Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

PHASE2CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

September 23, 2019

Primary Completion Date

April 1, 2021

Study Completion Date

April 16, 2021

Conditions
Ulcerative Colitis
Interventions
DRUG

ABX464 25mg

ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks

DRUG

ABX464 50mg

ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks

DRUG

ABX464 100mg

ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks

DRUG

Placebo

Two capsules of placebo once daily for 16 weeks

Trial Locations (130)

30033

Atlanta Center for Gastroenterology, P.C, Decatur

78212

Southern Star Research Institute, LLC, San Antonio

78705

Central Texas Clinical Research, LLC, Austin

92103

UCSD Health System, San Diego

Unknown

Medizinische Universität Innsbruck, Innsbruck

Klinikum Klagenfurt am Wörthersee, Klagenfurt

Ordensklinikum Linz GmbH - Barmherzige Schwestern, Linz

AKH - Medizinische Universität Wien, Vienna

Gomel Regional Clinical Hospital, Homyel

Minsk city diagnostic center, Minsk

Regional Clinical Hospital, Minsk

Vitebsk Regional Clinical Hospital, Vitebsk

Vitebsk regoinal clinical specialized center, Vitebsk

AZ Sint-Lucas, Bruges

C. H. U. St-Pierre, Brussels

UZA, Edegem

Universitair Ziekenhuis Gent, Ghent

UZ Leuven, Leuven

Brandon Medical Arts Clinic, Brandon

South Edmonton Gastroenterology, Edmonton

LHSC - Victoria Hospital, London

The Ottawa Hospital - General Campus, Ottawa

Allen Whey Khye Lim Professional Corporation, Saskatoon

Mount Sinai Hospital, Toronto

Fakultni nemocnice u sv. Anny v Brne, Brno

Hepato-Gastroenterologie HK s.r.o., Hradec Králové

MUDr. GREGAR s.r.o., Olomouc

Fakultni nemocnice Ostrava, Ostrava-Kunčice

Nemocnice Na Bulovce, Prague

Thomayerova nemocnice, Prague

Nemocnice Slany, Slaný

CHU Amiens - Hopital Sud, Amiens

CHU Besançon - Hôpital Jean Minjoz, Besançon

CHU Clermont Ferrand - Hôpital d'Estaing, Clermont-Ferrand

Hôpital Beaujon, Clichy

CHU de Grenoble - Hôpital Nord, Grenoble

Centre Hospitalier Départemental Les Oudairies, La Roche-sur-Yon

CHU Lille - Hôpital Claude Huriez, Lille

Hôpital Nord - CHU Marseille, Marseille

Hopital Saint Eloi, Montpellier

CHU Nantes - Hôtel Dieu, Nantes

CHU Nice - Hôpital de l'Archet 2, Nice

CHU Reims - Hôpital Robert Debré, Reims

CHU Rennes - Hôpital Pontchaillou, Rennes

CHU de Rouen - Hôpital Charles Nicolle, Rouen

CHU Saint Etienne - Hôpital Nord, Saint-Etienne

CHU Strasbourg - Hôpital Hautepierre, Strasbourg

Hopital Rangueil, Toulouse

Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin

Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth, Düsseldorf

Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt

Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt, Halle

Universitaetsklinikum Halle (Saale), Halle

Medizinische Hochschule Hannover, Hanover

Johanna-Etienne-Krankenhaus, Neuss

Tumorzentrum Nordthueringen MVZ GmbH, Nordhausen

Dr. Tasso Bieler, Riesa

Universitaetsklinikum Ulm, Ulm

DRC Gyogyszervizsgalo Kozpont Kft., Balatonfüred

Obudai Egeszsegugyi Centrum Kft., Budapest

Pannonia Maganorvosi Centrum, Budapest

Semmelweis Egyetem, Budapest

Debreceni Egyetem, Debrecen

Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont, Debrecen

Petz Aladar Megyei Oktato Korhaz, Győr

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna

Fondazione Poliambulanza Istituto Ospedaliero, Brescia

Azienda Ospedaliero Universitaria Mater Domini, Catanzaro

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

Ospedale Sacro Cuore Don Calabria, Negrar

Azienda Ospedaliera di Padova, Padua

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello), Pisa

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

Istituto Clinico Humanitas, Rozzano

Szpital Uniwersytecki nr 2 im.dr J. Biziela, Bydgoszcz

Uniwersyteckie Centrum Kliniczne, Gdansk

Centrum Medyczne Plejady, Krakow

Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz

Wojskowy Szpital Kliniczny w Lublinie, Lublin

Trialmed CRS, Piotrkow Trybunalski

Centrum Medyczne Grunwald, Poznan

KO-MED Centra Kliniczne Pulawy, Puławy

Gabinet Lekarski Bartosz Korczowski, Rzeszów

Centrum Zdrowia MDM, Warsaw

Nzoz Vivamed, Warsaw

Centrum Zdrowia Tuchow Sp. z o.o., Wierzchosławice

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Wroclaw

Centrum Medyczne Oporow, Wroclaw

LexMedica, Wroclaw

"Clinical Center Dr Dragisa Misovic Dedinje", Belgrade

Clinical Center Bezanijska Kosa, Belgrade

Clinical Center Zvezdara, Belgrade

General Hospital Uzice, Užice

"General Hospital Djordje Joanovic", Zrenjanin

Alian s.r.o., Bardejov

Cliniq s.r.o., Bratislava

Gastromedic, s.r.o., Nové Zámky

Gastro I, s.r.o., Prešov

Accout Center s.r.o., Šahy

Endomed, s.r.o., Vranov nad Topľou

General Hospital Celje, Celje

University Medical Centre Maribor, Maribor

General Hospital Murska Sobota, Murska Sobota

Centro Médico Teknon, Barcelona

Hospital Universitario Reina Sofia, Córdoba

Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria

Hospital Quironsalud Malaga, Málaga

CNE Cherkasy Regional Hospital of Cherkasy Regional Council, Cherkasy

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital, Dnipro

Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk

CHI Kharkiv City Clinical Hospital #13, Kharkiv

CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC, Kharkiv

Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv

CI Kherson CCH, Kherson

Khmelnytska Regional Hospital, Khmelnytskyi

Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital, Kyiv

Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU, Lviv

Ternopil University Hospital, Ternopil

A. Novak Transcarpathian Regional Clinical Hospital, Uzhhorod

CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM, Vinnytsia

M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU, Vinnytsia

MCIC MC LLC Health Clinic, Vinnytsia

CI City Clinical Hospital #6 Dept of Gastroenterology, Zaporizhzhia

"CNCE City Hospital 9 Zaporizhzhia CC", Zaporizhzhia

Fairfield General Hospital, Bury

Guy's Hospital, London

University College London Hospitals, London

Nottingham University Hospitals Queen's Medical Centre, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abivax S.A.

INDUSTRY