Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To estimate the difference in effectiveness between treatment with etanercept 50 mg twice weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN) topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).

• Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.

• Is a candidate for systemic therapy or phototherapy in the opinion of the investigator.

• Other inclusion criteria may apply.

Exclusion Criteria:

• Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.

• Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept on psoriasis.

• Diagnosed with medication-induced or medication-exacerbated psoriasis.

• Significant concurrent medical conditions.

• Has any active localized infection; requiring local intervention or chronic or localized infections.

• Other exclusion criteria may apply.