Trial results for deucravacitinib (Sotyktu) in Alopecia Areata were posted on ClinicalTrials.gov on 2025-02-28. The study, which was terminated, evaluated efficacy and safety, showing that the 6 mg once daily dose resulted in a mean change of -5.809 in the Severity of Alopecia Tool (SALT) score, compared to -7.302 for placebo at Week 24.
Background
Deucravacitinib, also known as Sotyktu, was investigated for its potential in treating Alopecia Areata. This condition is an autoimmune disorder that causes hair loss.
Trial design
This Phase 2 study (NCT05556265) was designed to evaluate the efficacy and safety of deucravacitinib in adult participants with Alopecia Areata. A total of 94 participants were enrolled before the trial was terminated. The study compared deucravacitinib at two dosage regimens (6 mg once daily and 6 mg twice daily) against placebo.
Key results
The study measured the change from baseline in the Severity of Alopecia Tool (SALT) score at Week 24 during the placebo-controlled treatment period. Key results include:
- For the deucravacitinib 6 mg once daily group, the mean change from baseline in SALT score was -5.809 (Standard Deviation: 13.3892).
- For the deucravacitinib 6 mg twice daily group, the mean change from baseline in SALT score was 1.027 (Standard Deviation: 14.7258).
- For the placebo group, the mean change from baseline in SALT score was -7.302 (Standard Deviation: 17.8732).
Regarding safety, the number of participants with treatment emergent adverse events (TEAEs) in the placebo-controlled period was 25 for deucravacitinib 6 mg once daily, 28 for deucravacitinib 6 mg twice daily, and 20 for placebo. Specific counts of participants with certain TEAEs were also reported: 1 for deucravacitinib 6 mg once daily, 1 for deucravacitinib 6 mg twice daily, and 0 for placebo in one outcome; and 1 for deucravacitinib 6 mg once daily, 3 for deucravacitinib 6 mg twice daily, and 0 for placebo in another outcome.
What this means
The results indicate that neither the deucravacitinib 6 mg once daily nor the 6 mg twice daily dosage showed superior efficacy compared to placebo in improving the Severity of Alopecia Tool (SALT) score at Week 24. The 6 mg once daily dose demonstrated a mean change of -5.809, which was less improvement than the -7.302 observed with placebo. The 6 mg twice daily dose showed a mean increase of 1.027, suggesting a worsening of the SALT score. The termination of this Phase 2 study, coupled with these efficacy findings, suggests that deucravacitinib may not be an effective treatment for Alopecia Areata at the doses studied.
Source
The information regarding these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05556265, titled "A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata," were posted on 2025-02-28 on clinicaltrials.gov.