a study of baricitinib (ly3009104) in combination with topical corticosteroids in adults with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the efficacy and safety of baricitinib in combination with topical corticosteroids (tcs) in participants with moderate to severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * have been diagnosed with moderate to severe atopic dermatitis for at least 12 months. * have had inadequate response 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 episodes 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 randomization. * received prior treatment with any oral janus kinase (jak) inhibitor less than 4 weeks prior to randomization. * received any parenteral corticosteroids administered by intramuscular or intravenous (iv) injection within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study. * have had an intra-articular corticosteroid injection within 6 weeks prior to planned randomization. * have high blood pressure characterized by a repeated systolic blood pressure \>160 millimeters of mercury (mm hg) or diastolic blood pressure \>100 mm hg. * 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 recurrent (≥2) 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, tuberculosis. * have specific laboratory abnormalities. * have received certain treatments that are contraindicated. * pregnant or breastfeeding.

Keywords: eczema atopic eczema