A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
3期
已完成
NCT03952559
| 适应症 | Atopic Dermatitis |
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| 分期 | 3期 |
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| 申办方 | Eli Lilly and Company |
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| 状态 | 已完成 |
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| 受试者人数 | 516 人 |
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| 干预(药物) | Baricitinib, Topical corticosteroid |
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| 开始日期 | 2019年5月24日 |
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| 完成日期 | 2022年4月24日 |
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| 结果公布日 | 2023年6月29日 |
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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-blind | 16.4 Percentage of participants |
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| Baricitinib Double-blind Low Dose | 18.2 Percentage of participants |
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| Baricitinib Double-blind Medium Dose | 25.8 Percentage of participants |
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| Baricitinib Double-blind High Dose | 41.7 Percentage of participants |
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| p-value | 0.7261 |
| 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 <6 | 63.2 ± 30 nanogram per milliliter (ng/mL) |
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| Baricitinib Open Label High Dose 6 to <10 | 40.1 ± 32 nanogram per milliliter (ng/mL) |
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| Baricitinib Open Label High Dose 10 to <18 | 50.6 ± 29 nanogram per milliliter (ng/mL) |
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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 <6 | 251 ± 18 hour*nanogram per milliliter (h*ng/mL) |
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| Baricitinib Open Label High Dose 6 to <10 | 178 ± 18 hour*nanogram per milliliter (h*ng/mL) |
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| Baricitinib Open Label High Dose 10 to <18 | 290 ± 44 hour*nanogram per milliliter (h*ng/mL) |
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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。