AzTrials
AzTrials

Ulcerative ColitisPhase 3NCT05507203

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

A Phase 3 study testing ABX464 in people with Ulcerative Colitis, run by Abivax S.A. at 264 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… 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
639 participants
Where
264 sitesin 24 countries
Study dates
16 Nov 2022to 25 Jun 2025
Phase
Phase 3

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

  • Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old will be enrolled. To be eligible, adolescent subjects must weight ≥ 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
  • Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
  • Documented diagnosis of UC confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies or biopsies taken at screening may be used.
  • Active disease defined by modified Mayo score (MMS) ≥ 5 with rectal bleeding subscore (RBS) ≥ 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
  • Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic or biosimilar therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA or sulfasalazine is not accepted).
  • Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with the contraception requirements described in the protocol.
  • Subjects able and willing to comply with study visits and procedures as per protocol.
  • Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.

Who cannot join

  • 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).
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  • Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.
  • Subjects on antidiarrheals including those working on motility (e.g., loperamide, diphenoxylate with atropine, etc.).
  • Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii).
  • Subjects who do not meet the washout period requirements prior to the screening endoscopy
  • Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period:
  • Hemoglobin ≤ 8.0 g dL-1
  • Absolute neutrophil count < 750 mm-3
  • Platelets < 100,000 mm-3
  • Creatinine clearance < 60 mL.min-1 (Cockroft-Gault formula)
  • Total serum bilirubin > 1.5 x ULN
  • Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN
  • Subjects with the following conditions (infection):
  • Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy.
  • Herpes zoster reactivation within the last 2 months prior to screening.
  • Subjects with active infection at screening or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 1 month of screening or during screening. Fungal infection of nail beds is allowed.
  • Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested ≥ 2 weeks after completing treatment.
  • Subjects with HIV infection.
  • Subjects having acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen [HbsAg], or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable HBV DNA, or detectable HBV DNA).
  • Subjects having acute or chronic hepatitis C infection at screening as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA [assessed centrally] are eligible).
  • Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see study protocol.
  • Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart Association (NYHA) class 3 or 4 symptoms.
  • Subjects with a family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval [Fridericia or Bazett correction] >450 milliseconds for male and > 460 milliseconds for female).
  • Subjects with a history of torsade de pointe (TdP).
  • Acute or chronic of clinically relevant pulmonary, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history (note: treated autoimmune hypothyroidy and autoimmune diabetes are allowed).
  • Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).
  • Subjects previously treated with ABX464.
  • Subjects with a known hypersensitivity to the active substance or to any of the excipients.
  • WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study, or male subject with WOCBP partner who intends to be pregnant during the study.
  • Illicit drug or alcohol abuse or dependence.
  • Subjects who received live vaccine within 3 months prior to screening and/or who's planning to receive such a vaccine during the study duration.
  • Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer, and during the study.
  • Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

Trial locations and contacts

264 sites in 24 countries.

264 sites in 24 countries

United States54 sites

  • GI Alliance - Southlake

    Austin, Texas, 76092

  • Central Texas Clinical Research, LLC

    Austin, Texas, 78705

  • Novel Research LLC

    Bellaire, Texas, 77401

  • Clinical Research Of Brandon, LLC

    Brandon, Florida, 33511

  • Access Research Institute

    Brooksville, Florida, 34613

  • Texas Digestive Disease Consultants

    Cedar Park, Texas, 78613

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

    Charlotte, North Carolina, 28207

  • Eagle Clinical Research

    Chicago, Illinois, 60621

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Wexner Medical Center

    Columbus, Ohio, 43210

  • Baylor Scott and White

    Dallas, Texas, 75246

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • GI Alliance - Garland

    Garland, Texas, 75044

  • Gastroenterology Center of the MidSouth PC

    Germantown, Tennessee, 38138

  • GI Alliance

    Glenview, Illinois, 60026

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976

  • GI Alliance

    Gurnee, Illinois, 60031

  • Birmingham Digestive Health Research

    Homewood, Alabama, 35209

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Biopharma Informatic, Inc. Research Center

    Houston, Texas, 77043

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Nature Coast Clinical Research - Inverness

