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COMPLETED
NCT05507216
PHASE3

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

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

636

Start Date

2023-01-25

Completion Date

2025-07-15

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 (262)

University of Alabama -Birmingham

Birmingham, Alabama, United States

Research Solutions of Arizona, PC

Litchfield Park, Arizona, United States

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

National Institute of Clinical Research

Bakersfield, California, United States

Citrus Valley Gastroenterology

Covina, California, United States

United Medical Doctors

Murrieta, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Clinical Applications Laboratories

San Diego, California, United States

Santa Maria Gastroenterology Medical Group

Santa Maria, California, United States

Danbury Hospital

Danbury, Connecticut, United States

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, United States

IHS Health

Kissimmee, Florida, United States

Research Associates of South Florida

Miami, Florida, United States

Sanchez Clinical Research, Inc

Miami, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

Sarkis Clinical Trials - Parent

Ocala, Florida, United States

AdventHealth Medical Group

Orlando, Florida, United States

Arnold Palmer Hospital For Children

Orlando, Florida, United States

Omega Research Orlando, LLC

Orlando, Florida, United States

Advanced Medical Research Center

Port Orange, Florida, United States

GCP Clinical Research, LLC

Tampa, Florida, United States

University of South Florida - PARENT

Tampa, Florida, United States

The University of Iowa

Iowa City, Iowa, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Tandem Clinical Research, LLC

Marrero, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

BVL Clinical Research

Liberty, Missouri, United States

Premier Health Research

Sparta, New Jersey, United States

NY Scientific Corp.

Brooklyn, New York, United States

Mount Sinai

New York, New York, United States

Plains Clinical Research Center, LLC

Fargo, North Dakota, United States

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, United States

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, United States

Rapid City Medical Center, LLC

Rapid City, South Dakota, United States

Digestive Health Research, LC

Hermitage, Tennessee, United States

Texas Clinical Research Institute, LLC

Arlington, Texas, United States

Inquest Clinical Research

Baytown, Texas, United States

Gastroenterology Consultants of South Texas, PA

Harlingen, Texas, United States

Digestive System Healthcare

Pasadena, Texas, United States

LinQ Research, LLC

Pearland, Texas, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

Richmond VA Medical Center

Richmond, Virginia, United States

Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

Roanoke, Virginia, United States

The Vancouver Clinic

Vancouver, Washington, United States

DIM Clinica Privada

Ramos Mejía, Buenos Aires, Argentina

CEMIC

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Clinicas Baigorria

Rosario, Santa Fe Province, Argentina

Centro de Investigacion CICE

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Gastroenterología Diagnóstica y Terapéutica (Gedyt)

Ciudad Autonoma Buenos Aires, Argentina

GZA Ziekenhuizen

Antwerp, Belgium

AZ Maria Middelares

Ghent, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

AZ Delta

Roeselare, Belgium

University Clinical Centre of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina

