Trial results for a Phase 4 study (NCT05710185) investigating deucravacitinib for Palmoplantar Pustulosis were posted on ClinicalTrials.gov on 2025-12-16. The trial was terminated, and 0 participants achieved a ppPASI-50 response.
Background
Deucravacitinib was being investigated as a treatment for Palmoplantar Pustulosis (PPP).
Trial design
The study (NCT05710185) was a Phase 4, prospective, single-arm, open-label trial. It enrolled 3 participants with Palmoplantar Pustulosis. Participants were administered deucravacitinib 6 mg daily for 24 weeks. The trial was terminated.
Key results
The trial reported several outcome measurements for the 3 participants with Palmoplantar Pustulosis:
- For the "Proportion of Participants Who Achieve a ppPASI-50 Response, or at Least 50% Improvement in ppPASI Score," 0 Participants were reported to have achieved this response.
- For the "Number of Patients Who Achieve a Physicians Global Assessment Score of 0 or 1," 0 participants were reported.
- Regarding "Change From Baseline in the Dermatology Quality Life Index (DLQI)":
- A mean change of 0.5 units on a scale (Standard Deviation: 8.49) was observed.
- Another measurement showed a mean change of -5 units on a scale (Standard Deviation: 0.00).
- For "Change From Baseline in ppPASI":
- A mean change of -3.7 units on a scale (Standard Deviation: 9.05) was reported.
- Another measurement showed a mean change of -1.4 units on a scale (Standard Deviation: 0.00).
- For "Change From Baseline in EQ-5D VAS":
- A mean change of -10.5 units on a scale (Standard Deviation: 24.75) was observed.
- Another measurement showed a mean change of 4 units on a scale (Standard Deviation: 0.00).
- For "Change From Baseline in the Itch Visual Analogue Scale (Itch-VAS)":
- A mean change of 32 units on a scale (Standard Deviation: 21.21) was observed.
- Another measurement showed a mean change of 25 units on a scale (Standard Deviation: 0.00).
What this means
The termination of this Phase 4 trial and the reported outcomes, particularly the 0 participants achieving a ppPASI-50 response or a Physicians Global Assessment Score of 0 or 1, suggest that deucravacitinib did not demonstrate a positive efficacy signal for Palmoplantar Pustulosis in this small cohort. The mixed changes observed in other scales like DLQI, ppPASI, EQ-5D VAS, and Itch-VAS, without clear positive trends or statistical analyses, further support this interpretation. These results indicate that deucravacitinib may not be a viable treatment option for Palmoplantar Pustulosis based on this study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05710185, titled "Deucravacitinib for the Treatment of Palmoplantar Pustulosis," were posted on 2025-12-16 on clinicaltrials.gov.