | |
| 220 | The Chaim Sheba Medical Center | Ramat Gan | Israel | 5265601 | |
| 221 | Policlinio, AOU Consoziale Policlinico di Bari | Bari | Italy | 70124 | |
| 222 | Policlinico Sant'Orsola Malpighi | Bologna | Italy | 40138 | |
| 223 | Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura | Milano | Italy | 20097 | |
| 224 | ASST Fatebenefratelli Sacco | Milano | Italy | 20157 | |
| 225 | AOU di Padova | Padova | Italy | 35128 | |
| 226 | Università Campus Biomedico di Roma | Roma | Italy | 00128 | |
| 227 | Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata' | Roma | Italy | 00133 | |
| 228 | Policlinico Universitario Agostino Gemelli | Roma | Italy | 168 | |
| 229 | Azienda Ospedaliera San Paolo-Polo Universitario | San Donato Milanese | Italy | 20097 | |
| 230 | AO Ordine Mauriziano | Torino | Italy | 10128 | |
| 231 | Juntendo University Hospital | Bunkyo-ku | Japan | 1040061 | |
| 232 | Fukui Prefectural Hospital | Fukui-ken | Japan | 910-8526 | |
| 233 | National Hospital Organization Fukuoka Hospital | Fukuoka | Japan | 815-8555 | |
| 234 | National Hospital Organization Fukuyama Medical Center | Fukuyama | Japan | 720-8520 | |
| 235 | Gunma University Hospital | Gunma | Japan | 371-0034 | |
| 236 | Hachinohe City Hospital | Hachinohe | Japan | 031-8555 | |
| 237 | Hamamatsu University Hospital | Hamamatsu | Japan | 431-3192 | |
| 238 | National Hospital Organization Mito Medical Center | Higashi-Ibaraki | Japan | 311-3193 | |
| 239 | Iizuka Hospital | Iizuka-shi | Japan | ||
| 240 | Tsujinaka Hospital Kashiwanoha | Kashiwa | Japan | 277-0871 | |
| 241 | Kyushu Rosai Hospital | Kita-kyushu | Japan | 800-0229 | |
| 242 | Kobe University Hospital | Kobe | Japan | 650-0017 | |
| 243 | Dokkyo Medical University Saitama Medical Center | Koshigaya | Japan | 343-8555 | |
| 244 | Hidaka Coloproctologic Clinic | Kurume | Japan | 839-0809 | |
| 245 | Red Cross Kyoto Daini Hospital | Kyoto | Japan | 602-8026 | |
| 246 | University Hospital Kyoto Perfectural University of Medicine | Kyoto | Japan | 602-8566 | |
| 247 | Nagasaki University Hospital | Nagasaki | Japan | 852-8501 | |
| 248 | Yokoyama IBD Clinic | Nagoya | Japan | 460-0022 | |
| 249 | Nishinomiya Municipal Central | Nishinomiya | Japan | 663-8014 | |
| 250 | Oita Red Cross Hospital | Oita | Japan | 870-0033 | |
| 251 | Kinshukai Infusion Clinic | Osaka | Japan | 530-0011 | |
| 252 | Takagi Clinic | Sendai | Japan | 981-3213 | |
| 253 | Shizuoka Medical Center | Sunto-gun | Japan | 411-8611 | |
| 254 | Tokyo Medical University Hospital | Tokyo | Japan | 160-0023 | |
| 255 | Toyota Kosei Hospital | Toyota | Japan | 470-0396 | |
| 256 | Khalidi Hospital and Medical Center | Amman | Jordan | 11183 | |
| 257 | Abdali Hospital | Amman | Jordan | 1184 | |
| 258 | Jordan University Hospital | Amman | Jordan | 11942 | |
| 259 | Irbid Specialty Hospital | Irbid | Jordan | 21110 | |
| 260 | King Abdullah University Hospital | Irbid | Jordan | 22110 | |
| 261 | Kyungpook National University Chilgok Hospital | Busan | Korea, Republic of | 41404 | |
| 262 | Inje University Haeundae Paik Hospital | Busan | Korea, Republic of | 48108 | |