General Hospital Prim.dr.Abdulah Nakas

Sarajevo, Bosnia and Herzegovina

University Clinical Center Tuzla

Tuzla, Bosnia and Herzegovina

HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

Fortaleza, Ceará, Brazil

Hospital Aliança

Salvador, Estado de Bahia, Brazil

Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao

Salvador, Estado de Bahia, Brazil

L2IP - Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, Brazil

CDC - Centro Digestivo de Curitiba

Curitiba, Paraná, Brazil

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

Caxias do Sul, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

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

Botucatu, São Paulo, Brazil

CECIP - Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, Brazil

Pesquisare Saúde

Santo André, São Paulo, Brazil

Praxis Pesquisa Medica

Santo André, São Paulo, Brazil

Irmandade da Santa Casa da Misericórdia de Santos

Santos, São Paulo, Brazil

Hepatogastro

São Paulo, São Paulo, Brazil

Hospital Sirio Libanes

São Paulo, Brazil

Diagnostic Consultation Center CONVEX EOOD

Sofia, Bulgaria

Acibadem City Clinic Mladost Eood

Sofia, Bulgaria

MC Medica Plus

Veliko Tarnovo, Bulgaria

(G.I.R.I.) GI Research Institute

Vancouver, British Columbia, Canada

Gordon and Leslie Diamond Health Care Centre - Vancouver General Hospital

Vancouver, British Columbia, Canada

Newfoundland and Labrador Health Services

Winnipeg, Manitoba, Canada

London Health Sciences Centre (LHSC) - Victoria Hospital

London, Canada

Poliklinika Borzan d.o.o

Osijek, Croatia

University hospital centre Zagreb

Zagreb, Croatia

Institut klinicke a experimentalni mediciny

Prague, Czechia

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes Maritimes, France

Hôpital Nord - CHU Marseille

Marseille, Bouches-du-Rhône, France

Hopital Rangueil

Toulouse, Haute Garonne, France

Institut des MICI

Neuilly, Hauts De Seine, France

CHU Rennes - Hôpital Pontchaillou

Rennes, Ille Et Vilaine, France

CHU de Grenoble - Hôpital Nord

Grenoble, Isere, France

Hospital de brabois

Vandœuvre-lès-Nancy, Moselle, France

CHU Lille - Hôpital Claude Huriez

Lille, Nord, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, Rhone, France

CHU Amiens - Hopital Sud

Amiens, Somme, France

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, Vendée, France

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

INLUGA im Haus der Gesundheit

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Charité - Campus Charité Mitte

Berlin, Germany

DRK Kliniken Berlin Westend

Berlin, Germany

Krankenhaus Waldfriede e. V.

Berlin, Germany

Evangelisches Krankenhaus Kalk GmbH

Cologne, Germany

Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen

Hamburg, Germany

Siloah St. Trudpert Klinikum

Pforzheim, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Semmelweis Egyetem

Budapest, Hungary

Gyongyosi Bugat Pal Korhaz

Gyöngyös, Hungary

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary

Clinfan Szolgaltato Kft.

Szekszárd, Hungary

Origin Hospital

Hyderabad, Andhra Pradesh, India

Yashoda Super Speciality Hospital

Hyderabad, Andhra Pradesh, India

Gandhi Hospital

Secunderabad, Andhra Pradesh, India

Surat Institute of Digestive Sciences

Surat, Gujarat, India

Gujarat Hospital

Surat, Gujarat, India

Isha Multispeciality Hospital

Vadodara, Gujarat, India

Lokmanya Tilak Municipal General Hospital & Medical College

Mumbai, Maharashtra, India

Datta Meghe Institute of Medical Sciences (Deemed University)

Wardha, Maharashtra, India

Fortis Escorts Heart Institute and Research Centre

New Delhi, National Capital Territory of Delhi, India

Maharaja Agrasen Hospital

New Delhi, National Capital Territory of Delhi, India

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Institute of Post Graduate Medical Education And Research

Kolkata, West Bengal, India

Vydehi Institute of Medical Sciences and Research Centre

Bengaluru, India

Gleneagles Global Hospitals

Hyderabad, India

Connolly Hospital

Abbotstown, Dublin, Ireland

Midland Regional Hospital

Mullingar, Westmeath, Ireland

Beaumont Hospital

Dublin, Ireland

St Vincents University Hospital

Dublin, Ireland

Portiuncula Hospital

Galway, Ireland

HaEmek Medical Center

Afula, Israel

Soroka University Medical Center

Beersheba, Israel

Carmel Medical Center

Haifa, Israel

Wolfson Medical Center

Holon, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Galilee Medical Center Institute of Gastroenterology

Nahariya, Israel

Rabin Medical Center-Beilinson Campus

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases

Rehovot, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Azienda Ospedaliero Universitaria Mater Domini

Catanzaro, Italy

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milan, Italy

Azienda Ospedale-Università di Padova

Padova, Italy

Università Campus Bio-Medico di Roma

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, Japan

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Aso Co.,Ltd Iizuka Hospital

Iizuka-shi, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Our Lady of the Snow St. Mary's Hospital

