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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:March 2013
End Date:November 2013

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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

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.

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.

Inclusion Criteria:

- Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque
psoriasis for at least 12 months; in generally good health; on stable dose of
non-prohibited medications; able to stop current psoriasis therapy (systemic or
topical) for several weeks prior to and during study participation.

Exclusion Criteria:

- Serious underlying disease including viral disorders such as hepatitis or HIV or skin
condition that would interfere with skin biopsies or evaluation of psoriasis;
conditions that could interfere with drug absorption after oral administration;
history of malignancy or auto-immune disease.

- Use of oral or injected corticosteroids (steroids).
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Tampa, Florida 33609
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