AzTrials
AzTrials

Ulcerative ColitisPhase 3NCT05535946

ABTECT - Maintenance

A Phase 3 study testing ABX464 in people with Ulcerative Colitis, run by Abivax S.A. at 413 sites in 34 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
ABX464
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,116 participants
Where
413 sitesin 34 countries
Study dates
16 Jan 2023to May 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients' clinical response status must be available.
  • Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
  • Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
  • Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with contraception requirements as described in Section 4.4. (Contraception) of the protocol.
  • Subjects must be able and willing to comply with study visits and procedures as per protocol.
  • Subjects should be affiliated to a health insurance policy whenever required by a participating country or state
  • Subject must have completed the maintenance phase
  • Investigator and subject must assess and agree that the subject has received, and will continue to receive benefit from being in the study

Who cannot join

  • Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).
  • Subjects who have developed any major illness/condition (eg. primary sclerosis cholangitis, Crohn's disease, colectomy, diverting ileostomy, colon cancer or colonic adenomas [low or high grade dysplasia]).
  • Subjects with evidence of an unstable clinical condition (eg. toxic megacolon, fulminant colitis, bowel perforation, uncontrolled ischemic disease, congestive heart failure with NYHA class 3 or 4 symptoms) during the induction study that, in the investigator's judgment, will substantially increase the risk to the subject if he or she participates in the study.
  • Subjects who plan to participate in other investigational studies during the maintenance study.
  • Male or female planning a pregnancy, or pregnant female subjects
  • Introduction during induction study of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).
Show all 11Show fewer
  • Any changes in the laboratory values during the induction period that could jeopardize subject's safety in the opinion of the investigator. If any doubts, the investigator should contact the sponsor study medical monitor.
  • Subject who is planning to receive live vaccine during the study.
  • Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • Subject continues to satisfy exclusion criteria listed above for the maintenance phase
  • Introduction during maintenance phase of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).

Trial locations and contacts

413 sites in 34 countries.

413 sites in 34 countries

United States72 sites

  • Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals

    Aurora, Colorado, 80014

  • Central Texas Clinical Research, LLC

    Austin, Texas, 78705

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Texas Digestive Disease Consultants

    Cedar Park, Texas, 78613

  • Charlotte Gastroenterology and Hepatology, P.L.L.C

    Charlotte, North Carolina, 28207

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33762

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Columbia Digestive Health Research

    Columbia, South Carolina, 29204

  • Wexner Medical Center

    Columbus, Ohio, 43210

  • Citrus Valley Gastroenterology

    Covina, California, 91723

  • Baylor Scott and White

    Dallas, Texas, 75246

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • AIG Digestive Disease Research

    Florham Park, New Jersey, 07932

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • Gastroenterology Center of the MidSouth PC

    Germantown, Tennessee, 38138

  • Gastroenterology Associates, PA

    Greenville, South Carolina, 29607

  • GI Alliance

    Gurnee, Illinois, 60031

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • The University of Iowa

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • University of California (San Diego)

    La Jolla, California, 92093

  • Auzmer Research

    Lakeland, Florida, 33813

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • Research Solutions of Arizona, PC

    Litchfield Park, Arizona, 85340

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205-7199

  • Infinite Clinical Research Inc

    Miami, Florida, 33133

  • Research Associates of South Florida, LLC

    Miami, Florida, 33134

  • University of Miami

    Miami, Florida, 33136

  • MedOne Clinical Research LLC

    Miami, Florida, 33145

  • Nicklaus Children's Hospital

    Miami, Florida, 33155-3009

  • Medical Professional Clinical Research Center

    Miami, Florida, 33165

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

  • United Medical Doctors

    Murrieta, California, 92563

  • Lucida Clinical Trials LLC

    New Bedford, Massachusetts, 02740

  • Mount Sinai

    New York, New York, 10029

  • California Medical Research Associates Inc.

