At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 330 enrolled
Drug / intervention
75mg SHP647 (PF-00547659) +1 moredrug
Likely dose
75mg SHP647 (PF-00547659)from 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 Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)
In Brief
A Phase 2 clinical trial evaluating 75mg SHP647 (PF-00547659) and 225mg SHP647 (PF-00547659) for Ulcerative Colitis. Completed, enrolled 330 participants across 99 sites in 21 countries.
Detailed Summary
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartMar 2013
Primary CompletionDec 2017
TodayJul 2026
First PostedJan 18, 2013
Enrollment StartMar 18, 2013
Primary CompletionDec 13, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.5 years ago
Interventions
75mg SHP647 (PF-00547659)drug
75 mg sterile liquid injected subcutaneously every 4 weeks.
225mg SHP647 (PF-00547659)drug
225 mg sterile liquid injected subcutaneously every 4 weeks.