ABTECT - Maintenance

October 23, 2025 updated by: Abivax S.A.

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, placebo-controlled 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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 study which consists of 2 treatment phases.

This study consists of a 44-week maintenance treatment phase (Part 1 and Part 2), followed by a 4-year Long Term Extension (LTE) treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

The maintenance phase is a 44-week double blind, placebo-controlled, phase. Subjects who are clinical responders after 8 weeks induction will be randomized to Part 1, and those who are non-clinical responders will be randomized to Part 2.

At the end of the 44-week maintenance phase, subjects will continue their allocated treatment until the maintenance phase is unblinded.

Once the study is unblinded, all subjects receiving obefazimod will continue their allocated treatment. Subjects receiving placebo will be allocated to obefazimod 25 mg or can terminate the study.

Study Type

Interventional

Enrollment (Actual)

1116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, 1431
        • Cemic
      • Buenos Aires, Argentina, C1013AAB
        • STAT Research S.A.
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas Quilmes
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5016
        • Hospital Privado Centro Medico de Cordoba S.A
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro de Investigacion CICE
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research Institute
      • South Brisbane, Queensland, Australia, 4101
        • Mater Hospital Brisbane
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Graz, Austria, 8036
        • Lkh - Universitaetsklinikum Graz
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck
      • Linz, Austria, 4010
        • Ordensklinikum Linz GmbH - Barmherzige Schwestern
      • Salzburg, Austria, 5020
        • LKH - Universitätsklinikum der PMU Salzburg
      • Sankt Veit an der Glan, Austria, 9300
        • KH der Barmherzigen Brüder St.Veit an der Glan
  • Belgium
      • Antwerp, Belgium, 2018
        • GZA Ziekenhuizen
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Brussels, Belgium, 1000
        • C. H. U. St-Pierre
      • Ghent, Belgium, 9000
        • AZ Sint-Lucas
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Ghent, Belgium, 9000
        • AZ Maria Middelares
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • Clinique CHC MontLégia
      • Roeselare, Belgium, 8800
        • AZ Delta
      • Yvoir, Belgium, 5530
        • CHU UCL Namur
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41920-180
        • Hospital Aliança
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • L2IP - Instituto de Pesquisas Clínicas Ltda.
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-934
        • Hospital Felicio Rocho
    • Paraná
      • Curitiba, Paraná, Brazil, 80430-160
        • CDC - Centro Digestivo de Curitiba
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
        • Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-004
        • Hospital Moinhos de Vento
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Jaú, São Paulo, Brazil, 17201-130
        • CECIP - Centro de Estudos Clínicos do Interior Paulista
      • Santo André, São Paulo, Brazil, 09080-110
        • Pesquisare Saude
      • Santo André, São Paulo, Brazil, 09090-790
        • Praxis Pesquisa Medica
      • Santos, São Paulo, Brazil, 11075-101
        • Irmandade da Santa Casa da Misericórdia de Santos
      • São Paulo, São Paulo, Brazil, 04543-011
        • Hepatogastro
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Medical center Medconsult Pleven OOD
      • Sofia, Bulgaria, 1431
        • DCC "Alexandrovska", EOOD
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultation Center CONVEX EOOD
      • Sofia, Bulgaria, 1606
        • UMHATEM 'N.I. Pirogov', EAD
      • Sofia, Bulgaria, 1784
        • ACIBADEM CityClinic Oncological center
      • Veliko Tarnovo, Bulgaria, 5000
        • MC Medica Plus
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R 1W2
        • Gastroenterology and Internal Medicine Research Institute (GIRI)
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre (LHSC) - Victoria Hospital
      • North Bay, Ontario, Canada, P1B 2H3
        • Scott Shulman Medicine Professional Corporation
      • North York, Ontario, Canada, M6A 3B4
        • Toronto Immune & Digestive Health Institute
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
      • Wuhu, Anhui, China, 241001
        • Yijishan Hospital of Wannan Medical College
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Fuzhou, Fujian, China, 350025
        • The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510655
        • The Sixth Affiliated Hospital of Sun Yat-sen University
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
    • Hu'nan
      • Changsha, Hu'nan, China, 410011
        • The 2nd Xiangya Hospital of Central South University
      • Hengyang, Hu'nan, China, 421001
        • The First Affiliated Hospital of University of South China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital, Wuhan University
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Changzhou No.2 People's Hospital
      • Nanjing, Jiangsu, China, 210002
        • General Hospital of Eastern Theater Command
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Medical College
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • The First Affiliated Hospital of Gannan Medical University
      • Ganzhou, Jiangxi, China, 341000
        • Jiangxi Gannan Medical College Affiliated 1 st Hospital
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Shengjing Hospital of China Medical University, Hua Xiang branch hospital
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Binzhou Medical University Hospital
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
      • Qingdao, Shandong, China, 266003
        • The Affiliated Hospital of Qingdao University
      • Tai’an, Shandong, China, 271000
        • Taian City Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
        • Shanghai General Hospital
      • Shanghai, Shanghai Municipality, China, 200001
        • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300121
        • Tianjin Union Medical Center
    • Yun'nan
      • Kunming, Yun'nan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Croatia