    Northridge, California, 91324

  • Ocala GI Research

    Ocala, Florida, 34471

  • Digestive Health Center PA

    Ocean Springs, Mississippi, 39564

  • Care Access Research LLC

    Ogden, Utah, 84403

  • Board of Regents of the University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Clinnova Research Solutions

    Orange, California, 92868

  • Arnold Palmer Hospital For Children

    Orlando, Florida, 32806

  • Advanced Research Institute, Inc.

    Orlando, Florida, 32825

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • Rapid City Medical Center, LLC

    Rapid City, South Dakota, 57701

  • Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

    Roanoke, Virginia, 24014

  • Rochester Clinical Research

    Rochester, New York, 14609

  • University of Utah

    Salt Lake City, Utah, 84112

  • Clinical Applications Laboratories

    San Diego, California, 92103

  • GI Alliance - Southlake

    Southlake, Texas, 76092

  • Henry Ford Hospital

    Sterling Heights, Michigan, 48313

  • GI Alliance

    Sun City, Arizona, 85351

  • GCP Clinical Research, LLC

    Tampa, Florida, 33609

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Alliance Clinical Research

    Tampa, Florida, 33615

  • University of Arizona

    Tucson, Arizona, 85724

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, 15401

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • TPMG Clinical Research Williamsburg

    Williamsburg, Virginia, 23188

  • Wilmington Health

    Wilmington, North Carolina, 28401

  • Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan48 sites

  • Asahikawa Medical University Hospital

    Asahikawa-shi, Hokkaido, 078-8510

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, Tokyo-To, 113-8519

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, 818-8502

  • Shinseikai Sai Gastroenterology, Proctology

    Fujiidera-shi, Osaka, 583-0027

  • NHO Fukuyama Medical Center

    Fukuyama-shi, Hiroshima, 720-8520

  • Matsuaikai Matsuda Hospital

    Hamamatsu, Shizuoka, 432-8061

  • JA-Hiroshima General Hospital

    Hatsukaichi-shi, Hiroshima, 738-8503

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 734-8530

  • NHO Mito Medical Center

    Ibaraki, 311-3193

  • Aso Co.,Ltd Iizuka Hospital

    Iizuka-shi, Fukuoka, 820-8505

  • Jiaikai Izuro Imamura Hospital

    Kagoshima, Kagoshima-ken, 892-0824

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, Kagoshima-ken, 892-0843

  • Sameshima Hospital

    Kagoshima, Kagoshima-ken, 892-0846

  • Gokeikai Ofuna Chuo Hospital

    Kamakura-shi, Kanagawa, 247-0056

  • NHO Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

  • Kokikai Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba, 277-0871

  • Kawasaki Municipal Hospital

    Kawasaki-shi, Kanagawa, 210-0013

  • Aoyama Clinic

    Kobe, Hyōgo, 650-0015

  • Showa University Koto Toyosu Hospital

    Kōtoku, Tokyo-To, 135-8577

  • Kumagaya General Hospital

    Kumagaya-shi, Saitama, 360-8567

  • Kaiseikai Hattori Clinic

    Kumamoto, Kumamoto, 860-0004

  • NHO Kure Medical Center and Chugoku Cancer Center

    Kure-shi, Hiroshima, 737-0023

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Our Lady of the Snow St. Mary's Hospital

    Kurume-shi, Fukuoka, 830-8543

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime, 790-0024

  • Kitasato University Kitasato Institute Hospital

    Minatoku, Tokyo-To, 108-8642

  • Nagaoka Red Cross Hospital

    Nagaoka-shi, Niigata, 940-2085

  • Saiseikai Niigata Hospital

    Niigata, Niigata, 950-1104

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, Oita Prefecture, 870-0823

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • NHO Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • Keiaikai Nakagami Hospital

