NCT07828327

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Nov 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 14, 2026

Last Update Submit

September 21, 2026

Conditions

Allergic Bronchopulmonary AspergillosisABPASevere Eosinophilic Asthma

Keywords

ABPADepemokimab

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 eosinophilic 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)

Depemokimab treatment

EXPERIMENTAL

Depemokimab treatment will be given by injections administered every 6 months.

Drug: Depemokimab

Interventions

DepemokimabDRUG

100 mg (1mL) Subcutaneous Solution

Depemokimab treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, China

Location

MeSH Terms

Conditions

Aspergillosis, Allergic BronchopulmonaryPulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Pulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Qian Qi

CONTACT

+8613706380314qiqianqlh@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

September 14, 2026

First Posted

September 18, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)