Phase II Study of RC1416 Injection in COPD
Recruiting · NCT07402551 · Interventional (participants receive a specific treatment) · Lead sponsor: Nanjing RegeneCore Biotech Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
RC1416RC1416 Placebo
What this trial is about
This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Who can take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Body Mass Index (BMI) ≥ 16 kg/m².
- Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a history of COPD for ≥ 12 months at screening.
- Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \< 0.7, and post-bronchodilator FEV1 ≥ 30% and \< 80% of the predicted value at screening.
- A current smoker or former smoker with a smoking history of ≥ 10 pack-years, or a history of exposure to other risk factors.
- A score of ≥ 2 on the modified Medical Research Council (mMRC) dyspnea scale at screening.
- Medical records or relevant documentation showing ≥ 2 moderate COPD. exacerbations (AECOPD) or ≥ 1 severe AECOPD within the 12 months prior to screening.
- Medical records or relevant documentation showing receipt of background triple therapy (ICS + LABA + LAMA) for ≥ 3 months prior to randomization.
- A blood eosinophil count ≥ 150/mm³ (0.15×10⁹/L) at screening.
Exclusion criteria
- A current diagnosis of asthma or a history of asthma.
- Presence of other significant pulmonary diseases except COPD as judged by the Investigator.
- History of malignancy .
- A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to signing the informed consent form.
- Presence of recurrent, chronic, or other active infections at screening.
- Currently receiving or planning to start long-term oxygen therapy or mechanical ventilation during the study period.
- Diagnosis of α1-antitrypsin deficiency.
- Active hepatitis B, active hepatitis C, positive human immunodeficiency virus (HIV) antibody, or positive Treponema pallidum antibody (TP-Ab).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it is running
46 locations listed.
- Anhui Provincial Chest Hospital - Hefei, Anhui, China
- Wan Bei General Hospital of Wanbei Coal power Group - Suzhou, Anhui, China
- Yongchuan Hospital Affiliated to Chongqing Medical University - Chongqing, Chongqing Municipality, China
- The Affiliated Bishan Hospital of Chongqing Medical University - Chongqing, Chongqing Municipality, China
- Zhongshan Hospital Xiamen University - Xiamen, Fujian, China
- The first affiliated hospital of guangzhou medical university - Guangzhou, Guangdong, China
- The First Affiliated Hospital of Jinan University - Guangzhou, Guangdong, China
- The first affiliated hospital of guangzhou medical university - Guangzhou, Guangdong, China
- Huizhou Third People's Hospital - Huizhou, Guangdong, China
- Jiangmen Central Hospital - Jiangmen, Guangdong, China
- Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital) - Qingyuan, Guangdong, China
- The First Affiliated Hospital of guangxi Medical University - Nanning, Guangxi, China
- The First People's Hospital of Yulin - Yulin, Guangxi, China
- Affiliated Hospital of Zunyi Medical University - Zunyi, Guizhou, China
- Anyang People's Hospital - Anyang, Henan, China
- Jiaozuo Second People's Hospital - Jiaozuo, Henan, China
- Nanyang First People's Hospital - Nanyang, Henan, China
- Nanyang Second People's Hospital - Nanyang, Henan, China
- Sanmenxia Central Hospital - Sanmenxia, Henan, China
- Xinxiang First People's Hospital - Xinxiang, Henan, China
- Yichang Central People's Hospital - Yichang, Hubei, China
- Loudi Central Hospital - Loudi, Hunan, China
- The Affiliated Hospital of Inner Mongolia Medical University - Hohhot, Inner Mongolia, China
- The First People's Hospital of Lianyungang City - Lianyungang, Jiangsu, China
- Nanjing First Hospital - Nanjing, Jiangsu, China
- Xuzhou Central Hospital - Xuzhou, Jiangsu, China
- Suining County People's Hospital - Xuzhou, Jiangsu, China
- Yangzhou University Affiliated Hospital - Yangzhou, Jiangsu, China
- Jiu Jiang NO.1 People's Hospital - Jiujiang, Jiangxi, China
- People's Hospital of Pingxiang City - Pingxiang, Jiangxi, China
- The Second Hospital of Jilin University - Changchun, Jilin, China
- Shengjing Hospital of China Medical University - Shenyang, Liaoning, China
- LiaoCheng People's Hospital - Liaocheng, Shandong, China
- Qingdao Municipal Hospital - Qingdao, Shandong, China
- The Second People's Hospital of Weifang - Weifang, Shandong, China
- Zaozhuang Municipal Hospital - Zaozhuang, Shandong, China
- Zibo Municipal Hospital - Zibo, Shandong, China
- Shanghai Pulmonary Hospital - Shanghai, Shanghai Municipality, China
- The Third People's Hospital of Chengdu City - Chengdu, Sichuan, China
- The First People's Hospital of Shuangliu District, Chengdu - Chengdu, Sichuan, China
- Chengdu Fifth People's Hospital - Chengdu, Sichuan, China
- Mianyang central hospital - Mianyang, Sichuan, China
- Suining Central Hospital - Suining, Sichuan, China
- Zigong First People's Hospital Zigong Academy of Medicalsciences - Zigong, Sichuan, China
- The First People's Hospital of Hangzhou (Westlake University Affiliated The First People's Hospital of Hangzhou) - Hangzhou, Zhejiang, China
- The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU - Wenzhou, Zhejiang, China