Pustules Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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. -

Locations
Other Locations
China
First Hospital of China Medical University
RECRUITING
Shenyang
Contact Information
Primary
Hao Guo, Doctor
guohao27@126.com
024-83282524
Time Frame
Start Date: 2026-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: First Hospital of China Medical University

This content was sourced from clinicaltrials.gov