Xeligekimab for moderate-to-severe palmoplantar pustulosis
Clinical Observation of Xeligekimab in the Treatment of Moderate to Severe Palmoplantar Pustulosis
This study will test whether Xeligekimab injections can reduce symptoms and improve quality of life in adults with moderate to severe palmoplantar pustulosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Hospital of China Medical University Academic / other |
| Drugs / interventions | methotrexate, Xeligekimab |
| Locations | 1 site (Shenyang) |
| Trial ID | NCT07503652 on ClinicalTrials.gov |
What this trial studies
This phase 4 interventional study gives Xeligekimab injections to adults 18–75 who have had palmoplantar pustulosis for at least six months and meet thresholds for moderate-to-severe disease (PPPASI ≥12, PPPIGA ≥3) and impaired quality of life (DLQI ≥10). Participants must have had prior inadequate response or intolerance to at least one topical or systemic therapy and will be excluded for recent biologic use, active infections, severe liver or kidney dysfunction, pregnancy, or other psoriasis subtypes. The protocol follows clinical skin signs, physician global scores, pustule counts, and patient-reported quality-of-life measures over the treatment period. Safety monitoring includes laboratory tests and infection screening to detect adverse events and treatment-related risks.
Who should consider this trial
Good fit: Adults aged 18–75 with clinically diagnosed PPP for ≥6 months, PPPASI ≥12 and PPPIGA ≥3, DLQI ≥10, and prior inadequate response or intolerance to at least one treatment.
Not a fit: People with other psoriasis types, recent biologic use (IL-17A within 3 months or IL-23/TNF-α within 4 months), active infections, severe liver/kidney disease, pregnancy, or lactation are unlikely to qualify or derive benefit.
Why it matters
Potential benefit: If successful, Xeligekimab could reduce pustules and pain and improve daily functioning for people with moderate-to-severe PPP.
How similar studies have performed: Some biologics have shown benefit in PPP and related forms of psoriasis, but clinical data specifically on Xeligekimab for PPP are limited, so this approach is relatively novel for this indication.
Eligibility criteria
Show full inclusion / exclusion 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. \-
Where this trial is running
Shenyang
- First Hospital of China Medical University — Shenyang, China (Recruiting)
Study contacts
- Study coordinator: Hao Guo, Doctor
- Email: guohao27@126.com
- Phone: 024-83282524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.