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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01186744

A3921111

Details and patient eligibility

About

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.

Enrollment: 666 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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666 participants in 4 patient groups

Active Treatment (10 mg) BID / Placebo BID

Experimental group

Description:

Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Active Treatment (10 mg) BID

Experimental group

Description:

Continuous active treatment (CP-690,550) for 56 weeks

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Active Treatment (5 mg) BID / Placebo BID

Experimental group

Description:

Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Active Treatment (5 mg) BID

Experimental group

Description:

Continuous active treatment (CP-690,550) for 56 weeks

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550