      • Koprivnica, Croatia, 48000
        • General Hospital "Dr.Tomislav Bardek" Koprivnica
      • Osijek, Croatia, 31000
        • Clinical Hospital Centre Osijek
      • Zagreb, Croatia, 10000
        • University Hospital Centre Zagreb
  • Czechia
      • Brno, Czechia, 60200
        • CCR Brno, s.r.o.
      • Brno, Czechia, 60200
        • SurGal clinic s.r.o.
      • Hradec Králové, Czechia, 500 12
        • Hepato-Gastroenterologie HK s.r.o.
      • Olomouc, Czechia, 77900
        • PreventaMed s.r.o.
      • Ostrava, Czechia, 708 52
        • Fakultni nemocnice Ostrava
      • Ostrava, Czechia, 702 00
        • CCR Ostrava s.r.o.
      • Prague, Czechia, 140 21
        • Institut klinicke a experimentalni mediciny
      • Slaný, Czechia, 274 01
        • Nemocnice Slany
  • France
      • Paris, France, 75475
        • Hôpital Saint-Louis
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06200
        • CHU Nice - Hopital de l'Archet 2
    • Ardennes
      • Reims, Ardennes, France, 51100
        • CHU Reims - Hôpital Robert Debré
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13915
        • Hopital Nord - CHU Marseille
    • Calvados
      • Caen, Calvados, France, 14033
        • Chu Caen - Hôpital de La Côte de Nacre
    • Cote dÝOr
      • Dijon, Cote dÝOr, France, 21000
        • CHU Dijon - Hôpital Bocage Central
    • Doubs
      • Besançon, Doubs, France, 25000
        • CHU Besançon - Hôpital Jean Minjoz
    • Gironde
      • Pessac, Gironde, France, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Hôpital Rangueil
    • Hauts De Seine
      • Neuilly, Hauts De Seine, France, 92200
        • Institut des MICI
    • Herault
      • Montpellier, Herault, France, 34295
        • Hopital Saint Eloi
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, France, 35000
        • CHU Rennes - Hôpital Pontchaillou
    • Isère
      • Grenoble, Isère, France, 38043
        • CHU de Grenoble - Hopital Albert Michallon
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • CHU Nantes - Hotel Dieu
    • Meurthe Et Moselle
      • Vandœuvre-lès-Nancy, Meurthe Et Moselle, France, 20199 - 54505
        • Universite de Lorraine - Faculte de Medecine - INSERM U954
    • Nord
      • Lille, Nord, France, 59037
        • CHU Lille - Hôpital Claude Huriez
    • Pays de la Loire Region
      • Saint-Étienne-de-Montluc, Pays de la Loire Region, France, 42055
        • CHU Saint Etienne - Hôpital Nord
    • Puy De Dome
      • Clermont-Ferrand, Puy De Dome, France, 63000
        • CHU Clermont Ferrand - Hôpital d'Estaing
    • Pyrenees Atlantiques
      • Pau, Pyrenees Atlantiques, France, 64000
        • Centre Hospitalier de Pau - Hôpital François Mitterrand
    • Rhone
      • Pierre-Bénite, Rhone, France, 69495
        • Centre Hospitalier Lyon Sud
    • Somme
      • Amiens, Somme, France, 80054
        • CHU Amiens - Hopital Sud
    • Val De Marne
      • Créteil, Val De Marne, France, 94010
        • Hôpital Henri Mondor
      • Le Kremlin-Bicêtre, Val De Marne, France, 94275
        • Hôpital Bicêtre
    • Vendée
      • La Roche-sur-Yon, Vendée, France, 85925
        • Centre Hospitalier Departemental Les Oudairies
  • Germany
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin Westend
      • Berlin, Germany, 12203
        • Charite - Campus Benjamin Franklin
      • Berlin, Germany, 10117
        • Charité - Campus Charité Mitte
      • Berlin, Germany, 10318
        • Gastroenterologie Berlin Karlshorst
      • Hamburg, Germany, 20251
        • Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69121
        • Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Medius Klinik Nuertingen
      • Pforzheim, Baden-Wurttemberg, Germany, 75179
        • Siloah St. Trudpert Klinikum
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitaetsklinikum Ulm
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen
      • Munich, Bavaria, Germany, 81377
        • LMU-Campus Grosshadern
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Universitaetsklinikum Frankfurt Goethe-Universitaet
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67067
        • INLUGA im Haus der Gesundheit
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Greece
      • Athens, Greece, 10676
        • General Hospital of Athens "Evangelismos"
      • Corfu, Greece, 49100
        • Corfu General Hospital "St. Eirini"
      • Heraklion, Greece, 71110
        • University General Hospital of Heraklion
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki "Hippokration"
  • Hungary
      • Budapest, Hungary, 1033
        • ClinExpert Kft.
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem
      • Budapest, Hungary, 1136
        • Pannónia Magánorvosi Centrum
      • Budapest, Hungary, 1082
        • Semmelweis Egyetem
      • Békéscsaba, Hungary, 5600
        • Bekes Varmegyei Kozponti Korhaz
      • Gyöngyös, Hungary, 3200
        • Gyongyosi Bugat Pal Korhaz
      • Szekszárd, Hungary, 7100
        • Clinfan Szolgaltato Kft.
  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education and Research
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500048
        • Origin Hospital
      • Hyderabad, Andhra Pradesh, India, 500082
        • Yashoda Super Speciality Hospital
      • Secunderabad, Andhra Pradesh, India, 500003
        • Gandhi Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380009
        • Navneet Memorial Hospital 'Sushrusha'
      • Rajkot, Gujarat, India, 360005
        • Shree Giriraj Multispeciality Hospital
      • Surat, Gujarat, India, 395002
        • Surat Institute of Digestive Sciences
      • Surat, Gujarat, India, 395010
        • Unity Hospital ICU and Trauma
      • Surat, Gujarat, India, 395009
        • Gujarat Hospital
      • Vadodara, Gujarat, India, 390007
        • Isha Multispeciality Hospital
    • Haryana
      • Gurgaon, Haryana, India, 122002
        • Fortis Memorial Research Institute
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • M. S. Ramaiah Medical College and Hospital
      • Belagāve, Karnataka, India, 590010
        • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
      • Mangalore, Karnataka, India, 575003
        • Vinaya Hospital and Research Center
    • Kerala
      • Kochi, Kerala, India, 682041
        • Amrita Institute of Medical Sciences and Research Centre
      • Kochi, Kerala, India, 682040
        • Lakeshore Hospital and Research Centre Ltd.
    • Maharashtra
      • Mumbai, Maharashtra, India, 400022