    Inverness, Florida, 34452

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • Gastro Health & Nutrition

    Katy, Texas, 78754

  • Auzmer Research

    Lakeland, Florida, 33813

  • Gastro Care Institute

    Lancaster, California, 93534

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Lubbock Digestive Disease Associates

    Lubbock, Texas, 79410

  • Care Access Research Lumberton

    Lumberton, North Carolina, 28358

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • GI Alliance -Gurnee

    Mansfield, Texas, 76063

  • Medical Professional Clinical Research Center

    Miami, Florida, 33165

  • Lucida Clinical Trials LLC

    New Bedford, Massachusetts, 02740

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • One Health Research Clinic Atlanta, LLC

    Norcross, Georgia, 30093

  • California Medical Research Associates Inc.

    Northridge, California, 91324

  • Care Access Research LLC

    Ogden, Utah, 84403

  • Clinnova Research Solutions

    Orange, California, 92868

  • Endoscopic Research, Inc.

    Orlando, Florida, 32803

  • Orlando Health-Orlando Regional Medical Center

    Orlando, Florida, 32806

  • Advanced Research Institute, Inc.

    Orlando, Florida, 32825

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida, 32503

  • Rochester Clinical Research

    Rochester, New York, 14609

  • University of Utah

    Salt Lake City, Utah, 84112

  • University of Washington

    Seattle, Washington, 98195

  • DSI Research LLC

    Springboro, Ohio, 45066

  • GI Alliance

    Sun City, Arizona, 85351

  • Theia Clinical Research Centers, LLC

    Temple Terrace, Florida, 33617

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • Digestive Research of Central Texas, LLC

    Waco, Texas, 76301

  • GI Alliance - Webster

    Webster, Texas, 77598

Other trials in United States

China41 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

  • The 2nd Xiangya Hospital of Central South University

    Changsha, Hu'nan, 410011

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force

    Fuzhou, Fujian, 350025

  • Jiangxi Gannan Medical College Affiliated 1 st Hospital

    Ganzhou, Jiangxi, 341000

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

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

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The First Affiliated Hospital of University of South China

    Hengyang, Hu'nan, 421001

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313099

  • 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

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Liuzhou People's Hospital

    Liuzhou, Guangxi Zhuang, 545006

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

    Luoyang, Henan, 471003

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646099

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210002

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan, 473000

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200082

  • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

    Shanghai, Shanghai Municipality, 200127

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110022

  • West China Hospital, Sichuan University

    Sichuan

  • 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

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

    Wuhan, Hubei, 430030

  • Renmin Hospital, Wuhan University

    Wuhan, Hubei, 430060

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • The First Affiliated Hospital of Sun Yat-sen University

    Yuexiu, Guangdong, 510080

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

Other trials in China

India16 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

  • Fortis Memorial Research Institute

    Gurgaon, Haryana, 122002

  • S. R. Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • Amrita Institute Of Medical Sciences and Research Centre

    Kochi, Kerala, 682041

  • Nil Ratan Sircar Medical College

    Kolkata, West Bengal, 700014

  • Chhatrapati Shahuji Maharaj (CSM) Medical University

    Lucknow, Uttar Pradesh, 226003

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001

  • Kingsway Hospital

    Nagpur, Maharashtra, 440001

  • Midas Multispeciality Hospital Pvt Ltd

    Nagpur, Maharashtra, 440010

  • Chopda Medicare & Research Centre

    Nashik, Maharashtra, 422005

  • Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Sahyadri Specialty Hospital

    Pune, Maharashtra, 411028

  • Shree Giriraj Multispeciality Hospital

    Rajkot, Gujarat, 360005

  • Unity Hospital ICU and Trauma

    Surat, Gujarat, 395010

Other trials in India

South Korea16 sites

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 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

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • 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

Poland15 sites

  • Przychodnia Specjalistyczna Insula

    Bełchatów, 97-400

  • Szpital Zakonu Bonifratow Sp. z o.o.

