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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02489227
Study type Interventional
Source Coherus Biosciences, Inc.
Contact
Status Completed
Phase Phase 3
Start date August 2015
Completion date March 2017

See also
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