A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Baricitinib; Placebo; Topical corticosteroid
Intervention description: Administered orally.; Administered orally.; Administered as standard-of-care.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: eczema; atopic eczema

Summary:

      The purpose of this study is to determine the efficacy and safety of baricitinib in
      combination with topical corticosteroids in participants with moderate to severe atopic
      dermatitis who have experienced failure to cyclosporine or are intolerant to, or have
      contraindication to cyclosporine.
    

Eligibility 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.

        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 unstable 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.