ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

August 18, 2026 updated by: Abivax S.A.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

636

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
      • Ciudad Autonoma Buenos Aires, Argentina, C1117ABK
        • Gastroenterología Diagnóstica y Terapéutica (Gedyt)
    • Buenos Aires
      • Ramos Mejía, Buenos Aires, Argentina
        • DIM Clinica Privada
    • Ciudad Autonoma Buenos Aires
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1431
        • CEMIC
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1280AEB
        • Hospital Británico de Buenos Aires
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina
        • Centro de Investigaciones Clinicas Baigorria
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro de Investigacion CICE
  • Belgium
      • Antwerp, Belgium, 2018
        • GZA Ziekenhuizen
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Ghent, Belgium, 9000
        • AZ Maria Middelares
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
        • University Clinical Centre of the Republic of Srpska
      • Sarajevo, Bosnia and Herzegovina
        • General Hospital Prim.dr.Abdulah Nakas
      • Tuzla, Bosnia and Herzegovina
        • University Clinical Center Tuzla
  • Brazil
      • São Paulo, Brazil
        • Hospital Sirio Libanês
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-370
        • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41920-180
        • Hospital Aliança
      • Salvador, Estado de Bahia, Brazil
        • CLIAGEN - Clinica de Atenção em Gastroenterologia, Especialidades e Nutrição
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • L2IP - Instituto de Pesquisas Clínicas Ltda.
    • 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
        • Hospital de Clinicas de Porto Alegre
    • 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 Saúde
      • Santo André, São Paulo, Brazil, 09090-970
        • Praxis Pesquisa Médica
      • Santos, São Paulo, Brazil, 11075-101
        • Irmandade da Santa Casa da Misericórdia de Santos
      • São Paulo, São Paulo, Brazil, 04543-011
        • Hepatogastro
  • Bulgaria
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultation Center CONVEX EOOD
      • Sofia, Bulgaria
        • Acibadem City Clinic Mladost Eood
      • Veliko Tarnovo, Bulgaria, 5000
        • MC Medica Plus
  • Canada
      • London, Canada
        • London Health Sciences Centre (LHSC) - Victoria Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute
      • Vancouver, British Columbia, Canada
        • Gordon and Leslie Diamond Health Care Centre - Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Newfoundland and Labrador Health Services
  • Croatia
      • Osijek, Croatia, 31000
        • Poliklinika Borzan d.o.o
      • Zagreb, Croatia, 10000
        • University Hospital Centre Zagreb
  • Czechia
      • Prague, Czechia, 14021
        • Institut klinicke a experimentalni mediciny
  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06200
        • CHU Nice - Hopital de l'Archet 2
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13915
        • Hôpital Nord - CHU Marseille
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Hopital Rangueil
    • Hauts De Seine
      • Neuilly, Hauts De Seine, France, 92200
        • Institut des MICI
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, France, 35000
        • CHU Rennes - Hôpital Pontchaillou
    • Isere
      • Grenoble, Isere, France, 38043
        • CHU de Grenoble - Hôpital Nord
    • Moselle
      • Vandœuvre-lès-Nancy, Moselle, France, 57070
        • Hospital de brabois
    • Nord
      • Lille, Nord, France, 59037
        • CHU Lille - Hôpital Claude Huriez
    • Rhone
      • Pierre-Bénite, Rhone, France, 69495
        • Centre Hospitalier LYON SUD
    • Somme
      • Amiens, Somme, France, 80054
        • CHU Amiens - Hopital Sud
    • Vendée
      • La Roche-sur-Yon, Vendée, France, 85925
        • Centre Hospitalier Departemental Les Oudairies
  • Germany
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin Westend
      • Berlin, Germany, 14163
        • Krankenhaus Waldfriede e. V.
      • Berlin, Germany, 10117
        • Charité - Campus Charité Mitte
      • Cologne, Germany
        • Evangelisches Krankenhaus Kalk GmbH
      • Hamburg, Germany, 20251
        • Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen
      • Pforzheim, Germany
        • Siloah St. Trudpert Klinikum
      • Ulm, Germany
        • Universitaetsklinikum Ulm
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67067
        • INLUGA im Haus der Gesundheit
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem
      • Gyöngyös, Hungary, 3200
        • Gyongyosi Bugat Pal Korhaz
      • Kaposvár, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
      • Szekszárd, Hungary, 7100
        • Clinfan Szolgaltato Kft.
  • India
      • Bengaluru, India
        • Vydehi Institute of Medical Sciences and Research Centre
      • Hyderabad, India
        • Gleneagles Global Hospitals
    • 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
      • Surat, Gujarat, India, 395002
        • Surat Institute of Digestive Sciences
      • Surat, Gujarat, India, 395009
        • Gujarat Hospital
      • Vadodara, Gujarat, India, 390007
        • Isha Multispeciality Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400022
        • Lokmanya Tilak Municipal General Hospital & Medical College
      • 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
