NCT07402551

Phase II Study of RC1416 Injection in COPD

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Nanjing RegeneCore Biotech Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	RC1416	There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
DRUG	RC1416 Placebo	Each subjects will receive the placebo by subcutaneous injection.

Timeline

• Start date: 2026-03-06
• Primary completion: 2028-05-31
• Completion: 2028-08-30
• First posted: 2026-02-11
• Last updated: 2026-04-17

Locations

41 sites across 1 country: China