Conditions: Plaque Psoriasis
Keywords: plaque psoriasis tofacitinib biopsy Janus Kinase randomized placebo controlled clinical trial psoriasis vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: (CP-6890,550) Tofacitinib intervention 2: Placebo intervention 3: (CP-690,550) Tofacitinib intervention 4: Placebo
Intervention descriptions: intervention 1: 2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks intervention 2: 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks intervention 3: 2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks intervention 4: 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Protocol document: