Ulcerative Colitis Clinical Trial
Official title:
A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.
| Status | Recruiting |
| Enrollment | 1050 |
| Est. completion date | June 2025 |
| Est. primary completion date | April 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility | Inclusion Criteria: - Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients' clinical response status must be available. - Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1. - Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met. - Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in Section 4.4. (Contraception) of this protocol. - Subjects must be able and willing to comply with study visits and procedures as per protocol. - Subjects should be affiliated to a health insurance policy whenever required by a participating country or state Exclusion Criteria: - Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106). - Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study. - Subjects who plan to participate in other investigational studies during the maintenance study. - Male or female planning a pregnancy within the coming 12 months |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | CEMIC | Buenos Aires | |
| Argentina | CINME - Centro De Investigaciones Metabolicas | Buenos Aires | |
| Argentina | Hospital Britanico de Buenos Aires | Buenos Aires | |
| Argentina | Hospital Italiano de Buenos Aires | Buenos Aires | |
| Argentina | STAT Research S.A. | Buenos Aires | |
| Argentina | Hospital Privado Centro Medico de Cordoba S.A | Córdoba | Cordoba |
| Argentina | Instituto de Investigaciones Clinicas Quilmes | Quilmes | Buenos Aires |
| Argentina | Centro de Investigacion CICE | San Miguel De Tucumán | Tucuman |
| Argentina | Centro de Investigaciones Medicas Tucuman | San Miguel De Tucumán | Tucuman |
| Australia | Flinders Medical Centre | Bedford Park | South Australia |
| Australia | Blacktown Hospital | Blacktown | New South Wales |
| Australia | Box Hill Hospital | Box Hill | Victoria |
| Australia | Concord Repatriation General Hospital | Concord | New South Wales |
| Australia | St Vincent's Hospital Melbourne | Fitzroy | Victoria |
| Australia | Footscray Hospital | Footscray | Victoria |
| Australia | Austin Health | Heidelberg | Victoria |
| Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | Coral Sea Clinical Research Institute | North Mackay | Queensland |
| Australia | Royal Melbourne Hospital | Parkville | Victoria |
| Australia | Mater Hospital Brisbane | South Brisbane | Queensland |
| Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
| Austria | LKH - Universitaetsklinikum Graz | Graz | |
| Austria | Medizinische Universität Innsbruck | Innsbruck | |
| Austria | Ordensklinikum Linz GmbH - Barmherzige Schwestern | Linz | |
| Austria | LKH - Universitätsklinikum der PMU Salzburg | Salzburg | |
| Austria | KH der Barmherzigen Brüder St.Veit an der Glan | St Veit an der Glan | |
| Belgium | GZA Ziekenhuizen | Antwerpen | |
| Belgium | AZ Klina | Brasschaat | |
| Belgium | Universitair Ziekenhuis Brussel | Brussel | |
| Belgium | C. H. U. St-Pierre | Bruxelles | |
| Belgium | AZ Maria Middelares | Gent | |
| Belgium | AZ Sint-Lucas | Gent | |
| Belgium | AZ Sint-Lucas | Gent | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | UZ Leuven | Leuven | |
| Belgium | Clinique CHC MontLégia | Liège | |
| Belgium | AZ Delta | Roeselare | |
| Belgium | CHU UCL Namur | Yvoir | |
| Bosnia and Herzegovina | University Clinical Centre of the Republic of Srpska | Banja Luka | |
| Bosnia and Herzegovina | University Clinical Centre Sarajevo | Sarajevo | |
| Brazil | Hospital Felício Rocho | Belo Horizonte | Minas Gerais |
| Brazil | UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Botucatu | Sao Paulo |
| Brazil | L2IP - Instituto de Pesquisas Clínicas Ltda. | Brasília | Distrito Federal |
| Brazil | Hospital das Clínicas da Faculdade de Medicina da UNICAMP | Campinas | Sao Paulo |
| Brazil | Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS) | Caxias Do Sul | Rio Grande Do Sul |
| Brazil | CDC - Centro Digestivo de Curitiba | Curitiba | Paraná |
| Brazil | HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Fortaleza | Ceará |
| Brazil | CECIP - Centro de Estudos Clínicos do Interior Paulista | Jaú | Sao Paulo |
| Brazil | Hospital Ernesto Dornelles | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital Moinhos de Vento | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital Aliança | Salvador | Bahia |
| Brazil | Faculdade de Medicina do ABC | Santo André | Sao Paulo |
| Brazil | Pesquisare Saúde | Santo André | Sao Paulo |
| Brazil | Praxis Pesquisa Médica | Santo André | Sao Paulo |
| Brazil | Irmandade da Santa Casa da Misericórdia de Santos | Santos | Sao Paulo |
| Brazil | Centro Multidisciplinar de Estudos Clínicos - CEMEC | São Bernardo | Sao Paulo |
| Brazil | Hepatogastro | São Paulo | Sao Paulo |
| Brazil | Hospital Sírio-Libanês | São Paulo | Sao Paulo |
| Bulgaria | Medical center Medconsult Pleven OOD | Pleven | |
| Bulgaria | ACIBADEM CityClinic Oncological center | Sofia | |
| Bulgaria | DCC "Alexandrovska", EOOD | Sofia | |
| Bulgaria | Diagnostic Consultation Center CONVEX EOOD | Sofia | |
| Bulgaria | UMHATEM 'N.I. Pirogov', EAD | Sofia | |
| Bulgaria | MC Medica Plus | Veliko Tarnovo | |
| Canada | Gastroenterology and Internal Medicine Research Institute (GIRI) | Edmonton | Alberta |
| Canada | Nova Scotia Health Authority | Halifax | Nova Scotia |
| Canada | London Health Sciences Centre (LHSC) - Victoria Hospital | London | Ontario |
| Canada | Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal | Montréal | Quebec |
| Canada | Montreal General Hospital | Montréal | Quebec |
| Canada | Scott Shulman Medicine Professional Corporation | North Bay | Ontario |
| Canada | Toronto Immune & Digestive Health Institute | North York | Ontario |
| Canada | Kensington Screening Clinic | Toronto | Ontario |
| Canada | (G.I.R.I.) GI Research Institute | Vancouver | British Columbia |
| Canada | Gordon and Leslie Diamond Health Care Centre - Vancouver General Hospital | Vancouver | British Columbia |
| Canada | Health Sciences Centre | Winnipeg | Manitoba |
| China | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing |
| China | Peking University First Hospital | Beijing | Beijing |
| China | The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui |
| China | Binzhou Medical University Hospital | Binzhou | Shandong |
| China | The First Hospital of Jilin University | Changchun | Jilin |
| China | The 2nd Xiangya Hospital of Central South University | Changsha | Hunan |
| China | Xiangya Hospital, Central South University | Changsha | Hunan |
| China | Changzhou No.2 People's Hospital | Changzhou | Jiangsu |
| China | Army Specialty Medical Center of The Chinese People's Liberation Army | Chongqing | Sichuan |
| China | The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force | Fuzhou | Fujian |
| China | The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian |
| China | Jiangxi Gannan Medical College Affiliated 1 st Hospital | Ganzhou | Jiangxi |
| China | Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
| China | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
| China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | The First Affiliated Hospital of University of South China | Hengyang | Hunan |
| China | Jinan Central Hospital | Jinan | Shandong |
| China | Qilu Hospital of Shandong University | Jinan | Shandong |
| China | The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan |
| China | The Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan |
| China | The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
| China | General Hospital of Eastern Theater Command | Nanjing | Jiangsu |
| China | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi |
| China | The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
| China | Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch | Shanghai | Shanghai |
| China | Shanghai Changhai Hospital | Shanghai | Shanghai |
| China | Shanghai General Hospital | Shanghai | Shanghai |
| China | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
| China | Shengjing Hospital of China Medical University, Hua Xiang branch hospital | Shenyang | Liaoning |
| China | Taian City Central Hospital | Tai'an | Shandong |
| China | Renmin Hospital, Wuhan University | Wuhan | Hubei |
| China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei |
| China | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
| China | Yijishan Hospital of Wannan Medical College | Wuhu | Anhui |
| China | The Affiliated Hospital of Xuzhou Medical College | Xuzhou | Jiangsu |
| China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
| Croatia | General Hospital "Dr.Tomislav Bardek" Koprivnica | Koprivnica | |
| Croatia | Clinical Hospital Centre Osijek | Osijek | |
| Croatia | Solmed Polyclinic | Zagreb | |
| Croatia | University hospital centre Zagreb | Zagreb | |
| Czechia | CCR Brno, s.r.o. | Brno | |
| Czechia | SurGal Clinic s.r.o. | Brno | |
| Czechia | Hepato-Gastroenterologie HK s.r.o. | Hradec Kralove | |
| Czechia | PreventaMed s.r.o. | Olomouc | |
| Czechia | CCR Ostrava s.r.o. | Ostrava | |
| Czechia | Fakultni nemocnice Ostrava | Ostrava | |
| Czechia | Institut klinicke a experimentalni mediciny | Praha 4 | |
| Czechia | ISCARE a.s. | Praha 9 | |
| Czechia | Nemocnice Slany | Slaný | |
| Czechia | Krajska nemocnice T. Bati a.s. | Zlín | |
| France | CHU Amiens - Hopital Sud | Amiens | Somme |
| France | CHU Besançon - Hôpital Jean Minjoz | Besançon | Doubs |
| France | CHU Caen - Hôpital de la Côte de Nacre | Caen | Calvados |
| France | CHU Clermont Ferrand - Hopital d'Estaing | Clermont-Ferrand | Puy De Dome |
| France | Hôpital Henri Mondor | Créteil | Val De Marne |
| France | CHU Dijon - Hôpital Bocage Central | Dijon | Cote dÝOr |
| France | CHU de Grenoble - Hôpital Albert Michallon | Grenoble | Isère |
| France | Centre Hospitalier Départemental Les Oudairies | La Roche-sur-Yon | Vendée |
| France | Hôpital Bicêtre | Le Kremlin-Bicêtre | Val De Marne |
| France | CHU Lille - Hôpital Claude Huriez | Lille | Nord |
| France | Hôpital Nord - CHU Marseille | Marseille | Bouches-du-Rhône |
| France | Hopital Saint Eloi | Montpellier | Herault |
| France | CHU Nantes - Hôtel Dieu | Nantes | Loire Atlantique |
| France | Institut des MICI | Neuilly | Hauts De Seine |
| France | CHU Nice - Hôpital de l'Archet 2 | Nice | Alpes Maritimes |
| France | Hôpital Saint-Louis | Paris | |
| France | Centre Hospitalier de Pau - Hôpital François Mitterrand | Pau | Pyrenees Atlantiques |
| France | CHU Bordeaux - Hôpital Haut-Lévêque | Pessac | Gironde |
| France | Centre Hospitalier Lyon Sud | Pierre-Bénite | Rhone |
| France | CHU Reims - Hôpital Robert Debré | Reims | Ardennes |
| France | CHU Rennes - Hôpital Pontchaillou | Rennes | Ille Et Vilaine |
| France | CHU Saint Etienne - Hôpital Nord | Saint-Étienne | Loire |
| France | Hopital Rangueil | Toulouse | Haute Garonne |
| France | Universite de Lorraine - Faculte de Medecine - INSERM U954 | Vandœuvre-lès-Nancy | Meurthe Et Moselle |
| Germany | Universitaetsklinikum Augsburg | Augsburg | Bayern |
| Germany | Charité - Campus Benjamin Franklin | Berlin | |
| Germany | Charité - Campus Charité Mitte | Berlin | |
| Germany | DRK Kliniken Berlin Westend | Berlin | |
| Germany | Gastroenterologie Berlin Karlshorst | Berlin | |
| Germany | Universitaetsklinikum Freiburg | Freiburg | Baden Wuerttemberg |
| Germany | Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen | Hamburg | |
| Germany | Medizinische Hochschule Hannover | Hannover | Niedersachsen |
| Germany | Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt | Heidelberg | Baden Wuerttemberg |
| Germany | Universitaetsklinikum Heidelberg | Heidelberg | Baden Wuerttemberg |
| Germany | Universitaetsklinikum Schleswig-Holstein - Campus Kiel | Kiel | Schleswig Holstein |
| Germany | INLUGA im Haus der Gesundheit | Ludwigshafen | Rheinland Pfalz |
| Germany | LMU-Campus Grosshadern | Muenchen | Bayern |
| Germany | Medius Klinik Nuertingen | Nürtingen | Baden Wuerttemberg |
| Germany | Siloah St. Trudpert Klinikum | Pforzheim | Baden Wuerttemberg |
| Germany | Universitaetsklinikum Tuebingen | Tuebingen | Baden Wuerttemberg |
| Germany | Universitaetsklinikum Ulm | Ulm | Baden Wuerttemberg |
| Greece | University General Hospital of Alexandroupolis | Alexandroupolis | |
| Greece | General Hospital of Athens "Evangelismos" | Athens | |
| Greece | Corfu General Hospital "St. Eirini" | Corfu | |
| Greece | University General Hospital of Heraklion | Heraklion | |
| Greece | General Hospital of Thessaloniki "Hippokration" | Thessaloníki | |
| Hungary | Bekes Varmegyei Kozponti Korhaz | Békéscsaba | |
| Hungary | Clinexpert Kft. | Budapest | |
| Hungary | Obudai Egeszsegugyi Centrum Kft. | Budapest | |
| Hungary | Pannonia Maganorvosi Centrum | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont | Debrecen | |
| Hungary | Gyongyosi Bugat Pal Korhaz | Gyongyos | |
| Hungary | Clinfan Szolgaltato Kft. | Szekszard | |
| Hungary | Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz | Szombathely | |
| India | Navneet Memorial Hospital 'Sushrusha' | Ahmedabad | Gujarat |
| India | M. S. Ramaiah Medical College and Hospital | Bangalore | Karnataka |
| India | K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre | Belagave | Karnataka |
| India | Postgraduate Institute of Medical Education and Research | Chandigarh | |
| India | SRM Institutes for Medical Sciences | Chennai | Tamilnadu |
| India | Amrita Institute Of Medical Sciences and Research Centre | Cochin | Kerala |
| India | Lakeshore Hospital and Research Centre Ltd. | Cochin | Kerala |
| India | Fortis Memorial Research Institute | Gurgaon | Haryana |
| India | Origin Hospital | Hyderabad | Andhra Pradesh |
| India | Yashoda Super Speciality Hospital | Hyderabad | Andhra Pradesh |
| India | S. R. Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan |
| India | Institute of Post Graduate Medical Education And Research | Kolkata | West Bengal |
| India | Nil Ratan Sircar Medical College | Kolkata | West Bengal |
| India | Chhatrapati Shahuji Maharaj (CSM) Medical University | Lucknow | Uttar Pradesh |
| India | Dayanand Medical College and Hospital | Ludhiana | Punjab |
| India | Vinaya Hospital and Research Center | Mangalore | Karnataka |
| India | King Edward Memorial Hospital Research Centre | Mumbai | Maharashtra |
| India | Lokmanya Tilak Municipal General Hospital & Medical College | Mumbai | Maharashtra |
| India | Midas Multispeciality Hospital Pvt Ltd | Nagpur | Maharashtra |
| India | Chopda Medicare & Research Centre | Nashik | Maharashtra |
| India | All India Institute of Medical Sciences | New Delhi | Delhi |
| India | Fortis Escorts Heart Institute and Research Centre | New Delhi | Delhi |
| India | Maharaja Agrasen Hospital | New Delhi | Delhi |
| India | Ruby Hall Clinic | Pune | Maharashtra |
| India | Sahyadri Specialty Hospital | Pune | Maharashtra |
| India | Shree Giriraj Multispeciality Hospital | Rajkot | Gujarat |
| India | Gandhi Hospital | Secunderabad | Andhra Pradesh |
| India | Gujarat Hospital | Surat | Gujarat |
| India | Surat Institute of Digestive Sciences | Surat | Gujarat |
| India | Unity Hospital ICU and Trauma | Surat | Gujarat |
| India | Isha Multispeciality Hospital | Vadodara | Gujarat |
| India | Datta Meghe Institute of Medical Sciences (Deemed University) | Wardha | Maharashtra |
| Ireland | Connolly Hospital | Dublin | |
| Ireland | St Vincents University Hospital | Dublin | |
| Ireland | Portiuncula Hospital | Galway | |
| Ireland | University Hospital Galway | Galway | Glaway |
| Ireland | Our Lady of Lourdes | Louth | |
| Ireland | Midland Regional Hospital | Mullingar | Westmeath |
| Israel | HaEmek Medical Center | Afula | |
| Israel | Soroka University Medical Center | Be'er Sheva | |
| Israel | Bnai Zion Medical Center | Haifa | |
| Israel | Wolfson Medical Center | Holon | |
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Israel | Meir Medical Center | Kfar- Sava | |
| Israel | Rabin Medical Center-Beilinson Campus | Petach Tikva | |
| Israel | Chaim Sheba Medical Center | Ramat Gan | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Italy | Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo | Alessandria | |
| Italy | Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS | Bologna | |
| Italy | Fondazione Poliambulanza Istituto Ospedaliero | Brescia | |
| Italy | Azienda Ospedaliera Giuseppe Brotzu | Cagliari | |
| Italy | Presidio Ospedaliero Garibaldi Nesima | Catania | |
| Italy | Azienda Ospedaliero Universitaria Mater Domini | Catanzaro | |
| Italy | Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) | Milano | |
| Italy | Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" | Napoli | |
| Italy | Ospedale Sacro Cuore Don Calabria | Negrar | Verona |
| Italy | Azienda Ospedaliera di Padova | Padova | |
| Italy | Ospedale Cervello | Palermo | |
| Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | |
| Italy | Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) | Pisa | |
| Italy | Ospedale di Circolo | Rho | Milano |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | |
| Italy | Università Campus Bio-Medico di Roma | Roma | |
| Italy | Istituto Clinico Humanitas | Rozzano | Milano |
| Italy | Istituto Clinico Humanitas | Rozzano | Milano |
| Italy | I.R.C.C.S Policlinico San Donato | San Donato Milanese | Milano |
| Italy | IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia |
| Italy | Azienda Sanitaria Universitaria Integrata di Udine | Udine | |
| Italy | Ospedale San Bortolo di Vicenza | Vicenza | |
| Japan | Fukuoka University Chikushi Hospital | Chikushino-shi | Fukuoka-Ken |
| Japan | Shinseikai Sai Gastroenterology, Proctology | Fujidera-shi | Osaka-Fu |
| Japan | NHO Fukuyama Medical Center | Fukuyama-shi | Hiroshima-Ken |
| Japan | Matsuaikai Matsuda Hospital | Hamamatsu-shi | Shizuoka-Ken |
| Japan | JA-Hiroshima General Hospital | Hatsukaichi-shi | Hiroshima-Ken |
| Japan | NHO Mito Medical Center | Higashiibaraki-gun | Ibaraki-Ken |
| Japan | Hiroshima Prefectural Hospital | Hiroshima-shi | Hiroshima-Ken |
| Japan | Aso Co.,Ltd Iizuka Hospital | Iizuka-shi | Fukuoka-Ken |
| Japan | Jiaikai Izuro Imamura Hospital | Kagoshima-shi | Kagoshima-Ken |
| Japan | Kagoshima IBD Gastroenterology Clinic | Kagoshima-shi | Kagoshima-Ken |
| Japan | Sameshima Hospital | Kagoshima-shi | Kagoshima-Ken |
| Japan | Gokeikai Ofuna Chuo Hospital | Kamakura-shi | Kanagawa-Ken |
| Japan | NHO Kanazawa Medical Center | Kanazawa-shi | Ishikawa-Ken |
| Japan | Kokikai Tsujinaka Hospital Kashiwanoha | Kashiwa-shi | Chiba-Ken |
| Japan | Kawasaki Municipal Hospital | Kawasaki-shi | Kanagawa-Ken |
| Japan | Aoyama Clinic | Kobe-shi | Hyogo-Ken |
| Japan | Showa University Koto Toyosu Hospital | Koto-Ku | Tokyo-To |
| Japan | Kumagaya General Hospital | Kumagaya-shi | Saitama-Ken |
| Japan | Kaiseikai Hattori Clinic | Kumamoto-shi | Kumamoto-Ken |
| Japan | NHO Kure Medical Center and Chugoku Cancer Center | Kure-shi | Hiroshima-Ken |
| Japan | Kurume University Hospital | Kurume-shi | Fukuoka-Ken |
| Japan | Our Lady of the Snow St. Mary's Hospital | Kurume-shi | Fukuoka-Ken |
| Japan | Ehime Prefectural Central Hospital | Matsuyama-shi | Ehime-Ken |
| Japan | Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo-To |
| Japan | Saiseikai Niigata Hospital | Niigata-shi | Niigata-Ken |
| Japan | Ishida Clinic of IBD and Gastroenterology | Oita-shi | Oita-Ken |
| Japan | NHO Okayama Medical Center | Okayama-shi | Okayama-Ken |
| Japan | Okayama University Hospital | Okayama-shi | Okayama-Ken |
| Japan | Keiaikai Nakagami Hospital | Okinawa-shi | Okinawa-Ken |
| Japan | JCHO Osaka Hospital | Osaka-shi | Osaka-Fu |
| Japan | Kinshukai Infusion Clinic | Osaka-shi | Osaka-Fu |
| Japan | NHO Osaka National Hospital | Osaka-shi | Osaka-Fu |
| Japan | SUBARU Health Insurance Society Ota Memorial Hospital | Ota-shi | Gunma-Ken |
| Japan | Saga University Hospital | Saga-shi | Saga-Ken |
| Japan | Saga-Ken Medical Centre Koseikan | Saga-shi | Saga-Ken |
| Japan | JCHO Hokkaido Hospital | Sapporo-shi | Hokkaido |
| Japan | JCHO Tokyo Yamate Medical Center | Shinjuku-Ku | Tokyo-To |
| Japan | Tokyo Metropolitan Bokutoh Hospital | Sumida-ku | Tokyo-To |
| Japan | Kagawa Prefectural Central Hospital | Takamatsu-shi | Kagawa-Ken |
| Japan | Takamatsu Red Cross Hospital | Takamatsu-shi | Kagawa-Ken |
| Japan | Toyohashi Municipal Hospital | Toyohashi-shi | Aichi-Ken |
| Japan | Mie University Hospital | Tsu-shi | Mie-Ken |
| Japan | NHO Ureshino Medical Center | Ureshino-shi | Saga-Ken |
