Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
Condition(s) studied
Investigational drug(s) / intervention(s)
ABX464: All subjects will receive ABX464 given at 25 mg QD.
Study summary
This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (QD) at 25 mg in subjects who have been previously enrolled in the ABX464-102 or ABX464-104 studies (OLE and maintenance studies) and who are willing to continue their treatment.
All subjects will receive ABX464 given at 25 mg QD. The enrolment in this long-term study will be based on the endoscopic improvement, the willingness of the subject to carry on his/her participation and also based on investigator's judgement.
Subjects will be treated with ABX464 for a maximum period of 54 months. Subjects will be followed up quarterly. After the treatment period, subjects will be followed for 4 additional weeks for safety purposes.
Eligibility
Primary outcome measure(s)
- Number of adverse events in ABX464 treated subjects — From Baseline to a maximum period of 78 months
To evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck | Innsbruck | Austria | |
| Medical University of Vienna | Vienna | Austria | |
| Antwerp University Hospital | Antwerp | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| South Edmonton Gastroenterology | Edmonton | Canada | |
| Fakultni nemocnice u sv. Anny v Brne | Brno | Czechia | |
| Nemocnice Slany | Slaný | Czechia | |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble | France | |
| Centre Hospitalier Universitaire De Montpellier | Montpellier | France | |
| CHU Nantes - Hôtel Dieu | Nantes | France | |
| Institut des MICI | Neuilly-sur-Seine | France | |
| CHU Saint Etienne - Hôpital Nord | Saint-Etienne | France | |
| Goethe University Frankfurt | Frankfurt | Germany | |
| Studiengesellschaft BSF UG (haftungsbeschraenkt) | Halle | Germany | |
| Medizinische Hochschule Hannover | Hanover | Germany | |
| DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | Hungary | |
| Semmelweis University | Budapest | Hungary | |
| Vasutegeszseguegyi Nonprofit Koezhasznu Kft. | Debrecen | Hungary | |
| Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház I. Belgyógyászat | Győr | Hungary | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy | |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | |
| IRCCS Ospedale Sacro Cuore Don Calabria | Verona | Italy | |
| Centrum Medyczne Plejady | Krakow | Poland | |
| Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. i M. Nastaj sp. p | Lublin | Poland | |
| Wojskowy Szpital Kliniczny w Lublinie | Lublin | Poland | |
| Medicome Sp. z o. o. | Oświęcim | Poland | |
| Trialmed CRS | Piotrkow Trybunalski | Poland | |
| Termedia Sp. z o.o (NSZOZ Termedica - Centrum Badan Klinicznych) | Poznan | Poland | |
| Ośrodek Badań Klinicznych "METABOLICA" | Tarnów | Poland | |
| Medical Network Sp. z o.o. | Warsaw | Poland | |
| Santa Sp. z o.o. | Warsaw | Poland | |
| Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska | Wroclaw | Poland | |
| Centrum Medyczne Oporow | Wroclaw | Poland | |
| LexMedica | Wroclaw | Poland | |
| Samodzielny PZOZ w Lecznej | Łęczna | Poland | |
| Kliničko bolnički centar Zvezdara | Belgrade | Serbia | |
| Opšta bolnica "Đorđe Joanović" Zrenjanin Odsek za gastroenterologiju | Zrenjanin | Serbia | |
| Cliniq s.r.o. | Bratislava | Slovakia | |
| GASTRO I, s.r.o. | Prešov | Slovakia | |
| Endomed s.r.o | Vranov nad Topľou | Slovakia |
+ 6 more sites — see the full list on the official registry below.
More Abivax S.A. trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05177835 on ClinicalTrials.gov ↗ ← All trials in Poland