NCT07503652 Clinical Observation of Xeligekimab in the Treatment of Moderate to Severe Palmoplantar Pustulosis
| NCT ID | NCT07503652 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | First Hospital of China Medical University |
| Condition | Palmoplantar Pustulosis (PPP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 10 participants in total. It began in 2026-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07503652 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Palmoplantar Pustulosis (PPP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07503652 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07503652 currently recruiting?
Yes, NCT07503652 is actively recruiting participants. Contact the research team at guohao27@126.com for enrollment information.
Where is the NCT07503652 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT07503652 clinical trial?
NCT07503652 is sponsored by First Hospital of China Medical University. The trial plans to enroll 10 participants.