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NCT05710185
Deucravacitinib for the Treatment of Palmoplantar Pustulosis
Conditions: Palmoplantar Pustulosis
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 18
Sponsor: Brigham and Women's Hospital
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.
Eligibility Criteria
Inclusion Criteria:• Adults aged 18 years of age and olderDermatologist confirmed diagnosis of PPP for at least 6 monthsModerate-severe PPP, defined as a ppPASI > 12Inadequate response to topical therapy and a candidate for systemic or phototherapyWilling to discontinue current topical and/or systemic PPP treatments, except for OTC emollientsExclusion Criteria:• Participants with other immune-mediated conditions requiring concurrent systemic immunosuppressant treatmentsCurrent/recent administration of PPP-specific medications including:Rituximab within 6 months of the baseline visitBiologics within 12 weeks of baseline visitSystemic steroids, oral immunosuppressants (azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, tacrolimus), oral retinoids (acitretin, isotretinoin), apremilast, or dapsone within 4 weeks of baseline visitPhototherapy within 4 weeks of baseline visitPrescription topical medications (including calcineurin inhibitors, crisaborole, retinoids, steroids, tar, vitamin D analogs) within 2 weeks of baseline visitHistory 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 daysEvidence 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 treatmentHuman immunodeficiency virus infection (positive HIV antibody)Active hepatitis BActive hepatitis CEvidence of clinically significant laboratory abnormality including:Absolute WBC count < 3000/mm3Platelet count < 100,000/mm3Hemoglobin < 9.0 g/dlALT or AST > 3 times the upper limit of normalHistory 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 trialMajor surgery within 4 weeks of baseline visitReceipt of live vaccine within 8 weeks of baseline visitPregnant or breastfeeding individualsInability to comply with any of the study proceduresIndividuals who are incarcerated or compulsory detained
Source: ClinicalTrials.gov (NCT05710185). StuddyBuddy aggregates publicly available trial information.