Kurume-shi, Fukuoka, Japan

Kiryu Kosei General Hospital

Kiryu-shi, Gunma, Japan

SUBARU Health Insurance Society Ota Memorial Hospital

Ota-shi, Gunma, Japan

NHO Fukuyama Medical Center

Fukuyama-shi, Hiroshima, Japan

NHO Kure Medical Center and Chugoku Cancer Center

Kure-shi, Hiroshima, Japan

JCHO Hokkaido Hospital

Sapporo, Hokkaido, Japan

Aoyama Clinic

Kobe, Hyōgo, Japan

NHO Kanazawa Medical Center

Kanazawa, Ishikawa-ken, Japan

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, Japan

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, Japan

Jiaikai Izuro Imamura Hospital

Kagoshima, Kagoshima-ken, Japan

Kagoshima IBD Gastroenterology Clinic

Kagoshima, Kagoshima-ken, Japan

Sameshima Hospital

Kagoshima, Kagoshima-ken, Japan

Kawasaki Municipal Hospital

Kawasaki-shi, Kanagawa, Japan

Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, Japan

Kaiseikai Hattori Clinic

Kumamoto, Kumamoto, Japan

Saiseikai Niigata Hospital

Niigata, Niigata, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

NHO Okayama Medical Center

Okayama, Okayama-ken, Japan

Keiaikai Nakagami Hospital

Okinawa-shi, Okinawa, Japan

Shinseikai Sai Gastroenterology, Proctology Clinic

Fujiidera, Osaka, Japan

NHO Osaka National Hospital

Osaka, Osaka, Japan

JCHO Osaka Hospital

Osaka, Osaka, Japan

Saga-Ken Medical Centre Koseikan

Saga, Saga-ken, Japan

Saga University Hospital

Saga, Saga-ken, Japan

NHO Ureshino Medical Center

Ureshino-shi, Saga-ken, Japan

Kumagaya General Hospital

Kumagaya-shi, Saitama, Japan

Matsuaikai Matsuda Hospital

Hamamatsu, Shizuoka, Japan

Showa University Koto Toyosu Hospital

Kōtoku, Tokyo-To, Japan

Kitasato University Kitasato Institute Hospital

Minatoku, Tokyo-To, Japan

JCHO Tokyo Yamate Medical Center

Shinjuku-ku, Tokyo-To, Japan

Asahikawa City Hospital

Asahikawa-shi, Japan

Asahikawa Medical University Hospital

Asahikawa-shi, Japan

Institute of Science Tokyo Hospital

Bunkyō City, Japan

Juntendo University Hospital

Bunkyō City, Japan

Fukui Prefectural Hospital

Fukui-shi, Japan

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji-shi, Japan

NHO Hirosaki General Medical Center

Hirosaki-shi, Japan

NHI Komatsu Municipal Hospital

Komatsu-shi, Japan

Kyorin University Hospital

Mitaka-shi, Japan

Nagaoka Red Cross Hospital

Nagaoka-shi, Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-shi, Japan

Keijinkai Matsushima Hospital

Yokohama, Japan

Lithuanian University of Health Sciences Kaunas Hospital

Kaunas, Lithuania

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania

Consultorio Medico, InvesclinicMX

Irapuato, Guanajuato, Mexico

Accelerium S de RL de CV

Monterrey, Nuevo León, Mexico

FAICIC S. de R.L. de C.V.

Veracruz, Mexico

Sociedad de Metabolismo y Corazon S.C

Veracruz, Mexico

Waikato Hospital

Hamilton, New Zealand

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Poland

Centrum Medyczne Pratia Gdynia

Gdynia, Poland

ETG Kielce Zagorska

Kielce, Poland

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, Poland

Centrum Medyczne Plejady

Krakow, Poland

Centrum Medyczne Plejady

Krakow, Poland

1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie

Lublin, Poland

NZOZ Neuromed M. i M. Nastaj Sp.P.

