Phase II Study of RC1416 Injection in COPD (NCT07402551) | Clinical Trial Compass
RecruitingPhase 2
Phase II Study of RC1416 Injection in COPD
China180 participantsStarted 2026-03-06
Plain-language 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).
Who can participate
Age range40 Years – 85 Years
SexALL
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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…
What they're measuring
1
moderate or severe COPD exacerbations (AECOPD) and forced expiratory volume in 1 Second (FEV1)