Ivarmacitinib for palmoplantar pustulosis (open-label, single-arm treatment)
A Prospective, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Ivarmacitinib in the Treatment of Palmoplantar Pustulosis
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | ivarmacitinib |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07270003 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, open-label trial at Xijing Hospital testing oral ivarmacitinib in adults with clinically confirmed palmoplantar pustulosis who have failed or are intolerant of prior systemic therapy. Participants who meet lab and safety criteria will receive ivarmacitinib and be followed for changes in skin pustules, redness, symptom severity, and any joint symptoms, along with routine safety labs. The trial excludes patients with significant cytopenias, abnormal liver or kidney tests, or active infections such as tuberculosis or hepatitis. Safety monitoring and symptom measures will be used to characterize both benefit and potential harms of the drug.
Who should consider this trial
Good fit: Adults (≥18) with confirmed palmoplantar pustulosis who have failed or cannot tolerate at least one conventional systemic therapy and meet the study's safety lab criteria are the intended participants.
Not a fit: Patients with significant laboratory abnormalities, active infections (including TB or hepatitis), or other medical conditions that pose safety risks are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, ivarmacitinib could offer an effective oral option that reduces pustules, pain, and daily impairment from PPP.
How similar studies have performed: Oral JAK inhibitors and other systemic agents have shown benefit in related psoriasis conditions, but PPP-specific evidence is limited and this approach remains under study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years old; clinically/pathologically confirmed PPP; failure/intolerance to ≥1 conventional systemic therapy (12-24 weeks of standard dosing); physician-judged suitability for ivarmacitinib; signed informed consent. Exclusion Criteria: * Lymphocyte count \<0.5×10⁹/L, neutrophils \<1×10⁹/L, platelets \<100×10⁹/L, or hemoglobin \<80g/L; serum creatinine \>132.6μmol/L, AST/ALT \>2×ULN, or total bilirubin \>2.0mg/dL; active infections (tuberculosis, hepatitis B/C, systemic candidiasis); other conditions hindering participation or data interpretation.
Where this trial is running
Xi'an, Shaanxi
- Xijing hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Gang Wang, Phd
- Email: xjwgang@fmmu.edu.cn
- Phone: 15102994796
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.