At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
ABX464drug
Likely dose
ABX464 50 mg orally once dailyAI-extracted
Key inclusion· 9
- ✓Prior enrollment in ABX464-101 study with completed 2-month initial treatment phase
- ✓Able and willing to comply with study visits and procedures
- ✓Hemoglobin >9.0 g/dL
- ✓Absolute neutrophil count ≥750/mm³
Key exclusion· 1
- ✕Any condition that could compromise safety or adherence to study protocol per investigator judgment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Follow-up Phase IIa Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 50 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis.
In Brief
A Phase 2 clinical trial evaluating ABX464 for Ulcerative Colitis. Completed, enrolled 22 participants across 1 site.
Detailed 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 (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesBelgium
CollaboratorsOrion Corporation, Orion Pharma
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartJan 2018
Primary CompletionJul 2022
Study CompletionAug 2022
TodayJul 2026
First PostedDec 11, 2017
Enrollment StartJan 20, 2018
Primary CompletionJul 12, 2022
Study CompletionAug 15, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.6 years ago
Interventions
ABX464drug
All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.