A Study to Investigate the Use of Benralizumab in Patients with Bullous Pemphigoid. - FJORD

Exclusion Criteria

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions
• 1 Forms of BP other than classic, predominantly cutaneous BP: eg, mucous membrane BP, epidermolysis bullosa acquisita, Brunsting-Perry BP, p200 BP, p105 BP, BP with concomitant pemphigus vulgaris, and drug-induced BP.
• 2 Comorbid disease that in the Investigator’s judgement might interfere with the evaluation of the IP or safety of the participant. This includes any disorder that in the opinion of the Investigator is not stable (eg, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment).
• 3 Current or history of malignancy within 5 years before the screening visit with the following exceptions:
• (a) Participants treated for in situ carcinoma of the cervix who have completed curative therapy and are in remission for at least 12 months prior to signing the informed consent and
• (b) Participants with superficial basal cell or squamous skin cancer.
• (c) 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 History of anaphylaxis to any biologic therapy or vaccine.
• 5 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.
• 6 Any clinically significant abnormal findings in physical examination, vital signs, electrocardiogram (ECG), hematology, or clinical chemistry during screening, 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.
• 7 Current active liver disease.
• (a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen 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, confirmed by repeated testing during screening 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.
• 8 A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
• Prior/Concomitant Therapy
• 9 Use of immunosuppressive medication, including, but not limited to: methotrexate, cyclosporine, azathioprine, within 4 weeks or 5 half-lives prior to the date informed consent is obtained, whichever is longer.
• Other Exclusions
• 10 Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
• 11 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. Participants on stable therapy for at least 3 months before randomization who intend to stay on treatment throughout the study with marketed biologics that are not likely to interfere with the assessment of safety and/or efficacy of benralizumab (eg, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic diseases) can participate in the study.
• 12 Known history of allergy or reaction to any component of the IP formulation.
• 13 Receipt of live attenuated vaccines 30 days prior to the date of randomization.
• 14 Previously received benralizumab (MEDI-563, FASENRA).
• 15 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.
• 16 Planned elective major surgical procedures during the conduct of the study.
• 17 Previous randomization in the present study.
• 18 Concurrent enrollment in another interventional (eg, investigational drug or device) clinical trial.
• 19 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• 20 For females only: Currently pregnant, breastfeeding, or lactating females.
• (a) A urine pregnancy test must be performed for FOCBP at Visit 1. A positive urine test result must be confirmed with a serum pregnancy test. If serum test is positive, the participant should be excluded.
• 21 Participant is unable to complete PRO assessments because of cognitive function (eg, dementia).