        • Lokmanya Tilak Municipal General Hospital & Medical College
      • Mumbai, Maharashtra, India, 400012
        • King Edward Memorial Hospital Research Centre
      • Nagpur, Maharashtra, India, 440010
        • Midas Multispeciality Hospital Pvt Ltd
      • Nagpur, Maharashtra, India, 440010
        • Kingsway Hospital
      • Nashik, Maharashtra, India, 422005
        • Chopda Medicare & Research Centre
      • Pune, Maharashtra, India, 411004
        • Sahyadri Specialty Hospital
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic
      • Wardha, Maharashtra, India, 442004
        • Datta Meghe Institute of Medical Sciences (Deemed University)
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, National Capital Territory of Delhi, India, 110025
        • Fortis Escorts Heart Institute and Research Centre
      • New Delhi, National Capital Territory of Delhi, India, 110026
        • Maharaja Agrasen Hospital
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • S. R. Kalla Memorial Gastro & General Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600026
        • SRM Institutes for Medical Sciences
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Chhatrapati Shahuji Maharaj (CSM) Medical University
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Institute of Post Graduate Medical Education And Research
      • Kolkata, West Bengal, India, 700014
        • Nil Ratan Sircar Medical College
  • Ireland
      • Dublin, Ireland, Dublin 4
        • St Vincents University Hospital
      • Dublin, Ireland, 15
        • Connolly Hospital
      • Galway, Ireland
        • Portiuncula Hospital
      • Louth, Ireland
        • Our Lady of Lourdes
    • Westmeath
      • Mullingar, Westmeath, Ireland, N91
        • Midland Regional Hospital
  • Israel
      • Afula, Israel, 18101
        • Haemek Medical Center
      • Beersheba, Israel, 84001
        • Soroka university medical center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Holon, Israel, 58100
        • Wolfson Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center-Beilinson Campus
      • Ramat Gan, Israel, 5265602
        • Chaim Sheba Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
      • Bologna, Italy, 40126
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
      • Brescia, Italy, 25124
        • Fondazione Poliambulanza Istituto Ospedaliero
      • Cagliari, Italy, 09131
        • Azienda Ospedaliera Giuseppe Brotzu
      • Catania, Italy, 95122
        • Presidio Ospedaliero Garibaldi Nesima
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliero Universitaria Mater Domini
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20157
        • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria- Università Degli Studi Della Campania "Luigi Vanvitelli"
      • Padua, Italy, 35128
        • Azienda Ospedaliera Di Padova
      • Palermo, Italy, 90146
        • Ospedale Cervello
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Pisa, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italy, 00128
        • Università Campus Bio-Medico di Roma
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria integrata di Udine
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo di Vicenza
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • IRCCS Ospedale Casa Sollievo della Sofferenza
    • Milano
      • Rho, Milano, Italy, 20017
        • Ospedale di Circolo
      • Rozzano, Milano, Italy, 20089
        • Ospedale San Raffaele
      • San Donato Milanese, Milano, Italy, 20097
        • I.R.C.C.S Policlinico San Donato
    • Verona
      • Negrar, Verona, Italy, 37024
        • Ospedale Sacro Cuore Don Calabria
  • Japan
      • Ibaraki, Japan, 311-3193
        • NHO Mito Medical Center
    • Aichi-ken
      • Toyohashi, Aichi-ken, Japan, 441-8570
        • Toyohashi Municipal Hospital
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Kokikai Tsujinaka Hospital Kashiwanoha
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0024
        • Ehime Prefectural Central Hospital
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Iizuka-shi, Fukuoka, Japan, 820-8505
        • Aso Co.,Ltd Iizuka Hospital
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
      • Kurume-shi, Fukuoka, Japan, 830-8543
        • Our Lady of the Snow St. Mary's Hospital
    • Gunma
      • Ota-shi, Gunma, Japan, 373-8585
        • SUBARU Health Insurance Society Ota Memorial Hospital
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • NHO Fukuyama Medical Center
      • Hatsukaichi-shi, Hiroshima, Japan, 738-8503
        • JA-Hiroshima General Hospital
      • Hiroshima, Hiroshima, Japan, 734-8530
        • Hiroshima Prefectural Hospital
      • Kure-shi, Hiroshima, Japan, 737-0023
        • NHO Kure Medical Center and Chugoku Cancer Center
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital
      • Sapporo, Hokkaido, Japan, 062-8618
        • JCHO Hokkaido Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0015
        • Aoyama Clinic
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8650
        • NHO Kanazawa Medical Center
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
      • Takamatsu, Kagawa-ken, Japan, 760-0017
        • Takamatsu Red Cross Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 892-0824
        • Jiaikai Izuro Imamura Hospital
      • Kagoshima, Kagoshima-ken, Japan, 892-0843
        • Kagoshima IBD Gastroenterology Clinic
      • Kagoshima, Kagoshima-ken, Japan, 892-0846
        • Sameshima Hospital
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Gokeikai Ofuna Chuo Hospital
      • Kawasaki-shi, Kanagawa, Japan, 210-0013
        • Kawasaki Municipal Hospital
      • Yokohama, Kanagawa, Japan, 224-8503
        • Showa University Northern Yokohama Hospital
      • Yokohama, Kanagawa, Japan, 220-0041
        • Keijinkai Matsushima Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-0004
        • Kaiseikai Hattori Clinic
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital
    • Niigata
      • Nagaoka-shi, Niigata, Japan, 940-2085
        • Nagaoka Red Cross Hospital
      • Niigata, Niigata, Japan, 950-1104
        • Saiseikai Niigata Hospital
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870-0823
        • Ishida Clinic of IBD and Gastroenterology
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Okayama University Hospital
      • Okayama, Okayama-ken, Japan, 701-1192
        • NHO Okayama Medical Center
    • Okinawa
      • Okinawa-shi, Okinawa, Japan, 904-2195
