a study of baricitinib (ly3009104) in children and adolescents with atopic dermatitis

Conditions: Atopic Dermatitis

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.

Keywords: eczema atopic eczema