ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission 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].

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: ABX464; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 639
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1013AAB
    • Stat Research S.A.
  • Ciudad Autonoma Buenos Aires, Argentina, C199AAB
    • Hospital Italiano de Buenos Aires
  • Córdoba, Argentina, X5016KEH
    • Hospital Privado Centro Medico de Cordoba S.A
  • Buenos Aires
    • Quilmes, Buenos Aires, Argentina, B1878GEG
      • Instituto de Investigaciones Clinicas Quilmes
• Australia
  • Canberra, Australia, 2605
    • Canberra Hospital
  • North Mackay, Australia, 4740
    • Coral Sea Clinical Research Institute
  • Perth, Australia, 6000
    • Royal Perth Hospital
  • South Brisbane, Australia, 4101
    • Mater Misericordiae Ltd
  • 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
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • 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
  • Salzburg, Austria, 5020
    • Lkh - Universitatsklinikum Der Pmu Salzburg
  • Sankt Veit an der Glan, Austria, 9300
    • KH der Barmherzigen Brüder St.Veit an der Glan
  • Vienna, Austria, 1090
    • Akh - Medizinische Universität Wien
• Belgium
  • Brasschaat, Belgium, 2930
    • AZ KLINA
  • Bruges, Belgium, 8310
    • AZ Sint-Lucas
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Brussels, Belgium, 1070
    • HUB Erasme
  • Brussels, Belgium, 1000
    • C. H. U. St-Pierre
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • Clinique CHC MontLégia
  • Yvoir, Belgium, 5530
    • CHU UCL Namur
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medical Center Medconsult Pleven OOD
  • Sofia, Bulgaria, 1527
    • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Sofia, Bulgaria, 1431
    • DCC "Alexandrovska", EOOD
  • Sofia, Bulgaria, 1606
    • UMHATEM 'N.I. Pirogov', EAD
  • Stara Zagora, Bulgaria, 6000
    • UMHAT Prof. Dr. Stoyan Kirkovich AD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5R 1W2
      • Gastroenterology and internal medicine research institute
  • Ontario
    • North Bay, Ontario, Canada, P1B 2H3
      • Scott Shulman Medicine Professional Corporation
    • Toronto, Ontario, Canada, M5T 3A9
      • Kensington Screening Clinic
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Centre- Montreal General Hospital
• China
  • Sichuan, China
    • West China Hospital, Sichuan University
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affiliated Hospital Of Bengbu Medical College
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
    • Wuhu, Anhui, China, 241001
      • Yijishan Hospital of Wannan Medical College
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
  • 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
    • Xiamen, Fujian, China, 361004
      • Zhongshan Hospital Xiamen University
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • The First People's Hospital of Foshan
    • Guangzhou, Guangdong, China, 510655
      • The Sixth Affiliated Hospital of Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
    • Yuexiu, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University
  • Guangxi Zhuang
    • Liuzhou, Guangxi Zhuang, China, 545006
      • Liuzhou People's Hospital
    • Nanning, Guangxi Zhuang, China, 530021
      • The People's Hospital Of Guangxi Zhuang Autonomous Region
  • Henan
    • Luoyang, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Nanyang, Henan, China, 473000
      • The First Affiliated Hospital of Nanyang Medical College
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University
  • Hu'nan
    • Changsha, Hu'nan, China, 410008
      • Xiangya Hospital, Central South University
    • 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, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital, Wuhan University
    • Wuhan, Hubei, China, 430030
      • ongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Changzhou No.2 People's Hospital
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China, 210002
      • General Hospital of Eastern Theater Command
  • Jiangxi
    • 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
  • 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
    • Liaocheng, Shandong, China, 252000
      • Liaocheng People's 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, 200082
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai Municipality, China, 200127
      • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
  • Sichuan
    • Chongqing, Sichuan, China, 400042
      • Army Specialty Medical Center of The Chinese People's Liberation Army
    • Luzhou, Sichuan, China, 646099
      • The Affiliated Hospital of Southwest Medical University
  • 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, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310018
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Huzhou, Zhejiang, China, 313099
      • Huzhou Central Hospital
• Czechia
  • Brno, Czechia, 60200
    • CCR Brno, s.r.o.
  • Brno, Czechia, 60200
    • SurGal Clinic s.r.o.
  • Brno, Czechia
    • Vojenska nemocnice Brno
  • Hradec Králové, Czechia, 50012
    • Hepato-Gastroenterologie HK s.r.o.
  • Olomouc, Czechia, 77200
    • PreventaMed s.r.o.
  • Ostrava, Czechia, 70200
    • CCR Ostrava s.r.o.
  • Slaný, Czechia, 27401
    • Nemocnice Slany
• France
  • Paris, France, 75475
    • Hôpital Saint-Louis
  • Ardennes
    • Reims, Ardennes, France, 51100
      • CHU Reims - Hôpital Robert Debré
  • Cote D'or
    • Dijon, Cote D'or, France, 21000
      • CHU Dijon - Hôpital Bocage Central
  • Doubs
    • Besançon, Doubs, France, 25000
      • CHU Besancon - Hopital Jean Minjoz
  • Gironde
    • Pessac, Gironde, France, 33604
      • Chu Bordeaux - Hôpital Haut-Lévêque
  • Herault
    • Montpellier, Herault, France, 34295
      • Hopital Saint Eloi
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • CHU Nantes - Hotel Dieu
  • 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
  • Pyrénées Atlantique
    • Pau, Pyrénées Atlantique, France, 64000
      • Centre Hospitalier de Pau - Hôpital François Mitterrand
  • Val De Marne
    • Créteil, Val De Marne, France, 94010