    Okinawa-shi, Okinawa, 904-2195

  • Kinshukai Infusion Clinic

    Osaka, Osaka, 530-0011

  • NHO Osaka National Hospital

    Osaka, Osaka, 540-0006

  • JCHO Osaka Hospital

    Osaka, Osaka, 553-0003

  • SUBARU Health Insurance Society Ota Memorial Hospital

    Ota-shi, Gunma, 373-8585

  • Saga-Ken Medical Centre Koseikan

    Saga, Saga-ken, 840-8571

  • Saga University Hospital

    Saga, Saga-ken, 849-8501

  • JCHO Hokkaido Hospital

    Sapporo, Hokkaido, 062-8618

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-Ku, Tokyo-To, 169-0073

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida-ku, Tokyo-To, 130-8575

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • NHO Ureshino Medical Center

    Ureshino-shi, Saga-ken, 843-0393

  • Keijinkai Matsushima Hospital

    Yokohama, Kanagawa, 220-0041

  • Showa University Northern Yokohama Hospital

    Yokohama, Kanagawa, 224-8503

Other trials in Japan

India33 sites

  • Navneet Memorial Hospital 'Sushrusha'

    Ahmedabad, Gujarat, 380009

  • M. S. Ramaiah Medical College and Hospital

    Bangalore, Karnataka, 560054

  • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

    Belagāve, Karnataka, 590010

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012

  • SRM Institutes for Medical Sciences

    Chennai, Tamil Nadu, 600026

  • Fortis Memorial Research Institute

    Gurgaon, Haryana, 122002

  • Origin Hospital

    Hyderabad, Andhra Pradesh, 500048

  • Yashoda Super Speciality Hospital

    Hyderabad, Andhra Pradesh, 500082

  • S. R. Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • Lakeshore Hospital and Research Centre Ltd.

    Kochi, Kerala, 682040

  • Amrita Institute Of Medical Sciences and Research Centre

    Kochi, Kerala, 682041

  • Nil Ratan Sircar Medical College

    Kolkata, West Bengal, 700014

  • Institute of Post Graduate Medical Education And Research

    Kolkata, West Bengal, 700020

  • Chhatrapati Shahuji Maharaj (CSM) Medical University

    Lucknow, Uttar Pradesh, 226003

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001

  • Vinaya Hospital and Research Center

    Mangalore, Karnataka, 575003

  • King Edward Memorial Hospital Research Centre

    Mumbai, Maharashtra, 400012

  • Lokmanya Tilak Municipal General Hospital & Medical College

    Mumbai, Maharashtra, 400022

  • Kingsway Hospital

    Nagpur, Maharashtra, 440010

  • Midas Multispeciality Hospital Pvt Ltd

    Nagpur, Maharashtra, 440010

  • Chopda Medicare & Research Centre

    Nashik, Maharashtra, 422005

  • Fortis Escorts Heart Institute and Research Centre

    New Delhi, National Capital Territory of Delhi, 110025

  • Maharaja Agrasen Hospital

    New Delhi, National Capital Territory of Delhi, 110026

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

  • Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Sahyadri Specialty Hospital

    Pune, Maharashtra, 411004

  • Shree Giriraj Multispeciality Hospital

    Rajkot, Gujarat, 360005

  • Gandhi Hospital

    Secunderabad, Andhra Pradesh, 500003

  • Surat Institute of Digestive Sciences

    Surat, Gujarat, 395002

  • Gujarat Hospital

    Surat, Gujarat, 395009

  • Unity Hospital ICU and Trauma

    Surat, Gujarat, 395010

  • Isha Multispeciality Hospital

    Vadodara, Gujarat, 390007

  • Datta Meghe Institute of Medical Sciences (Deemed University)

    Wardha, Maharashtra, 442004

Other trials in India

Poland28 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, 85-231

  • Trialmed CRS

    Kalisz, 62-800

  • Polimedica Centrum Badań, Profilaktyki I Leczenia

    Kielce, 25-355

  • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

    Knurów, 44-190

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

    Łęczna, 21-010

  • Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, 90-302

  • AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

    Lodz, 90-644

  • 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie

    Lublin, 20-049

  • ALLMEDICA sp. z o. o.

