Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma

September 14, 2026 updated by: Qian Qi, Qianfoshan Hospital

Effectiveness and Safety of Depemokimab in Allergic Bronchopulmonary Aspergillosis (ABPA) With Severe Eosinophilic Asthma(SEA): a Prospective Study of Real-world Experience

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects who have been identified to have severe eosinophilic asthma with ABPA will be consented and enrolled in the study to receive Depemokimab injections (100 mg subcutaneous) administered every 6 months.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 1Other 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 1For 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:

  • 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 Depemokimab 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Depemokimab treatment will be given by injections administered every 6 months.
Drug: Depemokimab
100 mg (1mL) Subcutaneous Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of steroid requiring exacerbations
Time Frame: 26 weeks
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe eosinophilic asthma complicated by ABPA
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
Time Frame: 26 weeks
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
Time Frame: 26 weeks
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
Lung Function (FEV1)
Time Frame: 26 weeks
The FEV1 change from baseline to End of Treatment
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABPA-008

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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