CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 357 enrolled
Drug / intervention
Placebo +4 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.

Search/NCT01620255
NCT01620255Phase 2Completed
CompareCT.gov

A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)

Shire·interventional·Posted Jun 15, 2012·Updated Jun 11, 2021

In Brief

A Phase 2 clinical trial evaluating Placebo and PF-00547659 SC Injection for Ulcerative Colitis. Completed, enrolled 357 participants across 190 sites in 21 countries.

Detailed Summary

To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.

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 PostedJun 15, 2012
Enrollment StartNov 2, 2012
Primary CompletionSep 22, 2014
Study CompletionFeb 4, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.0 years ago

Interventions

Placebodrug

Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks

PF-00547659 SC Injectiondrug

Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks

PF-00547659 SC Injectiondrug

Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks

PF-00547659 SC Injectiondrug

Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks

PF-00547659 SC Injectiondrug

Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks