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

Launched by ELI LILLY AND COMPANY · Oct 30, 2019

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female adults and adolescents (≥12 years and ≥40 kg)
• • Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) 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 determination that topical treatments are otherwise medically inadvisable
• 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