Deucravacitinib for the Treatment of Palmoplantar Pustulosis (NCT05710185) | Clinical Trial Compass
TerminatedPhase 4
Deucravacitinib for the Treatment of Palmoplantar Pustulosis
Stopped: Sponsor terminated funding
United States3 participantsStarted 2023-07-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pos…
What they're measuring
1
Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score
Timeframe: 16 weeks
2
Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score