Benralizumab in the Treatment of Patients With Severe Asthma With ABPA

Sponsor

Baylor Research Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04108962

Collaborator

(none)

Enrollment

Location

Arm

21.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ABPA Severe Asthma Allergic Bronchopulmonary Aspergillosis	Drug: Fasenra, 30 Mg/mL Subcutaneous Solution	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 23, 2019

Actual Primary Completion Date :

Sep 24, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Benralizumab treatment will be given by 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	Drug: Fasenra, 30 Mg/mL Subcutaneous Solution Anti-IL5 receptor alpha monoclonal antibody Other Names: Benralizumab

Arm

Intervention/Treatment

Experimental: Treatment

Benralizumab treatment will be given by 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

Drug: Fasenra, 30 Mg/mL Subcutaneous Solution

Anti-IL5 receptor alpha monoclonal antibody

Other Names:

Benralizumab

Outcome Measures

Primary Outcome Measures

Number of steroid requiring exacerbations [26 Weeks]
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA

Secondary Outcome Measures

Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire [26 Weeks]
The change from baseline score in Saint George Respiratory Questionnaire
Asthma Control as assessed by Asthma Control Questionnaire 6 [26 Weeks]
The change from baseline score in Asthma Control Questionnaire 6
Lung Function (FEV1) [26 Weeks]
The FEV1 change from baseline to End of Treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.