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A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy
Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Summary
This multicenter, randomized, double-blind, active-controlled study aims to evaluate the efficacy and safety of picankibart in Chinese patients with plaque psoriasis who demonstrated inadequate responses to interleukin-17 (IL-17) monoclonal antibody therapy and subsequently switched to picankibart. The trial will enroll approximate 310 participants with confirmed plaque psoriasis diagnosis and a poor response to IL-17 monoclonal antibody treatment. The study includes a 4-week screening phase, followed by an active treatment period of either 36 weeks, and concludes with a safety follow-up assessment at Week 48.
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Switching to Picankibart in Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2025-05-27
Completion Date
2027-01-19
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Picankibart
The participants in picankibart treatment group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32. The participants in IL-17 mAb continued treatment group will receive picankibart 200mg SC at Weeks 16, 20, 24 and 36.
Secukinumab
The participants in IL-17 mAb continued treatment group who have received secukinumab before enrollment, will receive secukinumab 300mg SC at Weeks 0, 4, 8 and 12.
Placebo
The participants in picankibart treatment group will receive placebo SC at Weeks 12, 16, 24 and 36. The participants in IL-17 mAb continued treatment group will receive placebo SC at Week 32.
Ixekizumab
The participants in IL-17 mAb continued treatment group who have received ixekizumab before enrollment, will receive ixekizumab 80mg SC at Weeks 0, 4, 8 and 12.
Locations (1)
Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)
Jinan, Shandong, China