Actively Recruiting
A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-12-18
360
Participants Needed
51
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety of 9MW1911 in patients with Chronic Obstructive Pulmonary Disease (COPD).
CONDITIONS
Official Title
A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 40 to 75 years inclusive
- Physician diagnosis of COPD for at least 1 year at screening
- History of 2 or more moderate or 1 or more severe COPD exacerbations within 12 months prior to screening
- Moderate-to-severe COPD with post-bronchodilator FEV1/FVC ratio below 0.7 and post-bronchodilator FEV1% predicted between 20% and 80% at screening
- Body Mass Index between 16 kg/m² and 32 kg/m²
- Current or former smoker with a smoking history of at least 10 pack-years
- Receiving standard care controller therapy for at least 3 months prior to screening and stable dose for at least 1 month prior to screening
You will not qualify if you...
- Current diagnosis or history of asthma
- Diagnosis of Alpha-1 Antitrypsin Deficiency
- Other significant lung diseases besides COPD, such as sarcoidosis, interstitial lung diseases, bronchiectasis, cystic fibrosis, constrictive bronchiolitis, severe pulmonary hypertension
- Long-term oxygen treatment over 15 hours per day, mechanical ventilation, or significant apnea needing CPAP or non-invasive ventilation
- History of lung removal or lung volume reduction surgery within 12 months prior to screening or planned surgery during the study
- Participation in pulmonary rehabilitation or planned rehabilitation within 4 weeks of screening
- Active respiratory infections during screening
- Moderate to severe COPD exacerbations within 4 weeks prior to or during screening
- Recent infections requiring hospitalization or antibiotics within 4 weeks prior to or during screening
- Treatment with oral, intravenous, or intramuscular corticosteroids over 10 mg prednisone per day within 4 weeks prior to study medication
- Recent heart attack, unstable angina within 12 months, or severe heart failure within 6 months prior to screening
- History or risk factors for dangerous heart rhythms
- Recent transient ischemic attack or stroke within 6 months prior to screening
- Unstable cardiovascular conditions like pulmonary embolism or deep vein thrombosis within 6 months before screening
- Active tuberculosis or certain infections unless inactive as judged by researchers
- Positive tests for HIV, active hepatitis B or C infection, or syphilis
- Active autoimmune disease or immunosuppressive therapy for autoimmune diseases
- Active or recent malignancy except certain cured low-grade tumors
- Recent live attenuated vaccine within 4 weeks prior to or during screening
- Recent biologic therapy within 3 months prior to screening
- Recent investigational therapy within 3 months or 5 drug half-lives prior to screening
- Significant ECG abnormalities such as prolonged QTc
- Liver enzyme or bilirubin levels above specified limits
- Reduced kidney function (eGFR below 60 mL/min/1.73m2)
- Serious medical conditions or lab abnormalities that could affect safety or participation
- History of alcohol or substance abuse within 12 months prior to screening
- Severe allergic reactions to biologic agents or components of the study drug
- Pregnant or breastfeeding women, or positive pregnancy test at screening
- Any condition the investigator believes makes participation inappropriate
AI-Screening
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Trial Site Locations
Total: 51 locations
1
Chizhou Central Hospital
Chizhou, Anhui, China
Actively Recruiting
2
Anhui Chest Hospital
Hefei, Anhui, China
Actively Recruiting
3
Gansu Provincial People's Hospital
Lanzhou, Gansu, China
Actively Recruiting
4
Huizhou Third People's Hospital
Huizhou, Guangdong, China
Actively Recruiting
5
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Actively Recruiting
6
Qingyuan Hospital Affiliated to Guangzhou Medical University
Qingyuan, Guangdong, China
Actively Recruiting
7
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Actively Recruiting
8
Hebei PetroChina Central Hospital
Langfang, Hebei, China
Actively Recruiting
9
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Actively Recruiting
10
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Actively Recruiting
11
Xinxiang First People's Hospital
Xinxiang, Henan, China
Actively Recruiting
12
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
13
Jingzhou First People's Hospital
Jinzhou, Hubei, China
Actively Recruiting
14
Yichang Central People's Hospital
Yichang, Hubei, China
Actively Recruiting
15
The Third Hospital of Changsha
Changsha, Hunan, China
Actively Recruiting
16
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Actively Recruiting
17
Shaoyang Central Hospital
Shaoyang, Hunan, China
Actively Recruiting
18
Xiangyang Central Hospital
Xiangyang, Hunan, China
Actively Recruiting
19
Yongzhou Central Hospital
Yongzhou, Hunan, China
Actively Recruiting
20
Yueyang Central Hospital
Yueyang, Hunan, China
Actively Recruiting
21
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
22
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China
Actively Recruiting
23
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Actively Recruiting
24
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
Not Yet Recruiting
25
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Actively Recruiting
26
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Actively Recruiting
27
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
28
Inner Mongolia Baogang Hospital
Baotou, Neimenggu, China
Actively Recruiting
29
Heze Municipal Hospital
Heze, Shandong, China
Actively Recruiting
30
Shandong Provincial Hospital
Jinan, Shandong, China
Actively Recruiting
31
Shandong Provincial Public Health Clinical Center
Jinan, Shandong, China
Actively Recruiting
32
Weifang Second People's Hospital
Weifang, Shandong, China
Actively Recruiting
33
Jinmei Group General Hospital
Jincheng, Shanxi, China
Actively Recruiting
34
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
35
Xi'an Chest Hospital
Xi’an, Shanxi, China
Actively Recruiting
36
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Actively Recruiting
37
Yibin Second People's Hospital
Yibin, Sichuan, China
Actively Recruiting
38
Yunnan Provincial First People's Hospital
Kunming, Yunnan, China
Actively Recruiting
39
Huzhou Central Hospital
Huzhou, Zhejiang, China
Actively Recruiting
40
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Actively Recruiting
41
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
42
Beijing Chaoyang Hospital
Beijing, China
Actively Recruiting
43
Beijing Luhe Hospital
Beijing, China
Actively Recruiting
44
Peking University Third Hospital
Beijing, China
Actively Recruiting
45
Chongqing jiangjin hospital
Chongqing, China
Actively Recruiting
46
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Actively Recruiting
47
Inner Mongolia Autonomous Region People's Hospital
Neimeng, China
Actively Recruiting
48
Chongming Hospital Affiliated to Shanghai University of Medicine & Health Sciences
Shanghai, China
Actively Recruiting
49
Shanghai Fifth People's Hospital
Shanghai, China
Actively Recruiting
50
Shanghai Pulmonary Hospital
Shanghai, China
Actively Recruiting
51
Yichang Central People's Hospital
Yichang, China
Actively Recruiting
Research Team
Y
Yongchang Sun, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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