Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

Inclusion Criteria:

• Male or female adults and adolescents (≥12 years and ≥40 kg)
• Chronic atopic dermatitis (according to American Academy of Dermatology ConsensusCriteria) that has been present for ≥1 year before the screening visit
• Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
• Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
• ≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
• History of inadequate response to treatment with topical medications; or determinationthat topical treatments are otherwise medically inadvisable

Exclusion Criteria:

• Prior treatment with dupilumab or tralokinumab
• Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4inhibitors such as crisaborole within 1 week prior to the baseline visit
• Treatment with any of the following agents within 4 weeks prior to the baseline visit:
• Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors,azathioprine, methotrexate, etc.)
• Phototherapy and photochemotherapy (PUVA) for AD
• Treatment with the following prior to the baseline visit:
• An investigational drug within 8 weeks or within 5 half-lives (if known) ofbaseline, whichever is longer
• Cell-depleting biologics, including to rituximab, within 6 months of baseline
• Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whicheveris longer
• Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit orplanned during the study
• Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g.,co-morbid severe uncontrolled asthma
• Evidence of active acute or chronic hepatitis
• History of human immunodeficiency virus (HIV) infection or positive HIV serology
• History of malignancy, including mycosis fungoides, within 5 years before thescreening visit, except completely treated in situ carcinoma of the cervix, completelytreated and resolved non-metastatic squamous or basal cell carcinoma of the skin
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeedduring the study