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

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.

Study Overview

• Status: Recruiting
• Conditions: Palmoplantar Pustulosis (PPP)
• Intervention / Treatment: Drug: Xeligekimab Injection

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hao Guo, Doctor; Phone Number: 024-83282524; Email: guohao27@126.com

Study Locations

• China
  • Shenyang, China
    • Recruiting
    • First Hospital of China Medical University
    • Contact: First Hospital of China Medical University; Phone Number: 024-83282524; Email: guohao27@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental: Drug group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse reactions and incidence	adverse reactions and incidence after the injection	one month

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Palmoplantar pustulosis; Xeligekimab
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: 【2025】897

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No