Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT07402551
Phase II Study of RC1416 Injection in COPD
A Phase 2 study testing RC1416 in people with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), run by Nanjing RegeneCore Biotech Co., Ltd. at 46 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- RC1416
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 46 sitesChina
- Study dates
- 6 Mar 2026to 30 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
46 sites in 1 country. Contact the study team or a site near you to ask about taking part.
46 sites in 1 country
China46 sites, 46 recruiting
- Recruiting
Anyang People's Hospital
Anyang, Henan, 455000
Mingyong Jia
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Ke Wang
- Recruiting
The Third People's Hospital of Chengdu City
Chengdu, Sichuan, 610031
Guoping Li
- Not yet recruiting
The First People's Hospital of Shuangliu District, Chengdu
Chengdu, Sichuan, 610200
Hu xiao rong, 028-85773618, 382606543@qq.com
- Recruiting
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
Xiao Liu
- Recruiting
Yongchuan Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, 402160
Zhang tie feng, 023-85389013, ychll2024@foxmail.com
- Recruiting
The Affiliated Bishan Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 402760
Rui Han
- Recruiting
The first affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, 510000
Nanshan Zhong
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510000
Shenming Liu
- Recruiting
The first affiliated hospital of guangzhou medical university
Guangzhou, Guangdong
Yuming Zhou
- Not yet recruiting
The First People's Hospital of Hangzhou (Westlake University Affiliated The First People's Hospital of Hangzhou)
Hangzhou, Zhejiang, 310006
wang li ming
- Recruiting
Anhui Provincial Chest Hospital
Hefei, Anhui, 230031
Haohui Fang
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010030
Lihong Wang
- Recruiting
Huizhou Third People's Hospital
Huizhou, Guangdong, 516002
Feng Wu
- Recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Yanming Huang
- Recruiting
Jiaozuo Second People's Hospital
Jiaozuo, Henan, 454000
Xinqu Xu
- Recruiting
Jiu Jiang NO.1 People's Hospital
Jiujiang, Jiangxi, 332000
Jun Li
- Recruiting
The First People's Hospital of Lianyungang City
Lianyungang, Jiangsu, 222061
Jiashu Li
- Recruiting
LiaoCheng People's Hospital
Liaocheng, Shandong, 252000
Yan Wang
- Recruiting
Loudi Central Hospital
Loudi, Hunan, 417000
Lixuan Chen
- Recruiting
Mianyang central hospital
Mianyang, Sichuan, 621099
Weiguo Xu
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Surong Fang
- Recruiting
The First Affiliated Hospital of guangxi Medical University
Nanning, Guangxi, 530021
Zhiyi He
- Recruiting
Nanyang First People's Hospital
Nanyang, Henan, 473000
Qun Ma
- Recruiting
Nanyang Second People's Hospital
Nanyang, Henan, 473000
Fengling, Ju
- Recruiting
People's Hospital of Pingxiang City
Pingxiang, Jiangxi
Haibo Shen
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266000
Yi Su
- Recruiting
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Qingyuan, Guangdong, 511518
Dongbo Tian
- Recruiting
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000
Kuan Liu
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Haiwen Lu
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Li Zhao
- Recruiting
Suining Central Hospital
Suining, Sichuan, 629000
Rong Qiu
- Recruiting
Wan Bei General Hospital of Wanbei Coal power Group
Suzhou, Anhui, 234000
Hui Jiang
- Recruiting
The Second People's Hospital of Weifang
Weifang, Shandong, 261041
Guoru Yang
- Recruiting
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325035
Liqin Wu
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
Yanping Du
- Recruiting
Xinxiang First People's Hospital
Xinxiang, Henan, 453000
Xiangjie Zhang
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Yanmin Wu
- Not yet recruiting
Suining County People's Hospital
Xuzhou, Jiangsu, 221200
Chen Bi, 0516-81302114, yxll_snry@163.com
- Recruiting
Yangzhou University Affiliated Hospital
Yangzhou, Jiangsu, 225012
Feng Wu
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443000
Xiaoqi Xiong
- Recruiting
The First People's Hospital of Yulin
Yulin, Guangxi, 537000
Linling Zhu
- Not yet recruiting
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277102
Sun li, 0632-3288020, zzslgcpll@163.com
- Recruiting
Zibo Municipal Hospital
Zibo, Shandong, 255499
Lijun Suo
- Recruiting
Zigong First People's Hospital Zigong Academy of Medicalsciences
Zigong, Sichuan, 643000
Zhiping Deng
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Yuanbo Lan
About this study
Official title: 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).
Read the 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.
- Being tested
- RC1416, RC1416 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC1416Drug
There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
RC1416 PlaceboDrug
Each subjects will receive the placebo by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| RC1416 Injection | Experimental | Not described Receives: Drug: RC1416 |
| Placebo Control | Placebo comparator | Not described Receives: Drug: RC1416 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During 52 weeks
Secondary outcomes (4)
The safety and tolerability
Adverse events, laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examinations.
Measured: During 52 weeks
pharmacokinetic
Css, DF, Tmax.
Measured: During 52 weeks
immunogenicity
ADA positivity rate and titer, and NAb positivity rate.
Measured: During 52 weeks
biomarkers predictive of the efficacy
FeNO, total IgE, eosinophil count, and TARC levels.
Measured: During 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start6 Mar 2026
- Primary completion31 May 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing RegeneCore Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402551
- Sponsor's protocol ID
- RJK-RC1416-301
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07402551
- Acronym / sponsor ID
- RJK-RC1416-301
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nanjing RegeneCore Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC1416 Injection | Experimental | Drug: RC1416 |
| Placebo Control | Placebo comparator | Drug: RC1416 Placebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC1416There are two doses in this part. Each subjects will receive the drug by subcutaneous injection. | Drug | RC1416 Injection |
| RC1416 PlaceboEach subjects will receive the placebo by subcutaneous injection. | Drug | Placebo Control |
Primary outcome
moderate or severe COPD exacerbations (AECOPD) and forced expiratory volume in 1 Second (FEV1)
Time frame: During 52 weeks
Evaluate the annualized rate of AECOPD and the change in FEV1 from baseline
4 secondary outcomes
The safety and tolerability
Time frame: During 52 weeks
pharmacokinetic
Time frame: During 52 weeks
immunogenicity
Time frame: During 52 weeks
biomarkers predictive of the efficacy
Time frame: During 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RC1416 in people with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), run by Nanjing RegeneCore Biotech Co., Ltd. at 46 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yumin Zhou, MD (+86-13826190798, zhouyumin410@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
moderate or severe COPD exacerbations (AECOPD) and forced expiratory volume in 1 Second (FEV1) (time frame: During 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.