Efficacy and Safety Study of the Use of Benralizumab for Patients with Moderate to Severe Atopic Dermatitis

Exclusion Criteria

• 1 Participants with active dermatological conditions (eg, psoriasis, seborrheic dermatitis, cutaneous lymphoma) other than atopic dermatitis that, in the investigator’s opinion, may interfere with the study assessments
• 2 Known active allergic or irritant contact dermatitis that, in the investigator’s opinion, may interfere with the study assessments
• 3 Current malignancy, or history of malignancy, with the exception of:
• (a) Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to the date informed consent, was obtained.
• (b) Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to the date informed consent, was obtained.
• 4 Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
• (a) Affect the safety of the participant throughout the study
• (b) Influence the findings of the studies or their interpretations
• (c) Impede the participant’s ability to complete the entire duration of study.
• 5 History of anaphylaxis to any biologic therapy or vaccine
• 6 A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy
• 7 Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening/run-in period which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant’s ability to complete entire duration of the study
• 8 Current active liver disease:
• (a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if participant otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis.
• (b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 times the upper limit of normal (ULN), confirmed by repeated testing during the run-in period. Transient increase of AST/ALT level that resolves by the time of randomization is acceptable if in the Investigator’s opinion the participant does not have an active liver disease and meets other eligibility criteria.
• 9 A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
• Prior/concomitant Therapy
• 10 Participants who have received treatment for AD with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase-4 (PDE4) inhibitors within the 7 days prior to the randomization visit
• 11 Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
• 12 Regular use (2 visits per week) of a tanning booth/parlor or phototherapy for AD within 4 weeks prior to the randomization visit
• 13 Use of immunosuppressive medication including, but not limited to: methotrexate, cyclosporine, azathioprine, systemic corticosteroids within 4 weeks or 5 half-lives prior to the date informed consent is obtained, whichever is longer.
• Other
• 14 Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
• 15 Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to the date informed consent is obtained, whichever is longer
• 16 Receipt of live attenuated vaccines 30 days prior to first dose of IP
• 17 Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to the date informed consent is obtained, whichever is longer
• 18 Previously received benralizumab (MEDI-563, FASENRA)
• 19 Change to allergen immunotherapy or new allergen immunotherapy within 30 days prior to the date of informed consent and anticipated changes in immunotherapy throughout the study
• 20 Planned elective major surgical procedures during the conduct of the study
• 21 Previous randomization in the present study
• 22 Concurrent enrollment in another clinical trial
• 23 AstraZeneca staff involved in the planning and/or conduct of the study
• 24 For females only: Currently pregnant, breastfeeding, or lactating females
• A serum pregnancy test will be done for FOCBP at Visit 1 and a urine pregnancy test must be performed for FOCBP at each subsequent treatment visit prior to IP administration. A positive urine test result must be confirmed with a serum pregnancy test. If serum test is positive, the participant should be excluded.