NCT02489227

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

A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Coherus Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO. The study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	CHS-1420
DRUG	Adalimumab

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-05-06
• Completion: 2017-03-01
• First posted: 2015-07-02
• Last updated: 2020-04-08
• Results posted: 2019-10-18

Locations

99 sites across 16 countries: United States, Bulgaria, Canada, Chile, Croatia, Estonia, Georgia, Israel, Italy, Latvia, Moldova, Poland, Russia, Slovakia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study