Treatment of Palmoplantar Pustulosis with Deucravacitinib

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

This study is testing if a daily dose of a new medication called deucravacitinib can help adults with palmoplantar pustulosis feel better and improve their quality of life over 24 weeks.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Drugs / interventions: Rituximab, methotrexate, deucravacitinib
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT05710185 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of deucravacitinib, administered at a dose of 6 mg daily, in adults diagnosed with palmoplantar pustulosis (PPP) for at least six months. Participants will receive the treatment for 24 weeks, with assessments every four weeks to monitor improvements in their condition and quality of life. The primary goal is to determine the proportion of patients achieving a significant reduction in disease severity, as measured by the palmoplantar pustular psoriasis area and severity index (ppPASI). Secondary endpoints include changes in quality of life and the frequency of adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of moderate to severe palmoplantar pustulosis who have not responded adequately to topical therapies.

Not a fit: Patients with other immune-mediated conditions requiring systemic immunosuppressants or those currently using specific medications for PPP may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and reduce symptoms for patients suffering from palmoplantar pustulosis.

How similar studies have performed: Other studies have shown promise with similar treatments for immune-mediated skin conditions, suggesting potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* • Adults aged 18 years of age and older

  * Dermatologist confirmed diagnosis of PPP for at least 6 months
  * Moderate-severe PPP, defined as a ppPASI \> 12
  * Inadequate response to topical therapy and a candidate for systemic or phototherapy
  * Willing to discontinue current topical and/or systemic PPP treatments, except for OTC emollients

Exclusion Criteria:

* • Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatments

  * Current/recent administration of PPP-specific medications including:

    * Rituximab within 6 months of the baseline visit
    * Biologics within 12 weeks of baseline visit
    * Systemic steroids, oral immunosuppressants (azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, tacrolimus), oral retinoids (acitretin, isotretinoin), apremilast, or dapsone within 4 weeks of baseline visit
    * Phototherapy within 4 weeks of baseline visit
    * Prescription topical medications (including calcineurin inhibitors, crisaborole, retinoids, steroids, tar, vitamin D analogs) within 2 weeks of baseline visit
  * History of active infection and/or febrile illness within 7 days; or infection requiring antibiotic treatment within 30 days; or serious infection requiring hospitalization and/or IV antibiotics within 90 days
  * Evidence of other infection including:

    * Active or untreated latent tuberculosis, defined as radiographic or laboratory evidence of active TB or positive quantiferon or PPD, unless the subject has completed the recommended treatment
    * Human immunodeficiency virus infection (positive HIV antibody)
    * Active hepatitis B
    * Active hepatitis C
  * Evidence of clinically significant laboratory abnormality including:

    * Absolute WBC count \< 3000/mm3
    * Platelet count \< 100,000/mm3
    * Hemoglobin \< 9.0 g/dl
    * ALT or AST \> 3 times the upper limit of normal
  * History of cancer within the past 5 years, excluding treated non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma)
  * Other uncontrolled chronic medical condition that may interfere with a patient's ability to participate in the clinical trial
  * Major surgery within 4 weeks of baseline visit
  * Receipt of live vaccine within 8 weeks of baseline visit
  * Pregnant or breastfeeding individuals
  * Inability to comply with any of the study procedures
  * Individuals who are incarcerated or compulsory detained

Where this trial is running

Boston, Massachusetts and 1 other locations

• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Liset Chacin

Conditions Palmoplantar Pustulosis