Atopic Dermatitis Study
Study Purpose:
The primary purpose of this clinical research study is to evaluate the safety and efficacy of the
investigational medication lebrikizumab (DRM06) in adolescents (≥ 12 to < 18 years of age and weighing
≥ 40 kg or 88 lb.) with moderate to severe AD.
Eligibility Criteria:
Adolescents (≥ 12 to < 18 years of age and weighing ≥ 40 kg or 88 lb.) who have had atopic dermatitis for at least one year may be eligible to participate in the Adore Study.
Key inclusion criteria:
• Male and female adolescents (≥ 12 to < 18 years of age and weighing ≥ 40 kg or 88 lb.)
• Chronic AD 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 AD involvement at the baseline visit
• History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise
medically inadvisable
Key exclusion criteria: • Participation in a prior lebrikizumab clinical study
• History of anaphylaxis as defined by the Sampson criteria
• Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitor (e.g., crisaborole) within 1 week prior to the baseline visit
• Treatment with any of the following agents within 4 weeks prior to the baseline visit:
o Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
o Phototherapy and photochemotherapy (PUVA) for AD
• Treatment with the following prior to the baseline visit:
o An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer
o Dupilumab within 8 weeks
o B cell-depleting biologics, including rituximab, within 6 months
o Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer
Other Trial Details (Benefits, For More Information, etc.):A special website has been created to provide more information about the ADore Study, which is a part of
the ADvocate Studies program. The website includes information on what to expect if you or your child is
enrolled. Visit www.ADvocatestudies.com for more information.