        • Keiaikai Nakagami Hospital
    • Osaka
      • Fujiidera-shi, Osaka, Japan, 583-0027
        • Shinseikai Sai Gastroenterology, Proctology
      • Osaka, Osaka, Japan, 540-0006
        • NHO Osaka National Hospital
      • Osaka, Osaka, Japan, 530-0011
        • Kinshukai Infusion Clinic
      • Osaka, Osaka, Japan, 553-0003
        • JCHO Osaka Hospital
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8571
        • Saga-ken Medical Centre Koseikan
      • Saga, Saga-ken, Japan, 849-8501
        • Saga University Hospital
      • Ureshino-shi, Saga-ken, Japan, 843-0393
        • NHO Ureshino Medical Center
    • Saitama
      • Kumagaya-shi, Saitama, Japan, 360-8567
        • Kumagaya General Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 432-8061
        • Matsuaikai Matsuda Hospital
    • Tokyo-To
      • Bunkyō City, Tokyo-To, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Kōtoku, Tokyo-To, Japan, 135-8577
        • Showa University Koto Toyosu Hospital
      • Minatoku, Tokyo-To, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Shinjuku-Ku, Tokyo-To, Japan, 169-0073
        • JCHO Tokyo Yamate Medical Center
      • Sumida-ku, Tokyo-To, Japan, 130-8575
        • Tokyo Metropolitan Bokutoh Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Kaunas, Lithuania, 47144
        • Lithuanian University of Health Sciences Kaunas Hospital
      • Klaipėda, Lithuania, LT-92288
        • Klaipeda University Hospital branch "Seamen's Hospital"
  • Mexico
      • Veracruz, Mexico, 91900
        • FAICIC S. de R.L. de C.V.
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazon S.C
    • Guanajuato
      • Irapuato, Guanajuato, Mexico, 36650
        • Consultorio Medico, InvesclinicMX
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Accelerium S de RL de CV
      • Monterrey, Nuevo León, Mexico, 64908
        • Christus Muguerza Sur S.A. de C.V.
      • Monterrey, Nuevo León, Mexico, 64660
        • Inspirepharma S. de R.L. de C.V.
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam UMC, locatie AMC
      • Geleen, Netherlands, 6162 BG
        • Zuyderland Medisch Centrum - Sittard-Geleen
      • Nijmegen, Netherlands, 6525 GA
        • Radboud UMC
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
      • Tilburg, Netherlands, 5022 GC
        • ETZ Elisabeth
      • Uden, Netherlands, 5406 PT
        • Bernhoven Uden
      • Utrecht, Netherlands, 3508 GA
        • UMC Utrecht
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital NZ
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Hamilton, New Zealand, 3200
        • Waikato Hospital
      • Tauranga, New Zealand, 3143
        • Tauranga Hospital
  • Poland
      • Bełchatów, Poland, 97-400
        • Przychodnia Specjalistyczna Insula
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Bydgoszcz, Poland, 85-231
        • NZOZ Centrum Medyczne KERmed
      • Gdynia, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
      • Kalisz, Poland, 62-800
        • Trialmed CRS
      • Kielce, Poland, 25-355
        • Polimedica Centrum Badań, Profilaktyki I Leczenia
      • Knurów, Poland, 44-190
        • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
      • Krakow, Poland, 30-363
        • Centrum Medyczne Plejady
      • Krakow, Poland, 31-637
        • NZOZ Centrum Medyczne ProMiMed
      • Lodz, Poland, 90-302
        • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
      • Lodz, Poland, 90-644
        • AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa
      • Lublin, Poland, 20-049
        • 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ W Lublinie
      • Nowy Targ, Poland, 34-400
        • ALLMEDICA sp. z o. o.
      • Olsztyn, Poland, 10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Opole, Poland, 45-819
        • Twoja Przychodnia Opolskie Centrum Medyczne
      • Oświęcim, Poland, 32-600
        • Medicome Sp. Z O.O.
      • Poznan, Poland, 60-529
        • Solumed Centrum Medyczne
      • Poznan, Poland, 61-293
        • Twoja Przychodnia PCM
      • Poznan, Poland, 60-681
        • NSZOZ Termedica - Centrum Badan Klinicznych
      • Rzeszów, Poland, 35-302
        • Gabinet Lekarski Bartosz Korczowski
      • Sosnowiec, Poland, 41-200
        • Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
      • Staszów, Poland, 28-200
        • KO-MED Centra Kliniczne Staszow
      • Swidnica, Poland, 58-100
        • DC-MED
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
      • Tarnów, Poland, 33-100
        • CenterMed Sp. z o.o.
      • Warsaw, Poland, 00-635
        • Centrum Zdrowia MDM
      • Warsaw, Poland, 03-580
        • NZOZ VIVAMED Jadwiga Miecz
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne Oporow
      • Wroclaw, Poland, 53-333
        • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
      • Zamość, Poland, 22-400
        • ETG Zamosc
      • Łęczna, Poland, 21-010
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Guimarães, Portugal, 4835-044
        • Hospital Da Senhora Da Oliveira Guimarăes
      • Lisbon, Portugal, 1500-650
        • Hospital da Luz
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
      • Viana do Castelo, Portugal, 4904-858
        • Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
  • Romania
      • Bucharest, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 013812
        • Spitalul de Oncologie Monza
      • Bucharest, Romania, 012015
        • SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
      • Bucharest, Romania, 014142
        • S.C Delta Health Care S.R.L
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
      • Craiova, Romania, 200073
        • Centrul Medical Renasterea Craiova
      • Oradea, Romania, 410469
        • S.C Pelican Impex S.R.L
      • Ploieşti, Romania, 100550
        • S.C Centrul Medical Valahia S.R.L
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Zvezdara
      • Belgrade, Serbia, 11000
        • Clinical Center " Dr Dragisa Misovic Dedinje"
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center "Bezanijska kosa
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac
      • Subotica, Serbia, 24000
        • General Hospital Subotica
      • Zrenjanin, Serbia, 23000
        • General Hospital "Djordje Joanovic"
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta
      • Bratislava, Slovakia, 82007
        • Cliniq s.r.o.
      • Košice, Slovakia, 040 13
        • Endomed, s.r.o.
      • Nitra, Slovakia, 949 01
