Trial results for deucravacitinib (Sotyktu) in participants with non-pustular palmoplantar and genital psoriasis were posted on ClinicalTrials.gov on 2026-04-17. In the genital psoriasis cohort, deucravacitinib 6mg QD led to a 48.4% Static Physician's Global Assessment of Genitalia (sPGA-G) response, compared to 0% for placebo.
Background
The study aimed to evaluate the safety and effectiveness of deucravacitinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.
Trial design
The study (NCT06042920) was a Phase 4, placebo-controlled trial that enrolled 130 participants. The study investigated deucravacitinib in individuals with non-pustular palmoplantar psoriasis and genital psoriasis. Participants received either deucravacitinib 6mg QD or placebo. The overall status of the trial is TERMINATED.
Key results
The trial evaluated several outcomes related to the effectiveness and safety of deucravacitinib:
- For the "Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response" in the genital psoriasis cohort:
- Participants receiving deucravacitinib 6mg QD achieved a 48.4% response.
- Participants receiving placebo achieved a 0% response.
- For the "Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response" in the palmoplantar psoriasis cohort:
- Participants receiving deucravacitinib 6mg QD achieved a 31.3% response.
- Participants receiving placebo achieved a 33.3% response.
- For the "Percentage of Participants Who Achieve a Palmoplantar Physician Global Assessment (Pp-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16":
- Participants receiving deucravacitinib 6mg QD achieved an 18.8% response.
- Participants receiving placebo achieved an 11.1% response.
- For "Change From Baseline in Genital Psoriasis Itch (GenPs) Numeric Rating Scale (NRS) Score at Week 16":
- The deucravacitinib 6mg QD group showed a mean change of -1.9 (Standard Deviation: 3.23).
- The placebo group showed a mean change of -0.8 (Standard Deviation: 2.95).
Regarding adverse events:
- In the palmoplantar psoriasis cohort, 17 participants in the deucravacitinib 6mg QD group experienced adverse events, compared to 7 in the placebo group.
- In the genital psoriasis cohort, 31 participants in the deucravacitinib 6mg QD group experienced adverse events, compared to 15 in the placebo group.
What this means
The trial results suggest that deucravacitinib may offer a benefit for patients with genital psoriasis, as evidenced by a substantial sPGA-G response rate compared to placebo and a greater reduction in itch scores. For palmoplantar psoriasis, the results for Pp-PASI-75 response did not show a clear advantage over placebo, though a modest improvement was observed in the Pp-PGA score. The higher number of adverse events in the deucravacitinib groups across both cohorts warrants consideration.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06042920, titled "A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis," were posted on 2026-04-17 on clinicaltrials.gov.