Deucravacitinib for the Treatment of Palmoplantar Pustulosis

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, single-arm, open-label trial of deucravacitinib 6 mg daily in patients with PPP. All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: University of Pennsylvania

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