At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 217 enrolled
Drug / intervention
ABX464drug
Likely dose
ABX464 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating ABX464 for Ulcerative Colitis. Completed, enrolled 217 participants across 120 sites in 16 countries.
Detailed Summary
A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustria, Belarus, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Serbia, Slovakia, Slovenia, Spain, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartJan 2020
Primary CompletionFeb 2023
TodayJul 2026
First PostedJul 17, 2019
Enrollment StartJan 13, 2020
Primary CompletionFeb 23, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.0 years ago
Interventions
ABX464drug
ABX464 All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.