    Nowy Targ, 34-400

  • Wojewodzki Specjalistyczny Szpital w Olsztynie

    Olsztyn, 10-561

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, 45-819

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • NSZOZ Termedica - Centrum Badan Klinicznych

    Poznan, 60-681

  • Twoja Przychodnia PCM

    Poznan, 61-293

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, 35-302

  • Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

    Sosnowiec, 41-200

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28-200

  • DC-MED

    Swidnica, 58-100

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

    Szczecin, 71-434

  • CenterMed Sp. z o.o.

    Tarnów, 33-100

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • NZOZ VIVAMED Jadwiga Miecz

    Warsaw, 03-580

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

  • Ars-Medica S.C Rybak Maria, Rybak Zbigniew

    Wroclaw, 53-333

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

France21 sites

  • CHU Amiens - Hopital Sud

    Amiens, Somme, 80054

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25000

  • CHU Caen - Hôpital de la Côte de Nacre

    Caen, Calvados, 14033

  • CHU Clermont Ferrand - Hopital d'Estaing

    Clermont-Ferrand, Puy De Dome, 63000

  • Hôpital Henri Mondor

    Créteil, Val De Marne, 94010

  • CHU Dijon - Hôpital Bocage Central

    Dijon, Cote dÝOr, 21000

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon, Vendée, 85925

  • Hôpital Nord - CHU Marseille

    Marseille, Bouches-du-Rhône, 13915

  • Hopital Saint Eloi

    Montpellier, Herault, 34295

  • CHU Nantes - Hôtel Dieu

    Nantes, Loire Atlantique, 44093

  • Institut des MICI

    Neuilly, Hauts De Seine, 92200

  • CHU Nice - Hôpital de l'Archet 2

    Nice, Alpes Maritimes, 06200

  • Hôpital Saint-Louis

    Paris, 75475

  • Centre Hospitalier de Pau - Hôpital François Mitterrand

    Pau, Pyrenees Atlantiques, 64000

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, Gironde, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhone, 69495

  • CHU Reims - Hôpital Robert Debré

    Reims, Ardennes, 51100

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, Ille Et Vilaine, 35000

  • CHU Saint Etienne - Hôpital Nord

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055

  • Hopital Rangueil

    Toulouse, Haute Garonne, 31059

  • Universite de Lorraine - Faculte de Medecine - INSERM U954

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 20199 - 54505

Other trials in France

China20 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangzhou, 510655

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yun'nan, 650032

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Shengjing Hospital of China Medical University, Hua Xiang branch hospital

    Shenyang, Liaoning, 110022

  • Taian City Central Hospital

    Tai’an, Shandong, 271000

  • Tianjin Union Medical Center

    Tianjin, Tianjin Municipality, 300121

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

South Korea20 sites

  • Korea University Ansan Hospital

    Ansan-si, North Chungcheong, 15355

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Dong-A University Hospital

    Busan, 49201

  • Yeungnam University Hospital

    Daegu, Gyeongsangbuk-do, 42415

  • Kyungpook National University Hospital

    Daegu, 41944

  • The Catholic University of Korea, Daejeon St. Mary's Hospital

    Daejeon, 34943

  • Gachon University Gil Medical Center

    Incheon, 21565

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Italy19 sites

  • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, 40126

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, 25124

  • Presidio Ospedaliero Garibaldi Nesima

    Catania, 95122

  • Azienda Ospedaliero Universitaria Mater Domini

    Catanzaro, 88100

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

    Milan, 20157

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

    Naples, 80131

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Verona, 37024

  • Ospedale Cervello

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Ospedale di Circolo

    Rho, Milano, 20017

  • Università Campus Bio-Medico di Roma

    Roma, 00128

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Ospedale San Raffaele

    Rozzano, Milano, 20089

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese, Milano, 20097

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine, 33100

  • Ospedale San Bortolo di Vicenza

    Vicenza, 36100

Other trials in Italy

Germany15 sites

  • Charité - Campus Charité Mitte

    Berlin, 10117

  • Gastroenterologie Berlin Karlshorst

    Berlin, 10318

  • DRK Kliniken Berlin Westend

    Berlin, 14050

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen

    Hamburg, 20251

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt

    Heidelberg, Baden-Wurttemberg, 69121

  • INLUGA im Haus der Gesundheit

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67067

  • LMU-Campus Grosshadern

    Munich, Bavaria, 81377

  • Medius Klinik Nuertingen

    Nürtingen, Baden-Wurttemberg, 72622

  • Siloah St. Trudpert Klinikum

    Pforzheim, Baden-Wurttemberg, 75179

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Spain15 sites

  • Centro Medico Teknon

    Barcelona, 08022

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Hospital General Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, Las Palmas, 35019

