Benralizumab treatment for adults with ABPA and severe asthma

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

This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Drugs / interventions: benralizumab
• Locations: 2 sites (Jinan, Shandong and 1 other locations)
• Trial ID: NCT07530770 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm observational study enrolls adults with physician-diagnosed severe asthma and ABPA who meet ISHAM diagnostic criteria. Participants receive benralizumab injections at weeks 0, 4, 8 and 16, with a termination/follow-up visit at week 24 to capture outcomes. The study collects real-world clinical measures including symptoms, exacerbations, corticosteroid use, eosinophil counts, IgE levels, and pulmonary function or imaging when available. There is no randomized control group and both safety signals and effectiveness outcomes will be monitored during follow-up.

Who should consider this trial

Good fit: Adults aged 18–75 with physician-diagnosed severe asthma and ABPA meeting ISHAM criteria (including relevant Aspergillus-specific IgE/IgG or elevated total IgE and commonly eosinophilia) are the intended participants.

Not a fit: Patients without eosinophilic inflammation, those whose ABPA is already well controlled on current therapy, or those with contraindications to benralizumab are less likely to benefit.

Why it matters

Potential benefit: If successful, benralizumab could reduce exacerbations, lower steroid requirements, and improve symptoms and lung function for patients with ABPA and severe asthma.

How similar studies have performed: Benralizumab is established for severe eosinophilic asthma and small case series suggest benefit in ABPA, but large controlled trials specifically in ABPA are limited.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong and 1 other locations

• Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China — Jinan, Shandong, China (Recruiting)
• Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Qian Qi, Dr.

Conditions Allergic Bronchopulmonary Aspergillosis; Severe Asthma; ABPA; Benralizumab