Deucravacitinib in Alopecia Areata: Phase II Trial Findings

Key Takeaways

• Week-24 efficacy endpoints were not met, and secondary endpoints also did not differ from placebo.
• The phase II multicentre trial used double-blinded, placebo-controlled 1:1:1 randomization to placebo, deucravacitinib 6 mg once daily, or deucravacitinib 6 mg twice daily.
• No new safety signals were identified; common adverse events included cold symptoms, acne, and folliculitis.

In 94 patients with alopecia areata, a phase II trial of deucravacitinib found no meaningful difference from placebo on the primary week-24 hair regrowth endpoint. The randomized, placebo-controlled study evaluated oral deucravacitinib, a selective allosteric TYK2 inhibitor.

The phase II multicenter, randomized, double-blinded, placebo-controlled trial in alopecia areata assigned patients 1:1:1 to placebo, deucravacitinib 6 mg once daily, or deucravacitinib 6 mg twice daily, with group sizes of 31, 32, and 31. The primary endpoint was change from baseline in Severity of Alopecia Tool (SALT) score at week 24. Secondary endpoints were SALT 50, SALT score of 20 or lower, and AA-IGA 0 or 1 with at least a 2-point improvement, and placebo recipients were rerandomized to active treatment through week 52.

At week 24, investigators found no meaningful difference from placebo in change from baseline in SALT score, and the trial did not meet its efficacy endpoints. The adjusted mean difference was 1.5 for deucravacitinib 6 mg once daily, with a 95% confidence interval from -6.2 to 9.2 and P=0.701. For deucravacitinib 6 mg twice daily, the adjusted mean difference was 8.2, with a 95% confidence interval from 0.2 to 16.2 and P=0.045.

No new safety signals were identified, and the safety profile was consistent with the known safety profile of deucravacitinib. Cold symptoms, acne, and folliculitis were common adverse events. Serious adverse events and treatment discontinuation because of side effects were low.