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Clinical trial

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

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Last updated:24th May 2019
Identifier: NCT03952559

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

Category Value
Date last updated at source 2019-10-18
Study type(s) Interventional
Expected enrolment 465
Study start date 2019-05-24
Estimated primary completion date 2021-02-08

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