Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis
NCT06696417 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1516
Last updated 2025-05-14
Summary
This is a multicenter, prospective, observational study of 1516 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of vunakizumab in patients with moderate-to-severe chronic plaque psoriasis. Approximately 50-100 clinical trial centers are planned to participate in the study. The study consisted of a 7-day screening period, a 52-week treatment period and an 8-week safety follow-up period.
The recommended dose of vunakizumab is 240 mg (120 mg in two injections), with subcutaneous injection at week 0, 2, and 4, followed by a dose every 4 weeks and a final injection at week 48 (the actual treatment regimen is based on the clinician's recommendation). After the corresponding assessment at 52 weeks, an 8-week safety follow-up period was entered until the end of the study.
Conditions
Interventions
- DRUG
-
Drug group:vunakizumab (IL-17A inhibitor)
The recommended dose of vunakizumab was 240 mg, administered subcutaneously at weeks 0, 2, and 4, then every 4 weeks, with a final injection at 48 weeks
Sponsors & Collaborators
-
First Hospital of China Medical University
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-17
- Primary Completion
- 2028-04-30
- Completion
- 2028-04-30
Countries
- China
Study Locations
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