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

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.

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: Drug group：vunakizumab (IL-17A inhibitor)

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.

• Study Type: Observational
• Enrollment (Estimated): 1516

Contacts and Locations

• Study Contact: Name: Xinghua Gao, professor; Phone Number: +86 24 83282116; Email: gaobarry@hotmail.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Hospital of China Medical University
      • Contact: xinghua gao; Phone Number: +86 24 83282116; Email: gaobarry@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Moderate and severe plaque psoriasis

Description

Inclusion Criteria:

• Age ≥18 years old at the time of signing the informed consent, regardless of gender;
• Moderate to severe plaque psoriasis was diagnosed;
• Plan to receive vunakizumab therapy as assessed by the investigator;
• The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study; Patients voluntarily sign informed consent forms.

Exclusion Criteria:

• Previous treatment with biological agents: including but not limited to anti-tumor necrosis factor-α (TNF-α), anti-IL-17, anti-IL-17 receptor, anti-IL-12 /IL-23 or IL-23p19 antibody drugs;
• Severe hypersensitivity to vunakizumab active ingredient or any excipients;
• Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
• Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after last receiving the study drug;
• Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall clinical clearance rate of skin lesions	The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90). (PASI: Psoriasis Area and Severity Index, 0 ≤ PASI ≤ 72, where a higher score indicates a greater extent of the disease and more severe skin lesion severity.); Proportion of subjects achieving sPGA 0/1 response at week 12. (sPGA 0/1 response is defined as an sPGA score of 0 (clear) or 1 (almost clear))	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time when subjects reached PASI 75 and PASI 90 within 12 weeks		Three months
The time when subjects reached PASI 75, PASI 90, PASI 100 at 52 weeks.		Twelve months
Changes in PASI scores relative to baseline at each visit point during 52 weeks.		Twelve months
The overall clinical clearance rate of skin lesions	Proportion of subjects with PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 at week 4, 12, and 52.	One month， Three months，Twelve months
Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52.	ACR20 refers to the improvement of at least 20% in the number of swollen and tender joints in rheumatoid arthritis treatment, along with improvement of at least 20% in at least three of the other five assessment criteria. ACR50 and ACR70 are defined using the same criteria, representing a 50% and 70% improvement, respectively.	One month， Three months， Six months，Twelve months
Weeks 12 and 52 Treatment Satisfaction Questionnaire for Medication (TSQM) survey questionnaire.	0 ≤ TSQM ≤ 100, where a higher score indicates greater patient satisfaction with the medication	Three months，Twelve months

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: MA-DER-RWS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No