| Japan | Showa University Northern Yokohama Hospital | Yokohama-shi | Kanagawa-Ken |
| Korea, Republic of | Korea University Ansan Hospital | Ansan-si | Chungcheongbuk-do |
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Inje University Haeundae Paik Hospital | Busan | |
| Korea, Republic of | Kyungpook National University Hospital | Daegu | |
| Korea, Republic of | Yeungnam University Hospital | Daegu | Gyeongsangbuk-do |
| Korea, Republic of | The Catholic University of Korea, Daejeon St. Mary's Hospital | Daejeon | |
| Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do |
| Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Chung-Ang University Hospital | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Kyung Hee University Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea, St. Vincent's Hospital | Suwon-si | Gyeonggi-do |
| Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Wonju-si | Gangwon-do |
| Lithuania | Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | |
| Lithuania | Lithuanian University of Health Sciences Kaunas Hospital | Kaunas | |
| Lithuania | Klaipeda University Hospital branch "Seamen's Hospital" | Klaipeda | |
| Mexico | Consultorio Medico, InvesclinicMX | Irapuato | Guanajuato |
| Mexico | Accelerium S de RL de CV | Monterrey | Nuevo León |
| Mexico | Christus Muguerza Sur S.A. de C.V. | Monterrey | Nuevo León |
| Mexico | Inspirepharma S. de R.L. de C.V. | Monterrey | Nuevo León |
| Mexico | FAICIC S. de R.L. de C.V. | Veracruz | |
| Mexico | Sociedad de Metabolismo y Corazon S.C | Veracruz | |
| Netherlands | Amsterdam UMC, Locatie AMC | Amsterdam | |
| Netherlands | Radboud UMC | Nijmegen | |
| Netherlands | Erasmus MC | Rotterdam | |
| Netherlands | Zuyderland Medisch Centrum - Sittard-Geleen | Sittard-Geleen | |
| Netherlands | ETZ Elisabeth | Tilburg | |
| Netherlands | Bernhoven Uden | Uden | |
| Netherlands | UMC Utrecht | Utrecht | |
| New Zealand | Christchurch Hospital NZ | Christchurch | |
| New Zealand | Dunedin Hospital | Dunedin | |
| New Zealand | Auckland City Hospital | Grafton | |
| New Zealand | Waikato Hospital | Hamilton | |
| New Zealand | Tauranga Hospital | Tauranga | |
| Poland | Przychodnia Specjalistyczna Insula | Belchatow | |
| Poland | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | |
| Poland | NZOZ Centrum Medyczne KERmed | Bydgoszcz | |
| Poland | Centrum Medyczne Pratia Gdynia | Gdynia | |
| Poland | Trialmed CRS | Kalisz | |
| Poland | Polimedica Centrum Badan, Profilaktyki I Leczenia | Kielce | |
| Poland | Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla | Knurów | |
| Poland | Centrum Medyczne Plejady | Kraków | |
| Poland | NZOZ Centrum Medyczne ProMiMed | Kraków | |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Lecznej | Leczna | |
| Poland | AMICARE spólka z ograniczona odpowiedzialnoscia spólka komandytowa | Lódz | |
| Poland | Santa Familia Centrum Badan, Profilaktyki i Leczenia | Lódz | |
| Poland | 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie | Lublin | |
| Poland | ALLMEDICA sp. z o. o. | Nowy Targ | |
| Poland | Wojewodzki Specjalistyczny Szpital w Olsztynie | Olsztyn | |
| Poland | Twoja Przychodnia Opolskie Centrum Medyczne | Opole | |
| Poland | Medicome Sp. z o.o. | Oswiecim | |
| Poland | NSZOZ Termedica - Centrum Badan Klinicznych | Poznan | |
| Poland | SOLUMED Centrum Medyczne | Poznan | |
| Poland | Twoja Przychodnia PCM | Poznan | |
| Poland | Gabinet Lekarski Bartosz Korczowski | Rzeszów | |
| Poland | Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA | Sosnowiec | |
| Poland | KO-MED Centra Kliniczne Staszow | Staszów | |
| Poland | DC-MED | Swidnica | |
| Poland | Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. | Szczecin | |
| Poland | CenterMed Sp. z o.o. | Tarnów | |
| Poland | Centrum Zdrowia MDM | Warsaw | |
| Poland | NZOZ VIVAMED Jadwiga Miecz | Warszawa | |
| Poland | Ars-Medica S.C Rybak Maria, Rybak Zbigniew | Wroclaw | |
| Poland | Centrum Medyczne Oporow | Wroclaw | |
| Poland | ETG Zamosc | Zamosc | |
| Portugal | Hospital de Braga | Braga | |
| Portugal | Hospital da Senhora da Oliveira Guimarães | Guimarães | |
| Portugal | Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisboa | |
| Portugal | Hospital da Luz | Lisboa | |
| Portugal | Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião | Santa Maria Da Feira | |
| Portugal | Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE | Viana Do Castelo | |
| Romania | Spitalul de Oncologie Monza | Bucharest | |
| Romania | S.C Delta Health Care S.R.L | Bucuresti | |
| Romania | SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie | Bucuresti | |
| Romania | Spitalul Clinic Colentina | Bucuresti | |
| Romania | Spitalul Clinic Judetean de Urgenta Cluj Napoca | Cluj-Napoca | |
| Romania | Centrul Medical Renasterea Craiova | Craiova | |
| Romania | S.C Pelican Impex S.R.L | Oradea | |
| Romania | S.C Centrul Medical Valahia S.R.L | Ploiesti | |
| Serbia | Clinical Center " Dr Dragisa Misovic Dedinje" | Belgrade | |
| Serbia | Clinical Hospital Center "Bezanijska kosa | Belgrade | |
| Serbia | Clinical Hospital Center Zvezdara | Belgrade | |
| Serbia | University Clinical Center Kragujevac | Kragujevac | |
| Serbia | General Hospital Subotica | Subotica | |