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Montecelo

    Pontevedra, 36071

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41017

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Brazil9 sites

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, São Paulo, 18618-686

  • L2IP - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

  • Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • CDC - Centro Digestivo de Curitiba

    Curitiba, Paraná, 80430-160

  • CECIP - Centro de Estudos Clínicos do Interior Paulista

    Jaú, São Paulo, 17201-130

  • Hospital Aliança

    Salvador, Estado de Bahia, 41920-180

  • Pesquisare Saúde

    Santo André, São Paulo, 09080-110

  • Irmandade da Santa Casa da Misericórdia de Santos

    Santos, São Paulo, 11075-101

  • Hepatogastro

    São Paulo, São Paulo, 04543-011

Other trials in Brazil

Czechia8 sites

  • CCR Brno, s.r.o.

    Brno, 60200

  • SurGal Clinic s.r.o.

    Brno, 60200

  • Hepato-Gastroenterologie HK s.r.o.

    Hradec Králové, 500 12

  • PreventaMed s.r.o.

    Olomouc, 77900

  • CCR Ostrava s.r.o.

    Ostrava, 702 00

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Institut klinicke a experimentalni mediciny

    Prague, 140 21

  • Nemocnice Slany

    Slaný, 274 01

Other trials in Czechia

Slovakia8 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta

    Banská Bystrica, 97517

  • Cliniq s.r.o.

    Bratislava, 82007

  • Endomed, s.r.o.

    Košice, 040 13

  • KM Management spol. s r.o.

    Nitra, 949 01

  • Fakultna nemocnica Nitra

    Nitra, 95001

  • Gastro I, s.r.o.

    Prešov, 080 01

  • Gastro LM s.r.o.

    Prešov, 08001

  • Accout Center s.r.o.

    Šahy, 93601

Other trials in Slovakia

Belgium7 sites

  • C. H. U. St-Pierre

    Brussels, 1000

  • AZ Maria Middelares

    Ghent, 9000

  • AZ Sint-Lucas

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Clinique CHC MontLégia

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

  • CHU UCL Namur

    Yvoir, 5530

Other trials in Belgium

Israel7 sites

  • HaEmek Medical Center

    Afula, 18101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5265602

  • Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Netherlands7 sites

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Geleen, 6162 BG

  • Radboud UMC

    Nijmegen, 6525 GA

  • Erasmus MC

    Rotterdam, 3015 GD

  • ETZ Elisabeth

    Tilburg, 5022 GC

  • Bernhoven Uden

    Uden, 5406 PT

  • UMC Utrecht

    Utrecht, 3508 GA

Other trials in Netherlands

Turkey (Türkiye)7 sites

  • Gazi University Medical Faculty

    Ankara, 06500

  • Antalya Training and Research Hospital

    Antalya, 07100

  • Koc University Hospital

    Istanbul, 34010

  • Medicana Kadikoy Hospital

    Istanbul, 34724

  • Acibadem Kozyatagi Hospital

    Istanbul, 34742

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Inonu University Gastroenterology

    Malatya, 44280

Other trials in Turkey (Türkiye)

