NCT02134210

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

A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Chronic Plaque Psoriasis (RaPsOdy)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 521 (actual)
• Sponsor: Coherus Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Etanercept	Head-to-head comparison
DRUG	CHS-0214

Timeline

• Start date: 2014-06-16
• Primary completion: 2015-07-27
• Completion: 2016-05-12
• First posted: 2014-05-09
• Last updated: 2019-06-28
• Results posted: 2019-05-13

Locations

100 sites across 7 countries: United States, Australia, Canada, Germany, Israel, Poland, South Africa