RecruitingNCT06696417

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


Sponsor

First Hospital of China Medical University

Enrollment

1,516 participants

Start Date

Feb 17, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Drug group:vunakizumab (IL-17A inhibitor) for people with moderate to severe plaque psoriasis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDrug 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


Locations(1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

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NCT06696417


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