A Phase 1, Open-Label Study of the Pharmacokinetics of Ritlecitinib in Children Aged 6-12 Years With Alopecia Areata.

IF 1.2 4区医学 Q3 DERMATOLOGY

Pediatric Dermatology Pub Date : 2025-02-09 DOI:10.1111/pde.15895

Mercedes E Gonzalez, John Browning, Stacy Smith, Anna Plotka, Jing Daisy Zhu, Shyam Parvatini, Yeamin Huh, Robert Wolk

{"title":"A Phase 1, Open-Label Study of the Pharmacokinetics of Ritlecitinib in Children Aged 6-12 Years With Alopecia Areata.","authors":"Mercedes E Gonzalez, John Browning, Stacy Smith, Anna Plotka, Jing Daisy Zhu, Shyam Parvatini, Yeamin Huh, Robert Wolk","doi":"10.1111/pde.15895","DOIUrl":null,"url":null,"abstract":"Background: Alopecia areata (AA) is an autoimmune disease characterized by hair loss that can negatively impact quality of life. AA has a significant pediatric prevalence; however, no systemic treatments are approved for AA in patients aged < 12 years. Ritlecitinib, a JAK3/TEC family kinase inhibitor, is approved to treat adults and adolescents with severe AA aged ≥ 12 years. This study evaluated ritlecitinib pharmacokinetic (PK) parameters and safety in pediatric patients with AA aged 6 to < 12 years.Methods: In this single-group, uncontrolled, open-label study, participants received ritlecitinib 20 mg once daily for 7 days. PK parameters of ritlecitinib on Day 7 were measured and summarized descriptively. Safety outcomes, including incidence of adverse events (AEs), were evaluated.Results: Fifteen participants were enrolled and 14 (93.3%) completed the study. The median time to maximum concentration (Tmax) for plasma concentrations of ritlecitinib on Day 7 was ~0.5 h. The mean half-life of ritlecitinib was ~1.19 h. Geometric means (% coefficient of variation) for area under the curve from 0 to 24 h (AUC24) and maximum concentration (Cmax) were 437.5 ng·h/mL (30%) and 208.7 ng/mL (38%), respectively. Four AEs were experienced by 3 participants, with 1 AE of urticaria resulting in permanent discontinuation. No severe AEs, serious AEs, or clinically meaningful laboratory abnormalities were reported.Conclusions: Ritlecitinib PK parameters in pediatric patients were successfully characterized in the present study. Ritlecitinib 20 mg once daily was generally well tolerated in pediatric patients with AA.Trial registration: NCT05650333.","PeriodicalId":19819,"journal":{"name":"Pediatric Dermatology","volume":" ","pages":""},"PeriodicalIF":1.2000,"publicationDate":"2025-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/pde.15895","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"DERMATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Alopecia areata (AA) is an autoimmune disease characterized by hair loss that can negatively impact quality of life. AA has a significant pediatric prevalence; however, no systemic treatments are approved for AA in patients aged < 12 years. Ritlecitinib, a JAK3/TEC family kinase inhibitor, is approved to treat adults and adolescents with severe AA aged ≥ 12 years. This study evaluated ritlecitinib pharmacokinetic (PK) parameters and safety in pediatric patients with AA aged 6 to < 12 years.

Methods: In this single-group, uncontrolled, open-label study, participants received ritlecitinib 20 mg once daily for 7 days. PK parameters of ritlecitinib on Day 7 were measured and summarized descriptively. Safety outcomes, including incidence of adverse events (AEs), were evaluated.

Results: Fifteen participants were enrolled and 14 (93.3%) completed the study. The median time to maximum concentration (T_max) for plasma concentrations of ritlecitinib on Day 7 was ~0.5 h. The mean half-life of ritlecitinib was ~1.19 h. Geometric means (% coefficient of variation) for area under the curve from 0 to 24 h (AUC₂₄) and maximum concentration (C_max) were 437.5 ng·h/mL (30%) and 208.7 ng/mL (38%), respectively. Four AEs were experienced by 3 participants, with 1 AE of urticaria resulting in permanent discontinuation. No severe AEs, serious AEs, or clinically meaningful laboratory abnormalities were reported.

Conclusions: Ritlecitinib PK parameters in pediatric patients were successfully characterized in the present study. Ritlecitinib 20 mg once daily was generally well tolerated in pediatric patients with AA.

Trial registration: NCT05650333.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Pediatric Dermatology 医学-皮肤病学

CiteScore

3.20

自引率

6.70%

发文量

269

审稿时长

1 months

期刊介绍： Pediatric Dermatology answers the need for new ideas and strategies for today''s pediatrician or dermatologist. As a teaching vehicle, the Journal is still unsurpassed and it will continue to present the latest on topics such as hemangiomas, atopic dermatitis, rare and unusual presentations of childhood diseases, neonatal medicine, and therapeutic advances. As important progress is made in any area involving infants and children, Pediatric Dermatology is there to publish the findings.