BENITIONSClinical Trial Intelligence

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

3상 완료 NCT03952559

대상 질환Atopic Dermatitis
임상 단계3상
스폰서Eli Lilly and Company
상태완료
참여자 수516 명
중재(약물)Baricitinib, Topical corticosteroid
시작일2019년 5월 24일
완료일2022년 4월 24일
결과 공개일2023년 6월 29일

요약

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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