| Serbia | General Hospital "Djordje Joanovic" | Zrenjanin | |
| Slovakia | Accout Center s.r.o. | Šahy | |
| Slovakia | Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banská Bystrica | |
| Slovakia | Cliniq s.r.o. | Bratislava | |
| Slovakia | Endomed, s.r.o. | Košice | |
| Slovakia | Fakultna nemocnica Nitra | Nitra | |
| Slovakia | KM Management spol. s r.o. | Nitra | |
| Slovakia | Gastro I, s.r.o. | Prešov | |
| Slovakia | Gastro LM s.r.o. | Prešov | |
| Spain | Centro Medico Teknon | Barcelona | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitario Reina Sofia | Córdoba | Cordoba |
| Spain | Complejo Hospitalario Universitario de Ferrol | Ferrol | La Coruña |
| Spain | Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid |
| Spain | Hospital Universitari de Girona Dr Josep Trueta | Girona | |
| Spain | Hospital General Juan Ramon Jimenez | Huelva | |
| Spain | Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas De Gran Canaria | Las Palmas |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Montecelo | Pontevedra | |
| Spain | Clinica Gaias - Santiago | Santiago De Compostela | La Coruña |
| Spain | Complejo Hospitalario Universitario de Santiago | Santiago De Compostela | La Coruña |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital Clinico Universitario de Valencia | Valencia | |
| Spain | Hospital Universitari i Politecnic La Fe | Valencia | |
| Spain | Hospital Universitario Miguel Servet | Zaragoza | |
| Switzerland | Clarunis - Universitäres Bauchzentrum Basel | Basel | |
| Switzerland | Inselspital - Universitaetsspital Bern | Bern | |
| Switzerland | Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern | Bern | |
| Switzerland | Universitaetsspital Zuerich | Zuerich | |
| Turkey | Gazi University Medical Faculty | Ankara | |
| Turkey | Antalya Training and Research Hospital | Antalya | |
| Turkey | Acibadem Kozyatagi Hospital | Istanbul | |
| Turkey | Koc University Hospital | Istanbul | |
| Turkey | Medicana Kadikoy Hospital | Istanbul | |
| Turkey | Ege University Medical Faculty | Izmir | |
| Turkey | Kocaeli Universitesi Tip Fakultesi | Kocaeli | |
| Turkey | Inonu University Gastroenterology | Malatya | |
| Turkey | Mersin University Medical Faculty | Mersin | |
| United Kingdom | The Ulster Hospital | Belfast | |
| United Kingdom | Bury Care Organisation | Bury | Greater Manchester |
| United Kingdom | Addenbrooke's Hospital | Cambridge | Cambridgeshire |
| United Kingdom | Royal Devon and Exeter Hospital (Wonford) | Exeter | Devon |
| United Kingdom | St Mark's Hospital | Harrow | Middlesex |
| United Kingdom | Huddersfield Royal Infirmary | Huddersfield | West Yorkshire |
| United Kingdom | Guy's Hospital | London | Greater London |
| United Kingdom | Hammersmith Hospital | London | Greater London |
| United Kingdom | King's College Hospital | London | Greater London |
| United Kingdom | Yeovil District Hospital | Yeovil | Somerset |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Texas Clinical Research Institute, LLC | Arlington | Texas |
| United States | Digestive Healthcare of Georgia | Atlanta | Georgia |
| United States | Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals | Aurora | Colorado |
| United States | Amel Med LLC | Austin | Texas |
| United States | Central Texas Clinical Research, LLC | Austin | Texas |
| United States | National Institute of Clinical Research | Bakersfield | California |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | GI Alliance - Baton Rouge | Baton Rouge | Louisiana |
| United States | Inquest Clinical Research | Baytown | Texas |
| United States | University of Alabama -Birmingham | Birmingham | Alabama |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Clinical Research Of Brandon, LLC | Brandon | Florida |
| United States | NY Scientific Corp. | Brooklyn | New York |
| United States | Access Research Institute | Brooksville | Florida |
| United States | Texas Digestive Disease Consultants | Cedar Park | Texas |
| United States | Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte | North Carolina |
| United States | Gastroenterology Associates of Tidewater | Chesapeake | Virginia |
| United States | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan |
| United States | Eagle Clinical Research | Chicago | Illinois |
| United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | Gastro Health Research | Cincinnati | Ohio |
| United States | West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Iowa Digestive Disease Center | Clive | Iowa |
| United States | Peak Gastroenterology Associates | Colorado Springs | Colorado |
| United States | Columbia Digestive Health Research | Columbia | South Carolina |
| United States | Wexner Medical Center | Columbus | Ohio |
| United States | Kindred Medical Institute for Clinical Trials, LLC | Corona | California |
| United States | Aurora Care Clinic | Costa Mesa | California |
| United States | Citrus Valley Gastroenterology | Covina | California |
| United States | Baylor Scott and White | Dallas | Texas |
| United States | Danbury Hospital | Danbury | Connecticut |
| United States | Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia |
