At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 131 enrolled
Drug / intervention
Cobitolimod +1 moredrug
Likely dose
Cobitolimod 30 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 Placebo-controlled, Double-blind, Randomised Study to Assess the Efficacy and Safety of Cobitolimod as an add-on to Current Practice in Chronic Active Treatment Refractory Ulcerative Colitis Patients
In Brief
A Phase 3 clinical trial evaluating Cobitolimod and Placebo for Colitis, Ulcerative. Completed, enrolled 131 participants across 37 sites in 7 countries.
Detailed Summary
The purpose of this study is to determine if cobitolimod (former called Kappaproct®) is effective in the treatment of chronic active ulcerative colitis patients not responding to available therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesCzechia, France, Germany, Hungary, Italy, Poland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedDec 2011
Primary CompletionJun 2013
Study CompletionMar 2014
TodayJul 2026
First PostedDec 16, 2011
Enrollment StartDec 1, 2011
Primary CompletionJun 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.5 years ago
Interventions
Cobitolimoddrug
30 mg rectal dose at week 0 and 4
Placebodrug
Rectal dose at week 0 and 4