Clinical Trials List
2025-06-09 - 2029-11-26
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
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Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
Co-Principal Investigator
- 陳詩華 無
- 趙文震 無
- 林奕宏 無
- 沈佩誼 無
- 莊子逸 無
- 廖培雅 無
- 王俊隆 無
- Wei- Chang Huang 無
- 李柏昕 無
- YEN-HSIANG HUANG 無
- 林雋 無
- 歐偉凡 無
- JENG-SEN TSENG 無
- 劉明承 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Inn-Wen Chong 無
- Ming-Ju Tsai 無
- Hung-Ling Huang 無
- 鄭孟軒 無
- jong rung Tsai 無
- Jui-Sheng Hsu 無
- 陳家閔 無
- 莊政皓 無
- 鄭至宏 無
- Wei-An Chang 無
- 張旭良 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
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
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
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the informed consent.
Elevated blood eosinophil count (BEC).
Moderate to severe COPD with frequent exacerbations, defined as:
A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (<) 0.70 and a post- bronchodilator FEV1 >30 percent (%) and <= 80% predicted normal values
A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
COPD assessment test (CAT) score >=10 at Visit 1.
Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years.
Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1.
Body mass index (BMI) >=16 kilogram per square meter (kg/m^2).
Male or eligible female participants.
Exclusion Criteria
The following subjects are excluded:
Participants with a current or prior physician diagnosis of asthma.
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 pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1.
Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day.
Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP]).
Unstable cardiovascular disease or arrhythmia.
Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).
The Estimated Number of Participants
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Taiwan
26 participants
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Global
981 participants