United Kingdom7 sites

  • Bury Care Organisation

    Bury, Greater Manchester, BL9 7TD

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • St Mark's Hospital

    Harrow, Middlesex, HA1 3UJ

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorkshire, HD3 3EA

  • Guy's Hospital

    London, Greater London, SE1 9RT

  • King's College Hospital

    London, Greater London, SE5 9NU

  • Yeovil District Hospital

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

Romania6 sites

  • SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

    Bucharest, 012015

  • Spitalul de Oncologie Monza

    Bucharest, 013812

  • S.C Delta Health Care S.R.L

    Bucharest, 014142

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006

  • Centrul Medical Renasterea Craiova

    Craiova, 200073

Other trials in Romania

Serbia6 sites

  • Clinical Center " Dr Dragisa Misovic Dedinje"

    Belgrade, 11000

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • Clinical Hospital Center "Bezanijska kosa

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • General Hospital Subotica

    Subotica, 24000

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000

Other trials in Serbia

Argentina5 sites

  • STAT Research S.A.

    Buenos Aires, C1013AAB

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • Hospital Privado Centro Medico de Cordoba S.A

    Córdoba, Córdoba Province, 5016

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

  • Centro de Investigacion CICE

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Hungary5 sites

  • Bekes Varmegyei Kozponti Korhaz

    Békéscsaba, 5600

  • Semmelweis Egyetem

    Budapest, 1082

  • Semmelweis Egyetem

    Budapest, 1088

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Gyongyosi Bugat Pal Korhaz

    Gyöngyös, 3200

Other trials in Hungary

Mexico5 sites

  • Consultorio Medico, InvesclinicMX

    Irapuato, Guanajuato, 36650

  • Inspirepharma S. de R.L. de C.V.

    Monterrey, Nuevo León, 64660

  • Christus Muguerza Sur S.A. de C.V.

    Monterrey, Nuevo León, 64908

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900

  • Sociedad de Metabolismo y Corazon S.C

    Veracruz, 91900

Other trials in Mexico

Portugal5 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital da Senhora da Oliveira Guimarães

    Guimarães, 4835-044

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

    Viana do Castelo, 4904-858

Other trials in Portugal

Australia4 sites

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Austria4 sites

  • LKH - Universitaetsklinikum Graz

    Graz, 8036

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • KH der Barmherzigen Brüder St.Veit an der Glan

    Sankt Veit an der Glan, 9300

Other trials in Austria

Bulgaria4 sites

  • Medical center Medconsult Pleven OOD

    Pleven, 5800

  • DCC "Alexandrovska", EOOD

    Sofia, 1431

  • UMHATEM 'N.I. Pirogov', EAD

    Sofia, 1606

  • MC Medica Plus

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Canada4 sites

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

  • London Health Sciences Centre (LHSC) - Victoria Hospital

    London, Ontario, N6A 5W9

  • Toronto Immune & Digestive Health Institute

    North York, Ontario, M6A 3B4

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Greece4 sites

  • General Hospital of Athens "Evangelismos"

    Athens, 10676

  • Corfu General Hospital "St. Eirini"

    Corfu, 49100

  • University General Hospital of Heraklion

    Heraklion, 71110

  • General Hospital of Thessaloniki "Hippokration"

    Thessaloniki, 54642

Other trials in Greece

Ireland3 sites

  • Connolly Hospital

    Dublin, 15

  • St Vincents University Hospital

    Dublin, DUBLIN 4

  • Midland Regional Hospital

    Mullingar, Westmeath, N91

Other trials in Ireland

Switzerland3 sites

  • Clarunis - Universitäres Bauchzentrum Basel

    Basel, 4031

  • Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern

    Bern, 3012

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Lithuania2 sites

  • Lithuanian University of Health Sciences Kaunas Hospital

    Kaunas, 47144

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50161

Other trials in Lithuania

Croatia1 site

  • Clinical Hospital Centre Osijek

    Osijek, 31000

Other trials in Croatia

New Zealand1 site

  • Waikato Hospital

    Hamilton, 3200

Other trials in New Zealand

About this study

Official title: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.

Read the detailed description

All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 study which consists of 2 treatment phases.

