BENITIONSClinical Trial Intelligence

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

3期 已完成 NCT03952559

适应症Atopic Dermatitis
分期3期
申办方Eli Lilly and Company
状态已完成
受试者人数516 人
干预(药物)Baricitinib, Topical corticosteroid
开始日期2019年5月24日
完成日期2022年4月24日
结果公布日2023年6月29日

摘要

The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement

Week 16 · Percentage of participants

Placebo Double-blind16.4 Percentage of participants
Baricitinib Double-blind Low Dose18.2 Percentage of participants
Baricitinib Double-blind Medium Dose25.8 Percentage of participants
Baricitinib Double-blind High Dose41.7 Percentage of participants
p-value0.7261
Odds Ratio (OR)1.13 (95% CI 0.58–2.21)

Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104

Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose · nanogram per milliliter (ng/mL)

Baricitinib Open Label High Dose 2 to <663.2 ± 30 nanogram per milliliter (ng/mL)
Baricitinib Open Label High Dose 6 to <1040.1 ± 32 nanogram per milliliter (ng/mL)
Baricitinib Open Label High Dose 10 to <1850.6 ± 29 nanogram per milliliter (ng/mL)

Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104

Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose · hour*nanogram per milliliter (h*ng/mL)

Baricitinib Open Label High Dose 2 to <6251 ± 18 hour*nanogram per milliliter (h*ng/mL)
Baricitinib Open Label High Dose 6 to <10178 ± 18 hour*nanogram per milliliter (h*ng/mL)
Baricitinib Open Label High Dose 10 to <18290 ± 44 hour*nanogram per milliliter (h*ng/mL)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。