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

NCT06696417 | Recruiting

• 1 other identifier: MA-DER-RWS-001
• Study Type: observational
• Target: 1,516
• Locations: 1 country
• Sites: 1

Brief 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

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• The overall clinical clearance rate of skin lesions

  1. 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.) 2. 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 Outcomes (6)

• The overall clinical clearance rate of skin lesions

  One month， Three months，Twelve months

• 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

• Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52.

  One month， Three months， Six months，Twelve months

Interventions

Drug group：vunakizumab (IL-17A inhibitor) DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate and severe plaque psoriasis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study only collects routine testing data and does not specifically collect biospecimens.

Central Study Contacts

Xinghua Gao, professor

CONTACT

+86 24 83282116; gaobarry@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Cheung Kong Scholars；Vice President, First Affiliated Hospital of China Medical University

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 20, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)