Clinical Trials List
Protocol Number223529
Not yet recruiting
2025-06-30 - 2028-08-31
Others
Recruiting3
The IMAGINE study: A phase 3b open label, single arm study to assess the effect of depemokimab on airway structure and function in asthma with Type 2 inflammation characterized by an eosinophilic phenotype utilizing quantitative high-resolution CT and bronchoscopic airway sampling in a sub-study
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Sponsor
GlaxoSmithKline Research & Development Limited
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳家閔 無
- Inn-Wen Chong 無
- Wei-An Chang 無
- 莊政皓 無
- 鄭至宏 無
- Ming-Ju Tsai 無
- 張旭良 無
- Hung-Ling Huang 無
- 鄭孟軒 無
- jong rung Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Pai-Chien Chou
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
asthma
Objectives
To describe the change from baseline
(Week 0) in total mucus plug
volume measured at total lung
capacity (TLC) at Week 26 following
treatment with depemokimab.
Test Drug
injection
Active Ingredient
L04AF09000
Dosage Form
220
Dosage
100 MG/ML
Endpoints
Population: Asthmatic patients with type 2 inflammation characterized by
an eosinophilic phenotype on medium to high dose inhaled corticosteroids
(ICS) plus another asthma controller.
Endpoint: Change from baseline in total mucus plug volume measured at
TLC at Week 26.
Summary Measure: Mean change from baseline in total mucus plug
volume measured at TLC at Week 26.
Treatment Condition: Depemokimab 100 mg.
Intercurrent Event and Handling strategies
• Treatment switch to any alternative biologic prior to Week 26:
Hypothetical strategy, i.e., had the intercurrent event (of switching to
an alternate biologic) not occurred.
• Modification to inhaled asthma medication: Treatment Policy
strategy, i.e., all participants shall be analyzed irrespective of any
modification to inhaled asthma medication;
• Addition of maintenance OCS use by participants who do not have a
baseline maintenance OCS (mOCS): Hypothetical strategy i.e., had
the intercurrent event (of using an additional maintenance OCS) not
occurred.
an eosinophilic phenotype on medium to high dose inhaled corticosteroids
(ICS) plus another asthma controller.
Endpoint: Change from baseline in total mucus plug volume measured at
TLC at Week 26.
Summary Measure: Mean change from baseline in total mucus plug
volume measured at TLC at Week 26.
Treatment Condition: Depemokimab 100 mg.
Intercurrent Event and Handling strategies
• Treatment switch to any alternative biologic prior to Week 26:
Hypothetical strategy, i.e., had the intercurrent event (of switching to
an alternate biologic) not occurred.
• Modification to inhaled asthma medication: Treatment Policy
strategy, i.e., all participants shall be analyzed irrespective of any
modification to inhaled asthma medication;
• Addition of maintenance OCS use by participants who do not have a
baseline maintenance OCS (mOCS): Hypothetical strategy i.e., had
the intercurrent event (of using an additional maintenance OCS) not
occurred.
Inclution Criteria
Participants are eligible to be included in the study only if all of the following criteria
apply:
• Participants must be ≥18 years of age, at the time of signing the informed consent
form (ICF). INC #1
• Documented physician diagnosis of asthma for ≥2 years as per the National Heart,
Lung, and Blood Institute guidelines (NHLBI, 2020) or GINA guidelines [GINA,
2024] along with the following: INC #2
• An eosinophilic phenotype as evidenced by a blood eosinophil count of ≥300
cells/μL at screening or a documented history of blood eosinophil count ≥300
cells/μL within 3 months prior to screening.
• Exhaled nitric oxide (FeNO) measure of ≥25ppb recorded at screening.
• Previously confirmed history of ≥ 2 exacerbations requiring treatment with
systemic corticosteroid (SCS; IM, IV, or oral), in the 12 months prior to
screening, despite the use of medium to high dose ICS.
Note: For participants receiving maintenance SCS, the CS treatment for the exacerbations
must have been a two-fold dose increase or greater.
• Uncontrolled asthma indicated by ACQ5 > 1.5 recorded at screening. INC #3
• Persistent airflow obstruction as indicated by pre-bronchodilator FEV1 <80%
predicted (GLI 2012) and recorded at screening. INC #4
• A well-documented requirement for regular treatment with medium or high dose ICS
(in the 12 months prior to screening with or without maintenance OCS). INC #5
apply:
• Participants must be ≥18 years of age, at the time of signing the informed consent
form (ICF). INC #1
• Documented physician diagnosis of asthma for ≥2 years as per the National Heart,
Lung, and Blood Institute guidelines (NHLBI, 2020) or GINA guidelines [GINA,
2024] along with the following: INC #2
• An eosinophilic phenotype as evidenced by a blood eosinophil count of ≥300
cells/μL at screening or a documented history of blood eosinophil count ≥300
cells/μL within 3 months prior to screening.
