Clinical Observation of Xeligekimab in the Treatment of Moderate to Severe Palmoplantar Pustulosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xeligekimab Injection.
- Who it may be relevant to
- Registry conditions: Palmoplantar Pustulosis (PPP). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 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
Primary outcome measures
- Standardized clinical assessment techniques [Time frame: one month]
Secondary outcome measures (1)
- adverse reactions and incidence [Time frame: one month]
Eligibility criteria
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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Hospital of China Medical University — Shenyang
Identifiers
NCT: NCT07503652 · 【2025】897