A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Baricitinib; Topical corticosteroid; Placebo
Intervention description: Administered orally.; Administered as standard-of-care.; Administered orally.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: eczema; atopic eczema

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.