Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513015-27-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afimkibart | Experimental | Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
|
| Placebo | Placebo Comparator | Participants will receive placebo IV followed by placebo SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimkibart | Drug | Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Clinical Remission | 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 |
| 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). | From baseline to Week 2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GA45330 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| 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 | Recruiting | Dothan | Alabama | 36305 | United States |
Not provided
| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 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 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 |
| Change in Bowel Urgency | Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe). | Baseline through Week 12 |
| Change in Abdominal Pain | Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe). | Baseline through Week 12 |
| Change in Fatigue | Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. 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 |
| Change in Health-Related Quality of Life | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. 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 |
| Overall Change in UC Symptoms | Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to"Much worse". | Baseline to Week 2 and Week 12 |
| Overall Severity in UC Symptoms | Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe". | Baseline to Week 2 and Week 12 |
| 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 30 Weeks after Baseline |
| Mayo Clinic Hospital | Recruiting | Scottsdale | Arizona | 85259 | United States |
| Arizona Digestive Health, P.C (ADH) | Recruiting | Sun City | Arizona | 85351 | United States |
| Om Research LLC | Recruiting | Apple Valley | California | 92307 | United States |
| Valley View Internal Medicine | Recruiting | Garden Grove | California | 92845 | United States |
| Gastro Care Associates | Recruiting | Lancaster | California | 93534 | United States |
| University of Southern California | Recruiting | Los Angeles | California | 90033-1057 | United States |
| Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education | Recruiting | Newport Beach | California | 92663 | United States |
| Stanford Medicine Outpatient Center | Recruiting | Redwood City | California | 94063 | United States |
| Peak Gastroenterology Associates | Recruiting | Colorado Springs | Colorado | 80907 | United States |
| Hi Tech and Global Research, LLC | Recruiting | Coral Gables | Florida | 33134 | United States |
| The Sister Life Research | Recruiting | Hialeah | Florida | 33013 | United States |
| LCC Medical Research Institute, LLC | Recruiting | Miami | Florida | 33126 | United States |
| Allied Biomedical Research Institute | Recruiting | Miami | Florida | 33155 | United States |
| Ambert Medical Research | Withdrawn | Miami | Florida | 33176 | United States |
| Integrity Trials LLC | Recruiting | Orlando | Florida | 32807 | United States |
| Digestive and Liver Center of Florida | Recruiting | Orlando | Florida | 32825 | United States |
| Advanced Medical Research Center | Recruiting | Port Orange | Florida | 32127 | United States |
| University of South Florida School of Medicine Morsani Center for Advanced Health Care | Recruiting | Tampa | Florida | 33612 | United States |
| Guardian Angel Research Center, LLC | Recruiting | Tampa | Florida | 33614 | United States |
| Santos Research Center, CORP | Recruiting | Tampa | Florida | 33615 | United States |
| Cleveland Clinic Florida | Recruiting | Weston | Florida | 33331 | United States |
