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

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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.

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Abbreviations

AA:

Alopecia areata

AD:

Atopic dermatitis

AT:

Alopecia totalis

AU:

Alopecia universalis

IRB:

Institutional Review Board

JAKs:

Janus kinases

SALT:

Severity of Alopecia Tool

STAT:

Signal transducer and activator of transcription

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Funding

This study was funded by grants to the Icahn School of Medicine at Mount Sinai and Northwestern University from Leo Pharma.

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Authors and Affiliations

  1. Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA

    Daniela Mikhaylov, Jacob W. Glickman, Ester Del Duca, John Nia, Peter Hashim, Giselle K. Singer, Yeriel Estrada & Emma Guttman-Yassky

  2. Department of Dermatology, University of Magna Graecia, Catanzaro, Italy

    Ester Del Duca

  3. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Alba L. Posligua, Aleksandra G. Florek, Erin Ibler, Erika L. Hagstrom, Stephanie M. Rangel, Maria Colavincenzo & Amy S. Paller

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  1. Daniela Mikhaylov
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Correspondence to Emma Guttman-Yassky.

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EGY is an employee of Mount Sinai and has received research funds (grants paid to the institution) from: Abbvie, Celgene, Eli Lilly, Janssen, Medimmune/Astra Zeneca, Novartis, Pfizer, Regeneron, Vitae, Glenmark, Galderma, Asana, Innovaderm, Dermira, UCB. EGY is also a consultant for Sanofi Aventis, Regeneron, Stiefel/GlaxoSmithKline, MedImmune, Celgene, Anacor, AnaptysBio, Dermira, Galderma, Glenmark, Novartis, Pfizer, Vitae, Leo Pharma, Abbvie, Eli Lilly, Kyowa, Mitsubishi Tanabe, Asana Biosciences, and Promius. AP has received research funds (paid to institution) from AbbVie, AnaptysBio, Eli Lilly, Incyte, Janssen, KrystalBio, Regeneron, UCB, is a consultant for Abbvie, Abeona, Alcimed, Almirall, Amagma, Anaptysbio, Arena, Azitra, BiomX, Boehringer Ingeheim, Castle Biosciences, Catawba, Dermira, Eli Lilly, Exicure, Forte, Kamari, Leo, Lifemax, NAOS, Novartis, Pfizer, Phoenix, Pierre Fabre, Regeneron, Sanofi/Genzyme, Seanergy, Trifecta, UCB, and serves on a data safety monitoring board for AbbVie, Bausch, Galderma, Novan. The other authors declare that they have no relevant conflicts of interest.

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Reviewed and approved by local IRB. Written and verbal informed consent was given by all patients before inclusion in the study.

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Mikhaylov, D., Glickman, J.W., Del Duca, E. et al. A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata. Arch Dermatol Res 315, 181–189 (2023). https://doi.org/10.1007/s00403-022-02336-0

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