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

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): 636
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1117ABK
    • Gastroenterología Diagnóstica y Terapéutica (Gedyt)
  • 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
  • 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
    • AZ Sint-Lucas
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Ghent, Belgium, 9000
    • AZ Maria Middelares
  • Roeselare, Belgium, 8800
    • AZ Delta
• Brazil
  • 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
  • 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, 90160-093
      • Hospital Ernesto Dornelles
    • 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, 09060-870
      • Faculdade de Medicina do ABC
    • Santo André, São Paulo, Brazil, 09080-110
      • Pesquisare Saude
    • Santo André, São Paulo, Brazil, 09090-970
      • Praxis Pesquisa Medica
    • Santos, São Paulo, Brazil, 11075-101
      • Irmandade da Santa Casa da Misericórdia de Santos
    • São Bernardo do Campo, São Paulo, Brazil, 09715-090
      • Centro Multidisciplinar de Estudos Clínicos - CEMEC
    • São Paulo, São Paulo, Brazil, 04543-011
      • Hepatogastro
• Bulgaria
  • Pleven, Bulgaria, 5800
    • DCC 'Sv. Pantaleymon' OOD
  • Sofia, Bulgaria, 1680
    • Diagnostic Consultation Center CONVEX EOOD
  • Veliko Tarnovo, Bulgaria, 5000
    • MC Medica Plus
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • (G.I.R.I.) GI Research Institute
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Nova Scotia Health Authority
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal
• Croatia
  • Koprivnica, Croatia, 48000
    • General Hospital "Dr.Tomislav Bardek" Koprivnica
  • Osijek, Croatia, 31000
    • Poliklinika Borzan d.o.o
  • Zadar, Croatia, 23000
    • General Hospital Zadar
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Solmed Polyclinic
• Czechia
  • Ostrava, Czechia, 70852
    • Fakultni nemocnice Ostrava
  • Prague, Czechia, 14021
    • Institut klinicke a experimentalni mediciny
  • Zlín, Czechia, 76275
    • Krajska nemocnice T. Bati a.s.
• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06200
      • CHU Nice - Hôpital de l'Archet 2
  • 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
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31059
      • Hôpital Rangueil
  • Hauts De Seine
    • Neuilly, Hauts De Seine, France, 92200
      • Institut des MICI
  • Ille Et Vilaine
    • Rennes, Ille Et Vilaine, France, 35000
      • CHU Rennes - Hopital Pontchaillou
  • Isere
    • Grenoble, Isere, France, 38043
      • CHU de Grenoble - Hôpital Nord
  • Moselle
    • Vantoux, 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
  • Hamburg, Germany, 20251
    • Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen
  • Baden-Wurttemberg
    • Nürtingen, Baden-Wurttemberg, Germany, 72622
      • Medius Klinik Nuertingen
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Universitaetsklinikum Augsburg
  • Rhineland-Palatinate
    • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67067
      • INLUGA im Haus der Gesundheit
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Debrecen, Hungary, 4025
    • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
  • Dunaújváros, Hungary, 2400
    • Obudai Egeszsegugyi Centrum Kft.
  • Gyöngyös, Hungary, 3200
    • Gyongyosi Bugat Pal Korhaz
  • Kaposvár, Hungary, 7400
    • Somogy Varmegyei Kaposi Mor Oktato 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
    • Surat, Gujarat, India, 395002
      • Surat Institute of Digestive Sciences
    • Surat, Gujarat, India, 395009
      • Gujarat Hospital
    • Vadodara, Gujarat, India, 390007
      • Isha Multispeciality Hospital
  • Karnataka
    • Mangalore, Karnataka, India, 575003
      • Vinaya Hospital and Research Center
  • Kerala
    • Kochi, Kerala, India, 682040
      • Lakeshore Hospital and Research Centre Ltd.
  • 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
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600026
      • SRM Institutes for Medical Sciences
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Institute of Post Graduate Medical Education And Research
• Ireland
  • Dublin, Ireland, 15
    • Connolly Hospital
  • Galway, Ireland
    • University Hospital Galway
  • 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
  • Haifa, Israel, 34362
    • Carmel 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
• 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
  • Catanzaro, Italy, 88100
    • Azienda Ospedaliero Universitaria Mater Domini
  • Milan, Italy, 20157
    • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Roma, Italy, 00128
    • Università Campus Bio-Medico di Roma
  • Milano
    • Rho, Milano, Italy, 20017
      • Ospedale di Circolo
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
• Japan
  • 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
    • 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
    • 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
    • Sapporo, Hokkaido, Japan, 062-8618
      • JCHO Hokkaido Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0015
      • Aoyama Clinic
  • Ibaraki
    • Ibaraki, Ibaraki, Japan, 311-3193
      • NHO Mito Medical Center
  • 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
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 860-0004
      • Kaiseikai Hattori Clinic
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Mie University Hospital
  • Niigata