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

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

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

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

Being tested
ABX464, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABX464Drug

    Also called Obefazimod

    Administered once daily, preferably in the morning, with food

  • PlaceboDrug

    Administered once daily, preferably in the morning, with food

Study groups in NCT05535946
Study groupRoleWhat they receive
ABX464 50mg - Responder subjects at the end of inductionPlacebo comparatorSubjects will be orally dosed during 44 weeks
Receives: Drug: ABX464
ABX464 25mg - Responder subjects at the end of inductionPlacebo comparatorSubjects will be orally dosed during 44 weeks
Receives: Drug: ABX464
Placebo - Responder subjects at the end of inductionPlacebo comparatorSubjects will be orally dosed during 44 weeks
Receives: Drug: Placebo
ABX464 50mg - Non responder subjects at the end of inductionExperimentalSubjects will be orally dosed during 44 weeks
Receives: Drug: ABX464
ABX464 25mg - Non responder subjects at the end of inductionExperimentalSubjects will be orally dosed during 44 weeks
Receives: Drug: ABX464
Long Term ExtensionExperimentalAt the end of the maintenance phase (week 44), subjects can continue their allocated treatment for up to 4 years. Once the maintenance phase is unblinded, subjects receiving placebo in the maintenance phase will be allocated to obefazimod 25 mg or can terminate the study.
Receives: Drug: ABX464

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of subjects in clinical remission at Week 44

    The Part 1 primary objective is to compare the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1] at Week 44.

    Measured: Week 44

  2. Number and percentage of all treatment-emergent adverse events (TEAEs)

    The Part 2 primary objective is safety

    Measured: Week 44

  3. Number and percentage of all serious adverse events (SAEs)

    The Part 2 primary objective is safety

    Measured: Week 44

  4. Number and percentage of all causally related TEAEs/SAEs

    The Part 2 primary objective is safety

    Measured: Week 44

Secondary outcomes (26)

  1. Proportion of subjects with endoscopic improvement at Week 44

    To compare the efficacy of ABX464 versus placebo on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44

    Measured: Week 44

  2. Proportion of subjects with corticosteroid-free clinical remission

    To compare the efficacy of ABX464 versus placebo on corticosteroid-free clinical remission (clinical remission at Week 44 and corticosteroid free for at least 12 weeks prior to Week 44 in the subpopulation with corticosteroids at maintenance study entry)

    Measured: Week 44

  3. Proportion of subjects with sustained clinical remission at Week 44

    To compare the efficacy of ABX464 versus placebo to sustain clinical remission at Week 44

    Measured: Week 44

  4. Proportion of subjects with HEMI per Geboes scoring at Week 44

    To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo at Week 44

    Measured: Week 44

  5. Proportion of subjects with endoscopic remission at Week 44

    To compare the efficacy of ABX464 versus placebo on endoscopic remission (MES = 0) at Week 44

    Measured: Week 44

  6. LTE Phase - Proportion of subjects in clinical remission at Year 1

    To evaluate the efficacy of obefazimod on clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1] at Year 1

    Measured: LTE Year 1

  7. LTE Phase - Proportion of subjects in clinical remission at Year 4

    To evaluate the efficacy of obefazimod on clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1] at Year 4

    Measured: LTE Year 4

  8. LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry

    To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 1 and corticosteroid free for at least 12 weeks prior to Year 1 in the subpopulation with corticosteroids at maintenance study entry)

    Measured: LTE Year 1

  9. LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry)

    To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 4 and corticosteroid free for at least 12 weeks prior to Year 4 in the subpopulation with corticosteroids at maintenance study entry)

    Measured: LTE Year 4

  10. LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 1

    To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1)

    Measured: LTE Year 1

  11. LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 4

    To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1)

    Measured: LTE Year 4

  12. LTE Phase - Proportion of subjects with endoscopic remission at LTE year 1

    To evaluate the efficacy of obefazimod on endoscopic remission ((Mayo Endoscopic Subscore (MES) = 0)

    Measured: LTE year 1

  13. LTE Phase - Proportion of subjects with endoscopic remission at LTE year 4

    To evaluate the efficacy of obefazimod on endoscopic remission (Mayo Endoscopic Subscore (MES) = 0)

