A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis (BREEZE-AD-PEDS)

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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date: May 24, 2019
Estimated Primary Completion Date: February 8, 2021
Estimated Study Completion Date: July 11, 2023

Arms:
- Experimental: Baricitinib Open Label High Dose
- Experimental: Baricitinib High Dose
- Experimental: Baricitinib Mid Dose
- Experimental: Baricitinib Low Dose
- Placebo Comparator: Placebo