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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• The overall clinical clearance rate of skin lesions [Срок оценки: Three months]

Вторичные конечные точки (6)

• The overall clinical clearance rate of skin lesions [Срок оценки: One month， Three months，Twelve months]
• The time when subjects reached PASI 75 and PASI 90 within 12 weeks [Срок оценки: Three months]
• The time when subjects reached PASI 75, PASI 90, PASI 100 at 52 weeks. [Срок оценки: Twelve months]
• Changes in PASI scores relative to baseline at each visit point during 52 weeks. [Срок оценки: Twelve months]
• Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52. [Срок оценки: One month， Three months， Six months，Twelve months]
• Weeks 12 and 52 Treatment Satisfaction Questionnaire for Medication (TSQM) survey questionnaire. [Срок оценки: Three months，Twelve months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• The First Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT06696417 · MA-DER-RWS-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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