        • KM Management spol. s r.o.
      • Nitra, Slovakia, 95001
        • Fakultna nemocnica Nitra
      • Prešov, Slovakia, 080 01
        • Gastro I, s.r.o.
      • Prešov, Slovakia, 08001
        • Gastro LM s.r.o.
      • Šahy, Slovakia, 93601
        • Accout Center s.r.o.
  • South Korea
      • Busan, South Korea, 49201
        • Dong-A University Hospital
      • Busan, South Korea, 48108
        • Inje University Haeundae Paik Hospital
      • Daegu, South Korea, 41944
        • Kyungpook National University Hospital
      • Daejeon, South Korea, 34943
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 02447
        • Kyung Hee University Hospital
      • Seoul, South Korea, 06973
        • Chung-Ang University Hospital
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Yonsei University Wonju Severance Christian Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • CHA Bundang Medical Center, CHA University
      • Suwon, Gyeonggi-do, South Korea, 16247
        • The Catholic university of Korea, St. Vincent's Hospital
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42415
        • Yeungnam University Hospital
    • North Chungcheong
      • Ansan-si, North Chungcheong, South Korea, 15355
        • Korea University Ansan Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08022
        • Centro Medico Teknon
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Dr Josep Trueta
      • Huelva, Spain, 21005
        • Hospital General Juan Ramon Jimenez
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Pontevedra, Spain, 36071
        • Hospital Montecelo
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Seville, Spain, 41017
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
    • La Coruña
      • Ferrol, La Coruña, Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Santiago de Compostela, La Coruña, Spain, 15702
        • Clínica Gaias - Santiago
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
        • Hospital Universitario de Gran Canaria Dr. Negrin
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
  • Switzerland
      • Basel, Switzerland, 4031
        • Clarunis - Universitäres Bauchzentrum Basel
      • Bern, Switzerland, 3010
        • Inselspital - Universitaetsspital Bern
      • Bern, Switzerland, 3012
        • Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern
      • Zurich, Switzerland, 8091
        • Universitaetsspital Zuerich
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06500
        • Gazi University Medical Faculty
      • Antalya, Turkey (Türkiye), 07100
        • Antalya Training And Research Hospital
      • Istanbul, Turkey (Türkiye), 34010
        • Koc University Hospital
      • Istanbul, Turkey (Türkiye), 34724
        • Medicana Kadikoy Hospital
      • Istanbul, Turkey (Türkiye), 34742
        • Acibadem Kozyatagi Hospital
      • Izmir, Turkey (Türkiye), 35100
        • Ege University Medical Faculty
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi
      • Malatya, Turkey (Türkiye), 44280
        • Inonu University Gastroenterology
      • Mersin, Turkey (Türkiye), 33343
        • Mersin University Medical Faculty
  • United Kingdom
      • Belfast, United Kingdom, BT16 1RH
        • The Ulster Hospital
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford)
    • Greater London
      • London, Greater London, United Kingdom, SE5 9NU
        • King's College Hospital
      • London, Greater London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, Greater London, United Kingdom, W12 ONN
        • Hammersmith Hospital
    • Greater Manchester
      • Bury, Greater Manchester, United Kingdom, BL9 7TD
        • Bury Care Organisation
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • St Mark's Hospital
    • Somerset
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Yeovil District Hospital
    • West Yorkshire
      • Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama -Birmingham
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast
      • Guntersville, Alabama, United States, 35976
        • Lakeview Clinical Research
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Research Solutions of Arizona, PC
      • Phoenix, Arizona, United States, 85008
        • Valleywise Health Medical Center
      • Sun City, Arizona, United States, 85351
        • GI Alliance
      • Tucson, Arizona, United States, 85724
        • University of Arizona
      • Tucson, Arizona, United States, 85715
        • Del Sol Research Management, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
      • Little Rock, Arkansas, United States, 72205-7199
        • University of Arkansas for Medical Sciences
    • California
      • Bakersfield, California, United States, 93309
        • National Institute of Clinical Research
      • Corona, California, United States, 92879
        • Kindred Medical Institute for Clinical Trials, LLC
      • Costa Mesa, California, United States, 92627
        • Aurora Care Clinic
      • Covina, California, United States, 91723
        • Citrus Valley Gastroenterology
      • La Jolla, California, United States, 92093
        • University of California (San Diego)
      • Lancaster, California, United States, 93534
        • Gastro Care Institute
      • Murrieta, California, United States, 92563
        • United Medical Doctors
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Northridge, California, United States, 91324
        • California Medical Research Associates Inc.
      • Orange, California, United States, 92868
        • Clinnova Research Solutions
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
    • Florida
      • Brandon, Florida, United States, 33511
        • Clinical Research of Brandon, LLC
      • Brooksville, Florida, United States, 34613
        • Access research Institute
      • Clearwater, Florida, United States, 33762
        • West Central Gastroenterology d/b/a Gastro Florida
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research, LLC
      • Kissimmee, Florida, United States, 34741
        • I.H.S Health, LLC
      • Lakeland, Florida, United States, 33813
        • Auzmer Research
      • Maitland, Florida, United States, 32751
        • Cfagi, Llc
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33157
        • Sanchez Clinical Research, Inc
      • Miami, Florida, United States, 33134
        • Research Associates of South Florida, LLC
      • Miami, Florida, United States, 33155-3009
        • Nicklaus Children's Hospital
