Allergic Bronchopulmonary AspergillosisNCT07828327
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
A study testing Depemokimab in people with Allergic Bronchopulmonary Aspergillosis and ABPA, run by Qianfoshan Hospital at 1 site in China.
Trial summary
An open-label study will evaluate effects of Depemokimab in the treatment of severe eosinophilic asthma in patients with allergic bronchopulmonary aspergillosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis, ABPA, Severe Eosinophilic Asthma
- What is being tested?
- Depemokimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and Male patients aged 18-75 years
- Diagnosis of Allergic Bronchopulmonary Aspergillosis (according to the ISHAM Working Group Diagnostic Criteria)
- Severe asthma requiring treatment with high dose ICS plus a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
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
Qian Qi, Dr., +86 13706380314, qiqianqlh@163.com
About this study
Official title: 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
Read the 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.
- Being tested
- Depemokimab
- Keywords
- ABPA, Depemokimab
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepemokimabDrug
100 mg (1mL) Subcutaneous Solution
| Study group | Role | What they receive |
|---|---|---|
| Depemokimab treatment | Experimental | Depemokimab treatment will be given by injections administered every 6 months. Receives: Drug: Depemokimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steroid requiring exacerbations
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe eosinophilic asthma complicated by ABPA
Measured: 26 weeks
Secondary outcomes (3)
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)
Measured: 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.
Measured: 26 weeks
Lung Function (FEV1)
The FEV1 change from baseline to End of Treatment
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Bronchopulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828327
- Sponsor's protocol ID
- ABPA-008
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Depemokimab in Allergic Bronchopulmonary Aspergillosis (ABPA) With Severe Eosinophilic Asthma(SEA): a Prospective Study of Real-world Experience
- ClinicalTrials.gov ID
- NCT07828327
- Acronym / sponsor ID
- ABPA-008
- Keywords
- ABPA, Depemokimab
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label study will evaluate effects of Depemokimab in the treatment of severe eosinophilic asthma in patients with allergic bronchopulmonary aspergillosis
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depemokimab treatment | Experimental | Drug: DepemokimabDepemokimab treatment will be given by injections administered every 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female and Male patients aged 18-75 years
- Diagnosis of Allergic Bronchopulmonary Aspergillosis (according to the ISHAM Working Group Diagnostic Criteria)
- Severe asthma requiring treatment with high dose ICS plus a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depemokimab100 mg (1mL) Subcutaneous Solution | Drug | Depemokimab treatment |
Primary outcome
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
3 secondary outcomes
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
Time frame: 26 weeks
Asthma Control as assessed by Asthma Control Questionnaire 6
Time frame: 26 weeks
Lung Function (FEV1)
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depemokimab in people with Allergic Bronchopulmonary Aspergillosis and ABPA, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Qi (+8613706380314, qiqianqlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steroid requiring exacerbations (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.