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Institute of Post Graduate Medical Education And Research
  • Ireland
      • Dublin, Ireland
        • Beaumont Hospital
      • Dublin, Ireland
        • St Vincents University Hospital
      • Galway, Ireland
        • Portiuncula Hospital
    • Dublin
      • Abbotstown, Dublin, Ireland, D15 X40D
        • Connolly Hospital
    • Westmeath
      • Mullingar, Westmeath, Ireland, N91
        • Midland Regional Hospital
  • Israel
      • Afula, Israel, 18101
        • Haemek Medical Center
      • Beersheba, Israel, 84001
        • Soroka University Medical Center
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Holon, Israel
        • Wolfson Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Nahariya, Israel
        • Galilee Medical Center Institute of Gastroenterology
      • 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
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliero Universitaria Mater Domini
      • Milan, Italy, 20157
        • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
      • Padova, Italy
        • Azienda Ospedale-Università di Padova
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italy, 00128
        • Università Campus Bio-Medico di Roma
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
  • Japan
      • Asahikawa-shi, Japan
        • Asahikawa City Hospital
      • Asahikawa-shi, Japan
        • Asahikawa Medical University Hospital
      • Bunkyō City, Japan
        • Juntendo University Hospital
      • Bunkyō City, Japan
        • Institute of Science Tokyo Hospital
      • Fukui-shi, Japan
        • Fukui Prefectural Hospital
      • Himeji-shi, Japan
        • Hyogo Prefectural Harima-Himeji General Medical Center
      • Hirosaki-shi, Japan
        • NHO Hirosaki General Medical Center
      • Komatsu-shi, Japan
        • NHI Komatsu Municipal Hospital
      • Mitaka-shi, Japan
        • Kyorin University Hospital
      • Nagaoka-shi, Japan
        • Nagaoka Red Cross Hospital
      • Sumida-ku, Japan
        • Tokyo Metropolitan Bokutoh Hospital
      • Takatsuki-shi, Japan
        • Osaka Medical and Pharmaceutical University Hospital
      • Yokohama, Japan
        • Keijinkai Matsushima 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
      • Kiryu-shi, Gunma, Japan, 376-0024
        • Kiryu Kosei General Hospital
      • Ota-shi, Gunma, Japan, 373-8585
        • SUBARU Health Insurance Society Ota Memorial Hospital
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • NHO Fukuyama Medical Center
      • Kure-shi, Hiroshima, Japan, 737-0023
        • NHO Kure Medical Center and Chugoku Cancer Center
    • Hokkaido
      • 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
      • Kawasaki-shi, Kanagawa, Japan, 210-0013
        • Kawasaki Municipal Hospital
      • Yokohama, Kanagawa, Japan, 224-8503
        • Showa University Northern Yokohama Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-0004
        • Kaiseikai Hattori Clinic
    • Niigata
      • Niigata, Niigata, Japan, 950-1104
        • Saiseikai Niigata Hospital
    • 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, Osaka, Japan, 583-0027
        • Shinseikai Sai Gastroenterology, Proctology Clinic
      • Osaka, Osaka, Japan, 540-0006
        • NHO Osaka National Hospital
      • 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
      • 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
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Kaunas, Lithuania, 47144
        • Lithuanian University of Health Sciences Kaunas 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
  • New Zealand
      • Hamilton, New Zealand, 3200
        • Waikato Hospital
  • Poland
      • Bydgoszcz, Poland, 85-231
        • NZOZ Centrum Medyczne KERmed
      • Gdynia, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
      • Kielce, Poland, 25-355
        • ETG Kielce Zagorska
      • Knurów, Poland, 44-190
        • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
      • Krakow, Poland, 30-363
        • Centrum Medyczne Plejady
      • Krakow, Poland
        • Centrum Medyczne Plejady
      • Lublin, Poland, 20-049
        • 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie
      • Lublin, Poland
        • NZOZ Neuromed M. i M. Nastaj Sp.P.
      • Nowy Targ, Poland, 34-400
        • ALLMEDICA sp. z o. o.
      • Olsztyn, Poland, 10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Oświęcim, Poland, 32-600
        • Medicome Sp. z o.o.
      • Piotrkow Trybunalski, Poland, 62-800
        • Trialmed CRS
      • Rzeszów, Poland, 35-302
        • Gabinet Lekarski Bartosz Korczowski
      • Staszów, Poland, 28-200
        • Nowe zdrowie-CK, Kieltucki i wspolnicy sp. j.
      • Swidnica, Poland, 58-100
        • DC-MED
      • Wierzchosławice, Poland, 33-122
        • Centrum Zdrowia Tuchow Sp. z o.o.
  • Romania
      • Bucharest, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 013812
        • Spitalul de Oncologie Monza
      • Bucharest, Romania, 012015
        • SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
      • 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
        • Clinical Hospital Center "Bezanijska kosa
      • Kragujevac, Serbia
        • University Clinical Center Kragujevac
      • Subotica, Serbia, 24000
        • General Hospital Subotica
      • Zrenjanin, Serbia
        • 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, 04013
        • Endomed, s.r.o.
      • Nitra, Slovakia, 04901
        • KM Management spol. s r.o.
      • Prešov, Slovakia, 08001
