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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABX464 -25mg | Experimental | All subjects will receive ABX464 given at 25 mg QD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 | Drug | All subjects will receive ABX464 given at 25 mg QD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events in ABX464 treated subjects | To evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. | From Baseline to a maximum period of 78 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reaching clinical remission at yearly visits. | To evaluate the long-term effect of ABX464 on clinical remission | From Baseline to a maximum period of 78 months |
| Percentage of subjects reaching endoscopic remission at yearly visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bram Verstockt, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitaet Innsbruck | Innsbruck | Austria | ||||
| Medical University of Vienna |
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Open Label Follow-up Study
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To evaluate the long-term effect of ABX464 on endoscopic remission |
| From Baseline to a maximum period of 78 months |
| Percentage of subjects reaching clinical response at yearly visits | To evaluate the long-term effect of ABX464 on clinical response | From Baseline to a maximum period of 78 months |
| Percentage of subjects reaching endoscopic improvement at yearly visits | To evaluate the long-term effect of ABX464 on endoscopic improvement | From Baseline to a maximum period of 78 months |
| 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 | 21-010 | 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 |
| Splošna bolnišnica Celje | Celje | Slovenia |
| Univerzitetni klinični center Maribor | Maribor | Slovenia |
| Splosna Bolnisnica Murska Sobota | Murska Sobota | Slovenia |
| Centro Medico Teknon | Barcelona | Spain |
| Communal non-commercial enterprise "Cherkasy Regional Hospital of Cherkasy regional council" | Cherkasy | Ukraine |
| Communal non-commercial enterprise "Khmelnytska Regional Hospital" of Khmelnytskiy regional council | Khmelnytskyi | Ukraine |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000623073 | ABX464 |
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