A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Baricitinib
Intervention description: Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 374.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: eczema; atopic eczema

Summary:

      This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult
      participants with moderate to severe atopic dermatitis (AD).
    

Eligibility criteria:

        Have participated in Study JAIW (NCT03435081), and meet specific completion requirements
        for that study, and do not meet any of the following Exclusions:

          -  Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction
             [MI], unstable angina, unstable arterial hypertension, severe heart failure, or
             cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine,
             hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed
             during a previous baricitinib study that, in the opinion of the investigator, pose an
             unacceptable risk to the participant if investigational product continues to be
             administered.

          -  Have a known hypersensitivity to baricitinib or any component of this investigational
             product.

          -  Had investigational product permanently discontinued at any time during a previous
             baricitinib study, except for participants who had investigational product
             discontinued during originating study because of rescue with an oral systemic AD
             therapy (e.g., corticosteroid, cyclosporine, methotrexate).

          -  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.

          -  Pregnant or breastfeeding

        OR

        • Have not participated in a Study JAIW (NCT03435081) and satisfy the following criteria:

        Inclusion Criteria:

          -  Have a diagnosis of atopic dermatitis (AD) at least 12 months before screening.

          -  Have moderate to severe AD, including all of the following:

               -  EASI score ≥16

               -  IGA score of ≥3

               -  10%- 50% BSA involvement

          -  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)

          -  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 before randomization

               -  received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4
                  weeks before randomization

               -  received any parenteral corticosteroid administered by intramuscular or
                  intravenous injection within 6 weeks of planned randomization or are anticipated
                  to require parenteral injection of corticosteroids during the study

               -  have had an intra-articular corticosteroid injection within 6 weeks of planned
                  randomization

               -  probenecid at the time of randomization that cannot be discontinued for the
                  duration of the study

          -  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: myocardial
             infarction (MI), unstable ischemic heart disease, stroke, or New York Heart
             Association Stage III/IV heart failure.

          -  Have a history of venous thromboembolic event (VTE), or are considered at high risk
             for VTE.

          -  Have a history or presence of cardiovascular, respiratory, hepatic, 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.