Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.

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

Details

• Lead Sponsor: Coherus Biosciences, Inc.
• Treatments: Adalimumab

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 of 0-5),

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

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