      • Miami, Florida, United States, 33165
        • Medical Professional Clinical Research Center
      • Miami, Florida, United States, 33133
        • Infinite Clinical Research Inc
      • Miami, Florida, United States, 33165
        • Reliant Medical Research, LLC
      • Miami, Florida, United States, 33145
        • MedOne Clinical Research LLC
      • Miami Lakes, Florida, United States, 33016
        • Wellness Clinical Research
      • Ocala, Florida, United States, 34471
        • Ocala GI Research
      • Ocala, Florida, United States, 34474
        • Sarkis Clinical Trials - Parent
      • Orlando, Florida, United States, 32806
        • Arnold Palmer Hospital for Children
      • Orlando, Florida, United States, 32808
        • Omega Research Orlando, LLC
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc.
      • Orlando, Florida, United States, 32825
        • Advanced Research Institute, Inc.
      • Pensacola, Florida, United States, 32503
        • Gastroenterology Associates of Pensacola, PA
      • St. Petersburg, Florida, United States, 33710
        • Advanced Research Institute, Inc.
      • Tampa, Florida, United States, 33614
        • Guardian Angel Research Center
      • Tampa, Florida, United States, 33615
        • Alliance Clinical Research
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research, LLC
      • Tampa, Florida, United States, 33606
        • Genesis Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta Center for Gastroenterology, P.C.
      • Norcross, Georgia, United States, 30093
        • One Health Research Clinic Atlanta, LLC
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
      • Chicago, Illinois, United States, 60621
        • Eagle Clinical Research
      • Glenview, Illinois, United States, 60026
        • GI Alliance
      • Gurnee, Illinois, United States, 60031
        • GI Alliance
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute, Inc.
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Research Foundation
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • GI Alliance - Baton Rouge
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Fall River, Massachusetts, United States, 02721
        • NECCR Primacare Research, LLC
      • New Bedford, Massachusetts, United States, 02740
        • Lucida Clinical Trials LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Center of Medical Research
      • Sterling Heights, Michigan, United States, 48313
        • Henry Ford Hospital
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Gastrointestinal Associates, PA
      • Ocean Springs, Mississippi, United States, 39564
        • Digestive Health Center PA
    • Missouri
      • Liberty, Missouri, United States, 64068
        • BVL Clinical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Egg Harbor, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC
      • Florham Park, New Jersey, United States, 07932
        • AIG Digestive Disease Research
    • New York
      • Brooklyn, New York, United States, 11235
        • NY Scientific Corp.
      • New York, New York, United States, 10029
        • Mount Sinai
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology and Hepatology, P.L.L.C
      • Lumberton, North Carolina, United States, 28358
        • Care Access Research Lumberton
      • Wilmington, North Carolina, United States, 28401
        • Wilmington Health
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Plains Clinical Research Center, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Gastro Health Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • Wexner Medical Center
      • Springboro, Ohio, United States, 45066
        • DSI Research LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical
      • Oklahoma City, Oklahoma, United States, 73104
        • Board of Regents of the University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Susquehanna Research Group, LLC
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
      • Uniontown, Pennsylvania, United States, 15401
        • Frontier Clinical Research, LLC
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Columbia Digestive Health Research
      • Greenville, South Carolina, United States, 29607
        • Gastroenterology Associates, PA
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center, LLC
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastroenterology Center of the MidSouth PC
      • Hermitage, Tennessee, United States, 37076
        • Digestive Health Research, LC
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Austin, Texas, United States, 78750
        • Amel Med LLC
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research, LLC
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Cedar Park, Texas, United States, 78613
        • Texas Digestive Disease Consultants
      • Dallas, Texas, United States, 75246
        • Baylor Scott and White
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • Fort Worth, Texas, United States, 76164
        • Valley Institute of Research
      • Garland, Texas, United States, 75044
        • GI Alliance - Garland
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77084
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, Inc. Research Center
      • Katy, Texas, United States, 77494
        • Gastro Health & Nutrition
      • Katy, Texas, United States, 77494
        • Mt.Olympus Medical Research
      • Pasadena, Texas, United States, 77505
        • Digestive System Healthcare
      • Pearland, Texas, United States, 77584
        • LinQ Research, LLC
      • San Marcos, Texas, United States, 78130
        • GI Alliance - San Marcos
      • Southlake, Texas, United States, 76092
        • GI Alliance - Southlake
      • Spring, Texas, United States, 77386
        • Texas Gastroenterology Associates
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
      • Webster, Texas, United States, 77598
        • GI Alliance - Webster
    • Utah
      • Ogden, Utah, United States, 84403
        • Care Access Research LLC
      • Salt Lake City, Utah, United States, 84112
        • University of Utah
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Research
      • Roanoke, Virginia, United States, 24014
        • Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
      • Williamsburg, Virginia, United States, 23188
        • TPMG Clinical Research Williamsburg
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria in maintenance phase:

