A Phase 2a Study Investigating the Effects of Ritlecitinib on Brainstem Auditory Evoked Potentials and Intraepidermal Nerve Fiber Histology in Adults with Alopecia Areata

July 2024 in “ Pharmacology Research & Perspectives ”

Samira Anderson, Guido Cavaletti, Linda J. Hood, Michael Polydefkis, D. Herrmann, Gary Rance, Brett King, Amy McMichael, Maryanne M. Senna, Brian Kim, Lynne Napatalung, Robert Wołk, Samuel H. Zwillich, Gregor Schaefer, Yankun Gong, Melanie Sisson, Holly Posner

ritlecitinib alopecia areata intraepidermal nerve fiber brainstem auditory evoked potentials

Studysummary In this phase 2a study of adults with alopecia areata, researchers observed that ritlecitinib treatment did not result in significant differences in brainstem auditory evoked potential changes or axonal swelling compared to placebo, suggesting the dog toxicity findings may not be clinically relevant in humans.

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This phase 2a study evaluated the effects of ritlecitinib on brainstem auditory evoked potentials (BAEP) and intraepidermal nerve fiber (IENF) histology in 71 adults with alopecia areata, with 36 receiving ritlecitinib and 35 receiving a placebo. Conducted across multiple countries, the study found no significant differences in BAEP or IENF parameters between the groups, indicating no neurological or audiological safety concerns. Ritlecitinib was generally well-tolerated, with most adverse events being mild or moderate. Efficacy assessments showed a greater reduction in Severity of Alopecia Tool (SALT) scores and higher Patient Global Impression of Change (PGI-C) response rates in the ritlecitinib group compared to placebo, supporting its safety and potential efficacy for treating alopecia areata.

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In this phase 2a study of adults with alopecia areata, researchers observed that ritlecitinib treatment did not result in significant differences in brainstem auditory evoked potential changes or axonal swelling compared to placebo, suggesting the dog toxicity findings may not be clinically relevant in humans.

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