| 263 | Kosin University Gospel Hospital | Busan | Korea, Republic of | 49267 | |
| 264 | DongA Medical Center | Busan | Korea, Republic of | 602739 | |
| 265 | Yeungnam University Medical Center | Daegu | Korea, Republic of | 42415 | |
| 266 | Konyang University Hospital | Daejeon | Korea, Republic of | 302-718 | |
| 267 | The Catholic University of Korea, Seoul St.Mary's Hospital | Daejeon | Korea, Republic of | 34943 | |
| 268 | Kyung Hee University Hospital | Dongdaemun-gu | Korea, Republic of | 2447 | |
| 269 | Dongguk University Ilsan Hospital | Goyang-si | Korea, Republic of | 10326 | |
| 270 | Chonnam National University Hospital | Gwangju | Korea, Republic of | 61469 | |
| 271 | CHA Bundang Medical Center, CHA University | Gyeonggi | Korea, Republic of | 13496 | |
| 272 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 03181 | |
| 273 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 274 | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 275 | The Catholic University of Korea St. Vincent's Hospital | Suwon-si | Korea, Republic of | 16247 | |
| 276 | Ajou University Hospital | Suwon | Korea, Republic of | 16499 | |
| 277 | Wonju Christian Hospital | Wonju | Korea, Republic of | 26426 | |
| 278 | Ewha Womans University Mokdong Hospital | YangCheon-Gu | Korea, Republic of | 07985 | |
| 279 | Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik | Kaunas | Lithuania | 44307 | |
| 280 | Vilnius University Hospital Santaros Klinikos, Public Institution | Vilnius | Lithuania | LT-08661 | |
| 281 | Hospital Sultanah Aminah | Johor Bharu | Malaysia | 80100 | |
| 282 | Hospital University Sains Malaysia | Kota Bharu | Malaysia | 16150 | |
| 283 | Hospital Raja Permaisuri Bainun | Kota Kinabalu | Malaysia | 88586 | |
| 284 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | 59100 | |
| 285 | Hospital Tengku Ampuan Afzan | Kuantan | Malaysia | 25100 | |
| 286 | Onze Lieve Vrouwe Gasthuis | Amsterdam | Netherlands | 1091 AC | |
| 287 | Rijnstate | Arnhem | Netherlands | 6815 AD | |
| 288 | Maxima Medisch Centrum | Eindhoven | Netherlands | 5600 PD | |
| 289 | Sint Franciscus Gasthuis | Rotterdam | Netherlands | 3045 PM | |
| 290 | Elisabeth-TweeSteden Ziekenhuis | Tilburg | Netherlands | 5022 GC | |
| 291 | Auckland City Hospital | Auckland | New Zealand | 1023 | |
| 292 | Waikato Hospital - Waikato | Hamilton | New Zealand | 3240 | |
| 293 | Alesund sjukehus | Alesund | Norway | 6010 | |
| 294 | Oslo Universitetssykehus HF | Gjettum | Norway | 1346 | |
| 295 | Akershus Universitetssykehus | Lørenskog | Norway | 1478 | |
| 296 | Universitetssykehuset Nord-Norge HF | Tromsø | Norway | 9038 | |
| 297 | 10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ | Bydgoszcz | Poland | 85-681 | |
| 298 | Synexus Polska Sp. z o.o. Oddzial w Czestochowie | Czestochowa | Poland | 42-202 | |
| 299 | Synexus Polska Sp. z o.o. | Gdańsk | Poland | 80-382 | |
| 300 | Private Practice - Dr. Krzysztof Cymerman | Gdynia | Poland | 81-157 | |
| 301 | Synexus Polska Sp. z o.o. | Gdynia | Poland | 81-537 | |
