At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 124 enrolled
Drug / intervention
LYC-30937-EC +1 moredrug
Likely dose
Not stated in 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 Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating LYC-30937-EC and Placebo for Colitis, Ulcerative. Completed, enrolled 124 participants across 71 sites in 7 countries.
Detailed Summary
The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1 at screening.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesCanada, Czechia, Hungary, Netherlands, Poland, Serbia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJul 2016
Primary CompletionMay 2018
TodayJul 2026
First PostedMay 5, 2016
Enrollment StartJul 1, 2016
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.2 years ago
Interventions
LYC-30937-ECdrug
Placebodrug