Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate Efficacy and Safety of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ \- 1.Male or Female patients must be 40 to 75 years of age inclusive; 2.Physician diagnosis of COPD for at least 1 year at screening; 3.Documented history of \>= 2 moderate or \>=1 severe COPD exacerbations within 12 months prior to screening.

• Moderate-to-severe COPD with post-BD FEV1/FVC rato\<0.7 and a post-BD FEV1%predicted ≥20% and\<80% at screening; 5.Body Mass Index (BMI) of 16 kg/m² to 32 kg/m²; 6.Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years 7.Participants with standard of care controller therapy, for ≥3 months prior to Screening and at a stable dose of controller therapy for at least 1 month prior to the screening;

Locations
Other Locations
China
Inner Mongolia Baogang Hospital
RECRUITING
Baotou
Beijing Chaoyang Hospital
RECRUITING
Beijing
Beijing Luhe Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The Third Hospital of Changsha
RECRUITING
Changsha
Chengdu Fifth People's Hospital
RECRUITING
Chengdu
Chizhou Central Hospital
RECRUITING
Chizhou
Chongqing jiangjin hospital
RECRUITING
Chongqing
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Anhui Chest Hospital
RECRUITING
Hefei
The First Affiliated Hospital of University of South China
RECRUITING
Hengyang
Heze Municipal Hospital
RECRUITING
Heze
Huizhou Third People's Hospital
RECRUITING
Huizhou
Huzhou Central Hospital
RECRUITING
Huzhou
Jiangmen Central Hospital
RECRUITING
Jiangmen
Jiaxing First Hospital
RECRUITING
Jiaxing
Shandong Provincial Hospital
RECRUITING
Jinan
Shandong Provincial Public Health Clinical Center
RECRUITING
Jinan
Jinmei Group General Hospital
RECRUITING
Jincheng
Jingzhou First People's Hospital
RECRUITING
Jinzhou
Jiujiang First People's Hospital
NOT_YET_RECRUITING
Jiujiang
Yunnan Provincial First People's Hospital
RECRUITING
Kunming
Hebei PetroChina Central Hospital
RECRUITING
Langfang
Gansu Provincial People's Hospital
RECRUITING
Lanzhou
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanyang Medical College
RECRUITING
Nanyang
Inner Mongolia Autonomous Region People's Hospital
RECRUITING
Neimeng
Pingxiang People's Hospital
RECRUITING
Pingxiang
Qingyuan Hospital Affiliated to Guangzhou Medical University
RECRUITING
Qingyuan
Chongming Hospital Affiliated to Shanghai University of Medicine & Health Sciences
RECRUITING
Shanghai
Shanghai Fifth People's Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Shaoyang Central Hospital
RECRUITING
Shaoyang
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
Weifang Second People's Hospital
RECRUITING
Weifang
Xi'an Chest Hospital
RECRUITING
Xi’an
Xiangyang Central Hospital
RECRUITING
Xiangyang
The First Affiliated Hospital of Xinxiang Medical University
RECRUITING
Xinxiang
Xinxiang First People's Hospital
RECRUITING
Xinxiang
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Affiliated Hospital of Yangzhou University
RECRUITING
Yangzhou
Yibin Second People's Hospital
RECRUITING
Yibin
Yichang Central People's Hospital
RECRUITING
Yichang
Yichang Central People's Hospital
RECRUITING
Yichang
Yongzhou Central Hospital
RECRUITING
Yongzhou
Yueyang Central Hospital
RECRUITING
Yueyang
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
The Affiliated Hospital of Zunyi Medical University
RECRUITING
Zunyi
Contact Information
Primary
Yongchang Sun, Doctor
suny@bjmu.edu.cn
(+86)15611963697
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2028-02
Participants
Target number of participants: 360
Treatments
Experimental: Phase II 9MW1911
9MW1911 is administered intravenously in two dose levels. Each dose group include 120 patients.
Placebo_comparator: Phase II Placebo
Phase II Placebo is administered intravenously. this group includes 120 patients.
Sponsors
Leads: Mabwell (Shanghai) Bioscience Co., Ltd.

This content was sourced from clinicaltrials.gov