A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

Launched by ELI LILLY AND COMPANY · Nov 3, 2017

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Eligibility criteria

• Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions:
• Exclusion Criteria:
• • Had investigational product permanently discontinued at any time during a previous Baricitinib study.
• • Had temporary investigational product interruption continue at the final study visit of a previous Baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study
• • OR
• Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:
• Inclusion Criteria:
• • Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
• • 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 randomization.
• • 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 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 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.