| Randomize Now, LLC | Recruiting | Atlanta | Georgia | 30308 | United States |
| Atlanta Gastroenterology Associates | Recruiting | Atlanta | Georgia | 30342 | United States |
| Gastroenterology Associates of Central Georgia | Recruiting | Macon | Georgia | 31201 | United States |
| Grand Teton Research Group, PLLC | Recruiting | Idaho Falls | Idaho | 83404 | United States |
| Illinois Gastroenterology Group-Glenview powered by GI Alliance | Recruiting | Glenview | Illinois | 60026 | United States |
| GI Alliance - Gurnee | Recruiting | Gurnee | Illinois | 60031 | United States |
| Gastro Health Partners, LLC | Recruiting | New Albany | Indiana | 47150 | United States |
| Kansas Gastroenterology, LLC under Clinical Trials Network | Recruiting | Wichita | Kansas | 67226 | United States |
| One GI: GHP - Gastroenterology Health Partners Louisville | Recruiting | Louisville | Kentucky | 40218 | United States |
| Louisiana Research Center - GastroIntestinal Associates | Recruiting | Shreveport | Louisiana | 71105 | United States |
| Allied Gastrointestinal Associates, PA | Recruiting | Flowood | Mississippi | 39232 | United States |
| Delta Gastroenterology & Endoscopy Center | Recruiting | Southaven | Mississippi | 38671 | United States |
| Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
| Ellipsis Research Group | Recruiting | Brooklyn | New York | 11215 | United States |
| NYU Inflammatory Bowel Disease Center | Recruiting | New York | New York | 10016 | United States |
| Weill Cornell Medical College | Recruiting | New York | New York | 10021 | United States |
| DiGiovanna Inst for Med Ed&Res | Recruiting | North Massapequa | New York | 11758 | United States |
| Queens Village Medical Care | Recruiting | Queens Village | New York | 11428 | United States |
| Gastroenterology Group Of Rochester, LLP | Recruiting | Rochester | New York | 14618 | United States |
| James J Peters Veterans Administration Medical Center - NAVREF | Recruiting | The Bronx | New York | 10468 | United States |
| Charlotte Gastroenterology and Hepatology, P.L.L.C | Recruiting | Charlotte | North Carolina | 28207 | United States |
| Omega Research North Carolina, LLC | Recruiting | Fuquay-Varina | North Carolina | 27526 | United States |
| Peters Medical Research (PMR), LLC | Recruiting | High Point | North Carolina | 27260 | United States |
| Dayton Gastroenterology, Inc. | Recruiting | Beavercreek | Ohio | 45440 | United States |
| University of Cincinnati Hospital | Recruiting | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
| Ohio Gastroenterology Group | Recruiting | Columbus | Ohio | 43202 | United States |
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
| Gastro Intestinal Research Institute of Northern Ohio | Recruiting | Westlake | Ohio | 44145 | United States |
| Frontier Clinical Re search, LLC | Recruiting | Uniontown | Pennsylvania | 15401 | United States |
| University Gastroenterology | Recruiting | Providence | Rhode Island | 02904 | United States |
| Gastroenterology Associates | Recruiting | Greenville | South Carolina | 29607 | United States |
| Gastro One | Recruiting | Cordova | Tennessee | 38018 | United States |
| Uni of Texas Medical Branch | Recruiting | Galveston | Texas | 77555 | United States |
| GI Alliance | Recruiting | Garland | Texas | 75044 | United States |
| Amel Med LLC | Recruiting | Georgetown | Texas | 78628 | United States |
| Cano Medical Center | Recruiting | Harlingen | Texas | 78550 | United States |
| Texas Digestive Specialists | Recruiting | Harlingen | Texas | 78550 | United States |
| Integrity Advanced Therapeutics PLLC | Not yet recruiting | Houston | Texas | 77090 | United States |
| GI Alliance - Bay Area Gastroenterology | Recruiting | Lubbock | Texas | 79410 | United States |
| TDDC dba GI Alliance Research | Recruiting | Mansfield | Texas | 76063 | United States |
