Conditions: Plaque Psoriasis
Keywords: PsO
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 521
Healthy volunteers: no

Brief 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).

Detailed description:
Pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 75% improvement from baseline according to the Psoriasis Area and Severity Index (PASI-75). Comparing CHS-0214 to Enbrel for efficacy and safety at a dosage of 50mg subcutaneous (Sc) twice weekly.

Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.

Arms:
arm 1: Enbrel 50mg twice weekly times 12 weeks arm 2: CHS-0214 50mg twice weekly times 12 weeks

Interventions: intervention 1: Etanercept intervention 2: CHS-0214
Intervention descriptions: intervention 1: Head-to-head comparison intervention 2: None

Protocol document: