At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 198 enrolled
Drug / intervention
BT-11 (440 mg) +2 moredrug
Likely dose
BT-11 (440 mg)from 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 , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating BT-11 (440 mg), BT-11 (880 mg), and 1 other intervention for Ulcerative Colitis. Completed, enrolled 198 participants across 16 sites in 5 countries.
Detailed Summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesBosnia and Herzegovina, Croatia, Poland, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartAug 2019
Primary CompletionDec 2020
Study CompletionJun 2021
TodayJul 2026
First PostedMar 4, 2019
Enrollment StartAug 14, 2019
Primary CompletionDec 10, 2020
Study CompletionJun 17, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.3 years ago
Interventions
BT-11 (440 mg)drug
Oral, once daily tablet
BT-11 (880 mg)drug
Oral, once daily tablet
Placebodrug
Oral, once daily tablet