| United States | Digestive Health Specialists of the Southeast | Dothan | Alabama |
| United States | Digestive Health Specialists of the Southeast | Dothan | Alabama |
| United States | AGA Clinical Research Associates, LLC | Egg Harbor Township | New Jersey |
| United States | NECCR Primacare Research, LLC | Fall River | Massachusetts |
| United States | Plains Clinical Research Center, LLC | Fargo | North Dakota |
| United States | Michigan Center of Medical Research | Farmington Hills | Michigan |
| United States | AIG Digestive Disease Research | Florham Park | New Jersey |
| United States | Gastrointestinal Associates, PA | Flowood | Mississippi |
| United States | Cook Children's Medical Center | Fort Worth | Texas |
| United States | Valley Institute of Research | Fort Worth | Texas |
| United States | GI Alliance - Garland | Garland | Texas |
| United States | Gastroenterology Center of the MidSouth PC | Germantown | Tennessee |
| United States | GI Alliance | Glenview | Illinois |
| United States | Gastroenterology Associates, PA | Greenville | South Carolina |
| United States | Lakeview Clinical Research | Guntersville | Alabama |
| United States | GI Alliance | Gurnee | Illinois |
| United States | Medical Research Center of Connecticut, LLC | Hamden | Connecticut |
| United States | Digestive Health Research, LC | Hermitage | Tennessee |
| United States | Baylor College Of Medicine | Houston | Texas |
| United States | Biopharma Informatic, Inc. Research Center | Houston | Texas |
| United States | Biopharma Informatic, LLC | Houston | Texas |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | Indiana University School of Medicine | Indianapolis | Indiana |
| United States | The University of Iowa | Iowa City | Iowa |
| United States | University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas |
| United States | Gastro Health & Nutrition | Katy | Texas |
| United States | Mt.Olympus Medical Research | Katy | Texas |
| United States | I.H.S Health, LLC | Kissimmee | Florida |
| United States | University of California (San Diego) | La Jolla | California |
| United States | Auzmer Research | Lakeland | Florida |
| United States | Gastro Care Institute | Lancaster | California |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | BVL Clinical Research | Liberty | Missouri |
| United States | Research Solutions of Arizona, PC | Litchfield Park | Arizona |
| United States | Applied Research Center of Arkansas | Little Rock | Arkansas |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | University of Louisville Research Foundation | Louisville | Kentucky |
| United States | Care Access Research Lumberton | Lumberton | North Carolina |
| United States | Blue Ridge Medical Research | Lynchburg | Virginia |
| United States | Cfagi, Llc | Maitland | Florida |
| United States | Tandem Clinical Research, LLC | Marrero | Louisiana |
| United States | Infinite Clinical Research Inc | Miami | Florida |
| United States | Medical Professional Clinical Research Center | Miami | Florida |
| United States | MedOne Clinical Research LLC | Miami | Florida |
| United States | Nicklaus Children's Hospital | Miami | Florida |
| United States | Reliant Medical Research, LLC | Miami | Florida |
| United States | Research Associates of South Florida, LLC | Miami | Florida |
| United States | Sanchez Clinical Research, Inc | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | Wellness Clinical Research | Miami Lakes | Florida |
| United States | United Medical Doctors | Murrieta | California |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Lucida Clinical Trials LLC | New Bedford | Massachusetts |
| United States | Mount Sinai | New York | New York |
| United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
| United States | One Health Research Clinic Atlanta, LLC | Norcross | Georgia |
| United States | California Medical Research Associates Inc. | Northridge | California |
| United States | Ocala GI Research | Ocala | Florida |
| United States | Sarkis Clinical Trials - Parent | Ocala | Florida |
| United States | Digestive Health Center PA | Ocean Springs | Mississippi |
| United States | Care Access Research LLC | Ogden | Utah |
| United States | Board of Regents of the University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Hightower Clinical | Oklahoma City | Oklahoma |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Clinnova Research Solutions | Orange | California |
| United States | Advanced Research Institute, Inc. | Orlando | Florida |
| United States | Arnold Palmer Hospital For Children | Orlando | Florida |
| United States | Endoscopic Research, Inc. | Orlando | Florida |
| United States | Omega Research Orlando, LLC | Orlando | Florida |
| United States | Digestive System Healthcare | Pasadena | Texas |
| United States | LinQ Research, LLC | Pearland | Texas |
| United States | Gastroenterology Associates of Pensacola, PA | Pensacola | Florida |
| United States | Valleywise Health Medical Center | Phoenix | Arizona |
| United States | UPMC | Pittsburgh | Pennsylvania |
| United States | Rapid City Medical Center, LLC | Rapid City | South Dakota |
