Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New asthma shot aims to help patients breathe easier

NCT ID NCT07403487

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This Phase 2 trial tests an injectable drug called RC1416 in 195 adults with moderate to severe asthma that is not well controlled. Participants will receive either the drug or a placebo by injection. The study will measure changes in lung function and track asthma attacks over time to see if RC1416 is safe and effective.

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 offer a new treatment option to better control moderate to severe asthma and reduce flare-ups.
What could go wrong
This is an early Phase 2 trial with only 195 participants, so results may not confirm effectiveness. The drug may cause side effects or fail to improve asthma control.

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 195 people

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

Started

Mar 2026

Expected to finish

Feb 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

18 to 75 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: * Male or female aged 18 and 75 years. * Diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of the 2024 GINA guidelines. * Have received medium-to-high dose ICS therapy for at least 3 consecutive months prior to screening, and maintained a stable treatment regimen and dose for ≥1 month prior to baseline. * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) measurement ≤80% of the predicted normal value at both the screening and baseline visits. * Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5 at both the screening and baseline visits. * Must have experienced ≥1 severe asthma exacerbation event within the 12 months prior to screening. * Positive bronchodilator reversibility test. Exclusion Criteria: * Individuals with a known history of allergy to the investigational product or its excipients. * Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function . * Experienced a severe asthma exacerbation event from within 1 month prior to screening until before dosing. * Used systemic corticosteroids within 1 week prior to screening. * Had a pulmonary or other site infection requiring intravenous antibiotics, antifungals, or antivirals from within 1 month prior to screening until before dosing. * Used traditional Chinese medicine with anti-asthmatic effects within 1 month prior to screening. * Underwent major surgery within 8 weeks prior to screening or plans to undergo major surgery during the study period. * With a history of malignancy within the past 5 years . * Active or incompletely treated tuberculosis * Used biologic/systemic immunosuppressant/immunomodulators within 12 weeks or 5 half-lives prior to screening. * Diagnosed active parasitic infection; suspected parasitic infection or high risk of infection. * Abnormal 12-lead electrocardiogram (ECG) at screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Moderate to severe asthma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

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

Moderate to severe asthma

How to take part

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

  1. The places running it

    44 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 Hangzhou First People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • Anqiing Municipal Hospital

    NOT_YET_RECRUITING

    Anqing, Anhui, 246004, China

  • Anyang People's Hospital

    RECRUITING

    Anyang, Henan, 455000, China

  • Chengdu Fifth People's Hospital

    RECRUITING

    Chengdu, Sichuan, 611130, China

  • Chengdu Third People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610031, China

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • Daqing Oilfield General Hospital

    RECRUITING

    Daqing, Heilongjiang, 163001, China

  • Gansu Provincial People's Hospital

    RECRUITING

    Lanzhou, Gansu, 730000, China

  • Heze Municipal Hospital

    RECRUITING

    Heze, Shandong, 274031, China

  • Huhhot First Hospital

    NOT_YET_RECRUITING

    Hohhot, Inner Mongolia, 010020, China

  • Jilin Central Hospital

    RECRUITING

    Jilin City, Jilin, 132011, China

  • Mianyang Central Hospital

    RECRUITING

    Mianyang, Sichuan, 621000, China

  • Nanjing Jiangning Hospital

    RECRUITING

    Nanjing, Jiangsu, 211100, China

  • Ningxia Hui Autonomous Region People's Hospital

    RECRUITING

    Yinchuan, Ningxia, 750002, China

  • Qilu Second Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250022, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, 266011, China

  • Sanmenxia Central Hospital

    RECRUITING

    Sanmenxia, Henan, 472000, China

  • Shanghai Pulmonary Hospital (Tongji University Affiliated Shanghai Pulmonary Hospital)

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110004, China

  • The Affiliated Hospital of Inner Mongolia

    NOT_YET_RECRUITING

    Hohhot, Inner Mongolia, 010030, China

  • The Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, Shandong, 272029, China

  • The Affiliated Hospital of North China University of Science and Technology

    RECRUITING

    Tangshan, Hebei, 063000, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, 221002, China

  • The Affiliated Yongchuan Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 402160, China

  • The First Affiliated Hospital of Hebei North University

    RECRUITING

    Zhangjiakou, Hebei, 075000, China

  • The First Affiliated Hospital of Henan University

    RECRUITING

    Kaifeng, Henan, 475000, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315010, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • The Fourth Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110031, China

  • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

    RECRUITING

    Harbin, Heilongjiang, 150001, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325027, China

  • The Third Affiliated Hospital of Qiqihar Medical University

    RECRUITING

    Qiqihar, Heilongjiang, 161000, China

  • The Third Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050051, China

  • Wanbei Coal-Electricity Group General Hospital

    RECRUITING

    Suzhou, Anhui, 234000, China

  • Xi'an International Medical Center Hospital

    RECRUITING

    Xi'an, Shaanxi, 710100, China

  • Xingtai People's Hospital

    RECRUITING

    Xingtai, Hebei, 054001, China

  • Xinxiang First People's Hospital

    RECRUITING

    Xinxiang, Henan, 453000, China

  • Xuzhou Central Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221009, China

  • Xuzhou Mining Group General Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221006, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, 264000, China

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, Hubei, 443003, China

  • Yuncheng Central Hospital

    RECRUITING

    Yuncheng, Shanxi, 044000, China

  • Zibo Central Hospital

    RECRUITING

    Zibo, Shandong, 255036, China

More trials for these conditions

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