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Phase II Study of RC1416 Injection in COPD

RecruitingPhase 2Ages 40 Years - 85 YearsAllNanjing RegeneCore Biotech Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • RC1416
  • RC1416 Placebo
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Where

46 sites
Anhui Provincial Chest Hospital
Hefei, China
Wan Bei General Hospital of Wanbei Coal power Group
Suzhou, China
Yongchuan Hospital Affiliated to Chongqing Medical University
Chongqing, China
The Affiliated Bishan Hospital of Chongqing Medical University
Chongqing, China
Zhongshan Hospital Xiamen University
Xiamen, China
The first affiliated hospital of guangzhou medical university
Guangzhou, China
The First Affiliated Hospital of Jinan University
Guangzhou, China
The first affiliated hospital of guangzhou medical university
Guangzhou, China

…and 38 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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