NCT06696417

Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis

A Prospective, Single-arm, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Not Previously Received Biologics

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,516 (estimated)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The vunakizumab is a humanized IL-17A inhibitor with innovative binding epitopes, which accurately binds to IL-17A, the core pathogenic factor of psoriasis. However, there is still a lack of efficacy and safety data in a large sample size of the Chinese population after marketing. Therefore, this study is intended to observe the efficacy and safety of vunachizumab in a larger population. The clinical efficacy of vunakizumab on special sites and the influence of comorbidity on the treatment of psoriasis are also paid attention to. At the same time, the improvement effect of vunakizumab on the quality of life and mental health of psoriasis patients is explored through patient-reported outcome (PRO) and patient satisfaction survey, so as to develop a clinical program that can benefit psoriasis patients physically and mentally.

Conditions

• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-17
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2024-11-20
• Last updated: 2025-05-14

Locations

1 site across 1 country: China