Real-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis

NCT07757841 | Not Yet Recruiting

• 1 other identifier: ABPA-007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Bronchopulmonary Aspergillosis; Severe Asthma; ABPA

Keywords

ABPA; Tezepelumab

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)

Experimental: Treatment

EXPERIMENTAL

Tezepelumab treatment will be given by injections administered every 4 weeks thereafter, for a total of 24 weeks of active treatment.

Drug: Tezepelumab

Interventions

Tezepelumab DRUG

210 mg (1.91 mL) Subcutaneous Solution

Experimental: 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

You may not qualify if:

• Clinically important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (i.e., chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoidosis, and pulmonary fibrosis).
• History of anaphylaxis to any biologic therapy. Known history of allergy or hypersensitivity reaction to tezepelumab or any of its components.
• Currently pregnant, breastfeeding, or lactating women. Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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 250014

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary; Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qian Qi

CONTACT

+8613706380314; qiqianqlh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)