    Katowice, 40-211

  • NZOZ Centrum Medyczne ProMiMed

    Krakow, 31-637

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

    Łęczna, 21-010

  • AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

    Lodz, 90-644

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, 45-819

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • NSZOZ Termedica - Centrum Badan Klinicznych

    Poznan, 60-681

  • Twoja Przychodnia PCM

    Poznan, 61-293

  • Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

    Sosnowiec, 41-200

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

    Szczecin, 71-434

  • NZOZ VIVAMED Jadwiga Miecz

    Warsaw, 03-580

  • PlanetMed sp. z o.o.

    Wroclaw, 52-210

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

Ukraine15 sites

  • CNE Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

  • RCNE Chernivtsi Regional Clinical Hospital Gastroenterology Subdivision Bukovinian SMU

    Chernivtsi, 58001

  • Dnipro Division Medical Center Clinic of Family Medicine of LLC

    Dnipro, 49000

  • CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, 76008

  • CNCE Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council

    Khmelnytskyi, 29000

  • CNCE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council

    Kyiv, 02091

  • Clinical Hospital Feofaniia of State Management of Affairs

    Kyiv, 03143

  • Medical Center of Limited Liability Company Medical Center Concilium Medical

    Kyiv, 04050

  • Medical Center of Limited Liability Company Saliutas

    Lviv, 79005

  • CNCE of Lviv Regional Council Lviv Regional Clinical Hospital

    Lviv

  • LLC Medical Center The Clinic of Hospodarskyy

    Ternopil, 46002

  • CNE Uzhhorod city MCH of UCC Dept of Therapy

    Uzhhorod, 88000

  • Limited Liability Company Medical Center Health Clinic, Medical Clinical Research Center

    Vinnytsia, 21009

  • CNE M.I. Pyrohov Vinnytsia RCH of Vinnytsia Regional Council, RSC Gastro Center

    Vinnytsia, 21018

  • Clinic of the SRI of Invalid Rehab (EST Complex) of Pirogov Memorial NMU

    Vinnytsia, 21029

Other trials in Ukraine

France12 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25000

  • 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 D'or, 21000

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, Val De Marne, 94275

  • Hopital Saint Eloi

    Montpellier, Herault, 34295

  • CHU Nantes - Hôtel Dieu

    Nantes, Loire Atlantique, 44093

  • Hôpital Saint-Louis

    Paris, 75475

  • Centre Hospitalier de Pau - Hôpital François Mitterrand

    Pau, Pyrénées Atlantique, 64000

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, Gironde, 33604

  • CHU Reims - Hôpital Robert Debré

    Reims, Ardennes, 51100

  • CHU Saint Etienne - Hôpital Nord

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

Other trials in France

Germany11 sites

  • Gastroenterologie Berlin Karlshorst

    Berlin, 10318

  • Charité - Campus Benjamin Franklin

    Berlin, 12203

  • Staedisches Klinikum Brandenburg

    Brandenburg an der Havel, Brandenburg, 14770

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main, Hesse, 60590

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt

    Heidelberg, Baden-Wurttemberg, 69121

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • LMU - Campus Grosshadern

    Munich, Bavaria, 81337

Other trials in Germany

Australia10 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Canberra Hospital

    Canberra, Australian Capital Territory, 2605

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Coral Sea Clinical Research Institute

    North Mackay, Queensland, 4740

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

Other trials in Australia

Italy10 sites

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, 25124

  • Azienda Ospedaliera Giuseppe Brotzu

    Cagliari, 09134

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Raffaele

    Milan, 20132

  • Ospedale Sacro Cuore Don Calabria

    Negrar

  • Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

    Pisa

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese, Milano, 20097

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

United Kingdom8 sites

  • The Ulster Hospital

    Belfast, BT16 1RH

  • Bury Care Organisation

    Bury, Greater Manchester, BL9 7TD

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorkshire, HD3 3EA

  • Royal London Hospital

    London, Greater London, E1 1FR

  • St Mark's the National Bowel Hospital

    London, Greater London, NW10 7NS

  • King's College Hospital

    London, Greater London, SE5 9NU

  • Hammersmith Hospital

    London, Greater London, W12 0HS

  • Yeovil District Hospital

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

Czechia7 sites

  • CCR Brno, s.r.o.

    Brno, 60200

  • SurGal Clinic s.r.o.

    Brno, 60200

  • Vojenska nemocnice Brno

    Brno

  • Hepato-Gastroenterologie HK s.r.o.