        • Gastro I, s.r.o.
      • Prešov, Slovakia, 08001
        • Gastro LM s.r.o.
      • Rimavská Sobota, Slovakia, 97901
        • Svet zdravia a.s.
      • Šahy, Slovakia, 93601
        • Accout Center s.r.o.
  • Spain
      • Barcelona, Spain, 08022
        • Centro Medico Teknon
      • Huelva, Spain, 21005
        • Hospital General Juan Ramon Jimenez
      • Pontevedra, Spain, 36071
        • Hospital Montecelo
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • La Coruña
      • Ferrol, La Coruña, Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
        • Hospital Universitario de Gran Canaria Dr. Negrín
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
  • Ukraine
      • Chernivtsi, Ukraine
        • RCNECRCH Dept of Proctology, SHEI Ukr BSMU
      • Dnipro, Ukraine
        • Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine
      • Kyiv, Ukraine
        • Medical Center of Limited Liability Company Arensia Exploratory Medicine
      • Kyiv, Ukraine
        • CNCE of Kyiv Regional Council Kyiv Regional Center of Rehabilitation Medicine
      • Kyiv, Ukraine
        • CNCE of Kyiv Regional Council Kyiv Regional Clinical Hospital, Clinical Center of Therapeutic Profil
      • Kyiv, Ukraine
        • Medical Center Universal Clinic Oberih of Limited Liability Company Kapital
      • Kyiv, Ukraine
        • Railway Transport Kyiv Clinical Hospital #2 of Healthcare Center Branch of JSC Ukrainian Railway
      • Lutsk, Ukraine
        • Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
      • Lviv, Ukraine
        • CNCE of Lviv Regional Council Lviv Regional Clinical Hospital
      • Lviv, Ukraine
        • SSH St. Panteleimon of MNPE "Lviv Territorial Med Union" MC of E&I care,Th. Center D.Halytskyi LNMU
      • Odesa, Ukraine
        • CNE Odesa Regional Clinical Hospital of Odesa Regional Council
      • Poltava, Ukraine
        • M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy
      • Uzhhorod, Ukraine
        • CNE A.Novak Transcarpathian Reg Clin Hospital of Transcarpathian Reg Council
      • Vinnytsia, Ukraine
        • CNCE M.I.Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council
      • Vinnytsia, Ukraine
        • CNCE Vinnytsia City Clinical Hospital #1, Dep of Clinical Therapy #2
      • Zhytomyr, Ukraine
        • Communal Enterprise Hospital #1 of Zhytomyr City Council
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
    • Greater London
      • London, Greater London, United Kingdom, SE1 9RT
        • Guy's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama -Birmingham
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Research Solutions of Arizona, PC
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
    • California
      • Bakersfield, California, United States, 93309
        • National Institute of Clinical Research
      • Covina, California, United States, 91723
        • Citrus Valley Gastroenterology
      • Murrieta, California, United States, 92563
        • United Medical Doctors
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories
      • Santa Maria, California, United States, 93458
        • Santa Maria Gastroenterology Medical Group
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
    • Florida
      • Clearwater, Florida, United States, 33762
        • West Central Gastroenterology d/b/a Gastro Florida
      • Kissimmee, Florida, United States, 34741
        • IHS Health
      • Miami, Florida, United States, 33157
        • Sanchez Clinical Research, Inc
      • Miami, Florida, United States, 33134
        • Research Associates of South Florida
      • Miami Lakes, Florida, United States, 33016
        • Wellness Clinical 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, 32804
        • AdventHealth Medical Group
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research, LLC
      • Tampa, Florida, United States, 33612
        • University of South Florida - PARENT
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research, LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
    • Missouri
      • Liberty, Missouri, United States, 64068
        • BVL Clinical Research
    • New Jersey
      • Sparta, New Jersey, United States, 07871
        • Premier Health Research
    • New York
      • Brooklyn, New York, United States, 11235
        • NY Scientific Corp.
      • New York, New York, United States, 10029
        • Mount Sinai
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Plains Clinical Research Center, LLC
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Susquehanna Research Group, LLC
      • Uniontown, Pennsylvania, United States, 15401
        • Frontier Clinical Research, LLC
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center, LLC
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
        • Digestive Health Research, LC
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Harlingen, Texas, United States, 78550
        • Gastroenterology Consultants of South Texas, PA
      • Pasadena, Texas, United States, 77505
        • Digestive System Healthcare
      • Pearland, Texas, United States, 77584
        • LinQ Research, LLC
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute, LLC
      • Tyler, Texas, United States, 75703
        • Tyler Research Institute, LLC
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Richmond VA Medical Center
      • Roanoke, Virginia, United States, 24014
        • Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
    • 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:

