Benralizumab in the Treatment of Patients With Severe Asthma With ABPA

NCT04108962 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 019-294
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ABPA; Severe Asthma; Allergic Bronchopulmonary Aspergillosis

Keywords

ABPA; Benralizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire

  26 Weeks

• Asthma Control as assessed by Asthma Control Questionnaire 6

  26 Weeks

• Lung Function (FEV1)

  26 Weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Fasenra, 30 Mg/mL Subcutaneous Solution DRUG

Anti-IL5 receptor alpha monoclonal antibody

Also known as: Benralizumab

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• Kao CC, Hanania NA, Parulekar AD. The impact of fungal allergic sensitization on asthma. Curr Opin Pulm Med. 2021 Jan;27(1):3-8. doi: 10.1097/MCP.0000000000000740.

  PMID: 33027187 DERIVED

MeSH Terms

Conditions

Asthma; Aspergillosis, Allergic Bronchopulmonary

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections

Study Officials

• Yolanda Mageto, MD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: December 23, 2019
• Primary Completion: September 24, 2021
• Study Completion: October 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)