RC1416 injection for moderate to severe COPD

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)

This study will test whether RC1416 injections given every two weeks for one year can reduce COPD flare-ups and improve breathing in adults with moderate to severe COPD who have had recent exacerbations.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Nanjing RegeneCore Biotech Co., Ltd. (Industry-sponsored)
• Locations: 41 sites (Hefei, Anhui and 40 other locations)
• Trial ID: NCT07402551 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase II study enrolls adults with moderate to severe COPD and a history of exacerbations. Participants receive RC1416 or placebo by injection every two weeks for 52 weeks while continuing their background COPD treatments. The main outcomes are the annualized rate of moderate or severe COPD exacerbations and the change in post-bronchodilator FEV1 from baseline over the 52-week treatment period. The trial will also measure FeNO, total IgE, blood eosinophils, and TARC to explore biological effects and potential responders.

Who should consider this trial

Good fit: Adults aged 40–85 with documented moderate to severe COPD (post-bronchodilator FEV1/FVC < 0.7 and FEV1 30–<80% predicted), a smoking or other exposure history, mMRC score ≥ 2, and at least two moderate or one severe exacerbation in the prior 12 months are the intended participants.

Not a fit: People with only mild COPD, without recent exacerbations, those outside the specified age or lung-function ranges, or those unable to attend biweekly injection visits are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If effective, RC1416 could lower the number of moderate or severe COPD exacerbations and modestly improve lung function over a year.

How similar studies have performed: Some biologic treatments targeting eosinophilic or allergic inflammation have shown benefit in COPD subgroups, but many novel agents remain unproven and published results have been mixed.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 40 other locations

• Anhui Provincial Chest Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Wan Bei General Hospital of Wanbei Coal power Group — Suzhou, Anhui, China (Not_yet_recruiting)
• The Affiliated Bishan Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Zhongshan Hospital Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• The first affiliated hospital of guangzhou medical university — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The first affiliated hospital of guangzhou medical university — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Huizhou Third People's Hospital — Huizhou, Guangdong, China (Not_yet_recruiting)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (Not_yet_recruiting)
• Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital) — Qingyuan, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital of guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• The First People's Hospital of Yulin — Yulin, Guangxi, China (Not_yet_recruiting)
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Not_yet_recruiting)
• Anyang People's Hospital — Anyang, Henan, China (Not_yet_recruiting)
• Jiaozuo Second People's Hospital — Jiaozuo, Henan, China (Not_yet_recruiting)
• Nanyang First People's Hospital — Nanyang, Henan, China (Not_yet_recruiting)
• Nanyang Second People's Hospital — Nanyang, Henan, China (Not_yet_recruiting)
• Sanmenxia Central Hospital — Sanmenxia, Henan, China (Not_yet_recruiting)
• Xinxiang First People's Hospital — Xinxiang, Henan, China (Not_yet_recruiting)
• Yichang Central People's Hospital — Yichang, Hubei, China (Not_yet_recruiting)
• Loudi Central Hospital — Loudi, Hunan, China (Not_yet_recruiting)
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Recruiting)
• The First People's Hospital of Lianyungang City — Lianyungang, Jiangsu, China (Not_yet_recruiting)
• Nanjing First Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Yangzhou University Affiliated Hospital — Yangzhou, Jiangsu, China (Not_yet_recruiting)
• Jiu Jiang NO.1 People's Hospital — Jiujiang, Jiangxi, China (Not_yet_recruiting)
• People's Hospital of Pingxiang City — Pingxiang, Jiangxi, China (Not_yet_recruiting)
• The Second Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• LiaoCheng People's Hospital — Liaocheng, Shandong, China (Not_yet_recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
• The Second People's Hospital of Weifang — Weifang, Shandong, China (Not_yet_recruiting)
• Zibo Municipal Hospital — Zibo, Shandong, China (Not_yet_recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The Third People's Hospital of Chengdu City — Chengdu, Sichuan, China (Not_yet_recruiting)
• Chengdu Fifth People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Mianyang central hospital — Mianyang, Sichuan, China (Not_yet_recruiting)
• Suining Central Hospital — Suining, Sichuan, China (Not_yet_recruiting)
• Zigong First People's Hospital Zigong Academy of Medicalsciences — Zigong, Sichuan, China (Not_yet_recruiting)
• The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yumin Zhou, MD

Conditions Moderate to Severe Chronic Obstructive Pulmonary Disease