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COMPLETED
NCT05507203
PHASE3

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

Sponsor: Abivax S.A.

View on ClinicalTrials.gov

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 conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].

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

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

639

Start Date

2022-11-16

Completion Date

2025-06-25

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DRUG

ABX464

Administered once daily in the morning with food

DRUG

Placebo

Administered once daily in the morning with food

Locations (264)

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Lakeview Clinical Research

Guntersville, Alabama, United States

Birmingham Digestive Health Research

Homewood, Alabama, United States

GI Alliance

Sun City, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

Gastro Care Institute

Lancaster, California, United States

California Medical Research Associates Inc.

Northridge, California, United States

Clinnova Research Solutions

Orange, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Clinical Research Of Brandon, LLC

Brandon, Florida, United States

Access Research Institute

Brooksville, Florida, United States

Nature Coast Clinical Research - Inverness

Inverness, Florida, United States

Auzmer Research

Lakeland, Florida, United States

Medical Professional Clinical Research Center

Miami, Florida, United States

Advanced Research Institute, Inc.

New Port Richey, Florida, United States

Endoscopic Research, Inc.

Orlando, Florida, United States

Orlando Health-Orlando Regional Medical Center

Orlando, Florida, United States

Advanced Research Institute, Inc.

Orlando, Florida, United States

Gastroenterology Associates of Pensacola, PA

Pensacola, Florida, United States

Theia Clinical Research Centers, LLC

Temple Terrace, Florida, United States

One Health Research Clinic Atlanta, LLC

Norcross, Georgia, United States

Eagle Clinical Research

Chicago, Illinois, United States

GI Alliance

Glenview, Illinois, United States

GI Alliance

Gurnee, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, United States

Lucida Clinical Trials LLC

New Bedford, Massachusetts, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Rochester Clinical Research

Rochester, New York, United States

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

Charlotte, North Carolina, United States

Care Access Research Lumberton

Lumberton, North Carolina, United States

Wexner Medical Center

Columbus, Ohio, United States

DSI Research LLC

Springboro, Ohio, United States

Gastroenterology Center of the MidSouth PC

Germantown, Tennessee, United States

GI Alliance - Southlake

Austin, Texas, United States

Central Texas Clinical Research, LLC

Austin, Texas, United States

Novel Research LLC

Bellaire, Texas, United States

Texas Digestive Disease Consultants

Cedar Park, Texas, United States

Baylor Scott and White

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

GI Alliance - Garland

Garland, Texas, United States

Baylor College Of Medicine

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Biopharma Informatic, Inc. Research Center

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Gastro Health & Nutrition

Katy, Texas, United States

Lubbock Digestive Disease Associates

Lubbock, Texas, United States

GI Alliance -Gurnee

Mansfield, Texas, United States

Digestive Research of Central Texas, LLC

Waco, Texas, United States

GI Alliance - Webster

Webster, Texas, United States

Care Access Research LLC

Ogden, Utah, United States

University of Utah

Salt Lake City, Utah, United States

Blue Ridge Medical Research

Lynchburg, Virginia, United States

University of Washington

Seattle, Washington, United States

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

STAT Research S.A.

Ciudad Autonoma Buenos Aires, Argentina

Hospital Privado Centro Medico de Cordoba S.A

Córdoba, Argentina

Canberra Hospital

Canberra, Australian Capital Territory, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Coral Sea Clinical Research Institute

North Mackay, Queensland, Australia

Mater Misericordiae Ltd

South Brisbane, Queensland, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

LKH - Universitaetsklinikum Graz

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, Austria

KH der Barmherzigen Brüder St.Veit an der Glan

Sankt Veit an der Glan, Austria

AKH - Medizinische Universität Wien

Vienna, Austria

AZ Sint-Lucas

Bruges, Belgium

C. H. U. St-Pierre

Brussels, Belgium

HUB Erasme

Brussels, Belgium

UZ Leuven

Leuven, Belgium

CHU UCL Namur

Yvoir, Belgium

Medical center Medconsult Pleven OOD

Pleven, Bulgaria

DCC "Alexandrovska", EOOD

Sofia, Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, Bulgaria

UMHAT Prof. Dr. Stoyan Kirkovich AD

Stara Zagora, Bulgaria

Gastroenterology and Internal Medicine Research Institute

Edmonton, Alberta, Canada

Scott Shulman Medicine Professional Corporation

North Bay, Ontario, Canada

McGill University Health Centre- Montreal General Hospital

Montreal, Quebec, Canada

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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

