A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Launched by ELI LILLY AND COMPANY · May 6, 2022

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ALL

Eligibility criteria

• Inclusion Criteria:
• * All participants must have prior treatment with dupilumab meeting one of the following conditions:
• • Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.
• • Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.
• • Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.
• • Participants who have chronic AD that has been present for ≥1 year before screening.
• • Have EASI ≥16 at baseline
• • Have IGA score ≥3 (Scale of 0 to 4) at baseline
• • Have ≥10% body surface area (BSA) of AD involvement at baseline
• • Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
• • Adolescents body weight must be ≥40 kg at baseline.
• Exclusion Criteria:
• • History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• • Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
• • Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
• • Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.
• • Have uncontrolled asthma that
• • might require bursts of oral or systemic corticosteroids, or
• • required the following due to ≥1 exacerbations within 12 months before baseline
• • systemic (oral and/or parenteral) corticosteroid treatment, or
• • hospitalization for \>24 hours.
• • Have known liver cirrhosis and/or chronic hepatitis of any etiology.
• • Had Dupilumab treatment within 4 weeks prior to baseline
• • Had prior treatment with tralokinumab.
• • Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline
• • Treatment with any of the following agents within 4 weeks prior to the baseline
• • systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
• • small molecules (e.g. JAK inhibitors)
• • phototherapy and photochemotherapy for AD