DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Group 1: Placebo Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Drug: Placebo
Placebo will be administered as subcutaneous injection.
|
| Experimental: Group 2: Guselkumab Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Biological: Guselkumab
Guselkumab will be administered as subcutaneous injection.
|
| Experimental: Group 3: Golimumab Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Biological: Golimumab
Golimumab will be administered as subcutaneous injection.
|
| Experimental: Group 4: JNJ-78934804 (High-dose) Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Biological: JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.
|
| Experimental: Group 5: JNJ-78934804 (Mid-dose) Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Biological: JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.
|
| Experimental: Group 6: JNJ-78934804 (Low-dose) Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
Biological: JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Clinical Remission at Week 48 [Week 48]
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.
Secondary Outcome Measures
- Percentage of Participants with Endoscopic Improvement at Week 48 [Week 48]
Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.
- Percentage of Participants with Symptomatic Remission at Week 48 [Week 48]
Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.
- Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48 [Week 48]
Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.
- Percentage of Participants with Clinical Remission at Week 24 [Week 24]
Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission based on the modified Mayo subscores
- Percentage of Participants with Adverse Events (AEs) [Up to Week 48]
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.
- Percentage of Participants with Serious Adverse Events (SAEs) [Up to Week 48]
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.
- Serum Concentrations of Guselkumab Over Time [Up to Week 48]
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.
- Serum Concentrations of Golimumab Over Time [Up to Week 48]
Serum concentration of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.
- Percentage of Participants with Antibodies to Guselkumab [Up to Week 48]
Percentage of participants with antibodies to guselkumab will be reported.
- Titers of Antibodies to Guselkumab [Up to Week 48]
Titers of antibodies to guselkumab will be reported.
- Percentage of Participants with Antibodies to Golimumab [Up to Week 48]
Percentage of Participants with Antibodies to golimumab will be reported.
- Titers of Antibodies to Golimumab [Up to Week 48]
Titers of antibodies to golimumab will be reported.
- Percentage of Participants with Neutralizing Antibodies to Guselkumab [Up to Week 48]
Percentage of participants with neutralizing antibodies to guselkumab will be reported.
- Percentage of Participants with Neutralizing Antibodies to Golimumab [Up to Week 48]
Percentage of participants with neutralizing antibodies to golimumab will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
-
Moderately to severely active UC as assessed by the modified Mayo Score
-
Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
-
If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion Criteria:
-
Has severe extensive colitis as defined in the protocol
-
Extent of inflammatory disease limited to the rectum
-
Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
-
Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
-
Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Valley Gastroenterology Medical Group | Arcadia | California | United States | 91006 |