| Southern Star Research Institute, LLC. | Recruiting | San Antonio | Texas | 78229 | United States |
| Baylor Scott and White Medical Center | Recruiting | Temple | Texas | 76508 | United States |
| Tyler Research Institute, LLC | Recruiting | Tyler | Texas | 75701 | United States |
| University of Texas Health Center at Tyler | Recruiting | Tyler | Texas | 75708 | United States |
| TDDC GI Alliance research Webster | Recruiting | Webster | Texas | 77598 | United States |
| Gastroenterology Associates of Tidewater | Recruiting | Chesapeake | Virginia | 23320 | United States |
| Emeritas Research Group | Recruiting | Lansdowne Town Center | Virginia | 20176 | United States |
| Gastroenterology Consultants of SWVA | Recruiting | Roanoke | Virginia | 24018 | United States |
| Hospital Britanico | Recruiting | Ciudad Autonoma Bs As | C1280AEB | Argentina |
| Instituto Medico CER | Recruiting | Quilmes | B1878DVB | Argentina |
| Macquarie University Hospital | Active, not recruiting | Macquarie Park | New South Wales | 2109 | Australia |
| Coral Sea Clinical Research Institute | Withdrawn | Mackay | Queensland | 4740 | Australia |
| Footscray Hospital | Withdrawn | Footscray | Victoria | 3011 | Australia |
| Royal Melbourne Hospital | Active, not recruiting | Parkville | Victoria | 3050 | Australia |
| Ordensklinikum Linz Barmherzige Schwestern | Active, not recruiting | Linz | 4010 | Austria |
| Klinikum Wels-Grieskirchen | Withdrawn | Wels | 4600 | Austria |
| AZORG Campus Aalst-Moorselbaan | Withdrawn | Aalst | 9300 | Belgium |
| CHU St Pierre (St Pierre) | Active, not recruiting | Brussels | 1000 | Belgium |
| Cliniques Universitaires St-Luc | Active, not recruiting | Brussels | 1200 | Belgium |
| AZ Oostende | Withdrawn | Ostend | 8400 | Belgium |
| Instituto Lobus Unimed Volta Redonda | Recruiting | Volta Redonda | Rio de Janeiro | 27258-000 | Brazil |
| Hospital Moinhos de Vento | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-000 | Brazil |
| Newdata Clinical Trials | Recruiting | Aracaju | Sergipe | 49055-000 | Brazil |
| CECIP - Centro de Estudos Clínicos do Interior Paulista | Recruiting | Jaú | São Paulo | 17210-190 | Brazil |
| Hospital Sírio-Libanês | Recruiting | São Paulo | São Paulo | 01308-050 | Brazil |
| Centro Paulista de Investigacao Clinica - CEPIC | Recruiting | São Paulo | São Paulo | 04266-010 | Brazil |
| Second Multiprofile Hospital For Active Treatment-Sofia | Withdrawn | Sofia Town | Sofia | 1202 | Bulgaria |
| MC " Sveti Ivan Rilski Chudotvorets- 2010 | Recruiting | Plovdiv | 4003 | Bulgaria |
| "City Clinic UMHAC" EOOD | Recruiting | Sofia | 1407 | Bulgaria |
| Barrie GI Associates | Recruiting | Barrie | Ontario | L4M 7G1 | Canada |
| GNRR Digestive Clinics and Research Center Inc. | Withdrawn | Brampton | Ontario | L6S 0E2 | Canada |
| London Health Sciences Centre Uni Campus | Recruiting | London | Ontario | N6A 5A5 | Canada |
| LDDI Clinical Trials Inc. | Recruiting | London | Ontario | N6K 1M6 | Canada |
| TIDHI Innovation Inc. | Recruiting | Toronto | Ontario | M6A 3B4 | Canada |
| CIUSSS-de-l?Est-de-l?Île-de-Montréal | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| Centro de Investigación Clínica UC-CICUC | Recruiting | Santiago | 8330034 | Chile |
| Beijing No.6 Hospital | Recruiting | Beijing | Beijing Municipality | 100007 | China |
| The First Affilliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
| Third Xiangya Hospital Centrel South University | Recruiting | Changsha | 410013 | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | 610041 | China |
| Guangzhou First People's Hospital | Recruiting | Guangzhou | 510180 | China |
| The second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | 510260 | China |
| Sir Run Run Shaw Hospital Zhejiang University | Recruiting | Hangzhou | 310016 | China |