| United States | Gastroenterology Consultants and Endoscopy Center of Southwest Virginia | Roanoke | Virginia |
| United States | Rochester Clinical Research | Rochester | New York |
| United States | Advanced Research Institute, Inc. | Saint Petersburg | Florida |
| United States | University of Utah | Salt Lake City | Utah |
| United States | Clinical Applications Laboratories | San Diego | California |
| United States | GI Alliance - San Marcos | San Marcos | Texas |
| United States | University of Washington | Seattle | Washington |
| United States | GI Alliance - Southlake | Southlake | Texas |
| United States | Texas Gastroenterology Associates | Spring | Texas |
| United States | DSI Research LLC | Springboro | Ohio |
| United States | Henry Ford Hospital | Sterling Heights | Michigan |
| United States | GI Alliance | Sun City | Arizona |
| United States | Alliance Clinical Research | Tampa | Florida |
| United States | GCP Clinical Research, LLC | Tampa | Florida |
| United States | Genesis Clinical Research | Tampa | Florida |
| United States | Guardian Angel Research Center | Tampa | Florida |
| United States | Cotton O'Neil Clinical Research Center | Topeka | Kansas |
| United States | Del Sol Research Management, LLC | Tucson | Arizona |
| United States | University of Arizona | Tucson | Arizona |
| United States | Tyler Research Institute, LLC | Tyler | Texas |
| United States | Frontier Clinical Research, LLC | Uniontown | Pennsylvania |
| United States | The Vancouver Clinic | Vancouver | Washington |
| United States | GI Alliance - Webster | Webster | Texas |
| United States | TPMG Clinical Research Williamsburg | Williamsburg | Virginia |
| United States | Wilmington Health | Wilmington | North Carolina |
| United States | Wake Forest Baptist | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Abivax S.A. |
United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Croatia, Czechia, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Switzerland, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of subjects in clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1 (friability is scored as 2)] at Week 44 | The study primary objective is to evaluate the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission at Week 44. | Week 44 | |
| Secondary | Proportion of subjects with endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44 | To evaluate the efficacy of ABX464 versus placebo on endoscopic improvement. | Week 44 | |
| Secondary | Proportion of subjects with symptomatic remission (SFS = 0 or 1 and RBS = 0) at Week 44 | To evaluate the efficacy of ABX464 versus placebo on symptomatic remission | Week 44 | |
| Secondary | Proportion of subjects with corticosteroid-free clinical remission (clinical remission at Week 44 and corticosteroid free for at least 12 weeks prior to Week 44 in the subpopulation with corticosteroids at maintenance study entry) | To evaluate the efficacy of ABX464 versus placebo on corticosteroid-free clinical remission. | Week 44 | |
| Secondary | Proportion of subjects with sustained clinical remission at Week 44 | To evaluate the efficacy of ABX464 versus placebo to sustain clinical remission. | Week 44 | |
| Secondary | Proportion of subjects with HEMI per Geboes scoring at Week 44 | To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo | Week 44 | |
| Secondary | Proportion of subjects with endoscopic remission (MES = 0) at Week 44. | To evaluate the efficacy of ABX464 versus placebo on endoscopic remission. | Week 44 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05702879 -
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
|
||
| Not yet recruiting |
NCT05953402 -
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
|
||
| Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
| Recruiting |
NCT03950232 -
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
| Completed |
NCT03124121 -
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
|
Phase 4 | |
| Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
| Withdrawn |
NCT04209556 -
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
|
Phase 2 | |
| Terminated |
NCT00061282 -
Clotrimazole Enemas for Pouchitis in Children and Adults
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04398550 -
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
|
N/A | |
| Recruiting |
NCT04314375 -
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
|
Phase 4 | |
| Active, not recruiting |
NCT04857112 -
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
|
Phase 2 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Active, not recruiting |
NCT04033445 -
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
| Active, not recruiting |
NCT06221995 -
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
|
||
| Recruiting |
NCT04767984 -
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
|
Phase 2 | |
| Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
| Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
|
Phase 1/Phase 2 | |
| Completed |
NCT03760003 -
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
|
Phase 2 | |
| Not yet recruiting |
NCT05539625 -
Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis
|
Phase 2 |