Status:
COMPLETED
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Lead Sponsor:
Celltrion
Conditions:
Psoriasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- \- Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.
Exclusion
- 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.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2022
Estimated Enrollment :
509 Patients enrolled
Trial Details
Trial ID
NCT04673786
Start Date
January 11 2021
End Date
May 12 2022
Last Update
June 5 2023
Active Locations (1)
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1
Clinical Research Centre
Tartu, Tartu Country, Estonia, Estonia, 50106