At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
BBT-401-1S or Placebodrug
Likely dose
BBT-401-1S or Placebo 200mgfrom 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 Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase
In Brief
A Phase 2 clinical trial evaluating BBT-401-1S or Placebo for Ulcerative Colitis. Completed, enrolled 38 participants across 30 sites in 4 countries.
Detailed Summary
This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesPoland, South Korea, Ukraine, United States
CollaboratorsCovance
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartJun 2021
Primary CompletionMay 2022
Study CompletionJul 2022
TodayJul 2026
First PostedOct 22, 2020
Enrollment StartJun 11, 2021
Primary CompletionMay 17, 2022
Study CompletionJul 12, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.7 years ago
Interventions
BBT-401-1S or Placebodrug
Administered by 200mg capsules of BBT-401-1S or placebo