The British journal of dermatology · 2026
Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in patients with alopecia areata: efficacy and safety results of a phase II, multicentre, randomized, double-blinded, placebo-controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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King Brett, Ehst Benjamin, Foley Peter, Reygagne Pascal, Ohyama Manabu, Szepietowski Jacek C, Popmihajlov Zoran, De Leonardis Francesco, Hippeli Lauren, Treitel Michelle, Johnson Brandon, Gilvary Coryandar, Vaile John, Daamen Carolin, Passeron Thierry
Аннотация
BACKGROUND: Alopecia areata (AA) is a common, immune-mediated inflammatory disease characterized by nonscarring hair loss. Tyrosine kinase (TYK)2 mediates signalling of select proinflammatory cytokines [e.g. interleukin (IL)-12, IL-23 and type I interferons], which may play a role in the pathogenesis of AA.
OBJECTIVES: To evaluate the efficacy and safety of deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, in patients with AA.
METHODS: Patients were randomized 1 : 1 : 1 to oral placebo, deucravacitinib 6 mg once daily, or deucravacitinib 6 mg twice daily. At week 24, patients randomized to placebo were rerandomized 1 : 1 to deucravacitinib 6 mg once daily or deucravacitinib 6 mg twice daily until week 52. The primary efficacy endpoint was change from baseline in Severity of Alopecia Tool (SALT) score at week 24. Secondary endpoints were proportions of patients achieving ≥ 50% reduction from baseline in SALT score (SALT 50), SALT score ≤ 20, and Alopecia Areata Investigator Global Assessment score of 0 (clear) or 1 (almost clear) with ≥ 2-point improvement from baseline at week 24. This trial was terminated following database lock at week 24, but before primary data readout, owing to a strategic decision by the sponsor and not as a result of any observed, expected or perceived efficacy or safety findings with deucravacitinib treatment. Early termination did not affect study power.
RESULTS: In total, 94 patients received placebo (n = 31), deucravacitinib 6 mg once daily (n = 32), or deucravacitinib 6 mg twice daily (n = 31). Baseline disease characteristics were balanced across treatment groups. No meaningful difference in change from baseline in SALT score at week 24 was observed between the deucravacitinib and placebo groups [6 mg once daily: adjusted mean difference 1.5, 95% confidence interval (CI) -6.2 to 9.2, P = 0.701; 6 mg twice daily: 8.2, 95% CI 0.2-16.2, P = 0.045]. Similarly, no differences were observed for any secondary endpoint. No new safety signals were identified.
CONCLUSIONS: This trial did not meet the efficacy endpoints and TYK2 inhibition by deucravacitinib may not play a major role in hair regrowth in patients with AA. The safety of deucravacitinib in patients with AA was consistent with the known safety profile of this TYK2 inhibitor.
OBJECTIVES: To evaluate the efficacy and safety of deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, in patients with AA.
METHODS: Patients were randomized 1 : 1 : 1 to oral placebo, deucravacitinib 6 mg once daily, or deucravacitinib 6 mg twice daily. At week 24, patients randomized to placebo were rerandomized 1 : 1 to deucravacitinib 6 mg once daily or deucravacitinib 6 mg twice daily until week 52. The primary efficacy endpoint was change from baseline in Severity of Alopecia Tool (SALT) score at week 24. Secondary endpoints were proportions of patients achieving ≥ 50% reduction from baseline in SALT score (SALT 50), SALT score ≤ 20, and Alopecia Areata Investigator Global Assessment score of 0 (clear) or 1 (almost clear) with ≥ 2-point improvement from baseline at week 24. This trial was terminated following database lock at week 24, but before primary data readout, owing to a strategic decision by the sponsor and not as a result of any observed, expected or perceived efficacy or safety findings with deucravacitinib treatment. Early termination did not affect study power.
RESULTS: In total, 94 patients received placebo (n = 31), deucravacitinib 6 mg once daily (n = 32), or deucravacitinib 6 mg twice daily (n = 31). Baseline disease characteristics were balanced across treatment groups. No meaningful difference in change from baseline in SALT score at week 24 was observed between the deucravacitinib and placebo groups [6 mg once daily: adjusted mean difference 1.5, 95% confidence interval (CI) -6.2 to 9.2, P = 0.701; 6 mg twice daily: 8.2, 95% CI 0.2-16.2, P = 0.045]. Similarly, no differences were observed for any secondary endpoint. No new safety signals were identified.
CONCLUSIONS: This trial did not meet the efficacy endpoints and TYK2 inhibition by deucravacitinib may not play a major role in hair regrowth in patients with AA. The safety of deucravacitinib in patients with AA was consistent with the known safety profile of this TYK2 inhibitor.