Trials / Active Not Recruiting
Active Not RecruitingNCT06945107
A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 308 (actual)
- Sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| DRUG | 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. |
| DRUG | 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. |
| DRUG | 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. |
Timeline
- Start date
- 2025-05-27
- Primary completion
- 2026-06-07
- Completion
- 2027-01-19
- First posted
- 2025-04-25
- Last updated
- 2026-03-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06945107. Inclusion in this directory is not an endorsement.