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

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.

Timeline

Start

2019-05-24

Primary completion

2022-04-24

Completion

2026-05

Outcome

Mixed primary results

registry NUMBER Placebo Double-blind: 16.4 Percentage of participants NCT03952559 ↗

registry NUMBER Baricitinib Double-blind Low Dose: 18.2 Percentage of participants NCT03952559 ↗

registry analysis (superiority test); Placebo Double-blind vs Baricitinib Double-blind Low Dose; p = 0.7261; Odds Ratio (OR) 1.13 (95% CI 0.58 to 2.21); Regression, Logistic NCT03952559 ↗

registry NUMBER Baricitinib Double-blind Medium Dose: 25.8 Percentage of participants NCT03952559 ↗

registry analysis (superiority test); Placebo Double-blind vs Baricitinib Double-blind Medium Dose; p = 0.0718; Odds Ratio (OR) 1.80 (95% CI 0.95 to 3.41); Regression, Logistic NCT03952559 ↗

registry NUMBER Baricitinib Double-blind High Dose: 41.7 Percentage of participants NCT03952559 ↗

registry analysis (superiority test); Placebo Double-blind vs Baricitinib Double-blind High Dose; p <0.0001; Odds Ratio (OR) 3.73 (95% CI 2.02 to 6.89); Regression, Logistic NCT03952559 ↗

Publications

• Wollenberg A, Ikeda M, Chu CY, Eichenfield LF, Seyger MMB, Prakash A, Angle R, Zhu D, Pontes M, Paller AS. Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years. J Dermatolog Treat. 2024 Dec;35(1):2411834. doi: 10.1080/09546634.2024.2411834. Epub 2024 Nov 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Baricitinib	Small molecule	0.5 mg	Oral
Subject	Baricitinib	Small molecule	1 mg	Oral
Subject	Baricitinib	Small molecule	2 mg	Oral
Subject	Baricitinib	Small molecule	4 mg	Oral

Indications