RC1416 injection for moderate to severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Anhui Provincial Chest Hospital
  Hefei, Anhui, China Recruiting
• Wan Bei General Hospital of Wanbei Coal power Group
  Suzhou, Anhui, China Recruiting
• Yongchuan Hospital Affiliated to Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• The Affiliated Bishan Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Zhongshan Hospital Xiamen University
  Xiamen, Fujian, China Recruiting
• The first affiliated hospital of guangzhou medical university
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yumin Zhou, MD
• Email: zhouyumin410@126.com
• Phone: +86-13826190798

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.