| 2 | Southern California Research Center | Coronado | California | United States | 92118 |
| 3 | University of California San Diego Health | La Jolla | California | United States | 92037 |
| 4 | Om Research LLC | Lancaster | California | United States | 93534 |
| 5 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 6 | Northshore Gastroenterology Research, LLC | San Diego | California | United States | 92103-2120 |
| 7 | University of Colorado | Aurora | Colorado | United States | 80045 |
| 8 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 9 | Pioneer Research Solutions Inc. | Coconut Creek | Florida | United States | 33066 |
| 10 | Homestead Cardiac & Vein Center | Homestead | Florida | United States | 33030 |
| 11 | Florida Research Center Inc. | Lakewood Ranch | Florida | United States | 34211 |
| 12 | Gastroenterology Group Of Naples | Naples | Florida | United States | 34102 |
| 13 | Omega Research Consultants | Orlando | Florida | United States | 32808 |
| 14 | Central Florida Internists | Saint Cloud | Florida | United States | 34769 |
| 15 | Synergy Clinical Research | Saint Petersburg | Florida | United States | 33705 |
| 16 | Gastroenterolgy Associates of Central GA | Macon | Georgia | United States | 31201 |
| 17 | Gastrointestinal Specialists of Georgia | Marietta | Georgia | United States | 30060 |
| 18 | Gastroenterology Consultants | Roswell | Georgia | United States | 30076 |
| 19 | Grand Teton Gastroenterology | Idaho Falls | Idaho | United States | 83404 |
| 20 | IU Health University Hospital | Indianapolis | Indiana | United States | 46202 |
| 21 | University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536 |
| 22 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 23 | Chevy Chase Clinical Research | Chevy Chase | Maryland | United States | 20815-7313 |
| 24 | Huron Gastroenterology Associates Center for Digestive Care | Ypsilanti | Michigan | United States | 48197 |
| 25 | GI Associates | Columbia | Missouri | United States | 65201 |
| 26 | Care Access Las Vegas | Las Vegas | Nevada | United States | 89148 |
| 27 | Crystal Run Healthcare LLP | Middletown | New York | United States | 10941 |
| 28 | Lenox Hill Hospital | New York | New York | United States | 10075 |
| 29 | Mohawk Valley Endoscopy Center | Utica | New York | United States | 13502-6313 |
| 30 | Tryon Medical Group | Charlotte | North Carolina | United States | 28210 |
| 31 | Onsite Clinical Solutions | Charlotte | North Carolina | United States | 28277 |
| 32 | Care Access Research, Kinston | Kinston | North Carolina | United States | 28501 |
| 33 | University Hospitals Case Medical Center | Cleveland | Ohio | United States | 44106 |
| 34 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 35 | Digestive Specialists, Inc | Springboro | Ohio | United States | 45066 |
| 36 | Care Access Research | Scranton | Pennsylvania | United States | 18508 |
| 37 | Digestive Disease Associates | Rock Hill | South Carolina | United States | 29732 |
| 38 | Etsu Quillen College Of Medicine | Johnson City | Tennessee | United States | 37604 |
| 39 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37067 |
| 40 | GI Specialists of Houston | Houston | Texas | United States | 77346 |
| 41 | Gastroenterology Clinic Of San Antonio P A | San Antonio | Texas | United States | 78229 |
| 42 | A1 Clinical Research | Spring | Texas | United States | 77386 |
| 43 | Medical College Of Virginia Hospital | Richmond | Virginia | United States | 23249 |
| 44 | Swedish Medical Center | Seattle | Washington | United States | 98104 |
| 45 | University of Washington | Seattle | Washington | United States | 98195 |