  • 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 comply with contraception requirements as described in Section 4.4. (Contraception) of the 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

Inclusion criteria in LTE phase:

  • Subject must have completed the maintenance phase
  • Investigator and subject must assess and agree that the subject has received, and will continue to receive benefit from being in the study

Exclusion Criteria in maintenance phase:

  • 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 (eg. primary sclerosis cholangitis, Crohn's disease, colectomy, diverting ileostomy, colon cancer or colonic adenomas [low or high grade dysplasia]).
  • Subjects with evidence of an unstable clinical condition (eg. toxic megacolon, fulminant colitis, bowel perforation, uncontrolled ischemic disease, congestive heart failure with NYHA class 3 or 4 symptoms) during the induction study that, in the investigator's judgment, will substantially increase the risk to the subject 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, or pregnant female subjects
  • Introduction during induction study of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).
  • Any changes in the laboratory values during the induction period that could jeopardize subject's safety in the opinion of the investigator. If any doubts, the investigator should contact the sponsor study medical monitor.
  • Subject who is planning to receive live vaccine during the study.
  • Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Exclusion criteria for LTE phase:

  • Subject continues to satisfy exclusion criteria listed above for the maintenance phase
  • Introduction during maintenance phase of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Drug: Placebo
Administered once daily, preferably in the morning, with food
Experimental: ABX464 50mg - Non responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Drug: ABX464
Administered once daily, preferably in the morning, with food
Other Names:
  • Obefazimod
Experimental: ABX464 25mg - Non responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Drug: ABX464
Administered once daily, preferably in the morning, with food
Other Names:
  • Obefazimod
Placebo Comparator: ABX464 50mg - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Drug: ABX464
Administered once daily, preferably in the morning, with food
Other Names:
  • Obefazimod
Placebo Comparator: ABX464 25mg - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Drug: ABX464
Administered once daily, preferably in the morning, with food
Other Names:
  • Obefazimod
Experimental: Long Term Extension
At the end of the maintenance phase (week 44), subjects can continue their allocated treatment for up to 4 years. Once the maintenance phase is unblinded, subjects receiving placebo in the maintenance phase will be allocated to obefazimod 25 mg or can terminate the study.
Drug: ABX464
Administered once daily, preferably in the morning, with food
Other Names:
  • Obefazimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of subjects in clinical remission at Week 44
Time Frame: Week 44
The Part 1 primary objective is to compare the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1] at Week 44.
Week 44
Number and percentage of all treatment-emergent adverse events (TEAEs)
Time Frame: Week 44
The Part 2 primary objective is safety
Week 44
Number and percentage of all serious adverse events (SAEs)
Time Frame: Week 44
The Part 2 primary objective is safety
Week 44
Number and percentage of all causally related TEAEs/SAEs
Time Frame: Week 44
The Part 2 primary objective is safety
Week 44

