A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis

This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.

CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, Stelara. The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara in patients with moderate to severe plaque psoriasis.

Inclusion Criteria:

- Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.

Exclusion Criteria:

• Patients diagnosed with forms of psoriasis other than plaque-type.
• Patients previously received ustekinumab or a biosimilar of ustekinumab.
• Patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex.