BENITIONSClinical Trial Intelligence

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

第3相 完了 NCT03952559

対象疾患Atopic Dermatitis
第3相
スポンサーEli Lilly and Company
ステータス完了
参加者数516 名
介入(薬剤)Baricitinib, Topical corticosteroid
開始日2019年5月24日
完了日2022年4月24日
結果公開日2023年6月29日

概要

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)

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