• Exhaled nitric oxide (FeNO) measure of ≥25ppb recorded at screening.
• Previously confirmed history of ≥ 2 exacerbations requiring treatment with
systemic corticosteroid (SCS; IM, IV, or oral), in the 12 months prior to
screening, despite the use of medium to high dose ICS.
Note: For participants receiving maintenance SCS, the CS treatment for the exacerbations
must have been a two-fold dose increase or greater.
• Uncontrolled asthma indicated by ACQ5 > 1.5 recorded at screening. INC #3
• Persistent airflow obstruction as indicated by pre-bronchodilator FEV1 <80%
predicted (GLI 2012) and recorded at screening. INC #4
• A well-documented requirement for regular treatment with medium or high dose ICS
(in the 12 months prior to screening with or without maintenance OCS). INC #5
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
5.2.1. Medical conditions
• Presence of a known pre-existing, clinically important lung condition other than
asthma. This includes (but is not limited to) current infection, bronchiectasis,
pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer.
Participants with current diagnoses of emphysema or chronic bronchitis (COPD
other than asthma) are excluded. EXC#1
• Participants with other conditions that could lead to elevated eosinophils such as
hyper-eosinophilic syndromes including (but not limited to) Eosinophilic
Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss
Syndrome) or eosinophilic esophagitis. EXC#2
• Participants who developed an exacerbation within 4 weeks before screening.
EXC#3
Note: participants may reschedule their screening visit such that the exacerbation is
resolved and at least 4 weeks have lapsed after the last dose of any medication to treat the
exacerbation.
• Participants with a known, pre-existing parasitic infestation within 6 months prior to
screening unless treated and evidenced to have been resolved. EXC#4
• A known immunodeficiency (e.g. human immunodeficiency virus- HIV), other than
that explained by the use of CSs taken as therapy for asthma. EXC#5
• A current malignancy or previous history of cancer in remission for less than
12 months prior to screening. EXC#6
Note: Participants who had localized carcinoma of the skin which was resected for cure
will not be excluded.
• Participants who have known, pre-existing, clinically significant cardiac, endocrine,
autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic,
hematologic or any other system abnormalities that are uncontrolled with standard
treatment. EXC#7
• Participants with current diagnosis of vasculitis. EXC#8
Note: Participants with high clinical suspicion of vasculitis at screening will be evaluated
and current vasculitis must be excluded prior to enrollment.
5.2.1. Medical conditions
• Presence of a known pre-existing, clinically important lung condition other than
asthma. This includes (but is not limited to) current infection, bronchiectasis,
pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer.
Participants with current diagnoses of emphysema or chronic bronchitis (COPD
other than asthma) are excluded. EXC#1
• Participants with other conditions that could lead to elevated eosinophils such as
hyper-eosinophilic syndromes including (but not limited to) Eosinophilic
Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss
Syndrome) or eosinophilic esophagitis. EXC#2
• Participants who developed an exacerbation within 4 weeks before screening.
EXC#3
Note: participants may reschedule their screening visit such that the exacerbation is
resolved and at least 4 weeks have lapsed after the last dose of any medication to treat the
exacerbation.
• Participants with a known, pre-existing parasitic infestation within 6 months prior to
screening unless treated and evidenced to have been resolved. EXC#4
• A known immunodeficiency (e.g. human immunodeficiency virus- HIV), other than
that explained by the use of CSs taken as therapy for asthma. EXC#5
• A current malignancy or previous history of cancer in remission for less than
12 months prior to screening. EXC#6
Note: Participants who had localized carcinoma of the skin which was resected for cure
will not be excluded.
• Participants who have known, pre-existing, clinically significant cardiac, endocrine,
autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic,
hematologic or any other system abnormalities that are uncontrolled with standard
treatment. EXC#7
• Participants with current diagnosis of vasculitis. EXC#8
Note: Participants with high clinical suspicion of vasculitis at screening will be evaluated
and current vasculitis must be excluded prior to enrollment.
The Estimated Number of Participants
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Taiwan
11 participants
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Global
103 participants
