A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:12/27/2018
Start Date:September 2010
End Date:January 2013

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A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5
mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and
subsequent withdrawal of active treatment at various timepoints during the 16 week double
blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP
690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and
subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID
and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are
candidates for systemic therapy or phototherapy.


Inclusion Criteria:

- 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at
least 12 months prior to first dose of study drug;

- Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's
Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at
least 10% of body surface area;

- No evidence of active or latent or inadequately treated infection with Tuberculosis or
other serious infections.

Exclusion Criteria:

- Non-plaque or drug induced forms of psoriasis;

- Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot
discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).

- Any uncontrolled significant medical condition.
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