A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Baricitinib; Placebo; Topical corticosteroid
Intervention description: Administered orally; Administered orally; Administered as standard-of-care
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Participants were randomized to one of the four double-blind treatment arms. A separate group of 33 participants received open label baricitinib as part of pharmacokinetic (PK) lead-in (not randomized) period.
Enrollment: 516.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: eczema; atopic eczema

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.
    

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.

          -  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
             entry or within 6 weeks prior to planned initiation of study drug.

          -  Have high blood pressure characterized by a repeated systolic or diastolic blood
             pressure >95th percentile based on age, sex and height.

          -  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.