    Measured: LTE year 4

  14. LTE Phase - Proportion of subjects with CS-free symptomatic remission by visit

    To evaluate the efficacy of obefazimod on CS-free symptomatic remission (symptomatic remission (SFS = 0 or 1 and RBS = 0) and corticosteroid free for at least 12 weeks prior to Week 44 in the subpopulation with corticosteroids at maintenance study entry) by visit (every 3-month)

    Measured: 4 years

  15. LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 1

    To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring

    Measured: LTE Year 1

  16. LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 4

    To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring

    Measured: LTE Year 4

  17. LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 1

    To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo

    Measured: LTE Year 1

  18. LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 4

    To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo

    Measured: LTE Year 4

  19. LTE Phase - Proportion of subjects with sustained clinical remission at LTE Year 1, in the sub-population of subjects with clinical remission at Week 44

    To evaluate the efficacy of obefazimod on sustained clinical remission Sustained clinical remission for the LTE is defined as clinical remission assessed at an endoscopy visit during the LTE in the sub-population of subjects in clinical remission at Week 44.

    Measured: LTE Year 1

  20. LTE Phase - Proportion of subjects with sustained clinical remission at LTE year 4, in the sub-population of subjects with clinical remission at Week 44

    To evaluate the efficacy of obefazimod on sustained clinical remission Sustained clinical remission for the LTE is defined as clinical remission assessed at an endoscopy visit during the LTE in the sub-population of subjects in clinical remission at Week 44.

    Measured: LTE year 4

  21. LTE Phase - Proportion of subjects with sustained endoscopic improvement at LTE Year 1, in the sub-population of subjects with endoscopic improvement at Week 44

    To evaluate the efficacy of obefazimod on sustained endoscopic improvement

    Measured: LTE Year 1

  22. LTE Phase - Proportion of subjects with sustained endoscopic improvement at LTE Year 4, in the sub-population of subjects with endoscopic improvement at Week 44

    To evaluate the efficacy of obefazimod on sustained endoscopic improvement

    Measured: LTE year 4

  23. LTE Phase - Proportion of subjects with symptomatic remission by visit

    To evaluate the efficacy of obefazimod on symptomatic remission (SFS = 0 or 1 and RBS = 0) by visit (every 3-month)

    Measured: 4 years

  24. LTE Phase - Proportion of subjects with sustained symptomatic remission by visit

    To evaluate the efficacy of obefazimod on sustained symptomatic remission (SFS = 0 or 1 and RBS = 0) by visit (every 3-month), in the sub-population of subjects with symptomatic remission at Week 44

    Measured: 4 years

  25. LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 1

    To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 1 and CS-free for at least 12 weeks immediately prior to Year 1)

    Measured: LTE Year 1

  26. LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 4

    To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 4 and CS-free for at least 12 weeks immediately prior to Year 4)

    Measured: LTE Year 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2022
  2. Study start16 Jan 2023
  3. Primary completion28 Apr 2026
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Among both induction studies, subjects assessed as responders will be randomized as follows into Part 1 of the maintenance study according to their induction treatment: * ABX464 Dose 50 mg QD * ABX464 Dose 25 mg QD * Placebo. All subjects with clinical response who were dosed with placebo in the induction studies will be randomized into the placebo group. Among both induction studies, subjects assessed as non-responders will be randomized as follows into Part 2 of the maintenance study according to their induction treatment: * ABX464 Dose 50 mg QD (all subjects who received 50 mg in induction) * ABX464 Dose 25 mg QD (all subjects who received 25 mg in induction) * Subjects who were allocated to placebo in the induction study will be randomized to obefazimod 50 mg or 25 mg in a blinded manner.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05535946
Sponsor's protocol ID
ABX464-107
Status last verified
Jul 2026
First submitted
7 Sep 2022
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABX464 in people with Ulcerative Colitis, run by Abivax S.A. at 413 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 413 sites in United States, Japan, India, Poland, France and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of subjects in clinical remission at Week 44 (time frame: Week 44). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05535946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in