BENITIONSClinical Trial Intelligence

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

Фаза 3 Завершено NCT03952559

ЗаболеваниеAtopic Dermatitis
ФазаФаза 3
СпонсорEli Lilly and Company
СтатусЗавершено
Участники516 участн.
ВмешательствоBaricitinib, Topical corticosteroid
Дата начала24.05.2019
Дата завершения24.04.2022
Публикация результатов29.06.2023

Кратко

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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