Trial results for deucravacitinib (Sotyktu) in a Phase 2 study (NCT06091956) for Lichen Planopilaris were posted on ClinicalTrials.gov on 2025-06-08. The study reported that 9 out of 12 enrolled participants showed a complete or partial response as measured by the Lichen Planopilaris Activity Index (LPPAI) score. Additionally, a mean reduction of -2.7 units was observed in one measurement of the Pruritus Visual Analogue Scale (VAS).
Background
Deucravacitinib is being investigated for the treatment of Lichen Planopilaris, a chronic inflammatory scalp condition.
Trial design
The study (NCT06091956) was a Phase 2 clinical trial that enrolled 12 participants. The trial investigated deucravacitinib for the treatment of Lichen Planopilaris.
Key results
For the outcome of "Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score," 9 participants in the deucravacitinib treatment group showed a response.
Regarding "Response to Deucravacitinib Measured by Physician Global Assessment (PGA) Score," 8 participants demonstrated a response.
The mean change in the Dermatology-LQI Score was 0.0 score on a scale (Standard Deviation: 4.2).
The mean change in Pruritus Visual Analogue Scale (VAS) was -1.6 units on a scale (Standard Deviation: 3.0).
Another measurement for the mean change in Pruritus Visual Analogue Scale (VAS) showed -2.7 units on a scale (Standard Deviation: 3.8).
The mean change in Pruritus Verbal Rating Scale (VRS) was -0.9 score on a scale (Standard Deviation: 0.7).
A second measurement for the mean change in Pruritus Verbal Rating Scale (VRS) was -0.9 score on a scale (Standard Deviation: 0.6).
The mean change in Numerical Rating Scale (NRS) for Itch was -1.9 score on a scale (Standard Deviation: 3.3).
The mean change in Skindex-16 was -21.0 score on a scale (Standard Deviation: 22.1).
Statistical analyses included a McNemar test with a p-value of 0.008. Wilcoxon (Mann-Whitney) tests yielded p-values of 0.629, 0.175, and 0.014 for various outcomes.
What this means
The results from this Phase 2 trial suggest that deucravacitinib may have a beneficial effect for patients with Lichen Planopilaris, particularly in reducing symptoms like pruritus and showing responses in disease activity scores. The observed responses in LPPAI and PGA, alongside reductions in various pruritus scales, indicate potential clinical activity. These findings warrant further investigation in larger clinical trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06091956, titled "A Study of Deucravacitinib to Treat LPP and FFA," were posted on 2025-06-08 on clinicaltrials.gov.