Completed Enrollment

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

I4V-MC-JAIP -

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.

Trial Summary

Age Range
2 - 17 years
Conditions the trial is for
Atopic Dermatitis (Eczema)
What the trial is testing?
Baricitinib, Placebo
Could I receive a Placebo?
Yes
Enrollment Goal
516
Trial Dates
May 24, 2019 - May 2026
How long will I be in the trial?
The study will last about 224 weeks and may include up to 28 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have been diagnosed with moderate to severe atopic dermatitis (eczema) for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old)

  • Participants must not have had satisfactory results with existing medications applied to the skin within 6 months before screening

  • Participants must be willing to stop taking certain eczema treatments

  • Participants must agree to use a lotion or cream that softens the skin daily

Participants Must Not:

  • Participants must not have other skin conditions (such as psoriasis or lupus) or a history of skin diseases or infections that did not respond to treatment or require frequent hospitalization and/or IV treatment

  • Participants must not have a skin infection that requires antibiotics

  • Participants must not have been treated with corticosteroids given by injection within 6 weeks prior to treatment assignment and are not expected to need corticosteroid injections during the study

  • Participants must not have uncontrolled high blood pressure, major surgery (within the last two months or planned to take place during the study), or recent blood clot, heart attack, chest pain, stroke, heart failure or any other serious or unstable disease or infection

  • Female participants must not be pregnant or breastfeeding

Lilly Trial Alerts

Not the right fit? Sign up to receive updates about new trials that are listed or when a new trial site begins enrolling near you.

Clinical Trial Resources