    • 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, Osaka, Japan, 583-0027
      • Shinseikai Sai Gastroenterology, Proctology Clinic
    • 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
    • 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
  • Klaipėda, Lithuania, 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, 64660
      • Inspirepharma S. de R.L. de C.V.
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital NZ
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital
  • Grafton, New Zealand, 1023
    • Auckland City Hospital
  • Hamilton, New Zealand, 3200
    • Waikato Hospital
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital
• Poland
  • 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
    • ETG Kielce Zagorska
  • Knurów, Poland, 44-190
    • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
  • Krakow, Poland, 30-363
    • Centrum Medyczne Plejady
  • 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
  • Oświęcim, Poland, 32-600
    • Medicome Sp. z o.o.
  • 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, 022328
    • Institutul Clinic Fundeni
  • Bucharest, Romania, 020125
    • Spitalul Clinic Colentina
  • Bucharest, Romania, 013812
    • Spitalul de Oncologie Monza
  • Bucharest, Romania, 030463
    • S.C Policlinica Ccbr S.R.L
  • Bucharest, Romania, 012015
    • SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
  • Bucharest, Romania, 014142
    • S.C Delta Health Care S.R.L
  • Bucharest, Romania, 12292
    • Lotus Med SRL
  • 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"
  • Subotica, Serbia, 24000
    • General Hospital Subotica
• 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.
  • Martin, Slovakia, 03659
    • Univerzitna nemocnica MARTIN
  • Nitra, Slovakia, 95001
    • Fakultna nemocnica Nitra
  • 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 Médico Teknon
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Dr Josep Trueta
  • Huelva, Spain, 21005
    • Hospital General Juan Ramon Jimenez
  • Pontevedra, Spain, 36071
    • Hospital Montecelo
  • Seville, Spain, 41017
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46010
    • Hospital Clinico 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. Negrin
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada
• United Kingdom
  • 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, 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
    • Phoenix, Arizona, United States, 85008
      • Valleywise Health Medical Center
    • Scottsdale, Arizona, United States, 85260
      • Reliance Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • California
    • Bakersfield, California, United States, 93309
      • National Institute of Clinical Research
    • Corona, California, United States, 92879
      • Kindred Medical Institute for Clinical Trials, LLC
    • 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
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Hospital
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut, LLC
  • Florida
    • Clearwater, Florida, United States, 33762
      • West Central Gastroenterology d/b/a Gastro Florida
    • Hialeah, Florida, United States, 33012
      • Superior Associates in Research
    • Kissimmee, Florida, United States, 34741
      • IHS Health
    • Miami, Florida, United States, 33157
      • Sanchez Clinical Research, Inc
    • Miami, Florida, United States, 33155-3009
      • Nicklaus Children's Hospital
    • Miami, Florida, United States, 33134
      • Research Associates of South Florida
    • Miami, Florida, United States, 33133
      • Infinite Clinical Research Inc
    • Miami, Florida, United States, 33165
      • Reliant Medical Research, LLC
    • 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
    • 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
  • Iowa
    • Clive, Iowa, United States, 50325
      • Iowa Digestive Disease Center
    • 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
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR Primacare Research, 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
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Gastrointestinal Associates, PA
  • Missouri
    • Liberty, Missouri, United States, 64068
      • BVL Clinical Research
  • New Jersey
    • 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
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Research Center, LLC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • 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
    • 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
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute, LLC
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • Fort Worth, Texas, United States, 76164
      • Valley Institute of Research
    • 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
    • Tyler, Texas, United States, 75703
      • Tyler Research Institute, LLC
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
  • Washington
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic

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 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

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 improvement (HEMI)	8 weeks

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): December 21, 2022
• 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 (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: ABX464-106

Drug and device information, study documents

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