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Recruiting Phase 2

Phase II Study of RC1416 Injection in COPD

NCT07402551 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-03-06
Last updated
2026-09-08

Condition(s) studied

Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

RC1416 →RC1416 Placebo

RC1416: There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.

RC1416 Placebo: Each subjects will receive the placebo by subcutaneous injection.

Study summary

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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • moderate or severe COPD exacerbations (AECOPD) and forced expiratory volume in 1 Second (FEV1) — During 52 weeks
    Evaluate the annualized rate of AECOPD and the change in FEV1 from baseline

Trial sites (46)

FacilityCityRegionStatus
Anhui Provincial Chest Hospital Hefei Anhui Recruiting
Wan Bei General Hospital of Wanbei Coal power Group Suzhou Anhui Recruiting
Yongchuan Hospital Affiliated to Chongqing Medical University Chongqing Chongqing Municipality Recruiting
The Affiliated Bishan Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Zhongshan Hospital Xiamen University Xiamen Fujian Recruiting
The first affiliated hospital of guangzhou medical university Guangzhou Guangdong Recruiting
The First Affiliated Hospital of Jinan University Guangzhou Guangdong Recruiting
The first affiliated hospital of guangzhou medical university Guangzhou Guangdong Recruiting
Huizhou Third People's Hospital Huizhou Guangdong Recruiting
Jiangmen Central Hospital Jiangmen Guangdong Recruiting
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital) Qingyuan Guangdong Recruiting
The First Affiliated Hospital of guangxi Medical University Nanning Guangxi Recruiting
The First People's Hospital of Yulin Yulin Guangxi Recruiting
Affiliated Hospital of Zunyi Medical University Zunyi Guizhou Recruiting
Anyang People's Hospital Anyang Henan Recruiting
Jiaozuo Second People's Hospital Jiaozuo Henan Recruiting
Nanyang First People's Hospital Nanyang Henan Recruiting
Nanyang Second People's Hospital Nanyang Henan Recruiting
Sanmenxia Central Hospital Sanmenxia Henan Recruiting
Xinxiang First People's Hospital Xinxiang Henan Recruiting
Yichang Central People's Hospital Yichang Hubei Recruiting
Loudi Central Hospital Loudi Hunan Recruiting
The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia Recruiting
The First People's Hospital of Lianyungang City Lianyungang Jiangsu Recruiting
Nanjing First Hospital Nanjing Jiangsu Recruiting
Xuzhou Central Hospital Xuzhou Jiangsu Recruiting
Suining County People's Hospital Xuzhou Jiangsu Not Yet Recruiting
Yangzhou University Affiliated Hospital Yangzhou Jiangsu Recruiting
Jiu Jiang NO.1 People's Hospital Jiujiang Jiangxi Recruiting
People's Hospital of Pingxiang City Pingxiang Jiangxi Recruiting
The Second Hospital of Jilin University Changchun Jilin Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
LiaoCheng People's Hospital Liaocheng Shandong Recruiting
Qingdao Municipal Hospital Qingdao Shandong Recruiting
The Second People's Hospital of Weifang Weifang Shandong Recruiting
Zaozhuang Municipal Hospital Zaozhuang Shandong Not Yet Recruiting
Zibo Municipal Hospital Zibo Shandong Recruiting
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality Recruiting
The Third People's Hospital of Chengdu City Chengdu Sichuan Recruiting
The First People's Hospital of Shuangliu District, Chengdu Chengdu Sichuan Not Yet Recruiting

+ 6 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07402551 on ClinicalTrials.gov ↗ ← All trials in China