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New shot aims to cut COPD attacks in half?

NCT ID NCT07402551

Disease control Sponsor: Nanjing RegeneCore Biotech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This Phase 2 trial tests an injection called RC1416 in 180 people with moderate to severe COPD. Participants will receive either the drug or a placebo to see if it reduces serious flare-ups and improves lung function over time. The study is double-blind, meaning neither patients nor doctors know who gets the real drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RC1416 injection
What this could lead to
If successful, RC1416 could become a new treatment option to reduce COPD exacerbations and help patients breathe better.
What could go wrong
This is an early Phase 2 trial with only 180 participants, so results may not apply to everyone. The drug may not work better than placebo or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate to severe chronic obstructive pulmonary disease (COPD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    46 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical University

    RECRUITING

    Zunyi, Guizhou, 563000, China

  • Anhui Provincial Chest Hospital

    RECRUITING

    Hefei, Anhui, 230031, China

  • Anyang People's Hospital

    RECRUITING

    Anyang, Henan, 455000, China

  • Chengdu Fifth People's Hospital

    RECRUITING

    Chengdu, Sichuan, 611130, China

  • Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)

    RECRUITING

    Qingyuan, Guangdong, 511518, China

  • Huizhou Third People's Hospital

    RECRUITING

    Huizhou, Guangdong, 516002, China

  • Jiangmen Central Hospital

    RECRUITING

    Jiangmen, Guangdong, 529000, China

  • Jiaozuo Second People's Hospital

    RECRUITING

    Jiaozuo, Henan, 454000, China

  • Jiu Jiang NO.1 People's Hospital

    RECRUITING

    Jiujiang, Jiangxi, 332000, China

  • LiaoCheng People's Hospital

    RECRUITING

    Liaocheng, Shandong, 252000, China

  • Loudi Central Hospital

    RECRUITING

    Loudi, Hunan, 417000, China

  • Mianyang central hospital

    RECRUITING

    Mianyang, Sichuan, 621099, China

  • Nanjing First Hospital

    RECRUITING

    Nanjing, Jiangsu, 210006, China

  • Nanyang First People's Hospital

    RECRUITING

    Nanyang, Henan, 473000, China

  • Nanyang Second People's Hospital

    RECRUITING

    Nanyang, Henan, 473000, China

  • People's Hospital of Pingxiang City

    RECRUITING

    Pingxiang, Jiangxi, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, 266000, China

  • Sanmenxia Central Hospital

    RECRUITING

    Sanmenxia, Henan, 472000, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110004, China

  • Suining Central Hospital

    RECRUITING

    Suining, Sichuan, 629000, China

  • Suining County People's Hospital

    NOT_YET_RECRUITING

    Xuzhou, Jiangsu, 221200, China

  • The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

    RECRUITING

    Wenzhou, Zhejiang, 325035, China

  • The Affiliated Bishan Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 402760, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    RECRUITING

    Hohhot, Inner Mongolia, 010030, China

  • The First Affiliated Hospital of Jinan University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • The First Affiliated Hospital of guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The First People's Hospital of Hangzhou (Westlake University Affiliated The First People's Hospital of Hangzhou)

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • The First People's Hospital of Lianyungang City

    RECRUITING

    Lianyungang, Jiangsu, 222061, China

  • The First People's Hospital of Shuangliu District, Chengdu

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610200, China

  • The First People's Hospital of Yulin

    RECRUITING

    Yulin, Guangxi, 537000, China

  • The Second Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130041, China

  • The Second People's Hospital of Weifang

    RECRUITING

    Weifang, Shandong, 261041, China

  • The Third People's Hospital of Chengdu City

    RECRUITING

    Chengdu, Sichuan, 610031, China

  • The first affiliated hospital of guangzhou medical university

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • The first affiliated hospital of guangzhou medical university

    RECRUITING

    Guangzhou, Guangdong, China

  • Wan Bei General Hospital of Wanbei Coal power Group

    RECRUITING

    Suzhou, Anhui, 234000, China

  • Xinxiang First People's Hospital

    RECRUITING

    Xinxiang, Henan, 453000, China

  • Xuzhou Central Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221009, China

  • Yangzhou University Affiliated Hospital

    RECRUITING

    Yangzhou, Jiangsu, 225012, China

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, Hubei, 443000, China

  • Yongchuan Hospital Affiliated to Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 402160, China

  • Zaozhuang Municipal Hospital

    NOT_YET_RECRUITING

    Zaozhuang, Shandong, 277102, China

  • Zhongshan Hospital Xiamen University

    RECRUITING

    Xiamen, Fujian, 361004, China

  • Zibo Municipal Hospital

    RECRUITING

    Zibo, Shandong, 255499, China

  • Zigong First People's Hospital Zigong Academy of Medicalsciences

    RECRUITING

    Zigong, Sichuan, 643000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.