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

Phase 3 Completed 509 enrolled Celltrion

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2021-01-11
Primary completion: 2021-08-04
Completion: 2022-05-12

Outcome

Met primary endpoint

paper Estimated treatment differences were 2.05 (90% CI -0.23, 4.32) and 0.94 (95% CI -2.29, 4.16); equivalence was achieved for both sets of assumptions. PMID 37991693 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CT-P43	Protein / enzyme biologic	45 mg	Subcutaneous
Subject	CT-P43	Protein / enzyme biologic	90 mg	Subcutaneous
Comparator	Ustekinumab	Monoclonal antibody	45 mg	Subcutaneous
Comparator	Ustekinumab	Monoclonal antibody	90 mg	Subcutaneous