At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 79 enrolled
Drug / intervention
Spesolimabdrug
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.
An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials
In Brief
A Phase 2 clinical trial evaluating Spesolimab for Colitis, Ulcerative. Completed, enrolled 79 participants across 38 sites in 12 countries.
Detailed Summary
To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesAustria, Belgium, Canada, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartOct 2018
Primary CompletionMay 2023
TodayJul 2026
First PostedAug 27, 2018
Enrollment StartOct 29, 2018
Primary CompletionMay 3, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.8 years ago
Interventions
Spesolimabdrug
Solution