A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic
MeSH terms: Dermatitis, Atopic; Genetic Diseases, Inborn; Skin Diseases, Genetic; Dermatitis; Skin Diseases
Intervention: Lebrikizumab; Placebo; Topical Corticosteroid
Intervention description: Administered SC; Administered SC; Self-applied
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 286.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Corticosteroids

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in
      combination with a topical corticosteroids in Japanese participants with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have chronic Atopic Dermatitis (AD) that has been present for ≥1 year before the
             screening.

          -  Have moderate-to-severe AD, including all of the following:

               -  EASI score ≥16 at the baseline

               -  IGA score ≥3 (scale of 0 to 4) at the baseline

               -  AD involvement on ≥10% of Body Surface Area (BSA) at the baseline

          -  Have a documented history provided by a physician and/or investigator of inadequate
             response to existing topical medications within 6 months preceding screening as
             defined by at least 1 of the following:

               -  Inability to achieve good disease control, defined as mild disease or better (for
                  example, IGA ≤2) after use of at least a medium-potency topical corticosteroids
                  (TCS) for at least 4 weeks, or for the maximum duration recommended by the
                  product prescribing information (for example, 14 days for super-potent TCS),
                  whichever is shorter. Topical corticosteroids may be used with or without Topical
                  calcineurin inhibitors (TCI) and/or topical Janus Kinase (JAK) inhibitors.

               -  Participants who failed systemic therapies intended to treat AD within 6 months
                  preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and
                  mycophenolate mofetil (MMF), will also be considered as surrogates for having
                  inadequate response to topical therapy.

          -  Body weight ≥40 kilogram (kg)

        Exclusion Criteria:

          -  Have a history of anaphylaxis

          -  Have uncontrolled chronic disease that might require bursts of oral corticosteroids
             for example, comorbid severe uncontrolled asthma within the past 12 months requiring
             systemic corticosteroid treatment or hospitalization for >24 hours at baseline.

          -  Have an active chronic or acute infection requiring treatment with systemic
             antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks
             before the baseline or superficial skin infections within 1 week before the baseline.

          -  Evidence of acute or chronic hepatitis or known liver cirrhosis.

          -  Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at
             screening and a confirmed diagnosis of PCP.

          -  Have a history of human immunodeficiency virus (HIV) infection or positive HIV
             serology at screening.

          -  Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus
             erythematosus) that may interfere with study assessments.

          -  Have presence of significant uncontrolled neuropsychiatric disorder.

          -  Have been exposed to a live vaccine within 12 weeks prior to baseline or are expected
             to need/receive a live vaccine during the study or up to 125 days after the last dose
             of study drug.