| 46 | Medical College Of Wisconsin | Milwaukee | Wisconsin | United States | 53226-3522 |
| 47 | Hospital de Clínicas José de San Martín | Buenos Aires | Argentina | 1121 | |
| 48 | Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo | Ciudad Autonoma Buenos Aires | Argentina | C1264AAN | |
| 49 | Hospital Britanico de Buenos Aires | Ciudad Autonoma de Buenos Aires | Argentina | C1280AEB | |
| 50 | Centro de Investigaciones Medicas Mar Del Plata | Mar Del Plata | Argentina | B7600FYK | |
| 51 | Box Hill Hospital | Box Hill | Australia | 3128 | |
| 52 | Concord Hospital | Concord | Australia | 2139 | |
| 53 | Western Health | Footscray | Australia | 3011 | |
| 54 | Coastal Digestive Health | Maroochydore | Australia | 4558 | |
| 55 | Royal Perth Hospital | Perth | Australia | 6000 | |
| 56 | The Alfred Hospital | Prahran | Australia | 3004 | |
| 57 | Kepler Universitätsklinikum GmbH | Linz | Austria | 4020 | |
| 58 | Universitätsklinikum Salzburg - Landeskrankenhaus | Salzburg | Austria | 5020 | |
| 59 | Klinikum Wels-Grieskirchen | Wels | Austria | 4600 | |
| 60 | Krankenhaus der Barmherzigen Brüder | Wien | Austria | 1020 | |
| 61 | Medizinische Universität Wien | Wien | Austria | 1090 | |
| 62 | CHU Saint-Pierre | Bruxelles | Belgium | 1000 | |
| 63 | AZ Maria Middelares | Gent | Belgium | 9000 | |
| 64 | CHU de Liège | Liege | Belgium | 4000 | |
| 65 | CHC MontLegia | Liège | Belgium | 4000 | |
| 66 | Vitaz | Sint-Niklaas | Belgium | ||
| 67 | Fundação Universidade de Caxias do Sul | Caxias Do Sul | Brazil | 95070-560 | |
| 68 | Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica | Curitiba | Brazil | 80430-180 | |
| 69 | Instituto Goiano de Gastroenterologia e Endoscopia Digestiva | Goiania | Brazil | 74535-170 | |
| 70 | Hospital Moinhos de Vento | Porto Alegre | Brazil | 90035-901 | |
| 71 | Hospital de Clínicas de Porto Alegre | Porto Alegre | Brazil | 90035-903 | |
| 72 | UFRJ-Hospital Universitário Clementino Fraga Filho | Rio de Janeiro | Brazil | 21941-913 | |
| 73 | SER - Serviços Especializados em Reumatologia da Bahia | Salvador | Brazil | 40.150-150 | |
| 74 | Praxis pesquisa médica | Santo André | Brazil | 09090-790 | |
| 75 | Irmandade da Santa Casa da Misericórdia de Santos | Santos | Brazil | 11075-101 | |
| 76 | Hospital Do Servidor Publico Estadual | Sao Paulo | Brazil | 04039-901 | |
| 77 | Hospital Nove de Julho | São Paulo | Brazil | 01409-902 | |
| 78 | BR Trials | São Paulo | Brazil | 03325-050 | |
| 79 | Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo | Brazil | 04502-001 | |
| 80 | Medical Centre Hipocrat | Haskovo | Bulgaria | 6300 | |
| 81 | Diagnostic Consultative Center - DCC Sv. Pantaleymon EOOD | Pleven | Bulgaria | 5800 | |
| 82 | Diagnostic - Consulting Center I-Sliven | Sliven | Bulgaria | 8800 | |
| 83 | University Hospital Alexandrovska - Clinic of Nephrology | Sofia-Grad | Bulgaria | 1431 | |
| 84 | UMHAT 'Tsaritsa Yoanna' | Sofia | Bulgaria | 1527 | |
| 85 | Medical Center -Medika Plus | Veliko Tarnovo | Bulgaria | 5000 | |
| 86 | Multriprofile Hospital for Active Treatment Hristo Botev | Vratsa | Bulgaria | 3000 | |
| 87 | Columbia Gastroenterology | New Westminster | British Columbia | Canada | |
| 88 | GIRI Gastrointestinal Research Institute | Vancouver | British Columbia | Canada | V6Z 2K5 |
| 89 | Health Sciences Centre | Winnipeg | Manitoba | Canada | R3A 1R9 |
| 90 | London Health Sciences Centre - University Campus | London | Ontario | Canada | N6A 5A5 |
| 91 | Mount Sinai Hospital | Toronto | Ontario | Canada | M5G 1X5 |
| 92 | St. Jerome Medical Research | Saint-Jerome | Quebec | Canada | V8R 4R2 |
| 93 | Viable Clinical Research | Bridgewater | Canada | B4V 3N2 | |
