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

Recruiting in Palo Alto (17 mi)

+152 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

At or above the 5th percentile of weight for age.

Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old).

Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.

See 2 more

Treatment Details

Interventions

Baricitinib (Janus Kinase (JAK) Inhibitor)
Placebo (Drug)
Topical corticosteroid (Corticosteroid)

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Baricitinib Open Label High Dose (PK Lead-in)Experimental Treatment2 Interventions

Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension (1 mL) QD.

Group II: Baricitinib Medium DoseExperimental Treatment2 Interventions

Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Group III: Baricitinib Low DoseExperimental Treatment2 Interventions

Group IV: Baricitinib High DoseExperimental Treatment2 Interventions

Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.

Group V: PlaceboPlacebo Group2 Interventions

Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.