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

Exclusion Criteria

• •Prior treatment with dupilumab or tralokinumab
• •Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors 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) of baseline, 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, whichever is longer
• •Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned 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 the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
• •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study