RecruitingPhase 2NCT07292714

A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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)

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

360 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

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

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called 9MW1911 to see if it can reduce the number of flare-ups (exacerbations) in people with moderate-to-severe COPD (chronic obstructive pulmonary disease) who continue to have episodes despite being on standard inhaler therapy. **You may be eligible if...** - You are between 40 and 75 years old - You have been diagnosed with COPD for at least 1 year - You have had 2 or more moderate flare-ups or 1 severe flare-up in the past year - Your lung function tests show moderate-to-severe COPD - You are a current or former smoker (at least 10 pack-years) - You have been on stable controller inhaler therapy for at least 3 months **You may NOT be eligible if...** - You have asthma or were diagnosed with asthma - You have alpha-1 antitrypsin deficiency - You are outside the BMI range of 16–32 kg/m² Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG9MW1911

Participants will receive IV 9MW1911 in each dose every 28 days.

DRUGPhase II placebo

Participants will receive IV placebo every 28 days.

Locations(51)

Chizhou Central Hospital

Chizhou, Anhui, China

Anhui Chest Hospital

Hefei, Anhui, China

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Huizhou Third People's Hospital

Huizhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Qingyuan Hospital Affiliated to Guangzhou Medical University

Qingyuan, Guangdong, China

The Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Hebei PetroChina Central Hospital

Langfang, Hebei, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Xinxiang First People's Hospital

Xinxiang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Jingzhou First People's Hospital

Jinzhou, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

The Third Hospital of Changsha

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Shaoyang Central Hospital

Shaoyang, Hunan, China

Xiangyang Central Hospital

Xiangyang, Hunan, China

Yongzhou Central Hospital

Yongzhou, Hunan, China

Yueyang Central Hospital

Yueyang, Hunan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Jiujiang First People's Hospital

Jiujiang, Jiangxi, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Inner Mongolia Baogang Hospital

Baotou, Neimenggu, China

Heze Municipal Hospital

Heze, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China

Shandong Provincial Public Health Clinical Center

Jinan, Shandong, China

Weifang Second People's Hospital

Weifang, Shandong, China

Jinmei Group General Hospital

Jincheng, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Xi'an Chest Hospital

Xi’an, Shanxi, China

Chengdu Fifth People's Hospital

Chengdu, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Yunnan Provincial First People's Hospital

Kunming, Yunnan, China

Huzhou Central Hospital

Huzhou, Zhejiang, China

Jiaxing First Hospital

Jiaxing, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Beijing Chaoyang Hospital

Beijing, China

Beijing Luhe Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

Chongqing jiangjin hospital

Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Inner Mongolia Autonomous Region People's Hospital

Neimeng, China

Chongming Hospital Affiliated to Shanghai University of Medicine & Health Sciences

Shanghai, China

Shanghai Fifth People's Hospital

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Yichang Central People's Hospital

Yichang, China

View Full Details on ClinicalTrials.gov

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NCT07292714

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