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

NCT07503652 | Recruiting Phase 4

• 1 other identifier: 【2025】897
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Palmoplantar Pustulosis (PPP)

Keywords

Xeligekimab; Palmoplantar pustulosis

Outcome Measures

Primary Outcomes (1)

• Standardized clinical assessment techniques

  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).

  one month

Secondary Outcomes (1)

• adverse reactions and incidence

  one month

Study Arms (1)

Experimental: Drug group

EXPERIMENTAL

Age: 18 to 75 years old, gender unrestricted. 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). The Dermatology Life Quality Index (DLQI) score is ≥ 10. Patients who have received at least one form of local or systemic treatment (such as high-dose corticosteroids, methotrexate) in the past and have shown poor response or intolerance. The patient or their family member signs the informed consent form.

Drug: Xeligekimab Injection

Interventions

Xeligekimab Injection DRUG

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.

Experimental: Drug group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

First Hospital of China Medical University

Shenyang, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hao Guo, Doctor

CONTACT

024-83282524; guohao27@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)