A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata

Daniela Mikhaylov, Jacob W. Glickman, Ester Del Duca, John Nia, Peter Hashim, Giselle K. Singer, Alba L. Posligua, Aleksandra G. Florek, Erin Ibler, Erika L. Hagstrom, Yeriel Estrada, Stephanie M. Rangel, Maria Colavincenzo, Amy S. Paller, Emma Guttman-Yassky*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Alopecia areata/AA is an autoimmune cause of nonscarring hair loss. The pathogenesis of AA involves many immune axes, including Th1/Th2 pathways. Delgocitinib is a pan-Janus kinase/JAK inhibitor that broadly blocks pro-inflammatory cytokines and has been effective in other inflammatory skin conditions. Recent human studies/reports have shown that use of some systemic JAK inhibitors led to hair regrowth, suggesting this medication class as a potential therapy for AA. However, topical treatment is desirable due to potential systemic side effects. To assess the efficacy and safety of topical delgocitinib in AA, we conducted a double-blind, randomized, vehicle-controlled clinical trial in 31 moderate-to-severe AA patients that were randomized 2:1 to receive delgocitinib ointment 30 mg/g (n = 20) or ointment vehicle (n = 11) for 12 weeks. The primary endpoint was change in severity of Alopecia Tool/SALT score from baseline to week 12. The secondary endpoint included safety profile by reported adverse events. Twenty-three subjects completed the trial, with eight discontinuing mostly due to voluntary withdrawal. Ten patients receiving delgocitinib ointment and three patients receiving vehicle showed SALT score improvements after 12 weeks, but the mean percent SALT improvement at week 12 compared to baseline between the two arms was not significant (p = 0.92). Our study suggests that delgocitinib ointment is not effective in moderate-to-severe AA, likely due to its inability to penetrate sufficiently deeply into the dermis of the scalp, but larger studies are necessary to assess whether a different formulation of topical JAK inhibitors may be suitable to treat mild or more localized forms of AA.

Original languageEnglish (US)
JournalArchives of Dermatological Research
DOIs
StateAccepted/In press - 2022

Keywords

  • Alopecia areata
  • Alopecia totalis
  • Alopecia universalis
  • Delgocitinib
  • JAK inhibitor
  • Moderate-to-severe AA
  • Vehicle-controlled

ASJC Scopus subject areas

  • Dermatology

Fingerprint

Dive into the research topics of 'A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata'. Together they form a unique fingerprint.

Cite this