A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
Phase 3
Completed
NCT03952559
| Condition | Atopic Dermatitis |
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| Phase | Phase 3 |
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| Sponsor | Eli Lilly and Company |
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| Status | Completed |
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| Enrollment | 516 participants |
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| Interventions | Baricitinib, Topical corticosteroid |
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| Start date | May 24, 2019 |
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| Completion date | Apr 24, 2022 |
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| Results posted | Jun 29, 2023 |
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Summary
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 |
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| Odds Ratio (OR) | 1.13 (95% CI 0.58–2.21) |
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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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Open in BENITIONS
View on ClinicalTrials.gov
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