NCT01710046

Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

An Exploratory Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study To Assess Mechanism Of Action (Moa) Of Cp-690,550 In The Skin When Administered Orally At 10 Mg Twice Daily (Bid) For 12 Weeks In Subjects With Moderate To Severe Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. These activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.

Detailed description

The final subject in Cohort 1 completed the study on 19-Nov-2013 (LSLV date). Because the study analyses were novel and exploratory, they required extensive analyses by study team and external experts. As a result of this analysis it was determined on 21-July-2014 that the data from Cohort 1 were sufficiently definitive and that enrollment of Cohort 2 would not be justified. Since this decision resulted in the LSLV for Cohort 1 becoming the LSLV for the study, the full data analysis and reporting is not projected to be complete within 12 Months of LSLV. The final analysis and final reporting is planned to be completed on 18-Feb-2015. Results for this data are anticipated to be released in April 2015.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	(CP-6890,550) Tofacitinib	2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
DRUG	Placebo	2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
DRUG	(CP-690,550) Tofacitinib	2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks
DRUG	Placebo	2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-10-18
• Last updated: 2015-04-13
• Results posted: 2015-04-13

Locations

5 sites across 1 country: United States