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)

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).

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: RC1416; Drug: RC1416 Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yumin Zhou, MD; Phone Number: +86-13826190798; Email: zhouyumin410@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • Not yet recruiting
      • Anhui Provincial Chest Hospital
      • Contact: Haohui Fang
    • Suzhou, Anhui, China, 234000
      • Not yet recruiting
      • Wan Bei General Hospital of Wanbei Coal power Group
      • Contact: Hui Jiang
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 402760
      • Not yet recruiting
      • The Affiliated Bishan Hospital of Chongqing Medical University
      • Contact: Rui Han
  • Fujian
    • Xiamen, Fujian, China, 361004
      • Not yet recruiting
      • Zhongshan Hospital Xiamen University
      • Contact: Yanping Du
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Yuming Zhou
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Nanshan Zhong
    • Guangzhou, Guangdong, China, 510000
      • Not yet recruiting
      • The First Affiliated Hospital of Jinan University
      • Contact: Shenming Liu
    • Huizhou, Guangdong, China, 516002
      • Not yet recruiting
      • Huizhou Third People's Hospital
      • Contact: Feng Wu
    • Jiangmen, Guangdong, China, 529000
      • Not yet recruiting
      • Jiangmen Central Hospital
      • Contact: Yanming Huang
    • Qingyuan, Guangdong, China, 511518
      • Not yet recruiting
      • Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
      • Contact: Dongbo Tian
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Not yet recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Zhiyi He
    • Yulin, Guangxi, China, 537000
      • Not yet recruiting
      • The First People's Hospital of Yulin
      • Contact: Linling Zhu
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Not yet recruiting
      • Affiliated Hospital Of Zunyi Medical University
      • Contact: Yuanbo Lan
  • Henan
    • Anyang, Henan, China, 455000
      • Not yet recruiting
      • Anyang People's Hospital
      • Contact: Mingyong Jia
    • Jiaozuo, Henan, China, 454000
      • Not yet recruiting
      • Jiaozuo Second People's Hospital
      • Contact: Xinqu Xu
    • Nanyang, Henan, China, 473000
      • Not yet recruiting
      • Nanyang First People's Hospital
      • Contact: Qun Ma
    • Nanyang, Henan, China, 473000
      • Not yet recruiting
      • Nanyang Second People's Hospital
      • Contact: Fengling, Ju
    • Sanmenxia, Henan, China, 472000
      • Not yet recruiting
      • Sanmenxia Central Hospital
      • Contact: Kuan Liu
    • Xinxiang, Henan, China, 453000
      • Not yet recruiting
      • Xinxiang First People's Hospital
      • Contact: Xiangjie Zhang
  • Hubei
    • Yichang, Hubei, China, 443000
      • Not yet recruiting
      • Yichang Central People's Hospital
      • Contact: Xiaoqi Xiong
  • Hunan
    • Loudi, Hunan, China, 417000
      • Not yet recruiting
      • Loudi Central Hospital
      • Contact: Lixuan Chen
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010030
      • Recruiting
      • The Affiliated Hospital of Inner Mongolia Medical University
      • Contact: Lihong Wang
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222061
      • Not yet recruiting
      • The First People's Hospital of Lianyungang City
      • Contact: Jiashu Li
    • Nanjing, Jiangsu, China, 210006
      • Not yet recruiting
      • Nanjing First Hospital
      • Contact: Surong Fang
    • Xuzhou, Jiangsu, China, 221009
      • Not yet recruiting
      • Xuzhou Central Hospital
      • Contact: Yanmin Wu
    • Yangzhou, Jiangsu, China, 225012
      • Not yet recruiting
      • Yangzhou University Affiliated Hospital
      • Contact: Feng Wu
  • Jiangxi
    • Jiujiang, Jiangxi, China, 332000
      • Not yet recruiting
      • Jiu Jiang NO.1 People's Hospital
      • Contact: Jun Li
    • Pingxiang, Jiangxi, China
      • Not yet recruiting
      • People's Hospital of Pingxiang City
      • Contact: Haibo Shen
  • Jilin
    • Changchun, Jilin, China, 130041
      • Not yet recruiting
      • The Second Hospital of Jilin University
      • Contact: Ke Wang
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital of China Medical University
      • Contact: Li Zhao
  • Shandong
    • Liaocheng, Shandong, China, 252000
      • Not yet recruiting
      • Liaocheng People's Hospital
      • Contact: Yan Wang
    • Qingdao, Shandong, China, 266000
      • Not yet recruiting
      • Qingdao Municipal Hospital
      • Contact: Yi Su
    • Weifang, Shandong, China, 261041
      • Not yet recruiting
      • The Second People's Hospital of Weifang
      • Contact: Guoru Yang
    • Zibo, Shandong, China, 255499
      • Not yet recruiting
      • Zibo Municipal Hospital
      • Contact: Lijun Suo
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Not yet recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Haiwen Lu
  • Sichuan
    • Chengdu, Sichuan, China, 611130
      • Recruiting
      • Chengdu Fifth People's Hospital
      • Contact: Xiao Liu
    • Chengdu, Sichuan, China, 610031
      • Not yet recruiting
      • The Third People's Hospital of Chengdu City
      • Contact: Guoping Li
    • Mianyang, Sichuan, China, 621099
      • Not yet recruiting
      • Mianyang Central Hospital
      • Contact: Weiguo Xu
    • Suining, Sichuan, China, 629000
      • Not yet recruiting
      • Suining Central Hospital
      • Contact: Rong Qiu
    • Zigong, Sichuan, China, 643000
      • Not yet recruiting
      • Zigong First People's Hospital Zigong Academy of Medicalsciences
      • Contact: Zhiping Deng
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325035
      • Not yet recruiting
      • The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
      • Contact: Liqin Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control	Drug: RC1416 Placebo; Each subjects will receive the placebo by subcutaneous injection.
Experimental: RC1416 Injection	Drug: RC1416; There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
moderate or severe COPD exacerbations (AECOPD) and forced expiratory volume in 1 Second (FEV1)	Evaluate the annualized rate of AECOPD and the change in FEV1 from baseline	During 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety and tolerability	Adverse events, laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examinations.	During 52 weeks
pharmacokinetic	Css, DF, Tmax.	During 52 weeks
immunogenicity	ADA positivity rate and titer, and NAb positivity rate.	During 52 weeks
biomarkers predictive of the efficacy	FeNO, total IgE, eosinophil count, and TARC levels.	During 52 weeks

Collaborators and Investigators

• Sponsor: Nanjing RegeneCore Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RJK-RC1416-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No