Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)

• Status: Completed
• Trial end date: 2016-05-12
• Target enrollment: 0
• Participant gender: All

Summary

This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones).

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

Details

• Lead Sponsor: Coherus Biosciences, Inc.
• Collaborators: Baxalta US Inc.; Shire
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Male or female adults

• PsO diagnosis for 6 months

• Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale or 0-5),

• Body Surface Area (BSA) involved with PsO greater than or equal to 10%

• Dermatology Life Quality Index (DQLI) greater than or equal to 10

• Previously received phototherapy or systemic non-biologic therapy for PsO

Exclusion Criteria:

• Forms of Psoriasis other than PsO

• Drug induced Psoriasis

• Positive QuantiFERON-tuberculosis (TB) Gold Test

• Presence of significant comorbid conditions

• Chemistry and hematology values outside protocol specified range

• Major systemic infections