Fuzhou, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Yuexiu, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi Zhuang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The 2nd Xiangya Hospital of Central South University

Changsha, Hu'nan, China

The First Affiliated Hospital of University of South China

Hengyang, Hu'nan, China

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

Wuhan, Hubei, China

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

Wuhan, Hubei, China

Renmin Hospital, Wuhan University

Wuhan, Hubei, China

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Jiangxi Gannan Medical College Affiliated 1 st Hospital

Ganzhou, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Taian City Central Hospital

Tai’an, Shandong, China

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

Shanghai, Shanghai Municipality, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Tianjin Union Medical Center

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yun'nan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Huzhou Central Hospital

Huzhou, Zhejiang, China

West China Hospital, Sichuan University

Sichuan, China

CCR Brno, s.r.o.

Brno, Czechia

SurGal Clinic s.r.o.

Brno, Czechia

Vojenska nemocnice Brno

Brno, Czechia

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, Czechia

PreventaMed s.r.o.

Olomouc, Czechia

CCR Ostrava s.r.o.

Ostrava, Czechia

Nemocnice Slany

Slaný, Czechia

CHU Reims - Hôpital Robert Debré

Reims, Ardennes, France

CHU Dijon - Hôpital Bocage Central

Dijon, Cote D'or, France

CHU Besançon - Hôpital Jean Minjoz

Besançon, Doubs, France

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, Gironde, France

Hopital Saint Eloi

Montpellier, Herault, France

CHU Nantes - Hôtel Dieu

Nantes, Loire Atlantique, France

CHU Saint Etienne - Hôpital Nord

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

CHU Clermont Ferrand - Hopital d'Estaing

Clermont-Ferrand, Puy De Dome, France

Centre Hospitalier de Pau - Hôpital François Mitterrand

Pau, Pyrénées Atlantique, France

Hôpital Henri Mondor

Créteil, Val De Marne, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, Val De Marne, France

Hôpital Saint-Louis

Paris, France

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Praxis fuer Gasroenterologie Prof. Dr. med Robert Ehehalt

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen

Erlangen, Bavaria, Germany

LMU - Campus Grosshadern

Munich, Bavaria, Germany

Staedisches Klinikum Brandenburg

Brandenburg an der Havel, Brandenburg, Germany

Universitaetsklinikum Frankfurt Goethe-Universitaet

Frankfurt am Main, Hesse, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, Germany

Gastroenterologie Berlin Karlshorst

Berlin, Germany

Charité - Campus Benjamin Franklin

Berlin, Germany

General Hospital of Athens "Evangelismos"

Athens, Greece

General Hospital of Thessaloniki "Hippokration"

Thessaloniki, Greece

Bekes Varmegyei Kozponti Korhaz

Békéscsaba, Hungary

Clinexpert Kft.

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Pannonia Maganorvosi Centrum

Budapest, Hungary

Debreceni Egyetem

Debrecen, Hungary

Navneet Memorial Hospital 'Sushrusha'

Ahmedabad, Gujarat, India

Shree Giriraj Multispeciality Hospital

Rajkot, Gujarat, India

Unity Hospital ICU and Trauma

Surat, Gujarat, India

Fortis Memorial Research Institute

Gurgaon, Haryana, India

M. S. Ramaiah Medical College and Hospital

Bangalore, Karnataka, India

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

Belagāve, Karnataka, India

Amrita Institute Of Medical Sciences and Research Centre

Kochi, Kerala, India

Kingsway Hospital

Nagpur, Maharashtra, India

Midas Multispeciality Hospital Pvt Ltd

Nagpur, Maharashtra, India

Chopda Medicare & Research Centre

Nashik, Maharashtra, India

Ruby Hall Clinic

Pune, Maharashtra, India

Sahyadri Specialty Hospital

Pune, Maharashtra, India

Dayanand Medical College and Hospital

Ludhiana, Punjab, India

S. R. Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, India

Chhatrapati Shahuji Maharaj (CSM) Medical University

Lucknow, Uttar Pradesh, India

Nil Ratan Sircar Medical College

Kolkata, West Bengal, India

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

I.R.C.C.S Policlinico San Donato

San Donato Milanese, Milano, Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy

Azienda Ospedaliera Giuseppe Brotzu

Cagliari, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Italy

Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

Pisa, Italy

Amsterdam UMC, Locatie AMC

Amsterdam, Netherlands

Zuyderland Medisch Centrum - Sittard-Geleen

Sittard, Netherlands

ETZ Elisabeth

Tilburg, Netherlands

Bernhoven Uden

Uden, Netherlands

Przychodnia Specjalistyczna Insula

Bełchatów, Poland

Szpital Zakonu Bonifratow Sp. z o.o.

Katowice, Poland

NZOZ Centrum Medyczne ProMiMed

Krakow, Poland

AMICARE spółka z ograniczoną odpowiedzialnością spółka komandytowa

Lodz, Poland

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, Poland

SOLUMED Centrum Medyczne

Poznan, Poland

NSZOZ Termedica - Centrum Badan Klinicznych

Poznan, Poland

Twoja Przychodnia PCM

Poznan, Poland

Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

Sosnowiec, Poland

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

Szczecin, Poland

NZOZ VIVAMED Jadwiga Miecz

Warsaw, Poland

PlanetMed sp. z o.o.

Wroclaw, Poland

Centrum Medyczne Oporow

Wroclaw, Poland

ETG Zamosc

Zamość, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

Łęczna, Poland

Hospital de Braga

Braga, Portugal

Hospital da Senhora da Oliveira Guimarães

Guimarães, Portugal

Hospital da Luz

Lisbon, Portugal

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

Santa Maria da Feira, Portugal

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

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

Suwon, Gyeonggi-do, South Korea

Yeungnam University Hospital

Daegu, Gyeongsangbuk-do, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Dong-A University Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea

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

Daejeon, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

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

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Clinica Gaias - Santiago

Santiago de Compostela, La Coruña, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Claraspital

Basel, Switzerland

Inselspital - Universitaetsspital Bern

Bern, Switzerland

Intesto Gastroenterologische Praxis, Crohn-Colitis-Zentrum Bern

Bern, Switzerland

Universitaetsspital Zuerich

Zurich, Switzerland

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Acibadem Kozyatagi Hospital

Istanbul, Turkey (Türkiye)

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi

Kocaeli, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Varlik Mah. Kazim Karabekir Cad.

Muratpaşa, Turkey (Türkiye)

CNE Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, Ukraine

RCNE Chernivtsi Regional Clinical Hospital Gastroenterology Subdivision Bukovinian SMU

Chernivtsi, Ukraine

Dnipro Division Medical Center Clinic of Family Medicine of LLC

Dnipro, Ukraine

CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council

Ivano-Frankivsk, Ukraine

CNCE Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council

Khmelnytskyi, Ukraine

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

Kyiv, Ukraine

Clinical Hospital Feofaniia of State Management of Affairs

Kyiv, Ukraine

Medical Center of Limited Liability Company Medical Center Concilium Medical

Kyiv, Ukraine

Medical Center of Limited Liability Company Saliutas

Lviv, Ukraine

CNCE of Lviv Regional Council Lviv Regional Clinical Hospital

Lviv, Ukraine

LLC Medical Center The Clinic of Hospodarskyy

Ternopil, Ukraine

CNE Uzhhorod city MCH of UCC Dept of Therapy

Uzhhorod, Ukraine

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

Vinnytsia, Ukraine

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

Vinnytsia, Ukraine

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

Vinnytsia, Ukraine

Royal London Hospital

London, Greater London, United Kingdom

St Mark's the National Bowel Hospital

London, Greater London, United Kingdom

King's College Hospital

London, Greater London, United Kingdom

Hammersmith Hospital

London, Greater London, United Kingdom

Bury Care Organisation

Bury, Greater Manchester, United Kingdom

Yeovil District Hospital

Yeovil, Somerset, United Kingdom

Huddersfield Royal Infirmary

Huddersfield, West Yorkshire, United Kingdom

The Ulster Hospital

Belfast, United Kingdom