Lublin, Poland

ALLMEDICA sp. z o. o.

Nowy Targ, Poland

Wojewodzki Specjalistyczny Szpital w Olsztynie

Olsztyn, Poland

Medicome Sp. z o.o.

Oświęcim, Poland

Trialmed CRS

Piotrkow Trybunalski, Poland

Gabinet Lekarski Bartosz Korczowski

Rzeszów, Poland

Nowe zdrowie-CK, Kieltucki i wspolnicy sp. j.

Staszów, Poland

DC-MED

Swidnica, Poland

Centrum Zdrowia Tuchow Sp. z o.o.

Wierzchosławice, Poland

SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

Bucharest, Romania

Spitalul de Oncologie Monza

Bucharest, Romania

Spitalul Clinic Colentina

Bucharest, Romania

Spitalul Clinic Judetean de Urgenta Cluj Napoca

Cluj-Napoca, Romania

S.C Pelican Impex S.R.L

Oradea, Romania

S.C Centrul Medical Valahia S.R.L

Ploieşti, Romania

Clinical Center " Dr Dragisa Misovic Dedinje"

Belgrade, Serbia

Clinical Hospital Center Zvezdara

Belgrade, Serbia

Clinical Hospital Center "Bezanijska kosa

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

General Hospital Subotica

Subotica, Serbia

General Hospital "Djordje Joanovic"

Zrenjanin, Serbia

Fakultna nemocnica s poliklinikou F.D. Roosevelta

Banská Bystrica, Slovakia

Cliniq s.r.o.

Bratislava, Slovakia

Endomed, s.r.o.

Košice, Slovakia

KM Management spol. s r.o.

Nitra, Slovakia

Gastro I, s.r.o.

Prešov, Slovakia

Gastro LM s.r.o.

Prešov, Slovakia

Svet zdravia a.s.

Rimavská Sobota, Slovakia

Accout Center s.r.o.

Šahy, Slovakia

Complejo Hospitalario Universitario de Ferrol

Ferrol, La Coruña, Spain

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Centro Medico Teknon

Barcelona, Spain

Hospital General Juan Ramon Jimenez

Huelva, Spain

Hospital Montecelo

Pontevedra, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

RCNECRCH Dept of Proctology, SHEI Ukr BSMU

Chernivtsi, Ukraine

Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

Dnipro, Ukraine

CNCE of Kyiv Regional Council Kyiv Regional Center of Rehabilitation Medicine

Kyiv, Ukraine

CNCE of Kyiv Regional Council Kyiv Regional Clinical Hospital, Clinical Center of Therapeutic Profil

Kyiv, Ukraine

Medical Center of Limited Liability Company Arensia Exploratory Medicine

Kyiv, Ukraine

Medical Center Universal Clinic Oberih of Limited Liability Company Kapital

Kyiv, Ukraine

Railway Transport Kyiv Clinical Hospital #2 of Healthcare Center Branch of JSC Ukrainian Railway

Kyiv, Ukraine

Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council

Lutsk, Ukraine

CNCE of Lviv Regional Council Lviv Regional Clinical Hospital

Lviv, Ukraine

SSH St. Panteleimon of MNPE "Lviv Territorial Med Union" MC of E&I care,Th. Center D.Halytskyi LNMU

Lviv, Ukraine

CNE Odesa Regional Clinical Hospital of Odesa Regional Council

Odesa, Ukraine

M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy

Poltava, Ukraine

CNE A.Novak Transcarpathian Reg Clin Hospital of Transcarpathian Reg Council

Uzhhorod, Ukraine

CNCE M.I.Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council

Vinnytsia, Ukraine

CNCE Vinnytsia City Clinical Hospital #1, Dep of Clinical Therapy #2

Vinnytsia, Ukraine

Communal Enterprise Hospital #1 of Zhytomyr City Council

Zhytomyr, Ukraine

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Guy's Hospital

London, Greater London, United Kingdom