Phase II Study of RC1416 Injection in COPD

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

In brief

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).

Key facts

Study ID

NCT07402551

Run by

Nanjing RegeneCore Biotech Co., Ltd.

People needed

180

Starts

2026-03-06

Expected to finish

2028-08-30

Last updated by the study team

2026-07-09

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU — Wenzhou, Zhejiang, China (enrolling)
• Wan Bei General Hospital of Wanbei Coal power Group — Suzhou, Anhui, China (enrolling)
• The Affiliated Bishan Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Zhongshan Hospital Xiamen University — Xiamen, Fujian, China (enrolling)
• The first affiliated hospital of guangzhou medical university — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (enrolling)
• The first affiliated hospital of guangzhou medical university — Guangzhou, Guangdong, China (enrolling)
• Huizhou Third People's Hospital — Huizhou, Guangdong, China (enrolling)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (enrolling)
• Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital) — Qingyuan, Guangdong, China (enrolling)
• The First Affiliated Hospital of guangxi Medical University — Nanning, Guangxi, China (enrolling)
• The First People's Hospital of Yulin — Yulin, Guangxi, China (enrolling)
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (enrolling)
• Anyang People's Hospital — Anyang, Henan, China (enrolling)
• Jiaozuo Second People's Hospital — Jiaozuo, Henan, China (enrolling)
• Nanyang First People's Hospital — Nanyang, Henan, China (enrolling)
• Nanyang Second People's Hospital — Nanyang, Henan, China (enrolling)
• Sanmenxia Central Hospital — Sanmenxia, Henan, China (enrolling)
• Xinxiang First People's Hospital — Xinxiang, Henan, China (enrolling)
• Yichang Central People's Hospital — Yichang, Hubei, China (enrolling)
• Loudi Central Hospital — Loudi, Hunan, China (enrolling)
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (enrolling)
• The First People's Hospital of Lianyungang City — Lianyungang, Jiangsu, China (enrolling)
• Nanjing First Hospital — Nanjing, Jiangsu, China (enrolling)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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