Palmoplantar Pustulosis (PPP)
Conditions
Keywords
Xeligekimab, Palmoplantar pustulosis
Brief summary
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
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 conditions by trained medical staff. Observe for 30 minutes after the injection to monitor for acute allergic reactions. Concomitant medication: Antibiotics or non-immunosuppressive agents (such as topical moisturizers) can be used, and the dosage and course of treatment should be recorded. In case of necessity, combined topical medications or UVB phototherapy (such as when the condition worsens in weeks 4, 8, and 12) can be used.
Sponsors
First Hospital of China Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized clinical assessment techniques | one month | The patient undergoes this procedure during each monthly follow-up visit for treatment. PPPASI (Palmar-Pediculitic Pustulosis Area and Severity Index): Technical points: Scoring range 0-72, assessing erythema, pustules/water blisters, scales and area. Formula: PPPASI = (E + P + D) × A × 0.2 (palms) + (E + P + D) × A × 0.3 (palmar side) + (E + P + D) × A × 0.5 (plantar). Two dermatologists independently score, taking the average, with inter-rater variation \< 10%. PPPIGA (Pediculitis Palmaris-Pediculitis Pedis Investigator Global Assessment): o Technical points: Scoring 0 (clear) to 4 (severe), based on visual inspection and palpation. After training, inter-rater consistency is high (Kappa coefficient ≥ 0.8). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse reactions and incidence | one month | adverse reactions and incidence after the injection |
Countries
China
Contacts
CONTACTHao Guo, Doctor
Outcome results
None listed