Trial results for deucravacitinib (Sotyktu) in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE) were posted on ClinicalTrials.gov on 2025-09-10. The Phase 2 study showed that deucravacitinib treatment arms achieved greater mean percentage changes from baseline in CLASI Activity Score (e.g., -48.56% and -48.93%) compared to placebo (-27.31%) at Week 16. Additionally, a higher percentage of deucravacitinib-treated participants achieved a ≥50% improvement in CLASI-A score (60.0% and 54.2%) versus placebo (21.7%).
Background
The study investigated deucravacitinib for the treatment of active discoid lupus erythematosus (DLE) and/or subacute cutaneous lupus erythematosus (SCLE). These are chronic inflammatory autoimmune diseases primarily affecting the skin, often causing disfiguring lesions.
Trial design
The study (NCT04857034) was a Phase 2, placebo-controlled trial that enrolled 74 participants. The study evaluated the safety, efficacy, and tolerability of deucravacitinib compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). The trial aimed to assess if deucravacitinib is biologically active and potentially effective in treating moderate to severe DLE/SCLE, with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.
Key results
The trial results, posted on ClinicalTrials.gov, included several key outcome measurements at Week 16:
- Percentage Change From Baseline in CLASI Activity Score at Week 16:
- For deucravacitinib Treatment 1, the mean change was -48.56% (Standard Deviation: 44.684).
- For deucravacitinib Treatment 2, the mean change was -48.93% (Standard Deviation: 33.302).
- For placebo, the mean change was -27.31% (Standard Deviation: 29.716).
- Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50):
- 60.0% of participants in the deucravacitinib Treatment 1 group achieved this improvement.
- 54.2% of participants in the deucravacitinib Treatment 2 group achieved this improvement.
- 21.7% of participants in the placebo group achieved this improvement.
- Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline:
- 60.0% of participants in the deucravacitinib Treatment 1 group showed this improvement.
- 66.7% of participants in the deucravacitinib Treatment 2 group showed this improvement.
- 39.1% of participants in the placebo group showed this improvement.
- Mean Change From Baseline in CLASI-A Score:
- For deucravacitinib Treatment 1, the mean change was -9.8 (Standard Deviation: 12.69).
- For deucravacitinib Treatment 2, the mean change was -7.5 (Standard Deviation: 5.92).
- For placebo, the mean change was -4.3 (Standard Deviation: 5.54).
What this means
The results from this Phase 2 trial indicate that deucravacitinib led to greater improvements in skin disease activity, as measured by CLASI scores, compared to placebo in patients with active discoid and/or subacute cutaneous lupus erythematosus. The consistent directional findings across multiple CLASI-related endpoints suggest potential therapeutic benefit for deucravacitinib in this patient population. These findings support further investigation into deucravacitinib as a treatment option for DLE/SCLE.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04857034, titled "A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)," were posted on 2025-09-10 on clinicaltrials.gov.