    Hradec Králové, 50012

  • PreventaMed s.r.o.

    Olomouc, 77200

  • CCR Ostrava s.r.o.

    Ostrava, 70200

  • Nemocnice Slany

    Slaný, 27401

Other trials in Czechia

Turkey (Türkiye)6 sites

  • Gazi University Medical Faculty

    Ankara, 06500

  • Acibadem Kozyatagi Hospital

    Istanbul, 34742

  • Ege University Medical Faculty

    Izmir, 35100

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Mersin University Medical Faculty

    Mersin, 33343

  • Varlik Mah. Kazim Karabekir Cad.

    Muratpaşa, 07100

Other trials in Turkey (Türkiye)

Austria5 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

  • AKH - Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Belgium5 sites

  • AZ Sint-Lucas

    Bruges, 8310

  • C. H. U. St-Pierre

    Brussels, 1000

  • HUB Erasme

    Brussels, 1070

  • UZ Leuven

    Leuven, 3000

  • CHU UCL Namur

    Yvoir, 5530

Other trials in Belgium

Hungary5 sites

  • Bekes Varmegyei Kozponti Korhaz

    Békéscsaba, 5600

  • Clinexpert Kft.

    Budapest, 1033

  • Semmelweis Egyetem

    Budapest, 1082

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Debreceni Egyetem

    Debrecen

Other trials in Hungary

Bulgaria4 sites

  • Medical center Medconsult Pleven OOD

    Pleven, 5800

  • DCC "Alexandrovska", EOOD

    Sofia, 1431

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia, 1527

  • UMHAT Prof. Dr. Stoyan Kirkovich AD

    Stara Zagora, 6000

Other trials in Bulgaria

Netherlands4 sites

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Sittard, 6162 BG

  • ETZ Elisabeth

    Tilburg, 5022 GC

  • Bernhoven Uden

    Uden, 5406 PT

Other trials in Netherlands

Portugal4 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 Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Spain4 sites

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Gaias - Santiago

    Santiago de Compostela, La Coruña, 15702

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Switzerland4 sites

  • Claraspital

    Basel, 4058

  • Inselspital - Universitaetsspital Bern

    Bern, 3010

  • Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern

    Bern, 3012

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Argentina3 sites

  • STAT Research S.A.

    Ciudad Autonoma Buenos Aires, C1013AAB

  • Hospital Privado Centro Medico de Cordoba S.A

    Córdoba, X5016KEH

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

Other trials in Argentina

Canada3 sites

  • Gastroenterology and Internal Medicine Research Institute

    Edmonton, Alberta, T5R 1W2

  • McGill University Health Centre- Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Scott Shulman Medicine Professional Corporation

    North Bay, Ontario, P1B 2H3

Other trials in Canada

Greece2 sites

  • General Hospital of Athens "Evangelismos"

    Athens, 10676

  • General Hospital of Thessaloniki "Hippokration"

    Thessaloniki, 54642

Other trials in Greece

About this study

Official title: 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].

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 in the morning with food

  • PlaceboDrug

    Administered once daily in the morning with food

Study groups in NCT05507203
Study groupRoleWhat they receive
ABX464 50mgExperimentalSubjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
Receives: Drug: ABX464
ABX464 25mgExperimentalSubjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
Receives: Drug: ABX464
PlaceboPlacebo comparatorSubjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
Receives: Drug: Placebo

What is being measured

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

  1. 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. 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).

    Measured: 8 weeks

Secondary outcomes (3)

  1. Proportion of Subjects Who Achieve Endoscopic Improvement at Week 8

    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).

    Measured: 8 weeks

  2. 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 Modified Mayo Score (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.

    Measured: 8 weeks

  3. Proportion of Subjects With HEMI Per Geboes at Week 8

    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.

    Measured: 8 weeks

Timeline

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

  1. First posted18 Aug 2022
  2. Study start16 Nov 2022
  3. Primary completion24 Jun 2025
  4. Study completion25 Jun 2025

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
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
639 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507203
Sponsor's protocol ID
ABX464-105
Status last verified
Aug 2026
First submitted
17 Aug 2022
Last updated
10 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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