Benralizumab in the Treatment of Patients With Severe Asthma With ABPA

Severe Asthma Clinical Trial

Official title:

Phase IV, Single-Center, Open-Label Study Evaluating the Effects of an Anti-IL5 Receptor Alpha (Benralizumab) Monoclonal Antibody in the Treatment of Severe Asthma in Patients With Allergic Bronchopulmonary Aspergillosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04108962
• Other study ID #: 019-294
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 23, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2022
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Subjects who have been identified to have severe asthma with ABPA will be consented and enrolled in the study to receive benralizumab injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment with a follow-up/termination visit eight weeks from the last injection. The termination visit will occur week 24 for subjects who complete the study treatment. Subjects who receive the first dose of benralizumab but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the termination visit.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• ABPA
• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Asthma
• Pulmonary Aspergillosis
• Severe Asthma

Intervention

Drug:
• Fasenra, 30 Mg/mL Subcutaneous Solution
Anti-IL5 receptor alpha monoclonal antibody

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of steroid requiring exacerbations	Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA	26 Weeks
Secondary	Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire	The change from baseline score in Saint George Respiratory Questionnaire	26 Weeks
Secondary	Asthma Control as assessed by Asthma Control Questionnaire 6	The change from baseline score in Asthma Control Questionnaire 6	26 Weeks
Secondary	Lung Function (FEV1)	The FEV1 change from baseline to End of Treatment	26 Weeks