Phase II Study of RC1416 Injection in COPD

Nanjing RegeneCore Biotech

Status and phase

Not yet enrolling

Phase 2

Conditions

Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: RC1416 Placebo

Drug: RC1416

Study type

Interventional

Funder types

Industry

Identifiers

NCT07402551

RJK-RC1416-301

Details and patient eligibility

About

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).

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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.