Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
This trial has been completed.
|Sponsor||Coherus Biosciences, Inc.|
|Start date||August 2015|
|End date||May 2016|
|Trial size||545 participants|
|Trial identifier||NCT02489227, CHS-1420-02|
This is a 3-part study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.
|Intervention model||parallel assignment|
|Masking||participant, care provider, investigator, outcomes assessor|
Difference between the percentage of subjects in each treatment group achieving a 75% improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12
time frame: 12 weeks
All participants at least 18 years old.
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 of 0-5), - Body Surface Area (BSA) involved with PsO greater than or equal to 10% 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
|Official title||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|
|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.|
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