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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513014-35-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Chugai Pharmaceutical | INDUSTRY |
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This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afimkibart | Experimental | Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
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| Placebo | Placebo Comparator | Participants will receive placebo IV followed by placebo SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimkibart | Drug | Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Clinical Remission at Week 12 | Percentage of participants achieving Modified Mayo Score (mMS) <=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. | At Week 12 |
| Percentage of Participants with Clinical Remission at Week 52 | Percentage of participants achieving mMS <= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Partial Modified Mayo Score (pmMS) | Change in pmMS from baseline to Week 2. pmMS is a composite score of ulcerative colitis signs and symptoms activity given by the sum of the SFS and RBS. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). | Baseline to Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan | Dothan | Alabama | 36305 | United States | ||
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Placebo | Drug | Placebo matching IV afimkibart. Placebo matching SC afimkibart. |
|
| Percentage of Participants with Endoscopic Improvement | Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. | At Week 12 |
| Percentage of Participants with Endoscopic Remission | Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12. | At Week 12 |
| Percentage of Participants with Clinical Response | Percentage of participants achieving a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS >= 1 or RBS = 0 or 1 (no blood seen or stool with streaks of blood) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). ES is measured on a scale from 0 (normal appearance of mucosa) to 3 (severe disease). | At Week 12 |
| Percentage of Participants with Histologic Improvement | Percentage of participants achieving a histologic improvement, defined as Geboes <=3.1 at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). | At Week 12 |
| Percentage of Participants with Histologic Remission | Percentage of participants achieving a histologic remission, defined as Geboes <2B at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). | At Week 12 |
| Percentage of Participants with Histologic-Endoscopic Mucosal Improvement | Percentage of participants achieving Geboes <= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). | At Week 12 |
| Percentage of Participants with Histologic-Endoscopic Remission | Percentage of participants achieving Geboes < 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). | At Week 12 |
| Percentage of Participants with Maintenance of Remission | Percentage of participants with clinical remission at both Week 12 and Week 52. Clinical remission is defined as mMS <= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease). mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. | Week 12 and Week 52 |
| Percentage of Participants with Corticosteroid-Free Remission | Percentage of participants in clinical remission at Week 52 with no corticosteroid use at least 8 weeks prior to Week 52. Clinical remission is defined as mMS <= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease). mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. | At Week 52 |
| Percentage of Participants with Endoscopic Improvement | Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. | At Week 52 |
| Percentage of Participants with Endoscopic Remission | Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 52. | At Week 52 |
| Percentage of Participants with Histologic Improvement | Percentage of participants achieving histologic improvement defined as Geboes <= 3.1 at Week 52. | At Week 52 |
| Percentage of Participants with Histologic Remission | Percentage of participants achieving histologic remission defined as Geboes <2B at Week 52. | At Week 52 |
| Percentage of Participants with Histologic-Endoscopic Mucosal Improvement | Percentage of participants achieving Geboes <= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). | At Week 52 |
| Percentage of Participants with Histologic-Endoscopic Remission | Percentage of participants achieving Geboes < 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). | At Week 52 |
| Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants | Percentage of participants achieving mMS <= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. | At Week 12 |
| Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants | Percentage of participants achieving mMS <= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. | At Week 52 |
| Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants | Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. | At Week 12 |
| Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants | Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 52 in biomarker-defined subgroups. | At Week 52 |
| Change in Bowel Urgency | Change in bowel urgency from baseline through Week 52. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe). | Baseline through Week 52 |
| Change in Abdominal Pain | Change in abdominal pain from baseline through Week 52. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe). | Baseline through Week 52 |
| Change in Fatigue | Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12 and Week 52. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue. | Baseline to Week 12 and Week 52 |
| Change in Health-Related Quality of Life | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12 and Week 52. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life. | Baseline to Week 12 and Week 52 |
| Overall Change in UC Symptoms | Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 12 and 52. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to "Much worse". | Baseline to Week 2, Week 12, and Week 52 |
| Overall Severity in UC Symptoms | Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 12 and 52. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe". | Baseline to Week 2, Week 12, and Week 52 |
| Incidence and Severity of Adverse Events (AEs) | Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest. | Up to 70 Weeks after Baseline |
| Om Research LLC |
| Lancaster |
| California |
| 93534 |
| United States |
| University of California Irvine | Orange | California | 92868 | United States |
| Amicis Research Center | Santa Clarita | California | 91355 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| Access Research Institute | Brooksville | Florida | 34613 | United States |
| Gastro Florida | Clearwater | Florida | 33756 | United States |
| J&A Clinical Research | Doral | Florida | 33126 | United States |
| Clinical Research of Osceola, LLC | Kissimmee | Florida | 34741 | United States |
| Auzmer Research | Lakeland | Florida | 33813 | United States |
| Florida Research Institute - Lakewood | Lakewood Rch | Florida | 34211 | United States |
| Homestead Associates in Research, Inc. | Miami | Florida | 33033 | United States |
| Allied Biomedical Research Institute, Inc | Miami | Florida | 33155 | United States |
| Miami Beach Clinical Research Center | Miami Beach | Florida | 33141 | United States |
| Eminat Research Group | Miramar | Florida | 33027 | United States |
| Nodal Medical Center, LLC | Tampa | Florida | 33607 | United States |
| Theia Clinical Research Centers, LLC | Tampa | Florida | 33613 | United States |
| Florida Medical Clinic | Zephyrhills | Florida | 33542 | United States |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | United States |
| Grand Teton Research Group, PLLC | Idaho Falls | Idaho | 83404 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Gastroenterology Health Partners, PLLC | New Albany | Indiana | 47150 | United States |
| Tri-State Gastroenterology Associates | Crestview Hills | Kentucky | 41017-3409 | United States |
| Robley Rex VA Medical Center | Louisville | Kentucky | 40206 | United States |
| Gastroenterology Health Partners, PLLC | Louisville | Kentucky | 40218 | United States |
| Louisiana Research Center - GastroIntestinal Associates | Shreveport | Louisiana | 71105 | United States |
| Brigham & Womens Hosp | Boston | Massachusetts | 02115 | United States |
| Boston University | Boston | Massachusetts | 02118 | United States |
| Michigan Center of Medical Research | Farmington Hills | Michigan | 48334 | United States |
| Allied Gastrointestinal Associates, PA | Flowood | Mississippi | 39232 | United States |
| Las Vegas Clinical Trials, LLC | North Las Vegas | Nevada | 89030 | United States |
| Intercity Gastroenterology | Fresh Meadows | New York | 11366 | United States |
| Pioneer Clinical Research NY | New York | New York | 10016 | United States |
| Mainstreet - Richmond Hill Clinic | Richmond Hill | New York | 11418 | United States |
| Digestive Health Partners, PA | Asheville | North Carolina | 28801 | United States |
| Peters Medical Research (PMR), LLC | High Point | North Carolina | 27260 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio Gastroenterology Group | Columbus | Ohio | 43202 | United States |
| Gastro Intestinal Research Institute of Northern Ohio | Westlake | Ohio | 44145 | United States |
| University Gastroenterology | Providence | Rhode Island | 02904 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Gastro One | Cordova | Tennessee | 38018 | United States |
| Gastrointestinal Associates of Northeast Tennessee | Johnson City | Tennessee | 37604 | United States |
| Texas Digestive Disease Consultants - Cedar Park | Cedar Park | Texas | 78613 | United States |
| The University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| GI Alliance | Garland | Texas | 75044 | United States |
| Baylor College of Medicine. | Houston | Texas | 77030 | United States |
| TDDC dba GI Alliance Research | Mansfield | Texas | 76063 | United States |
| Carta - Clinical Associates In Research Therapeutics Of America;LLC | San Antonio | Texas | 78212 | United States |
| Southern Star Research Institute, LLC. | San Antonio | Texas | 78229 | United States |
| GI Alliance - Southlake | Southlake | Texas | 76092 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| University of Texas Health Center at Tyler | Tyler | Texas | 75708 | United States |
| Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater | Chesapeake | Virginia | 23320 | United States |
| Gastroenterology Consultants of SWVA | Roanoke | Virginia | 24018 | United States |
| Univ of Wisconsin Hosp & Clin | Madison | Wisconsin | 53792 | United States |
| CIPREC Centro de Investigacion y Prevencion Cardiovascular | Ciudad Autonoma Buenos Aires | C1061AAS | Argentina |
| Expertia S.A- Mautalen Salud e Investigación | Ciudad Autonoma Buenos Aires | C1128AAE | Argentina |
| The Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
| Royal Prince Alfred Hospital | Sydney | New South Wales | 2050 | Australia |
| Mater Misericordiae Limited | South Brisbane | Queensland | 4101 | Australia |
| Lyell McEwin Hospital | Adelaide | South Australia | 5112 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria |
| Barmherzige Brüder Wien | Vienna | 1020 | Austria |
| CHC MontLégia | Liège | 4000 | Belgium |
| CHU de Liège (Sart Tilman) | Liège | 4000 | Belgium |
| Hospital de Clinicas de Porto Alegre X | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| CPQuali Pesquisa Clinica Ltda | São Paulo | São Paulo | 01228-000 | Brazil |
| BR Trials - Pesquisa Clínica | São Paulo | São Paulo | 03325-050 | Brazil |
| MHAT St. Ivan Rilski | Gorna Oryahovitsa | 5100 | Bulgaria |
| South Edmonton Gastroenterology | Edmonton | Alberta | T6K 4B2 | Canada |
| Hospital Guillermo Grant Benavente | Concepción | 4030000 | Chile |
| Clinica Universidad de Los Andes | Santiago | Chile |
| Medwal | Santiago | Chile |
| Peking University Third Hospital | Beijing | 100191 | China |
| Binzhou Medical university hospital | Binzhou | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Sichuan Provincial People's Hospital | Chengdu | 610072 | China |
| The First Affiliated Hospital Of Fujian Medical University | Fuzhou | 350005 | China |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | 510080 | China |
| The sixth affiliated hospital of Sun Yat-Sen University | Guangzhou | 510655 | China |
| Anhui Provincial Hospital | Hefei | 230001 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | 230022 | China |
| Huizhou First Hospital | Huizhou | China |
| Jinhua municipal central hospital | Jinhua | China |
| The 1st Affiliated Hospital of Nanchang Unversity | Nanchang | 330006 | China |
| Nanjing 1st Hospital | Nanjing | 210006 | China |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200127 | China |
| Peking University Shenzhen Hospital | Shenzhen | 518036 | China |
| Hebei Medical University - The Second Hospital | Shijiazhuang | 050004 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Wuhan | 430022 | China |
| Ren Min Hospital Affiliated Wu Han University | Wuhan | 430060 | China |
| Wuxi People's Hospital | Wuxi | 214023 | China |
| The Second Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | 710004 | China |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| Zhuzhou Central Hospital | Zhuzhou | China |
| Borzan Polyclinic | Osijek | 31000 | Croatia |
| SurGal Clinic s.r.o. | Brno | 602 00 | Czechia |
| Nemocnice Ceske Budejovice a.s. | České Budějovice | 370 01 | Czechia |
| Gastroenterologie s.r.o. | Hradec Králové | 500 02 | Czechia |
| Herlev Hospital | Herlev | 2730 | Denmark |
| CHU Amiens - Hopital Sud | Amiens | 80054 | France |
| CHU Dijon Bourgogne Hôpital François Mitterand | Dijon | 21000 | France |
| CH Dptal Les Oudairies | La Roche-sur-Yon | 85925 | France |
| CHRU de Lille - Hopital Claude Huriez | Lille | 59037 | France |
| Hopital Nord | Marseille | 13015 | France |
| Institut des MICI, Clinique Ambroise Paré | Neuilly-sur-Seine | 92200 | France |
| CHU Nice - Hopital de l'Archet 2 | Nice | 06202 | France |
| CHU Bordeaux - Hôpital Haut-Lévêque | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Hopital Robert Debre | Reims | 51092 | France |
| CHU de Rennes - Hopital de Pontchaillo | Rennes | 35033 | France |
| CHU Saint Etienne - Hôpital Nord | Saint-Etienne | 42055 | France |
| Hôpital de Rangueil | Toulouse | 31400 | France |
| Universitaetsklinikum Jena | Jena | 77430 | Germany |
| Clinexpert Kft. | Budapest | 1033 | Hungary |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 1036 | Hungary |
| Pannonia Maganorvosi Centrum | Budapest | 1136 | Hungary |
