Xeligekimab for moderate-to-severe palmoplantar pustulosis
Official title: Clinical Observation of Xeligekimab in the Treatment of Moderate to Severe Palmoplantar Pustulosis
Run by First Hospital of China Medical University · NCT07503652 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | First Hospital of China Medical University Academic / other |
| Drugs / interventions | methotrexate, Xeligekimab |
| Locations | 1 site (Shenyang) |
| Status | Recruiting |
| Started | March 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT07503652 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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First Hospital of China Medical University
Shenyang, China Recruiting
Study contacts
- Study coordinator: Hao Guo, Doctor
- Email: guohao27@126.com
- Phone: 024-83282524
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ivarmacitinib for palmoplantar pustulosis (open-label, single-arm treatment)
This trial will try the oral drug ivarmacitinib to see if it reduces pustules and other skin symptoms in adults with palmoplantar pustulosis who have not responded to at least one systemic therapy.
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Picankibart for palmoplantar pustulosis
This open-label study will test whether picankibart helps adults aged 18-65 with palmoplantar pustulosis who haven't improved after at least one standard systemic treatment.
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Bimekizumab for palmoplantar pustulosis (PPP)
This trial tests whether bimekizumab helps adults with palmoplantar pustulosis and is safe compared with a placebo.
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16-week delgocitinib cream treatment for adults with palmoplantar pustulosis
This 16-week test will see if applying delgocitinib cream twice daily helps adults with mild to severe palmoplantar pustulosis compared with a non-active cream.
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Collecting samples from people with skin conditions and healthy volunteers
This study is collecting samples from people with different skin conditions and healthy volunteers to see how their biology differs and learn more about these conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.