drugset / Trial / NCT05495568
To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 3 Study to Compare Pharmacokinetics, Efficacy and Safety of CT-P17 with Humira in Patients with Moderate to Severe Chronic Plaque Psoriasis
Timeline
- Start
- 2022-11-07
- Primary completion
- 2023-08-14
- Completion
- 2024-02-05
Publications
- Pariser DM, Lebwohl MG, Jaworski J, Trefler J, Daniluk S, Dudek A, Baran W, Owczarek W, Brzewski P, Sikora M, Krogulec M, Kim S, Suh J, Choi E, Cha J, Lee H, Lee S, Koo JY. CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study. Dermatol Ther (Heidelb). 2025 May;15(5):1079-1092. doi: 10.1007/s13555-025-01383-5. Epub 2025 Mar 27.
- Lebwohl MG, Koo JY, Jaworski J, Trefler J, Daniluk S, Dudek A, Baran W, Owczarek W, Kolinek J, Brzewski P, Sikora M, Krogulec M, Kim S, Bae Y, Jeon D, Choi E, Cha J, Lee H, Choi S, Pariser DM. Repeated Switching Between CT-P17 and EU Reference Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Active-Controlled, Phase 3, Interchangeability Study. Adv Ther. 2025 Mar;42(3):1582-1599. doi: 10.1007/s12325-024-03100-8. Epub 2025 Feb 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | CT-P17 | Monoclonal antibody | 40 mg | Subcutaneous |