Palmoplantar Pustulosis (PPP)Phase 4NCT07503652
Clinical Observation of Xeligekimab in the Treatment of Moderate to Severe Palmoplantar Pustulosis
A Phase 4 study testing Xeligekimab Injection in people with Palmoplantar Pustulosis (PPP), run by First Hospital of China Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Palmoplantar Pustulosis (PPP)
- What is being tested?
- Xeligekimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Hospital of China Medical University
Shenyang
First Hospital of China Medical University, 024-83282524, guohao27@126.com
About this study
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)
- Being tested
- Xeligekimab Injection
- Keywords
- Xeligekimab, Palmoplantar pustulosis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeligekimab InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Xeligekimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
- 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).
Measured: one month
Secondary outcomes (1)
adverse reactions and incidence
adverse reactions and incidence after the injection
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmoplantar Pustulosis (PPP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinghua, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503652
- Sponsor's protocol ID
- 【2025】897
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No