Atopic Dermatitis
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have been diagnosed with moderate to severe Atopic Eczema (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. - Have a medical contraindication to cyclosporine, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine in the past, or are eligible for treatment with cyclosporine but patient/family does not agree with the treatment.
Exclusion criteria
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 are 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 oral corticosteroids within 4 weeks prior to randomization or parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or 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 2 weeks prior to study entry or 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 ustable illness. - Have a current or recent and/or 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.
Outcome results
None listed