At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 213 enrolled
Drug / intervention
cobitolimod +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 Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
In Brief
A Phase 2 clinical trial evaluating cobitolimod and Placebo for Ulcerative Colitis. Completed, enrolled 213 participants across 64 sites in 10 countries.
Detailed Summary
The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesCzechia, France, Germany, Hungary, Poland, Russia, Serbia, Spain, Sweden, Ukraine
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJun 2017
Primary CompletionAug 2019
TodayJul 2026
First PostedJun 7, 2017
Enrollment StartJun 21, 2017
Primary CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.1 years ago
Interventions
cobitolimoddrug
Rectal administration
Placebodrug
Solution manufactured to mimic cobitolimod