| 94 | Viable Clinical Research | Dartmouth | Canada | B2W 6L4 | |
| 95 | Hospital Clinico Regional Dr. Guillermo Grant Benavente | Concepcion | Chile | 4030000 | |
| 96 | Clínica Dermacross S.A. | Santiago | Chile | 7640881 | |
| 97 | Complejo Asistencial Hospital Dr. Sótero del Río | Santiago | Chile | 8207257 | |
| 98 | Centro de Estudios Clínicos e Investigación Médica (CeCim) | Santiago | Chile | 8331143 | |
| 99 | Fakultni nemocnice Brno | Brno | Czechia | 625 00 | |
| 100 | Fakultní nemocnice u sv. Anny v Brn | Brno | Czechia | 656 91 | |
| 101 | Klinicke centrum ISCARE | Praha 9 | Czechia | 190 00 | |
| 102 | Aalborg Hospital | Aalborg | Denmark | 9000 | |
| 103 | Bispebjerg Og Frederiksberg Hospital | Copenhagen | Denmark | 2400 | |
| 104 | Herlev Hospital, University of Copenhagen | Herlev | Denmark | 2730 | |
| 105 | Nykøbing F. Sygehus | Nykøbing Falster | Denmark | 4800 | |
| 106 | Odense Universitetshospital | Odense | Denmark | 5000 | |
| 107 | East Tallinn Central Hospital | Tallinn | Estonia | 10138 | |
| 108 | West Tallinn Central Hospital | Tallinn | Estonia | 10617 | |
| 109 | Tartu University Hospital | Tartu | Estonia | 51014 | |
| 110 | CHU Amiens - Hopital Sud | AMIENS cedex 1 | France | 80054 | |
| 111 | Hôpital Beaujon | Clichy | France | 92110 | |
| 112 | Hopital Louis Mourier | Colombes Cedex | France | 92701 | |
| 113 | Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor | Créteil | France | 94010 | |
| 114 | CHU Grenoble | Grenoble | France | 38700 | |
| 115 | Centre Hospitalier Départemental VENDEE | La Roche sur Yon | France | 85925 | |
| 116 | Hôpital Nord - Marseille | Marseille | France | 13015 | |
| 117 | CHU Nimes - Hôpital Carémeau | Nîmes | France | 30029 | |
| 118 | Hôpital Yves Le Foll | Saint-Brieuc | France | 22027 | |
| 119 | Hopital de Rangueil | Toulouse cedex 09 | France | 31059 | |
| 120 | CHRU Nancy-Brabois | Vandoeuvre-les-Nancy | France | 54511 | |
| 121 | Gastroenterologische Spezialpraxis - Berlin-Karlshorst | Berlin-Karlshorst | Germany | 10318 | |
| 122 | Praxis Für Gastroenteroligie | Berlin | Germany | 10825 | |
| 123 | University Hospital Dresden | Dresden | Germany | 1307 | |
| 124 | Florence Nightingale Krankenhaus | Düsseldorf | Germany | 40489 | |
| 125 | Universitaetsklinik Erlangen | Erlangen | Germany | 91054 | |
| 126 | Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus | Frankfurt/Main | Germany | 60431 | |
| 127 | Klinikum Fulda - Tumorklinik - Germany | Fulda | Germany | 36043 | |
| 128 | BSF Studiengesellschaft | Halle | Germany | 06108 | |
| 129 | Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd | Heidelberg | Germany | 69115 | |
| 130 | University Hospital Heidelberg | Heidelberg | Germany | 69120 | |
| 131 | Universitätsklinikum Jena | Jena | Germany | 07747 | |
| 132 | Eugastro GmbH | Leipzig | Germany | 04103 | |
| 133 | Gemeinschaftspraxis Mainz Mitte am Gesundheitscentrum Mainz | Mainz | Germany | 55116 | |
| 134 | Universitatsklinikum Mannheim | Mannheim | Germany | 68167 | |
| 135 | Klinikum der Universität München | Munich | Germany | 81377 | |
| 136 | Praxis fur Innere Medizin und Gastroenterologie | Munster | Germany | 48149 | |
| 137 | MVZ Portal 10 | Münster | Germany | 48155 | |
| 138 | Medius Klinik Nürtingen | Nürtingen | Germany | 72622 | |
| 139 | Zentrum für Gastroenterologie Saar MVZ GmbH | Saarbrücken | Germany | 66111 | |
| 140 | Universitätsklinikum Ulm | Ulm | Germany | 89070 | |
| 141 | Gemeinschaftspraxis Jakobeit | Wipperfürth | Germany | 51688 | |
| 142 | Universitätsklinikum Würzburg | Würzburg | Germany | 97080 | |
| 143 | General Hospital of Athens 'G. Gennimatas' | Athens | Greece | 115 27 | |