      • Hôpital Henri Mondor
    • Le Kremlin-Bicêtre, Val De Marne, France, 94275
      • Hôpital Bicêtre
• Germany
  • Berlin, Germany, 12203
    • Charité - Campus Benjamin Franklin
  • Berlin, Germany, 10318
    • Gastroenterologie Berlin Karlshorst
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Universitaetsklinikum Heidelberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69121
      • Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitaetsklinikum Erlangen
    • Munich, Bavaria, Germany, 81337
      • LMU - Campus Grosshadern
  • Brandenburg
    • Brandenburg, Brandenburg, Germany, 14770
      • Staedisches Klinikum Brandenburg
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitaetsklinikum Frankfurt Goethe-Universitaet
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Universitaetsklinikum Essen
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
• Greece
  • Alexandroupoli, Greece, 68100
    • University General Hospital of Alexandroupolis
  • 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, 1136
    • Pannonia Maganorvosi Centrum
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem
  • Békéscsaba, Hungary, 5600
    • Békés Vármegyei Központi Kórház
  • Debrecen, Hungary
    • Debreceni Egyetem
  • Szombathely, Hungary, 9700
    • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380009
      • Navneet Memorial Hospital 'Sushrusha'
    • Rajkot, Gujarat, India, 360005
      • Shree Giriraj Multispeciality Hospital
    • Surat, Gujarat, India, 395010
      • Unity Hospital ICU and Trauma
  • 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
  • Kerala
    • Kochi, Kerala, India, 682041
      • Amrita Institute Of Medical Sciences and Research Centre
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • King Edward Memorial Hospital Research Centre
    • Nagpur, Maharashtra, India, 440001
      • Kingsway Hospital
    • Nagpur, Maharashtra, India, 440010
      • Midas Multispeciality Hospital Pvt Ltd
    • Nashik, Maharashtra, India, 422005
      • Chopda Medicare & Research Centre
    • Pune, Maharashtra, India, 411001
      • Ruby Hall Clinic
    • Pune, Maharashtra, India, 411028
      • Sahyadri Specialty Hospital
  • Punjab
    • Ludhiana, Punjab, India, 141001
      • Dayanand Medical College and Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302001
      • S. R. Kalla Memorial Gastro & General Hospital
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • Chhatrapati Shahuji Maharaj (CSM) Medical University
  • West Bengal
    • Kolkata, West Bengal, India, 700014
      • Nil Ratan Sircar Medical College
• Italy
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza Istituto Ospedaliero
  • Cagliari, Italy, 09134
    • Azienda Ospedaliera Giuseppe Brotzu
  • Catania, Italy, 95122
    • Presidio Ospedaliero Garibaldi Nesima
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Negrar, Italy
    • Ospedale Sacro Cuore Don Calabria
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Pisa, Italy
    • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo di Vicenza
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • I.R.C.C.S Policlinico San Donato
  • Verona
    • Negrar, Verona, Italy, 37024
      • Ospedale Sacro Cuore Don Calabria
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam UMC, locatie AMC
  • Nijmegen, Netherlands, 6525 GA
    • Radboud UMC
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC
  • Sittard, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard-Geleen
  • Tilburg, Netherlands, 5022 GC
    • ETZ Elisabeth
  • Uden, Netherlands, 5406 PT
    • Bernhoven Uden
• Poland
  • Bełchatów, Poland, 97-400
    • Przychodnia Specjalistyczna Insula
  • Katowice, Poland, 40-211
    • Szpital Zakonu Bonifratow Sp. z o.o.
  • Krakow, Poland, 31-637
    • NZOZ Centrum Medyczne ProMiMed
  • Krakow, Poland, 31-513
    • Centrum Medyczne Promed
  • Lodz, Poland, 90-644
    • AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa
  • Opole, Poland, 45-819
    • Twoja Przychodnia Opolskie Centrum Medyczne
  • Poznan, Poland, 60-529
    • SOLUMED Centrum Medyczne
  • Poznan, Poland, 61-293
    • Twoja Przychodnia PCM
  • Poznan, Poland, 60-681
    • NSZOZ Termedica - Centrum Badan Klinicznych
  • Sosnowiec, Poland, 41-200
    • Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia-Szczecinskie Centrum Medyczne 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, 52-210
    • PlanetMed Sp. z o.o.
  • 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 Guimarães
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz
  • 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
• 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
    • Ansan-si, Gyeonggi-do, South Korea, 15355
      • Korea University Ansan Hospital
    • 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
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofía
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15702
      • Clínica Gaias - Santiago
• Switzerland
  • Basel, Switzerland, 4058
    • Claraspital
  • 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
  • Istanbul, Turkey (Türkiye), 34010
    • Koç 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
  • Mersin, Turkey (Türkiye), 33343
    • Mersin University Medical Faculty
  • Muratpaşa, Turkey (Türkiye), 07100
    • Varlik Mah. Kazim Karabekir Cad.
• Ukraine
  • Cherkasy, Ukraine, 18009
    • CNE Cherkasy Regional Hospital of Cherkasy Regional Council
  • Chernivtsi, Ukraine, 58001
    • RCNE Chernivtsi Regional Clinical Hospital Gastroenterology Subdivision Bukovinian SMU
  • Dnipro, Ukraine, 49000
    • Dnipro Division Medical Center Clinic of Family Medicine of LLC
  • Ivano-Frankivsk, Ukraine, 76008
    • CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
  • Khmelnytskyi, Ukraine, 29000
    • CNCE Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council
  • Kyiv, Ukraine, 04050
    • Medical Center of Limited Liability Company Medical Center Concilium Medical
  • Kyiv, Ukraine, 02091
    • CNCE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council
  • Kyiv, Ukraine, 03143
    • Clinical Hospital Feofaniia of State Management of Affairs
  • Lviv, Ukraine, 79005
    • Medical Center of Limited Liability Company Saliutas
  • Lviv, Ukraine
    • CNCE of Lviv Regional Council Lviv Regional Clinical Hospital
  • Ternopil, Ukraine, 46002
    • LLC Medical Center The Clinic of Hospodarskyy
  • Uzhhorod, Ukraine, 88000
    • CNE Uzhhorod city MCH of UCC Dept of Therapy
  • Vinnytsia, Ukraine, 21009
    • Limited Liability Company Medical Center Health Clinic, Medical Clinical Research Center
  • Vinnytsia, Ukraine, 21018
    • CNE M.I. Pyrohov Vinnytsia RCH of Vinnytsia Regional Council, RSC Gastro Center
  • Vinnytsia, Ukraine, 21029
    • Clinic of the SRI of Invalid Rehab (EST Complex) of Pirogov Memorial NMU
• United Kingdom
  • Belfast, United Kingdom, BT16 1RH
    • The Ulster Hospital
  • Greater London
    • London, Greater London, United Kingdom, W12 0HS
      • Hammersmith Hospital
    • London, Greater London, United Kingdom, SE5 9NU
      • King's College Hospital
    • London, Greater London, United Kingdom, E1 1FR
      • Royal London 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
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists Of The Southeast
    • Guntersville, Alabama, United States, 35976
      • Lakeview Clinical Research
  • Arizona
    • Sun City, Arizona, United States, 85351
      • GI Alliance
    • Tucson, Arizona, United States, 85715
      • Del Sol Research Management, LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-7199
      • University of Arkansas for Medical Sciences
  • California
    • Costa Mesa, California, United States, 92627
      • Aurora Care Clinic
    • Lancaster, California, United States, 93534
      • Gastro Care Institute
    • Northridge, California, United States, 91324
      • California Medical Research Associates Inc.
    • Orange, California, United States, 92868
      • Clinnova Research Solutions
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
  • Florida
    • Brandon, Florida, United States, 33511
      • Clinical Research Of Brandon, LLC
    • Brooksville, Florida, United States, 34613
      • Access Research Institute
    • Lakeland, Florida, United States, 33813
      • Auzmer Research
    • Maitland, Florida, United States, 32751
      • Cfagi, Llc
    • Miami, Florida, United States, 33165
      • Medical Professional Clinical Research Center
    • Miami, Florida, United States, 33145
      • MedOne Clinical Research LLC
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute, Inc.
    • 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
    • Temple Terrace, Florida, United States, 33617
      • Theia Clinical Research Centers, LLC
  • 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, 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
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Research Foundation
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • GI Alliance - Baton Rouge
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • New Bedford, Massachusetts, United States, 02740
      • Lucida Clinical Trials LLC
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Digestive Health Center PA
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • Egg Harbor, New Jersey, United States, 08234
      • AGA Clinical Research Associates, LLC
  • New York
    • 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
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Gastro Health Research
    • Columbus, Ohio, United States, 43210
      • Wexner Medical Center
    • Springboro, Ohio, United States, 45066
      • DSI Research LLC
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Columbia Digestive Health Research
    • Greenville, South Carolina, United States, 29607
      • Gastroenterology Associates, PA
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastroenterology Center of the MidSouth PC
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research, LLC
    • Austin, Texas, United States, 76092
      • GI Alliance - Southlake
    • 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
    • Garland, Texas, United States, 75044
      • GI Alliance - Garland
    • 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, 78754
      • Gastro Health & Nutrition
    • San Marcos, Texas, United States, 78130
      • GI Alliance - San Marcos
    • Spring, Texas, United States, 77386
      • Texas Gastroenterology Associates
    • 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
    • Williamsburg, Virginia, United States, 23188
      • TPMG Clinical Research Williamsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old will be enrolled. To be eligible, adolescent subjects must weight ≥ 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
• 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.
• Documented diagnosis of UC confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies or biopsies taken at screening may be used.
• Active disease defined by modified Mayo score (MMS) ≥ 5 with rectal bleeding subscore (RBS) ≥ 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
• Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic or biosimilar therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA or sulfasalazine is not accepted).
• Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with the contraception requirements described in the protocol.
• Subjects 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 with UC limited to an isolated proctitis (≤ 15cm from anal verge) determined by endoscopy central reading.
• Subjects with primary sclerosing cholangitis or autoimmune hepatitis.
• Subjects who have failed on 5-ASA or sulfasalazine therapy only.
• Subjects with CD or presence or history of fistula, indeterminate colitis, infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis).
• History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
• History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of colonic cancer or evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not).
• Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.
• Subjects on antidiarrheals including those working on motility (e.g., loperamide, diphenoxylate with atropine, etc.).
• Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii).
• Subjects who do not meet the washout period requirements prior to the screening endoscopy

• Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period:

  • Hemoglobin ≤ 8.0 g dL-1
  • Absolute neutrophil count < 750 mm-3
  • Platelets < 100,000 mm-3
  • Creatinine clearance < 60 mL.min-1 (Cockroft-Gault formula)
  • Total serum bilirubin > 1.5 x ULN
  • Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN

• Subjects with the following conditions (infection):

  • Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy.
  • Herpes zoster reactivation within the last 2 months prior to screening.
  • Subjects with active infection at screening or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 1 month of screening or during screening. Fungal infection of nail beds is allowed.
  • Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested ≥ 2 weeks after completing treatment.
  • Subjects with HIV infection.
  • Subjects having acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen [HbsAg], or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable HBV DNA, or detectable HBV DNA).
  • Subjects having acute or chronic hepatitis C infection at screening as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA [assessed centrally] are eligible).
  • Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see study protocol.
• Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart Association (NYHA) class 3 or 4 symptoms.
• Subjects with a family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval [Fridericia or Bazett correction] >450 milliseconds for male and > 460 milliseconds for female).
• Subjects with a history of torsade de pointe (TdP).
• Acute or chronic of clinically relevant pulmonary, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history (note: treated autoimmune hypothyroidy and autoimmune diabetes are allowed).
• Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).
• Subjects previously treated with ABX464.
• Subjects with a known hypersensitivity to the active substance or to any of the excipients.
• WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study, or male subject with WOCBP partner who intends to be pregnant during the study.
• Illicit drug or alcohol abuse or dependence.
• Subjects who received live vaccine within 3 months prior to screening and/or who's planning to receive such a vaccine during the study duration.
• Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer, and during the study.
• Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
• Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABX464 50mg; Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks	Drug: ABX464; Administered once daily in the morning with food; Other Names: Obefazimod
Experimental: ABX464 25mg; Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks	Drug: ABX464; Administered once daily in the morning with food; Other Names: Obefazimod
Placebo Comparator: Placebo; Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks	Drug: Placebo; Administered once daily in the morning with food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8	To compare the efficacy of ABX464 versus placebo on clinical remission	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who achieve endoscopic improvement at week 8	To compare the efficacy of ABX464 versus placebo on endoscopic improvement	8 weeks
Proportion of subjects who achieve clinical response per MMS at week 8	To compare the efficacy of ABX464 versus placebo on clinical response as per MMS	8 weeks
Proportion of subjects with symptomatic remission at week 8	To compare the efficacy of ABX464 versus placebo on symptomatic remission	8 weeks
Proportion of subjects with HEMI per Geboes at week 8	To compare the efficacy of ABX464 versus placebo on histologic-endoscopic mucosal	8 weeks

Collaborators and Investigators

• Sponsor: Abivax S.A.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): June 24, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 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: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; ABX464
• Other Study ID Numbers: ABX464-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No