Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Psoriasis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00678210

A3921047

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed with plaque psoriasis for at least 6 months.
• Have plaque psoriasis covering at least 15% of their total body.
• Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
• Be willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion criteria

• Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
• Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
• Subject is participating in another trial using an investigational agent or procedure.
• Women who are pregnant or breast-feeding or considering becoming pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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197 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

2

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

3

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

4

Placebo Comparator group

Treatment:

Drug: Placebo