Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis

Effectiveness and Safety of Benralizumab in Allergic Bronchopulmonary Aspergillosis (ABPA): a Prospective Study of Real-world Experience

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

Study Overview

• Status: Recruiting
• Conditions: Severe Asthma; Allergic Bronchopulmonary Aspergillosis; ABPA
• Intervention / Treatment: Drug: Fasenra

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Qian Qi, Dr.; Phone Number: +86 13706380314; Email: qiqianqlh@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
      • Contact: Qian Qi, Doctor; Phone Number: +86 13706380314; Email: qiqianqlh@163.com
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
      • Contact: Qian Qi, Dr.; Phone Number: +86 13706380314; Email: qiqianqlh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

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

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

Description

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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; Other Names: Benralizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Function (FEV1)	The FEV1 change from baseline to End of Treatment	26 Weeks
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire	The change from baseline score in Saint George Respiratory Questionnaire. The Saint George Respiratory Questionnaire (SGRQ) total score ranges from 0 to 100. Higher scores indicate a worse outcome (greater health impairment/poorer quality of life)	26 Weeks
Asthma Control as assessed by Asthma Control Questionnaire 6	The change from baseline score in Asthma Control Questionnaire 6. ACQ-6 scores range from 0 to 6, where higher scores represent poorer asthma control. A score ≤0.75 indicates well-controlled asthma, while a score ≥1.5 indicates uncontrolled asthma.	26 Weeks

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Study Director: Qian Qi, Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Benralizumab; ABPA
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Bacterial Infections and Mycoses; Lung Diseases, Fungal; Mycoses; Pulmonary Aspergillosis; Aspergillosis; Asthma; Aspergillosis, Allergic Bronchopulmonary; benralizumab
• Other Study ID Numbers: ABPA-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No