Actively Recruiting
Phase II Study of RC1416 Injection in COPD
Led by Nanjing RegeneCore Biotech Co., Ltd. · Updated on 2026-04-17
180
Participants Needed
41
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Phase II Study of RC1416 Injection in COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Body Mass Index (BMI) 65 16 kg/m�b2.
- Diagnosed with chronic obstructive pulmonary disease (COPD) with medical records showing at least 12 months of history.
- Post-bronchodilator FEV1/FVC ratio less than 0.7, and FEV1 between 30% and less than 80% of the predicted value at screening.
- Current or former smoker with at least 10 pack-years smoking history, or history of exposure to other risk factors.
- Modified Medical Research Council (mMRC) dyspnea scale score of 2 or higher at screening.
- Medical records showing at least 2 moderate or 1 severe COPD exacerbations within the 12 months prior to screening.
- Medical records showing use of background triple therapy (ICS + LABA + LAMA) for at least 3 months before randomization.
- Blood eosinophil count of at least 150/mm�b3 (0.15�d7 10�b9/L) at screening.
You will not qualify if you...
- Current diagnosis or history of asthma.
- Presence of significant pulmonary diseases other than COPD as judged by the Investigator.
- History of malignancy.
- History of autoimmune diseases or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives prior to signing informed consent.
- 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.
- Diagnosis of b11-antitrypsin deficiency.
- Active hepatitis B or C infection, positive HIV antibody, or positive Treponema pallidum antibody (TP-Ab).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
Anhui Provincial Chest Hospital
Hefei, Anhui, China, 230031
Not Yet Recruiting
2
Wan Bei General Hospital of Wanbei Coal power Group
Suzhou, Anhui, China, 234000
Not Yet Recruiting
3
The Affiliated Bishan Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 402760
Not Yet Recruiting
4
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
Not Yet Recruiting
5
The first affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, China, 510000
Actively Recruiting
6
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
7
The first affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, China
Not Yet Recruiting
8
Huizhou Third People's Hospital
Huizhou, Guangdong, China, 516002
Not Yet Recruiting
9
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
10
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Qingyuan, Guangdong, China, 511518
Not Yet Recruiting
11
The First Affiliated Hospital of guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
12
The First People's Hospital of Yulin
Yulin, Guangxi, China, 537000
Not Yet Recruiting
13
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
Not Yet Recruiting
14
Anyang People's Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
15
Jiaozuo Second People's Hospital
Jiaozuo, Henan, China, 454000
Not Yet Recruiting
16
Nanyang First People's Hospital
Nanyang, Henan, China, 473000
Not Yet Recruiting
17
Nanyang Second People's Hospital
Nanyang, Henan, China, 473000
Not Yet Recruiting
18
Sanmenxia Central Hospital
Sanmenxia, Henan, China, 472000
Not Yet Recruiting
19
Xinxiang First People's Hospital
Xinxiang, Henan, China, 453000
Not Yet Recruiting
20
Yichang Central People's Hospital
Yichang, Hubei, China, 443000
Not Yet Recruiting
21
Loudi Central Hospital
Loudi, Hunan, China, 417000
Not Yet Recruiting
22
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 010030
Actively Recruiting
23
The First People's Hospital of Lianyungang City
Lianyungang, Jiangsu, China, 222061
Not Yet Recruiting
24
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Not Yet Recruiting
25
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Not Yet Recruiting
26
Yangzhou University Affiliated Hospital
Yangzhou, Jiangsu, China, 225012
Not Yet Recruiting
27
Jiu Jiang NO.1 People's Hospital
Jiujiang, Jiangxi, China, 332000
Not Yet Recruiting
28
People's Hospital of Pingxiang City
Pingxiang, Jiangxi, China
Not Yet Recruiting
29
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
Not Yet Recruiting
30
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
31
LiaoCheng People's Hospital
Liaocheng, Shandong, China, 252000
Not Yet Recruiting
32
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266000
Not Yet Recruiting
33
The Second People's Hospital of Weifang
Weifang, Shandong, China, 261041
Not Yet Recruiting
34
Zibo Municipal Hospital
Zibo, Shandong, China, 255499
Not Yet Recruiting
35
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Not Yet Recruiting
36
The Third People's Hospital of Chengdu City
Chengdu, Sichuan, China, 610031
Not Yet Recruiting
37
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China, 611130
Actively Recruiting
38
Mianyang central hospital
Mianyang, Sichuan, China, 621099
Not Yet Recruiting
39
Suining Central Hospital
Suining, Sichuan, China, 629000
Not Yet Recruiting
40
Zigong First People's Hospital Zigong Academy of Medicalsciences
Zigong, Sichuan, China, 643000
Not Yet Recruiting
41
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, China, 325035
Not Yet Recruiting
Research Team
Y
Yumin Zhou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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