| 302 | Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j. | Grudziadz | Poland | 86-300 | |
| 303 | Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | Poland | 40-040 | |
| 304 | Globe Badania Kliniczne | Klodzko | Poland | 57-100 | |
| 305 | Globe Badania Kliniczne | Klodzko | Poland | 57-300 | |
| 306 | Centrum medyczne plejady | Krakow | Poland | 30-363 | |
| 307 | Centrum Medyczne ProMiMed | Krakow | Poland | 31-637 | |
| 308 | AmiCare Centrum Medyczne | Lodz | Poland | 90-644 | |
| 309 | ETG Lublin | Lublin | Poland | 20-412 | |
| 310 | Niepubliczny Zaklad Opieki Zdrowotnej | Lublin | Poland | 20-582 | |
| 311 | Allmedica | Nowy Targ | Poland | 34-400 | |
| 312 | Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | Poland | 10-561 | |
| 313 | Twoja Przychodnia | Opole | Poland | 45-819 | |
| 314 | Centrum Medyczne | Piotrkow Trybunalski | Poland | 97-300 | |
| 315 | Synexus Polska Sp. z o.o. | Poznan | Poland | 60-702 | |
| 316 | Synexus Polska Sp. z o.o. | Poznan | Poland | 60-702 | |
| 317 | Twoja Przychodnia | Poznan | Poland | 61-293 | |
| 318 | Centrum Medyczne Medyk | Rzeszow | Poland | 35-326 | |
| 319 | Centrum Medyczne Promed | Skorzewo | Poland | 60-185 | |
| 320 | Endoskopia Sp z o.o. | Sopot | Poland | 81-756 | |
| 321 | Kiepury Clinic | Sosnowiec | Poland | 41-200 | |
| 322 | KO-Med Centrum Medyczne | Straszów | Poland | 28-200 | |
| 323 | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | Poland | 71-434 | |
| 324 | GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii | Torun | Poland | 87-100 | |
| 325 | GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii | Torun | Poland | 87-100 | |
| 326 | Endoterapia | Warsaw | Poland | 02-653 | |
| 327 | Centrum Zdrowia Matki, Dziecka i Młodzieży | Warszawa | Poland | 00-632 | |
| 328 | Synexus Polska Sp. z o.o. | Warszawa | Poland | 01-192 | |
| 329 | Synexus Polska Sp. z o.o. | Warszawa | Poland | 02-749 | |
| 330 | NZOZ Vivamed | Warszawa | Poland | 03-580 | |
| 331 | Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska | Wloclawek | Poland | 87-800 | |
| 332 | Synexus Polska Sp. z o.o. | Wroclaw | Poland | 50-381 | |
| 333 | Melita Medical Sp. z o.o. | Wroclaw | Poland | 50-449 | |
| 334 | Przychodnia Vistamed | Wroclaw | Poland | 50-449 | |
| 335 | Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego | Wroclaw | Poland | 50-556 | |
| 336 | ETG Zamosc | Zamosc | Poland | 22-400 | |
| 337 | Hosp. Sra. Da Oliveira - Guimaraes | Guimarães | Portugal | 4835-044 | |
| 338 | Hospital Beatriz Angelo | Loures | Portugal | 2674-514 | |
| 339 | Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE - Unidade de Vila Real | Santa Maria Da Feira | Portugal | 4520-211 | |
| 340 | Chvng - Unidade I | Vila Nova de Gaia | Portugal | 4434-502 | |
| 341 | Centro Hospitalar de Tondela Viseu, EPE | Viseu | Portugal | 3504-509 | |
| 342 | MSB General hospital | Belgrade | Serbia | 11000 | |
| 343 | Special hospital for Internal diseases, Oncomed system | Belgrade | Serbia | 11000 | |
| 344 | Zvezdara University Medical Center | Belgrade | Serbia | 11000 | |
| 345 | Clinical Hospital Center Bezanijska Kosa | Belgrade | Serbia | 11080 | |