| Huizhou Central People's Hospital | Recruiting | Huizhou | 516001 | China |
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | 330008 | China |
| The First Affiliate Hospital of Guangxi Medical University | Recruiting | Nanning | 530021 | China |
| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | 315000 | China |
| The Affiliated Hospital of Medical College Qingdao University | Recruiting | Qingdao | 266000 | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 200025 | China |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200092 | China |
| Shengjing Hospital of China Medical University | Recruiting | Shenyang | 110004 | China |
| First Affiliated Hospital of Soochow University | Recruiting | Suzhou | 215006 | China |
| The First Affiliated Hospital of Xiamen University | Active, not recruiting | Xiamen | 361003 | China |
| Zhongshan Hospital Xiamen University | Recruiting | Xiamen | 361004 | China |
| Borzan Polyclinic | Recruiting | Osijek | 31000 | Croatia |
| Clinical Hospital Center Sestre Milosrdnice | Withdrawn | Zagreb | 10000 | Croatia |
| Hepato-Gastroenterologie HK, s.r.o. | Recruiting | Hradec Králové | 500 12 | Czechia |
| Fakultni nemocnice Ostrava | Withdrawn | Ostrava - Poruba | 708 52 | Czechia |
| ISCARE a.s. | Recruiting | Prague | 170 04 | Czechia |
| Ålborg Universitets Hospital | Recruiting | Aalborg | 9000 | Denmark |
| CHU Tours - Hôpital Trousseau | Recruiting | Chambray-lès-Tours | 37170 | France |
| CHU Clermont Ferrand - Hôtel Dieu | Recruiting | Clermont-Ferrand | 63000 | France |
| Hôpital Henri Mondor | Recruiting | Créteil | 94000 | France |
| Polyclinique Grand Sud | Recruiting | Nîmes | 30900 | France |
| Hôpital de Brabois Adultes | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
| Universitätsklinikum Heidelberg | Withdrawn | Heidelberg | 69120 | Germany |
| Medizinisches Zentrum Klinikum Lueneburg | Recruiting | Lüneburg | 21339 | Germany |
| Klinikum Ernst von Bergmann | Withdrawn | Potsdam | 14467 | Germany |
| Észak-Pesti Centrumkórház-Honvédkórház | Withdrawn | Budapest | 1062 | Hungary |
| Semmelweis Egyetem | Recruiting | Budapest | 1082 | Hungary |
| Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont | Recruiting | Debrecen | 4025 | Hungary |
| Fejer Varmegyei Szent György Egyetemi Oktatokorhaz | Recruiting | Székesfehérvár | 8000 | Hungary |
| Vas-Oxy Egeszsegugyi Kft | Recruiting | Szombathely | 9700 | Hungary |
| Surat Institute of Digestive Sciences Hospitals | Recruiting | Surat | Gujarat | 395002 | India |
| Gujarat Gastro and Vascular Hospital | Recruiting | Surat | Gujarat | 395009 | India |
| Kingsway Hospital | Completed | Nagpur (urban) | Maharashtra | 440001 | India |
| MIDAS Multispeciality Hospital | Recruiting | Nagpur (urban) | Maharashtra | 440018 | India |
| Sahyadri Super Speciality Hospital | Recruiting | Nashik | Maharashtra | 422001 | India |
| SR Kalla Memorial Gastro & General Hospital | Recruiting | Jaipur | Rajasthan | 302006 | India |
| SMS Superspeciality Hospital | Recruiting | Jaipur | Rajasthan | 302007 | India |
| AIG Hospitals | Withdrawn | Gachibowli | Telangana | 500032 | India |
| Yashoda Hospitals | Recruiting | Secunderabad | Telangana | 500003 | India |
| Soroka Medical Center | Recruiting | Beersheba | 8410101 | Israel |
| The Chaim Sheba Medical Center | Recruiting | Ramat Gan | 5265601 | Israel |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti | Withdrawn | Bologna | Emilia-Romagna | 40138 | Italy |
| Policlinico Universitario Campus Biomedico Di Roma | Recruiting | Rome | Lazio | 00128 | Italy |
| Ospedale Isola Tiberina Gemelli | Recruiting | Rome | Lazio | 00186 | Italy |
| Asst Degli Spedali Civili Di Brescia | Recruiting | Brescia | Lombardy | 25123 | Italy |
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
| Azienda Ospedaliera San Gerardo di Monza | Recruiting | Monza MI | Lombardy | 20900 | Italy |
