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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2027
  • participants needed
    465
  • sponsor
    Eli Lilly and Company
Updated on 29 April 2022
corticosteroids
atopy
eczema
topical corticosteroid
ly3009104
topical agents
baricitinib

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.

Details
Condition Atopic Dermatitis
Treatment Placebo, Baricitinib, Topical corticosteroid
Clinical Study IdentifierNCT03952559
SponsorEli Lilly and Company
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

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
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period)
Agree to use emollients daily

Exclusion Criteria

Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections
A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past
Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics
Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma)
Have been treated with the following therapies
Monoclonal antibody for less than 5 half-lives prior to beginning study treatment
Received prior treatment with any oral Janus kinase (JAK) inhibitor
Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug or are anticipated to require parenteral injection of corticosteroids during the study
Have had an intra-articular corticosteroid injection within 2 weeks prior to study
Have high blood pressure characterized by a repeated systolic or diastolic blood pressure >95th percentile based on age, sex and height
entry or within 6 weeks prior to planned initiation of study drug
Have had major surgery within the past eight weeks or are planning major surgery during the study
Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure
Have a history of VTE or are considered at high risk of VTE as deemed by the investigator
Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster (shingles or chicken pox), tuberculosis
Have specific laboratory abnormalities
Have received certain treatments that are contraindicated
Pregnant or breastfeeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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