At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 355 enrolled
Drug / intervention
ABX464 100 mg +3 moredrug
Likely dose
ABX464 100 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 Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-α] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment
In Brief
A Phase 2 clinical trial evaluating ABX464 100 mg, ABX464 50 mg, and 2 other interventions for Ulcerative Colitis. Completed, enrolled 355 participants across 130 sites in 17 countries.
Detailed Summary
Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily 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, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartAug 2019
Primary CompletionApr 2021
Study CompletionApr 2021
TodayJul 2026
First PostedNov 30, 2018
Enrollment StartAug 13, 2019
Primary CompletionApr 1, 2021
Study CompletionApr 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.6 years ago
Interventions
ABX464 100 mgdrug
ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks
ABX464 50 mgdrug
ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks
ABX464 25 mgdrug
ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
Placebodrug
Two capsules of placebo once daily for 16 weeks