| 346 | University Clinical Hospital Center Dr Dragisa Misovic- Dedi | Belgrade | Serbia | 11080 | |
| 347 | General Hospital Leskovac | Leskovac | Serbia | 16000 | |
| 348 | General Hospital Vrsac | Vrsac | Serbia | 26300 | |
| 349 | General Hospital 'Djordje Joanovic' | Zrenjanin | Serbia | 23000 | |
| 350 | FNsP F.D.R. Banska Bystrica | Banska Bystrica | Slovakia | 974 01 | |
| 351 | Nemocnica s poliklinikou Brezno | Brezno | Slovakia | 977 01 | |
| 352 | ENDOMED s.r.o | Kosice | Slovakia | 040 13 | |
| 353 | GASTRO I. s.r.o. | Presov | Slovakia | 080 01 | |
| 354 | Vseobecna nemocnica Rimavska Sobota | Rimavska Sobota | Slovakia | 97912 | |
| 355 | Hosp. Gral. Juan Ramon Jimenez | Huelva | Spain | 21005 | |
| 356 | Hosp. Gral. Univ. Gregorio Marañon | Madrid | Spain | 28007 | |
| 357 | Hosp. Virgen Macarena | Sevilla | Spain | 41009 | |
| 358 | Hosp. Alvaro Cunqueiro | Vigo | Spain | 36213 | |
| 359 | Hosp. Univ. Miguel Servet | Zaragoza | Spain | 50009 | |
| 360 | Linkoping University Hospital | Linköping | Sweden | 581 85 | |
| 361 | Karolinska Universitetssjukhuset Solna | Stockholm | Sweden | 17176 | |
| 362 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaoshiung | Taiwan | 80756 | |
| 363 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
| 364 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
| 365 | National Taiwan University Hospital, Division of Infectious Diseases | Taipei | Taiwan | 100 | |
| 366 | Taipei Mackay Memorial Hospital | Taipei | Taiwan | 10449 | |
| 367 | Taipei Medical University | Taipei | Taiwan | 110301 | |
| 368 | Hacettepe University Hospital | Ankara | Turkey | 06230 | |
| 369 | Uludag University Medical Faculty | Bursa | Turkey | 16059 | |
| 370 | Istanbul University Istanbul Medical Faculty | Istanbul | Turkey | 34093 | |
| 371 | Acibadem Fulya Hospital | Istanbul | Turkey | 34349 | |
| 372 | Haydarpasa Numune Training and Research Hospital | Istanbul | Turkey | 34668 | |
| 373 | Dokuz Eylul Universitesi Tip Fakultesi | Izmir | Turkey | 35210 | |
| 374 | Mersin University Medical Faculty | Mersin | Turkey | 33343 | |
| 375 | Ondokuz Mayis University | Samsun | Turkey | 55420 | |
| 376 | Karadeniz Teknik University Medical Faculty | Trabzon | Turkey | 61080 | |
| 377 | Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi | Zonguldak | Turkey | 67000 | |
| 378 | Royal Victoria Hospital | Belfast | United Kingdom | BT12 6BA | |
| 379 | South Eastern Health and Social Care Trust | Belfast | United Kingdom | BT16 1RH | |
| 380 | Fairfield General Hospital | Bury | United Kingdom | BL9 7TD | |
| 381 | St. Mark's Hospital | Chesham | United Kingdom | HP5 3QW | |
| 382 | Egin Research | High Wycombe | United Kingdom | HP112QW | |
| 383 | King's College Hospital | London | United Kingdom | SE5 9RL | |
| 384 | Royal Stoke University Hospital | Stoke-On-Trent | United Kingdom | ST4 6QG |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT05197049
Other Study ID Numbers:
- CR109125
- 2020-006165-11
- CNTO1959CRD3004
First Posted:
Jan 19, 2022
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: