A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Baricitinib; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1645.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: eczema; atopic eczema

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in
      participants with atopic dermatitis.

      Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or
      were directly enrolled in the open-label arm.
    

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.