Trial results for a Phase 4 study (NCT05701995) investigating deucravacitinib (Sotyktu) for participants with plaque psoriasis were posted on ClinicalTrials.gov on 2025-09-10. The study demonstrated that 33.3% of participants treated with deucravacitinib 6mg QD achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16, compared to 6.7% for placebo.
Background
Deucravacitinib is an oral medication investigated for the treatment of psoriasis.
Trial design
The study (NCT05701995) was a Phase 4, randomized trial that enrolled 180 participants with plaque psoriasis. The trial aimed to evaluate the effect of deucravacitinib on quality of life in a community setting, comparing it against a placebo.
Key results
The trial results showed significant improvements in quality of life measures for participants receiving deucravacitinib compared to placebo at Week 16.
- For the outcome "Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1":
- In the Full Analysis Set, 33.3% of participants in the deucravacitinib 6mg QD group achieved a DLQI score of 0 or 1, compared to 6.7% in the placebo group. An analysis using Stratified Cochran-Mantel-Haenszel (CMH) method showed an Odds Ratio (OR) of 7.7 (95.0% CI: 2.5 to 23.6) with a p-value of 0.0001.
- Similar results were observed in a sub-population analysis, where 32.7% in the deucravacitinib group vs 6.1% in the placebo group achieved this outcome, with an OR of 8.5 (95.0% CI: 2.4 to 30.4) and a p-value of 0.0003.
- For the outcome "Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI)":
- In the Full Analysis Set, 72.5% of participants in the deucravacitinib 6mg QD group achieved a ≥ 4-point reduction, compared to 53.3% in the placebo group. The CMH analysis yielded an OR of 2.3 (95.0% CI: 1.2 to 4.4) with a p-value of 0.0107.
- A sub-population analysis showed 72.9% in the deucravacitinib group vs 53.1% in the placebo group achieved this outcome, with an OR of 2.3 (95.0% CI: 1.2 to 4.7) and a p-value of 0.0175.
- For the outcome "Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score":
- In the Full Analysis Set, the deucravacitinib 6mg QD group showed a mean change of -3.8 (Standard Deviation: 2.86), while the placebo group showed a mean change of -1.8 (Standard Deviation: 2.78). A covariance model analysis indicated an Adjusted Mean Difference of -2.0 (95.0% CI: -2.9 to -1.2) with a p-value of 0.0001.
- In a sub-population analysis, the deucravacitinib group showed a mean change of -3.8 (Standard Deviation: 2.73) vs -1.8 (Standard Deviation: 2.70) for placebo, with an Adjusted Mean Difference of -2.2 (95.0% CI: -3.0 to -1.3) and a p-value of 0.0001.
What this means
The results of this Phase 4 study indicate that deucravacitinib significantly improves quality of life and reduces itch in participants with plaque psoriasis in a community setting. The substantial differences observed in DLQI scores and itch reduction compared to placebo suggest that deucravacitinib can offer meaningful benefits for patients' daily lives and symptom management, reinforcing its role as a treatment option for this condition.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05701995, titled "A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting," were posted on 2025-09-10 on clinicaltrials.gov.