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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
203
All subjects will receive ABX464 given at 25 mg QD.
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
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.
Time frame: From Baseline to a maximum period of 78 months
Percentage of subjects reaching clinical remission at yearly visits.
To evaluate the long-term effect of ABX464 on clinical remission
Time frame: From Baseline to a maximum period of 78 months
Percentage of subjects reaching endoscopic remission at yearly visits
To evaluate the long-term effect of ABX464 on endoscopic remission
Time frame: 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
Time frame: 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
Time frame: From Baseline to a maximum period of 78 months
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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
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