NCT01620255

A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
DRUG	PF-00547659 SC Injection	Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
DRUG	PF-00547659 SC Injection	Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
DRUG	PF-00547659 SC Injection	Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
DRUG	PF-00547659 SC Injection	Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks

Timeline

• Start date: 2012-11-02
• Primary completion: 2014-09-22
• Completion: 2016-02-04
• First posted: 2012-06-15
• Last updated: 2021-06-11
• Results posted: 2017-03-27

Locations

190 sites across 21 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain