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

Coherus BioSciences

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: CHS-0214; Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02134210

CHS-0214-04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 521 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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521 participants in 2 patient groups

Enbrel (etanercept)

Active Comparator group

Description:

Enbrel 50mg twice weekly times 12 weeks

Treatment:

Drug: Etanercept

CHS-0214

Experimental group

Description:

CHS-0214 50mg twice weekly times 12 weeks

Treatment:

Drug: CHS-0214