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)
1 other identifier
interventional
180
1 country
41
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
March 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2028
April 17, 2026
March 1, 2026
2.2 years
January 28, 2026
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
The safety and tolerability
During 52 weeks
pharmacokinetic
During 52 weeks
immunogenicity
During 52 weeks
biomarkers predictive of the efficacy
During 52 weeks
Study Arms (2)
RC1416 Injection
EXPERIMENTALPlacebo Control
PLACEBO COMPARATORInterventions
There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Anhui Provincial Chest Hospital
Hefei, Anhui, 230031, China
Wan Bei General Hospital of Wanbei Coal power Group
Suzhou, Anhui, 234000, China
The Affiliated Bishan Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 402760, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
The first affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510000, China
The first affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, China
Huizhou Third People's Hospital
Huizhou, Guangdong, 516002, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Qingyuan, Guangdong, 511518, China
The First Affiliated Hospital of guangxi Medical University
Nanning, Guangxi, 530021, China
The First People's Hospital of Yulin
Yulin, Guangxi, 537000, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Anyang People's Hospital
Anyang, Henan, 455000, China
Jiaozuo Second People's Hospital
Jiaozuo, Henan, 454000, China
Nanyang First People's Hospital
Nanyang, Henan, 473000, China
Nanyang Second People's Hospital
Nanyang, Henan, 473000, China
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000, China
Xinxiang First People's Hospital
Xinxiang, Henan, 453000, China
Yichang Central People's Hospital
Yichang, Hubei, 443000, China
Loudi Central Hospital
Loudi, Hunan, 417000, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010030, China
The First People's Hospital of Lianyungang City
Lianyungang, Jiangsu, 222061, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Yangzhou University Affiliated Hospital
Yangzhou, Jiangsu, 225012, China
Jiu Jiang NO.1 People's Hospital
Jiujiang, Jiangxi, 332000, China
People's Hospital of Pingxiang City
Pingxiang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
LiaoCheng People's Hospital
Liaocheng, Shandong, 252000, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266000, China
The Second People's Hospital of Weifang
Weifang, Shandong, 261041, China
Zibo Municipal Hospital
Zibo, Shandong, 255499, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
The Third People's Hospital of Chengdu City
Chengdu, Sichuan, 610031, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130, China
Mianyang central hospital
Mianyang, Sichuan, 621099, China
Suining Central Hospital
Suining, Sichuan, 629000, China
Zigong First People's Hospital Zigong Academy of Medicalsciences
Zigong, Sichuan, 643000, China
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325035, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 11, 2026
Study Start
March 6, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
August 30, 2028
Last Updated
April 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share