A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
第3相
完了
NCT03952559
| 対象疾患 | Atopic Dermatitis |
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| 相 | 第3相 |
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| スポンサー | Eli Lilly and Company |
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| ステータス | 完了 |
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| 参加者数 | 516 名 |
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| 介入(薬剤) | Baricitinib, Topical corticosteroid |
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| 開始日 | 2019年5月24日 |
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| 完了日 | 2022年4月24日 |
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| 結果公開日 | 2023年6月29日 |
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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-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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