Clinical Trials List
2025-06-09 - 2029-11-26
Phase III
Recruiting8
A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation
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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
- 莊子逸 無
- 廖培雅 無
- 林雋 無
- 歐偉凡 無
- JENG-SEN TSENG 無
- 劉明承 無
- 陳詩華 無
- 趙文震 無
- 林奕宏 無
- 沈佩誼 無
- 王俊隆 無
- Wei- Chang Huang 無
- 李柏昕 無
- YEN-HSIANG HUANG 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鄭孟軒 無
- jong rung Tsai 無
- Jui-Sheng Hsu 無
- Wei-An Chang 無
- 張旭良 無
- Inn-Wen Chong 無
- Ming-Ju Tsai 無
- Hung-Ling Huang 無
- 陳家閔 無
- 莊政皓 無
- 鄭至宏 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 簡格凌 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
apply:
5.1.1. Age
• Participants must be ≥40 to ≤80 years of age, at the time of signing the ICF. INC#1
5.1.2. Blood eosinophils
• An eosinophilic phenotype with elevated BEC at two timepoints at least 14 days
apart. INC#2
• If the participant has a documented historical BEC of ≥150 cells/µL in the
12 months prior to Screening Visit 0, they must have at least one additional BEC
of ≥300 cells/µL from a sample collected at Screening Visit 0 or Screening
Visit 1.
or
• If historical BEC is not available, the participant must have at least one
BEC ≥300 cells/µL and the other ≥150 cells/µL among the samples collected at
Screening Visit 0 or Screening Visit 1.
5.1.3. Type of participant and disease characteristics
• Moderate to severe COPD with frequent exacerbations, defined as: INC#3
• A clinically documented history of COPD as defined by the American Thoracic
Society/European Respiratory Society for at least 1 year
• A post-salbutamol FEV1/FVC ratio of <0.70 and a post-salbutamol FEV1 >30%
and ≤80% predicted normal values calculated with GLI-Global Race Neutral
equations in line with the ATS recommendations [Bowerman, 2023] at
screening
• A well-documented history (e.g., medical record verification, including
capturing of all prior biologic use) of at least 2 moderate or 1 severe
exacerbation in the 12 months prior to screening
i. At least one qualifying exacerbation must have occurred while participant is
on ICS plus LAMA plus LABA
ii. Moderate exacerbations must have been treated with systemic
corticosteroids
iii. Severe exacerbations are those requiring hospitalization or observation
>24 hours in ED /urgent care facility
• CAT score ≥10 at Visit 1. INC#4
• Smoking status: Current or former cigarette smokers with a history of cigarette
smoking of ≥10 pack-years at Screening. Former smokers are defined as those who
have stopped all smoking (including tobacco, marijuana, or e-cigarettes) for at least 6
months prior to Screening Visit 1 INC#5
5.1.4. COPD Maintenance Therapy
• Participants should be on optimized inhaler therapy, defined as ICS plus LAMA plus
LABA either as multiple inhalers or a single combination inhaler* for at least 6
months prior to Screening Visit 1. INC#6
*Note: Where intolerance or safety risk is documented for ICS, dual therapy LABA
plus LAMA is allowed with prior discussion with the study medical monitor.
• Participants on adjunctive COPD therapies such as chronic macrolide antibiotics,
PDE4 or PDE3-4 inhibitors, or chronic oral corticosteroids (up to 15 mg prednisone
equivalent per day) may participate, provided they have been on these medications
for 6 months, and on a stable dose for at least 3 months immediately prior to
Screening Visit 1. These participants should remain on these therapies for the
duration of the study. INC#7
Exclusion Criteria
5.2.1. Medical conditions
5.2.1.1. Asthma
• Patients with a current or prior physician diagnosis of asthma* are excluded. EXC#1
• *A diagnosis of asthma should be based on both a history of typical respiratory
symptoms combined with evidence of variable expiratory airflow limitation at the
time of diagnosis consistent with GINA 2024 or other accepted guidelines.
Note: Country specific guidance on excluding participants with asthma are described
in Appendix 8.
5.2.1.2. Lung Disease
• Other clinically significant lung disease: The Investigator must judge that COPD is
the primary diagnosis accounting for the clinical manifestations of the lung disease.
Participants with α1-antitrypsin deficiency as the underlying cause of COPD are
excluded. Also excluded are participants with active tuberculosis, lung cancer,
bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension,
interstitial lung diseases or other active pulmonary diseases. EXC#2
• COPD stability: Participants with pneumonia, COPD exacerbation, or lower
respiratory tract infection within the 4 weeks prior to Screening Visit 1 are excluded.
EXC#3
• Lung resection: Participants with a history of, or plan for lung volume reduction
surgery / endobronchial valve procedure are excluded. EXC#4
• Pulmonary rehabilitation: Participants in the acute phase of a pulmonary
rehabilitation program within 4 weeks prior to Screening Visit 1 are excluded.
Participants who are in the maintenance phase of a pulmonary rehabilitation program
may participate. EXC#5
• Continuous oxygen: Patients requiring oxygen supplementation for more than 12
hours per day are excluded. Non-continuous (i.e., 12 hours or less per day) oxygen is
permitted up to 2 L/min at screening. EXC#6
• Cor pulmonale – resulting in right heart failure, severe pulmonary hypertension are
excluded. EXC#7.
• Chronic hypercapnia requiring NIPPV use (including BiPAP or CPAP) are excluded.
EXC#8
The Estimated Number of Participants
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Taiwan
26 participants
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Global
981 participants
