Clinical Observation of Xeligekimab in the Treatment of Moderate to Severe Palmoplantar Pustulosis

Обзор

Palmoplantar pustulosis (PPP) is a chronic and recurrent skin disease, mainly characterized by erythema, pustules and scales on the palms and soles, often accompanied by itching and pain, which seriously affects the quality of life of patients. Currently, the treatment options for PPP are limited. Traditional therapies such as topical glucocorticoids, phototherapy and oral immunosuppressants have unsatisfactory efficacy, and long-term use may cause significant side effects. The introduction of biologics has provided a new direction for the treatment of PPP, but targeted therapy research for PPP is still scarce, and there are unmet clinical needs. The exploratory study of Xeligekimab in PPP is expected to provide a new treatment option, alleviate symptoms and improve the quality of life of patients. This study takes the domestic Xeligekimab as the research object, aiming to verify its potential in PPP and contribute to the breakthrough of domestic biologics in the field of refractory skin diseases. If the study is successful, it can provide preliminary evidence support for the addition of PPP as an indication for Xeligekimab and offer a preliminary theoretical basis for adding a new option to targeted therapy for PPP.

Вмешательства

• Препарат Xeligekimab Injection
  Administration plan: Induction period (0-4 weeks): 200 mg (2 vials of 100 mg), administered subcutaneously every 2 weeks (at weeks 0, 2, and 4, Q2W) Maintenance period (8-20 weeks): 200 mg, administered subcutaneously every 4 weeks (at weeks 8, 12, 16, and 20, Q4W). Administration site: The abdomen is the preferred site, with the upper arm or thigh as alternative options. Before injection, check that the skin is free from infection or damage. The procedure should be performed under sterile con

Первичные конечные точки

• Standardized clinical assessment techniques [Срок оценки: one month]

Вторичные конечные точки (1)

• adverse reactions and incidence [Срок оценки: one month]

Критерии участия

Inclusion Criteria:Age: 18 - 75 years old, gender not restricted. Clinically diagnosed PPP for at least 6 months, meeting the diagnostic criteria of Navarini et al. (2017, Br J Dermatol).

Moderate to severe PPP: Baseline PPPASI score ≥ 12, PPPIGA score ≥ 3 (moderate or severe).

Dermatology Life Quality Index (DLQI) score ≥ 10. Has received at least one local or systemic treatment (such as high-dose corticosteroids, methotrexate) in the past and the treatment was ineffective or intolerable.

The patient or the patient's family signs the informed consent form. -

Exclusion Criteria:oInclude other types of psoriasis (such as pustular, erythrodermic, or punctate).

Have used IL-17A inhibitors within the recent 3 months, or IL-23/TNF-α inhibitors within the past 4 months.

Have severe comorbidities (such as ALT/AST > 3 times the upper limit of normal, eGFR < 30 mL/min/1.73 m²).

Active infections (tuberculosis, hepatitis B, hepatitis C, HIV), pregnancy or lactation, drug allergies, participation in other clinical studies, etc.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT07503652 · 【2025】897

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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