| Istituto Clinico Humanitas | Recruiting | Rozzano (MI) | Lombardy | 20089 | Italy |
| IRCCS Ospedale Sacro Cuore Don Calabria | Recruiting | Negrar | Veneto | 37024 | Italy |
| Boca Clinical Trials Mexico S.C. (Cd. Mexico) | Recruiting | Miguel Hidalgo | Mexico CITY (federal District) | 01120 | Mexico |
| FAICIC S de R.L. de C.V | Recruiting | Veracruz | 91900 | Mexico |
| ETZ Elisabeth | Active, not recruiting | Tilburg | 5022 GC | Netherlands |
| Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o. | Active, not recruiting | ?ód? | 93-357 | Poland |
| Gastromed Kralisz, Romatowski, Stachurska sp.j. | Withdrawn | Bia?ystok | 15-322 | Poland |
| Medical Center Kermed | Recruiting | Bydgoszcz | 85-231 | Poland |
| Szpital Miejski sw. Jana Paw?a II w Elblagu | Recruiting | Elblag | 82-300 | Poland |
| Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska | Withdrawn | Grudzadz | 86-300 | Poland |
| Osrodek Badan Klinicznych Bd Research | Recruiting | I?awa | 14-200 | Poland |
| MZ Badania Slowik Zymla Sp.j. | Active, not recruiting | Knurów | 44-190 | Poland |
| Centrum Medyczne Promed | Active, not recruiting | Krakow | 31-513 | Poland |
| Medrise sp z o.o | Recruiting | Lublin | 20-582 | Poland |
| Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa | Recruiting | Poznan | 61-731 | Poland |
| EMC Instytut Medyczny SA | Recruiting | Późna | 60-309 | Poland |
| Gabinety Lekarskie Rivermed | Recruiting | Późna | 61-441 | Poland |
| Endoskopia Sp. z o.o. | Recruiting | Sopot | 81-756 | Poland |
| Sonomed Sp. z o.o. | Recruiting | Szczecin | 71-685 | Poland |
| Centrum Zdrowia-MDM | Recruiting | Warsaw | 00-189 | Poland |
| Medon Clinical Research sp. z o.o | Recruiting | Warsaw | 02-679 | Poland |
| Vivamed Spolka Z Ograniczona Odpowiedzialnoscia | Recruiting | Warsaw | 03-580 | Poland |
| PlanetMed sp. z o.o. | Recruiting | Wroc?aw | 52-210 | Poland |
| Centrum Medyczne Oporow | Recruiting | Wroclaw | 52-416 | Poland |
| Hospital de Braga | Recruiting | Braga | 4710-243 | Portugal |
| Hospital da Luz Lisboa | Recruiting | Lisbon | 1500-650 | Portugal |
| Centro Hospitalar do Algarve - Hospital de Portimao | Recruiting | Portimão | 8500-338 | Portugal |
| Hospital de Sao Joao | Recruiting | Porto | 4202-451 | Portugal |
| Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião | Recruiting | Santa Maria da Feira | 4520-211 | Portugal |
| Hospital Sao Teotonio | Recruiting | Viseu | 3504-509 | Portugal |
| Klinical Investigations Group LLC | Recruiting | San Juan | 00909 | Puerto Rico |
| General Hospital "Djordje Joanovic" | Recruiting | Zrenjanin | 23000 | Serbia |
| KM Management spol. s r.o. | Withdrawn | Nitra | 949 01 | Slovakia |
| Accout Center s.r.o. | Withdrawn | Šahy | 936 01 | Slovakia |
| Hospital Universitario Puerta de Hierro Majadahonda | Active, not recruiting | Majadahonda | Madrid | 28222 | Spain |
| Hospital Clinico Univ. Lozano Blesa | Withdrawn | Zaragoza | 50009 | Spain |
| Hospital Universitario Miguel Servet | Active, not recruiting | Zaragoza | 50009 | Spain |
| China Medical University Hospital | Recruiting | Taichung | 40447 | Taiwan |
| Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University | Recruiting | Chiang Mai | 50200 | Thailand |
| Burapha University Hospital | Recruiting | Chon Buri | 20131 | Thailand |
| Sunpasitthiprasong Hospital | Recruiting | Ubonratchathani | 34000 | Thailand |
| Leicester General Hospital | Recruiting | Leicester | LE5 4PW | United Kingdom |
| Bronglais General Hospital | Recruiting | Llanrhystud | SY23 1ER | United Kingdom |
| King College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
| Peterborough City Hospital | Withdrawn | Peterborough | PE 3 9GZ | United Kingdom |
| Stepping Hill Hospital | Recruiting | Stockport | SK2 7JE | United Kingdom |
| New Cross Hospital | Recruiting | Wolverhampton | WV10 0QP | United Kingdom |