Trials / Completed
CompletedNCT01276509
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 265 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-00547659 SC injection | Placebo delivered SC, 3 doses separated by 4 weeks |
| DRUG | PF-00547659 SC injection | Drug dose level 1 delivered SC, 3 doses separated by 4 weeks |
| DRUG | PF-00547659 SC injection | Drug dose level 2 delivered SC, 3 doses separated by 4 weeks |
| DRUG | PF-00547659 SC injection | Drug dose level 3 delivered SC, 3 doses separated by 4 weeks |
Timeline
- Start date
- 2011-04-06
- Primary completion
- 2014-02-07
- Completion
- 2015-10-09
- First posted
- 2011-01-13
- Last updated
- 2021-06-03
- Results posted
- 2017-04-13
Locations
137 sites across 16 countries: United States, Austria, Belgium, Bulgaria, Canada, France, Germany, Japan, Netherlands, Norway, Poland, Serbia, Slovakia, South Africa, South Korea, Spain
Source: ClinicalTrials.gov record NCT01276509. Inclusion in this directory is not an endorsement.