  • 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 weigh ≥ 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 and 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 the current 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

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
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
Time Frame: 8 weeks
To compare the efficacy of ABX464 versus placebo on clinical remission. Clinical remission is defined as stool frequency subscore (SFS) = 0 or 1 and rectal bleeding subscore (RBS) = 0, and Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Who Achieve Endoscopic Improvement at Week 8
Time Frame: 8 weeks
To compare the efficacy of ABX464 versus placebo on endoscopic improvement. Endoscopic improvement is defined as Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).
8 weeks
Proportion of Subjects Who Achieve Clinical Response Per MMS at Week 8
Time Frame: 8 weeks

To compare the efficacy of ABX464 versus placebo on clinical response as per MMS.

MMS is the Modified Mayo Score. Modified Mayo score is a composite measure of ulcerative disease activity consisting of three components: stool frequency, rectal bleeding and endoscopic subscores. Each component is scored from 0 (normal or inactive disease) to 3 (severe activity).

The total range score ranges from 0 to 9, with higher scores indicating more severe disease activity.

Clinical Response is defined as a reduction from baseline in MMS ≥ 2 points and a relative reduction from baseline in MMS ≥ 30%, and a reduction from baseline in Rectal Bleeding Score (RBS) ≥ 1 point and/or RBS = 0 or 1.
8 weeks
Proportion of Subjects With HEMI Per Geboes at Week 8
Time Frame: 8 weeks

To compare the efficacy of ABX464 versus placebo on histologic-endoscopic mucosal improvement (HEMI).

HEMI is defined as endoscopic improvement associated with histologic improvement per Geboes score.
8 weeks

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 25, 2023

Primary Completion (Actual)

June 24, 2025

Study Completion (Actual)

July 15, 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 (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABX464-106

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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