Picankibart for palmoplantar pustulosis
Efficacy and Safety of Picankibart in the Treatment of Moderate-to-Severe Palmoplantar Pustulosis: A Prospective, Single-Arm, Open-Label Clinical Study
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07552454 on ClinicalTrials.gov |
What this trial studies
Researchers at Xijing Hospital will enroll 60 adults with clinically or histologically confirmed palmoplantar pustulosis in a prospective, single-arm, open-label protocol to receive picankibart. Eligible participants must have failed or been intolerant to at least one conventional systemic therapy, and those with active hepatitis B, hepatitis C, tuberculosis, or pregnancy are excluded. Participants will receive picankibart according to the study protocol with scheduled dermatology follow-up visits to monitor skin response and safety. As a single-center, uncontrolled trial, the study is intended to provide safety data and preliminary signals of effectiveness rather than definitive comparative efficacy.
Who should consider this trial
Good fit: Adults 18-65 with confirmed palmoplantar pustulosis who have failed or are intolerant of at least one conventional systemic agent and can comply with clinic follow-up are the ideal candidates.
Not a fit: Patients with active hepatitis B, hepatitis C, or tuberculosis, pregnant patients or those planning pregnancy within six months, and those who respond well to standard treatments are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, picankibart could reduce pustules and improve hand and foot function and quality of life for people with refractory palmoplantar pustulosis.
How similar studies have performed: Some biologic therapies for psoriasis have shown benefit in pustular variants, but evidence specific to picankibart in palmoplantar pustulosis is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-65 years, regardless of gender. Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and/or skin histopathology. Failed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions. Considered suitable for treatment with picankibart as assessed by the clinician. Voluntarily participate in the study and provide written informed consent. Exclusion Criteria: * Patients with active hepatitis B, hepatitis C, or tuberculosis. Pregnant patients or those planning pregnancy within 6 months. Subjects unable to comply with follow-up as required by the study protocol. Other conditions deemed unsuitable for this study.
Where this trial is running
Xi'an, Shaanxi
- Department of Dermatology, Xijing Hospital, Fourth Military Medical University, No. 127 of West Changle Road, 710032, Xi'an, Shaanxi, China — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Shuai Shao
- Email: 2269744794@qq.com
- Phone: 8619249282690
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.