| Clinfan Szolgaltato Kft. | Szekszárd | 7100 | Hungary |
| Jávorszky Ödön Kórház | Vác | 2600 | Hungary |
| Surat Institute of Digestive Sciences Hospitals | Surat | Gujarat | 395002 | India |
| Gujarat Gastro and Vascular Hospital | Surat | Gujarat | 395009 | India |
| SR Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | 302006 | India |
| Shaare Zedek Medical Center | Jerusalem | Bayit Vegan | 9103102 | Israel |
| Ospedale Madonna delle Grazie | Matera | Basilicate | 75100 | Italy |
| Universita'degli Studi di Napoli Federico II | Naples | Campania | 80131 | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia | Lombardy | 27100 | Italy |
| ASST Rhodense - Ospedale di Rho | Rho | Lombardy | 20017 | Italy |
| Tsujinaka Hospital Kashiwanoha | Chiba | 277-0871 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Hidaka Coloproctology Clinic | Fukuoka | 839-0809 | Japan |
| Japanese Red Cross Takayama Hospital | Gifu | 506-8550 | Japan |
| Aoyama Clinic;GI Endoscopy & IBD Center | Hyōgo | 650-0015 | Japan |
| Kagawa Prefectural Central Hospital | Kagawa | 760-8557 | Japan |
| Sameshima Hospital | Kagoshima | 892-0846 | Japan |
| Gokeikai Ofuna Chuo Hospital | Kanagawa | 247-0056 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| Ishida Clinic of IBD and Gastroenterology | Ōita | 870-0823 | Japan |
| Saga-ken Medical Centre Koseikan | Saga | 840-8571 | Japan |
| Saga University Hospital | Saga | 849-8501 | Japan |
| National Hospital Organization Shizuoka Medical Center | Shizuoka | 411-8611 | Japan |
| Matsuda Hospital | Shizuoka | 432-8061 | Japan |
| Kitasato University Kitasato Institute Hospital | Tokyo | 108-8642 | Japan |
| JCHO Tokyo Yamate Medical Center | Tokyo | 169-0073 | Japan |
| Tokai University Hachioji Hospital | Tokyo | 192-0032 | Japan |
| Yokohama City University Medical Center | Yokohama | 232-0024 | Japan |
| Boca Clinical Trials Mexico S.C. (Guadalajara) | Guadalajara | Jalisco | 44600 | Mexico |
| Accelerium S. de R.L. de C.V. | Monterrey | Nuevo León | 64000 | Mexico |
| Hospital General de Mexico | Mexico | Tlaxcala | 06726 | Mexico |
| SPZOZ w ??cznej | ??czna | 21-010 | Poland |
| Clinical Trials UMED Sp. z o. o. | ?ód? | 92-213 | Poland |
| Centrum Medyczne "Medis" | Bydgoszcz | 85-229 | Poland |
| Centrum Medyczne Lukamed Joanna Luka-Wendrowska | Chojnice | 89-600 | Poland |
| Endo-Med Sp. z o.o. | Karczew | 05-480 | Poland |
| Allmedica Badania Kliniczne Sp z o.o. Sp K. | Nowy Targ | 34-400 | Poland |
| Wojewodzki Specjalistyczny Szpital w Olsztynie | Olsztyn | 10-561 | Poland |
| SOLUMED Centrum Medyczne | Późna | 60-529 | Poland |
| Centrum Medyczne "MEDYK" | Rzeszów | 35-326 | Poland |
| Kiepury Clinic | Sosnowiec | 41-200 | Poland |
| Gastromed Sp. z o.o. | Toru? | 87-100 | Poland |
| Centralny Szpital Kliniczny MSW w Warszawie | Warsaw | 02-507 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 04-501 | Poland |
| Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci? | Wroc?aw | 53-149 | Poland |
| Penta Hospitals Przychodnie, Wroclaw Wejherowska | Wroc?aw | 54-239 | Poland |
| Melita Medical | Wroclaw | 53-611 | Poland |
| ETG Zamosc | Zamo?? | 22-400 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Hospital da Luz Lisboa | Lisbon | 1500-650 | Portugal |
| Centro Hospitalar do Algarve - Hospital de Portimao | Portimão | 8500-338 | Portugal |
| Hospital de Sao Joao | Porto | 4202-451 | Portugal |
| Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião | Santa Maria da Feira | 4520-211 | Portugal |
| Hospital Sao Teotonio | Viseu | 3504-509 | Portugal |
| Colentina Clinical Hospital | Bucharest | 020125 | Romania |
| Cantacuzino Clinical Hospital | Bucharest | 020475 | Romania |
| University Hospital Center Dr Dragisa Misovic - Dedinje | Belgrade | 11040 | Serbia |
| University Hospital Medical Center Bezanijska Kosa | Belgrade | 11080 | Serbia |
| University Hospital Medical Center Zvezdara | Belgrade | 11120 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Clinical Center of Vojvodina | Novi Sad | 21137 | Serbia |
| Cliniq s.r.o. | Bratislava | 811 09 | Slovakia |
| Endomed, s.r.o. | Košice | 040 01 | Slovakia |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Changhua Christian Medical Foundation Changhua Christian Hospital | Changhua | Changhua County | 50006 | Taiwan |
| National Taiwan University Hospital | Taipei | Zhongzheng District | 100 | Taiwan |
| Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University | Bangkok | 10330 | Thailand |
| Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni | Bangkok | 10700 | Thailand |
| Liver Research Unit, Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Thammasat University Hospital | Pathum Thani | 12120 | Thailand |
| Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University | Songkhla | 90110 | Thailand |
| Surin hospital | Surin | 32000 | Thailand |
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |