Benralizumab in the Treatment of Patients With Severe Asthma With ABPA

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase IV, open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Benralizumab

Criteria

SELECT INCLUSION CRITERIA

• Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA:

• Predisposing condition: Bronchial asthma

• Obligatory criteria (both should be present)

• Type I aspergillus skin test positive (immediate cutaneous hypersensitivity Aspergillus antigen) or elevated IgE level against Aspergillus fumigatus (Af)

• Aspergillus niger or Aspergillus flavus may be eligible provided antigen-specific IgE and IgG measurements are available for use.

• Elevated total IgE levels (>1,000IU/mL)*

• Other criteria (at least two of three)

• Presence of precipitating or IgG antibodies against Af in serum

• Radiographic pulmonary opacities consistent with ABPA

• Total eosinophil count >500 cells/uL in steroid naïve patients (may be historical)

• (if the patient meets all other criteria, an IgE value <1,000 IU/mL may be acceptable)

• Severe chronic asthma (for at least 12 months) requiring treatment with high dose ICS plus asthma controller prior to Visit 1

• Other acceptable asthma controllers include long acting bronchodilators (e.g. a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), a leukotriene inhibitor, theophylline preparations and/or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control

• Documented current treatment with high daily doses of ICS ( >500ug of FP equivalent) plus at least one other asthma controller for at least 3 months prior to Visit 1

• For ICS/LABA combination preparation, highest-strength maintenance doses approved in the U.S. will meet this criterion

• If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose for 3 months prior to entering the study.

• History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving oral corticosteroids as a maintenance therapy, an exacerbation is defined as a temporary increase of their maintenance dose for a minimum of 3 days.

• Weight > 40kg

SELECT EXCLUSION CRITERIA

• Clinical important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (ie. chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoid, and pulmonary fibrosis)

• History of anaphylaxis to any biologic therapy

• Known history of allergy or hypersensitivity reaction to benralizumab or any of its components

• Current smokers or former smokers with a smoking history of > 10 pack years. A former smoker is defined as a patient who quit smoking at least 6 months prior to Visit 1.

• Currently pregnant, breastfeeding, or lactating women

• Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.