A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: CP-690,550; Drug: Placebo/CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01309737

A3921079

Details and patient eligibility

About

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

Enrollment: 960 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
• A Psoriasis Area and Severity Index (PASI) score of 12 or greater
• Are considered to be candidates for systemic or light therapy
• Have no evidence of active or latent tuberculosis

Exclusion criteria

• Non-plaque or drug-induced forms of psoriasis
• Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
• Any uncontrolled significant medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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960 participants in 3 patient groups, including a placebo group

Active Treatment 10 mg BID

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Active Treatment 5 mg BID

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Placebo Treatment

Placebo Comparator group

Treatment:

Drug: Placebo/CP-690,550

Drug: Placebo/CP-690,550