Effect of Benralizumab in Atopic Dermatitis

Exclusion Criteria

• •1. History of anaphylaxis to any biologic therapy or vaccine
• •2. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light headedness, as judged by the investigator
• •3. Any history or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, hypertension, or congestive heart failure
• •4. Any history or symptoms of significant neurologic disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioral disturbances
• •5. Any history or symptoms of clinically significant autoimmune disease
• •6. Any history of clinically significant haematologic abnormality, including coagulopathy or any history of chronic treatment with anticoagulants (e.g. warfarin, etc) or antiplatelet agent (e.g, aspirin, etc)
• •7. Clinically significant abnormalities in laboratory test results at enrolment and during the screening period (including complete blood count, coagulation, chemistry panel and urinalysis) unless judged not significant by the investigator.
• •8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) confirmed during screening period
• •9. Being pregnant or lactating or have positive serum pregnancy test at enrolment or positive urine pregnancy test during the study
• •10. Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
• •11. Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
• •12. Presence of skin comorbidities that may interfere with study assessments
• •13. History of cancer: Patients 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 subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent. Patients who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date of informed consent.
• •14. Patient who has a scheduled in-patient surgery or hospitalization during the study.
• •15. History of Guillain-Barré syndrome
• •16. 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
• •17. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol
• •18. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
• •19. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
• •20. Receipt of any marketed (eg omalizumab) or investigational biologic within 4 months or 5 half-lives prior to randomization is obtained, whichever is longer
• •21. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
• •22. Any allergen immunotherapy within 4 months prior to or throughout the study.
• •23. Having used any of the following treatments within 4 weeks before the Day -2 baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during study:
• •1. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
• •2. Phototherapy for AD
• •24. Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer
• •25. 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)
• •26. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
• •27. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. Note: patients may be re-screened after infection resolves
• •28. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
• •29. Planned or anticipated major surgical procedure during the patient's participation in this study
• •30. Receipt of live attenuated vaccines 30 days prior to the date of randomization. Receipt of inactive/killed vaccinations (eg, inactive influenza) are allowed provided they are not administered within 1 week before/after any IP administration.
• •31. Patient is a member of the investigational team or his/her immediate family
• •32. Pregnant woman
• •33. Previously received benralizumab (MEDI-563)