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To evaluate the clinical relevance of the dog toxicity finding, this phase 2a, double\u2010blind study assessed BAEP changes and intraepidermal nerve fiber (IENF) histology in adults with alopecia areata treated with ritlecitinib. Patients were randomized to receive oral ritlecitinib 50\u2009mg once daily (QD) with a 4\u2010week loading dose of 200\u2009mg QD or placebo for 9\u2009months (placebo\u2010controlled phase); they then entered the active\u2010therapy extension and received ritlecitinib 50\u2009mg QD (with a 4\u2010week loading dose of 200\u2009mg in patients switching from placebo). Among the 71 patients, no notable mean differences in change from baseline (CFB) in Waves I\u2013V interwave latency (primary outcome) or Wave V amplitude on BAEP at a stimulus intensity of 80\u2009dB nHL were observed in the ritlecitinib or placebo group at Month 9, with no notable differences in interwave latency or Wave V amplitude between groups. The CFB in mean or median IENF density and in percentage of IENFs with axonal swellings was minimal and similar between groups at Month 9. Ritlecitinib treatment was also not associated with an imbalanced incidence of neurological and audiological adverse events. These results provide evidence that the BAEP and axonal swelling finding in dogs are not clinically relevant in humans.<\/jats:p>","DOI":"10.1002\/prp2.1204","type":"journal-article","created":{"date-parts":[[2024,7,6]],"date-time":"2024-07-06T03:13:55Z","timestamp":1720235635000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0731-4574","authenticated-orcid":false,"given":"Samira","family":"Anderson","sequence":"first","affiliation":[{"name":"Department of Hearing and Speech Sciences University of Maryland  College Park Maryland 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