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with endoscopic improvement at Week 44
Time Frame: Week 44
To compare the efficacy of ABX464 versus placebo on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44
Week 44
Proportion of subjects with corticosteroid-free clinical remission
Time Frame: Week 44
To compare the efficacy of ABX464 versus placebo on 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)
Week 44
Proportion of subjects with sustained clinical remission at Week 44
Time Frame: Week 44
To compare the efficacy of ABX464 versus placebo to sustain clinical remission at Week 44
Week 44
Proportion of subjects with HEMI per Geboes scoring at Week 44
Time Frame: Week 44
To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo at Week 44
Week 44
Proportion of subjects with endoscopic remission at Week 44
Time Frame: Week 44
To compare the efficacy of ABX464 versus placebo on endoscopic remission (MES = 0) at Week 44
Week 44
LTE Phase - Proportion of subjects in clinical remission at Year 1
Time Frame: LTE Year 1
To evaluate the efficacy of obefazimod on clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1] at Year 1
LTE Year 1
LTE Phase - Proportion of subjects in clinical remission at Year 4
Time Frame: LTE Year 4
To evaluate the efficacy of obefazimod on clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1] at Year 4
LTE Year 4
LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry
Time Frame: LTE Year 1
To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 1 and corticosteroid free for at least 12 weeks prior to Year 1 in the subpopulation with corticosteroids at maintenance study entry)
LTE Year 1
LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry)
Time Frame: LTE Year 4
To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 4 and corticosteroid free for at least 12 weeks prior to Year 4 in the subpopulation with corticosteroids at maintenance study entry)
LTE Year 4
LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 1
Time Frame: LTE Year 1
To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1)
LTE Year 1
LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 4
Time Frame: LTE Year 4
To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1)
LTE Year 4
LTE Phase - Proportion of subjects with endoscopic remission at LTE year 1
Time Frame: LTE year 1
To evaluate the efficacy of obefazimod on endoscopic remission ((Mayo Endoscopic Subscore (MES) = 0)
LTE year 1
LTE Phase - Proportion of subjects with endoscopic remission at LTE year 4
Time Frame: LTE year 4
To evaluate the efficacy of obefazimod on endoscopic remission (Mayo Endoscopic Subscore (MES) = 0)
LTE year 4
LTE Phase - Proportion of subjects with CS-free symptomatic remission by visit
Time Frame: 4 years
To evaluate the efficacy of obefazimod on CS-free symptomatic remission (symptomatic remission (SFS = 0 or 1 and RBS = 0) and corticosteroid free for at least 12 weeks prior to Week 44 in the subpopulation with corticosteroids at maintenance study entry) by visit (every 3-month)
4 years
LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 1
Time Frame: LTE Year 1
To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring
LTE Year 1
LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 4
Time Frame: LTE Year 4
To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring
LTE Year 4
LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 1
Time Frame: LTE Year 1
To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo
LTE Year 1
LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 4
Time Frame: LTE Year 4
To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo
LTE Year 4
LTE Phase - Proportion of subjects with sustained clinical remission at LTE Year 1, in the sub-population of subjects with clinical remission at Week 44
Time Frame: LTE Year 1
To evaluate the efficacy of obefazimod on sustained clinical remission Sustained clinical remission for the LTE is defined as clinical remission assessed at an endoscopy visit during the LTE in the sub-population of subjects in clinical remission at Week 44.
LTE Year 1
LTE Phase - Proportion of subjects with sustained clinical remission at LTE year 4, in the sub-population of subjects with clinical remission at Week 44
Time Frame: LTE year 4
To evaluate the efficacy of obefazimod on sustained clinical remission Sustained clinical remission for the LTE is defined as clinical remission assessed at an endoscopy visit during the LTE in the sub-population of subjects in clinical remission at Week 44.
LTE year 4
LTE Phase - Proportion of subjects with sustained endoscopic improvement at LTE Year 1, in the sub-population of subjects with endoscopic improvement at Week 44
Time Frame: LTE Year 1
To evaluate the efficacy of obefazimod on sustained endoscopic improvement
LTE Year 1
LTE Phase - Proportion of subjects with sustained endoscopic improvement at LTE Year 4, in the sub-population of subjects with endoscopic improvement at Week 44
Time Frame: LTE year 4
To evaluate the efficacy of obefazimod on sustained endoscopic improvement
LTE year 4
LTE Phase - Proportion of subjects with symptomatic remission by visit
Time Frame: 4 years
To evaluate the efficacy of obefazimod on symptomatic remission (SFS = 0 or 1 and RBS = 0) by visit (every 3-month)
4 years
LTE Phase - Proportion of subjects with sustained symptomatic remission by visit
Time Frame: 4 years
To evaluate the efficacy of obefazimod on sustained symptomatic remission (SFS = 0 or 1 and RBS = 0) by visit (every 3-month), in the sub-population of subjects with symptomatic remission at Week 44
4 years
LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 1
Time Frame: LTE Year 1
To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 1 and CS-free for at least 12 weeks immediately prior to Year 1)
LTE Year 1
LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 4
Time Frame: LTE Year 4
To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 4 and CS-free for at least 12 weeks immediately prior to Year 4)
LTE Year 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abivax S.A.

Investigators

  • Principal Investigator: Severine Vermeire, MD, PhD, UZ Leuven, Belgium
  • Principal Investigator: Bruce Sands, MD, PhD, Mount Sinai Health System Digestive Disease Institute, New York USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABX464-107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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