A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
NCT ID: NCT04673786
Last Updated: 2023-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
509 participants
INTERVENTIONAL
2021-01-11
2022-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT-P43
All patients who were initially randomized to the CT-P43 group on Day 1 (Week 0) will continue their treatment with CT-P43 until Week 40.
CT-P43
45mg or 90mg dose subcutaneous administration
Stelara
Patients who were initially randomized to Stelara group on Day 1 (Week 0) will be randomized again in a ratio of 1:1 to either continue Stelara or undergo transition to CT-P43 prior to dosing at Week 16. Thereafter, patients will continue their treatment until Week 40.
CT-P43
45mg or 90mg dose subcutaneous administration
Stelara
45mg or 90mg dose subcutaneous administration
Interventions
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CT-P43
45mg or 90mg dose subcutaneous administration
Stelara
45mg or 90mg dose subcutaneous administration
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Locations
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Clinical Research Centre
Tartu, Tartu Country, Estonia, Estonia
Countries
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References
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Papp KA, Lebwohl MG, Thaci D, Jaworski J, Kwiek B, Trefler J, Dudek A, Szepietowski JC, Reznichenko N, Narbutt J, Baran W, Kolinek J, Daniluk S, Bartnicka-Maslowska K, Reich A, Andrashko Y, Kim S, Bae Y, Jeon D, Jung J, Lee H, Pyo T, Ko W. Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study. BioDrugs. 2024 Jan;38(1):121-131. doi: 10.1007/s40259-023-00630-5. Epub 2023 Nov 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-001045-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CT-P43 3.1
Identifier Type: -
Identifier Source: org_study_id
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