Deucravacitinib for the Treatment of Palmoplantar Pustulosis

NCT05710185 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2023P000194
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Palmoplantar Pustulosis

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score

  The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity

  16 weeks

• Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score

  The ppPASI is the most commonly used disease severity measure use in palmoplantar pustulosis clinic trials. The ppPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. This second Primary Outcome was added by administrative error since the study only has one Primary Outcome Measure. Hence, the outcome and results are a duplication of the outcome measure reported, and this one was left incomplete in the previous results reporting submission.

  16 weeks

Secondary Outcomes (6)

• Change From Baseline in the Dermatology Quality Life Index (DLQI)

  Week 16, Week 24

• Change From Baseline in ppPASI

  Week 16, Week 24

• Percentage of Patient Who Achieve a Physicians Global Assessment Score of 0 or 1

  Week 16, Week 24

• Change From Baseline in EQ-5D VAS

  Week 16, Week 24

• Change From Baseline in the Itch Visual Analogue Scale (Itch-VAS)

  Week 16, Week 24

Study Arms (1)

Subjects with Palmoplantar pustulosis

EXPERIMENTAL

All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks.

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

See arm/group description

Subjects with Palmoplantar pustulosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director of Clinical Trials, Brigham and Women's Hospital Department of Dermatology
• Organization: Brigham and Women's Hospital

amostaghimi@mgb.org

617-732-5500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 31, 2025
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-12

Locations

US (2)