Trial results for deucravacitinib (Sotyktu) in moderate-to-severe scalp psoriasis were posted on ClinicalTrials.gov on 2025-03-13. The Phase 4 study demonstrated that 48.5% of participants treated with deucravacitinib achieved a Scalp-specific Physician Global Assessment (Ss-PGA) score of 0 or 1 at Week 16, compared to 13.7% in the placebo group (p=0.0001).
Background
Deucravacitinib is an oral medication investigated for the treatment of psoriasis. This study specifically focused on its efficacy and safety in participants with moderate-to-severe scalp psoriasis.
Trial design
This completed Phase 4 study (NCT05478499) enrolled 154 participants with moderate-to-severe scalp psoriasis. The trial's purpose was to compare the efficacy and safety of deucravacitinib to placebo in this population. Participants were randomized to receive either deucravacitinib or placebo.
Key results
At Week 16, deucravacitinib demonstrated superior efficacy compared to placebo across multiple endpoints:
- For the percentage of participants with a Scalp-specific Physician Global Assessment (Ss-PGA) score of 0 or 1 at Week 16:
- Deucravacitinib group: 48.5% (Full Analysis Set) and 50.0% (Patient sub-population with s-PGA ≥ 3)
- Placebo group: 13.7% (Full Analysis Set) and 12.8% (Patient sub-population with s-PGA ≥ 3)
- The Odds Ratio (OR) for the Full Analysis Set was 6.2 (95% CI: 2.5, 15.3; p=0.0001).
- For the percentage of participants with a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16:
- Deucravacitinib group: 38.8% (Full Analysis Set) and 40.6% (Patient sub-population with s-PGA ≥ 3)
- Placebo group: 2.0% (Full Analysis Set) and 2.1% (Patient sub-population with s-PGA ≥ 3)
- The Odds Ratio (OR) for the Full Analysis Set was 40.2 (95% CI: 4.6, 352.0; p=0.0001).
- For the change from baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16:
- Deucravacitinib group: mean change of -3.2 (SD: 2.95) (Full Analysis Set) and -3.3 (SD: 2.87) (Patient sub-population with s-PGA ≥ 3)
- Placebo group: mean change of -0.7 (SD: 2.27) (Full Analysis Set) and -0.9 (SD: 2.29) (Patient sub-population with s-PGA ≥ 3)
- The adjusted mean difference for the Full Analysis Set was -2.5 (95% CI: -3.3, -1.6; p=0.0001).
What this means
The results indicate that deucravacitinib significantly improved outcomes for participants with moderate-to-severe scalp psoriasis compared to placebo. The substantial differences in responder rates for Ss-PGA 0/1 and PSSI 90, alongside a notable reduction in scalp itch, suggest that deucravacitinib could be an effective treatment option for this specific manifestation of psoriasis. The consistent statistical significance (p=0.0001) across multiple key efficacy endpoints reinforces the robustness of these findings.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05478499, titled "Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis," were posted on 2025-03-13 on clinicaltrials.gov.