Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief 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).
Detailed description
Each participant will receive the study treatment once every two weeks for a total treatment duration of 52 weeks. The study aims to evaluate the annualized rate of moderate or severe COPD exacerbations (AECOPD) and the change in FEV1 from baseline over the 52-week treatment period. The changes in FeNO, total IgE, eosinophil count, and TARC levels from baseline will be evaluated.
Interventions
DRUGRC1416
There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
DRUGRC1416 Placebo
Each subjects will receive the placebo by subcutaneous injection.
Sponsors
Nanjing RegeneCore Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety and tolerability | During 52 weeks | Adverse events, laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examinations. |
| pharmacokinetic | During 52 weeks | Css, DF, Tmax. |
| immunogenicity | During 52 weeks | ADA positivity rate and titer, and NAb positivity rate. |
| biomarkers predictive of the efficacy | During 52 weeks | FeNO, total IgE, eosinophil count, and TARC levels. |
Countries
China
Contacts
CONTACTYumin Zhou, MD
Outcome results
None listed