A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Biological: Etanercept 50 mg; Other: Placebo; Drug: CP 690,550 10 mg; Drug: CP 690,550 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01241591

A3921080

Details and patient eligibility

About

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

Enrollment: 1,101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
• Have plaque-type psoriasis covering at least 10% of total body surface area
• Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion criteria

• Non-plaque or drug induced forms of psoriasis
• Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
• Cannot discontinue phototherapy
• Any uncontrolled significant medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,101 participants in 4 patient groups, including a placebo group

CP 690,550 5 mg BID+Placebo BIW

Experimental group

Treatment:

Drug: CP 690,550 5 mg

CP 690,550 10 mg BID+Placebo BIW

Experimental group

Treatment:

Drug: CP 690,550 10 mg

Placebo BID+Etanercept 50 mg BIW

Active Comparator group

Treatment:

Biological: Etanercept 50 mg

Placebo BID+Placebo BIW

Placebo Comparator group

Treatment:

Other: Placebo