| 144 | Sotiria General State Hospital of Chest Diseases | Athens | Greece | 115 27 | |
| 145 | Alexandra General Hospital of Athens | Athens | Greece | 11528 | |
| 146 | Nikaia General Hospital | Piraievs | Greece | 184 54 | |
| 147 | Hippokration Hospital | Thessaloniki | Greece | 54642 | |
| 148 | Obudai Egeszsegugyi Centrum Kft. | Budapest | Hungary | 1036 | |
| 149 | Pannónia Magánorvosi Centrum Kft | Budapest | Hungary | H-1136 | |
| 150 | Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp. | Szeged | Hungary | 6720 | |
| 151 | M S Ramaiah Medical College and Hospital | Bangalore | India | 560054 | |
| 152 | Apex Hospitals Ltd | Jaipur | India | 302017 | |
| 153 | All India Institute of Medical Sciences | New Delhi | India | 110029 | |
| 154 | Sir Ganga Ram Hospital | New Delhi | India | 110060 | |
| 155 | Yashoda Super Speciality Hospitals | Secunderabad | India | 500003 | |
| 156 | Haemek Medical Center - Afula | Afula | Israel | 1834111 | |
| 157 | Shaare Zedek Medical Center | Jerusalem | Israel | 9103102 | |
| 158 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 6423906 | |
| 159 | The Chaim Sheba Medical Center | Tel Hashomer | Israel | 52621 | |
| 160 | A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale | Catania | Italy | 95126 | |
| 161 | AOU Policlinico G.Martino | Messina | Italy | 98125 | |
| 162 | Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele | Milano | Italy | 20132 | |
| 163 | Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato | Monserrato | Italy | 09042 | |
| 164 | Universita degli Studi di Padova - Azienda Ospedaliera di Padova | Padova | Italy | 35128 | |
| 165 | Policlinico Universitario Agostino Gemelli | Roma | Italy | 00168 | |
| 166 | Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy | 71013 | |
| 167 | Ospedale Molinette, AO Città della Salute e della Scienza di | Torino | Italy | 10126 | |
| 168 | Kosin University Gospel Hospital | Busan | Korea, Republic of | 49267 | |
| 169 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 41944 | |
| 170 | Chungnam National University Hospital | Daejeon | Korea, Republic of | 35015 | |
| 171 | Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | Korea, Republic of | 18450 | |
| 172 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 03181 | |
| 173 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 174 | The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 175 | The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | Korea, Republic of | 6591 | |
| 176 | Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik | Kaunas | Lithuania | LT-50009 | |
| 177 | Clinica de Investigacion en Reumatologia y Obesidad | Guadalajara | Mexico | 44650 | |
| 178 | Centro Regiomontano de Estudios Clínicos Roma S.C. | Monterrey | Mexico | 64610 | |
| 179 | Hospital Universitatio de Saltillo | Saltillo | Mexico | 25020 | |
| 180 | Academisch Medisch Centrum Universiteit van Amsterdam | Amsterdam | Netherlands | 105 AZ | |
| 181 | Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands | 3318 AT | |
| 182 | Leiden University Medical Center | Leiden | Netherlands | 2333 ZA | |
| 183 | Erasmus Medisch Centrum | Rotterdam | Netherlands | 3015 GD | |
| 184 | Ikazia Ziekenhuis | Rotterdam | Netherlands | 3083 AN | |
| 185 | UMC Utrecht | Utrecht | Netherlands | 3584 CX | |
| 186 | Hutt Hospital | Lower Hutt | New Zealand | 5010 | |
| 187 | Sykehuset Immlandet HF Gjøvik | Gjøvik | Norway | 2819 | |
| 188 | Akershus Universitetssykehus | Lørenskog | Norway | 1478 | |
| 189 | Lovisenberg Diakonale Sykehus | Oslo | Norway | 0440 | |
| 190 | Oslo University Hospital HF Ullevål sykehus | Oslo | Norway | 0450 | |
| 191 | St. Olavs Hospital | Trondheim | Norway | 7030 | |
| 192 | Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj | Ksawerów | Poland | 95-054 | |
| 193 | AmiCare Centrum Medyczne | Lodz | Poland | 90-644 | |
| 194 | Pracownia Endoskopowa Szpital Zakonu Bonifratrow sw. Jana Bozego w Lodzi sp. z o.o. | Lodz | Poland | 93-357 | |
| 195 | ETG Lublin | Lublin | Poland | 20-412 | |
| 196 | Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | Poland | 10-561 | |
| 197 | EuroMediCare Szpital Specjalistyczny z Przychodnia | Wroclaw | Poland | 54-144 | |
| 198 | Centro Hospitalar de Lisboa Norte - Hospital Santa Maria | Lisboa | Portugal | 1649-035 | |
| 199 | Hospital Beatriz Angelo | Loures | Portugal | 2674-514 | |
| 200 | Military Medical Academy, Clinic for Psychiatry | Belgrade | Serbia | 11000 | |
| 201 | University Clinical Center of Serbia | Belgrade | Serbia | 11000 | |
| 202 | University Clinical Hospital Center Dr Dragisa Misovic- Dedi | Belgrade | Serbia | 11000 | |
| 203 | Zvezdara University Medical Center | Belgrade | Serbia | 11000 | |
| 204 | General Hospital Vrsac | Vrsac | Serbia | 26300 | |
| 205 | General Hospital 'Djordje Joanovic' | Zrenjanin | Serbia | 23000 | |
| 206 | FNsP F.D.R. Banska Bystrica | Banska Bystrica | Slovakia | 974 01 | |
| 207 | GASTRO I. s.r.o. | Presov | Slovakia | 080 01 | |
| 208 | Gastroenterology Department ENDOMED, s.r.o. | Vranov nad Toplou | Slovakia | 093 01 | |
| 209 | Splosna bolnisnica Celje | Celje | Slovenia | 3000 | |
| 210 | Univerzitetni klinicni center Ljubljana | Ljubljana | Slovenia | 1000 | |
| 211 | UKS Maribor | Maribor | Slovenia | 2000 | |
| 212 | Hosp. Clinic I Provincial de Barcelona | Barcelona | Spain | 08036 | |
| 213 | Hosp. Univ. La Paz | Madrid | Spain | 28046 | |
| 214 | Hosp. de Navarra | Pamplona | Spain | 31008 | |
| 215 | Corporacio Sanitari Parc Tauli | Sabadell | Spain | 8208 | |
| 216 | Hosp. Univ. Marques de Valdecilla | Santander | Spain | 39008 | |
| 217 | Hosp. Univ. de Torrejon | Torrejón de Ardoz | Spain | 28850 | |
| 218 | Hosp. Clinico Univ. de Valencia | Valencia | Spain | 46010 | |
| 219 | Hosp. Alvaro Cunqueiro | Vigo | Spain | 36213 | |
| 220 | INSELSPITAL, Universitätsspital Bern | Bern | Switzerland | 3010 | |
| 221 | Gastroenterologische Praxis Balsiger und Seibold | Bern | Switzerland | 3012 | |
| 222 | Spital Bülach | Bülach | Switzerland | 8180 | |
| 223 | Hôpitaux Universitaires de Genève - HUG | Genève | Switzerland | 1205 | |
| 224 | UniversitaetsSpital Zuerich | Zuerich | Switzerland | 8091 | |
| 225 | Changhua Christian Hospital | Changhua | Taiwan | 500 | |
| 226 | National Cheng Kung University Hospital | Tainan | Taiwan | 70403 | |
| 227 | National Taiwan University Hospital, Division of Infectious Diseases | Taipei | Taiwan | 100 | |
| 228 | Acibadem Fulya Hospital | D:14/4 Nisantasi | Turkey | 34340 | |
| 229 | Ege Universitesi Tip Fakultesi | Izmir | Turkey | 35100 | |
| 230 | Mersin University Medical Faculty | Mersin | Turkey | 33343 | |
| 231 | Karadeniz Teknik University Medical Faculty | Trabzon | Turkey | 61080 | |
| 232 | North Tyneside General Hospital | Hexham | United Kingdom | NE46 1QJ | |
| 233 | Egin Research | High Wycombe | United Kingdom | HP112QW | |
| 234 | Airedale General Hospital | Keighley | United Kingdom | BD20 6TD | |
| 235 | Whipps Cross University Hospital | London | United Kingdom | E11 1NR | |
| 236 | Guy's and St Thomas' Hospital | London | United Kingdom | SE1 7EH | |
| 237 | St George's University Hosptial NHS Foundation Trust | London | United Kingdom | SW17 0QT |
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.- CR109179
- 78934804UCO2001
- 2021-005528-39