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Moderate to Severe AsthmaPhase 2NCT07403487

Phase II Trial of RC1416 Injection in Asthma

A Phase 2 study testing RC1416 in people with Moderate to Severe Asthma, run by Nanjing RegeneCore Biotech Co., Ltd. at 44 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a phase II study of RC1416 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of RC1416 in subjects with severe uncontrolled asthma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Moderate to Severe Asthma
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
195 participants
Where
44 sitesChina
Study dates
10 Mar 2026to 28 Feb 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

44 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Guo Qian contact

+86-025-58608860

guoqian@regenecore.com

44 sites in 1 country

China44 sites, 44 recruiting

  • Anqiing Municipal Hospital

    Anqing, Anhui, 246004

    0556-5223968

    Not yet recruiting

  • Anyang People's Hospital

    Anyang, Henan, 455000

    Jia Ming Yong

    Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    Yang Ting

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Guo Li Ping

    Recruiting

  • Chengdu Third People's Hospital

    Chengdu, Sichuan, 610031

    Li Guo Ping

    Recruiting

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan, 611130

    Liu Xiao

    Recruiting

  • The Affiliated Yongchuan Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 402160

    Zhang tie feng, 023-85382120

    Recruiting

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163001

    Li Li

    Recruiting

  • Affiliated Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

    Wang li ming, 0571-56005600

    Recruiting

  • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang, 150001

    Yang Shan Jun

    Recruiting

  • Heze Municipal Hospital

    Heze, Shandong, 274031

    Liu Xun Chao

    Recruiting

  • Huhhot First Hospital

    Hohhot, Inner Mongolia, 010020

    Song fei fang, 0471-5281222

    Not yet recruiting

  • The Affiliated Hospital of Inner Mongolia

    Hohhot, Inner Mongolia, 010030

    Gao jun zhen, 0471-3451027

    Not yet recruiting

  • Jilin Central Hospital

    Jilin City, Jilin, 132011

    Wang Yu Hong

    Recruiting

  • Qilu Second Hospital of Shandong University

    Jinan, Shandong, 250022

    Xu Shao Hua

    Recruiting

  • The Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272029

    jiang Bo

    Recruiting

  • The First Affiliated Hospital of Henan University

    Kaifeng, Henan, 475000

    Huang Zhi Ang

    Recruiting

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu, 730000

    Zhang Hong

    Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

    Xu Wei Guo

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Zuo Wei

    Recruiting

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 211100

    Zhang Xiu Wei

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

    Ma hong ying, 0574-87085588

    Recruiting

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011

    Han Wei

    Recruiting

  • The Third Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang, 161000

    jiang Yun Fei

    Recruiting

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472000

    Liu Kuan

    Recruiting

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

    Shanghai, Shanghai Municipality, 200433

    Guo Jian

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Zhao Li

    Recruiting

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110031

    Gu xiiu, 024-31365555

    Recruiting

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

    Zhao Yun Xia

    Recruiting

  • Wanbei Coal-Electricity Group General Hospital

    Suzhou, Anhui, 234000

    Jiang Hui

    Recruiting

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

    Tangshan, Hebei, 063000

    Yu Chang Li

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325027

    Wu Li Qin

    Recruiting

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi, 710100

    Fu En Qing

    Recruiting

  • Xingtai People's Hospital

    Xingtai, Hebei, 054001

    Gao Zhi Guo

    Recruiting

  • Xinxiang First People's Hospital

    Xinxiang, Henan, 453000

    Li Rong Kai

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

    Zhang Wen Hui

    Recruiting

  • Xuzhou Mining Group General Hospital

    Xuzhou, Jiangsu, 221006

    Zhao jie, 0516-85326063

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

    Wu yan min, 0516-83956108

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

    Zou Shen Chun

    Recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

    Xiong Xiao Qi

    Recruiting

  • Ningxia Hui Autonomous Region People's Hospital

    Yinchuan, Ningxia, 750002

    Zhuan Bing

    Recruiting

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

    Zhang Hai Xia

    Recruiting

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei, 075000

    Liu Jian Hua

    Recruiting

  • Zibo Central Hospital

    Zibo, Shandong, 255036

    Yin Xin Da

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of RC1416 Injection in Adult Patients With Moderate to Severe Asthma

This study is a phase II study of RC1416 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of RC1416 in subjects with severe uncontrolled asthma.

Read the detailed description

RC1416 is a bispecific homodimer nanobody .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 195 severe uncontrolled asthma subjects will be enrolled in three groups to access the efficacy and safety of RC1416.

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 groups in NCT07403487
Study groupRoleWhat they receive
RC1416ExperimentalNot described
Receives: Drug: RC1416
RC1416 PlaceboPlacebo comparatorNot described
Receives: Drug: RC1416 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)

    Mean change from baseline in Pre-BD forced expiratory volume in 1 Second (FEV1)

    Measured: During 32 weeks

Secondary outcomes (15)

  1. Severe asthma exacerbation

    Severe asthma exacerbation events, Time to the first asthma exacerbation

    Measured: During 32 weeks

  2. Pre-BD FEV1

    Measured: During 32 weeks

  3. Morning and evening peak expiratory flow (PEF)

    Mean change from baseline of absolute value and percentage

    Measured: During 32 weeks

  4. forced vital capacity (FVC)

    Mean change from baseline of absolute value and percentage

    Measured: During 32 weeks

  5. Forced mid-expiratory flow (FEF25-75%) before bronchodilator (BD)

    Mean change from baseline of absolute value and percentage

    Measured: During 32 weeks

  6. Asthma loss of control (LOAC)

    Asthma loss of control (LOAC) events, Time to the first Asthma loss of control

    Measured: During 32 weeks

  7. Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit

    Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit events

    Measured: During 32 weeks

  8. Asthma Control Questionnaire-6 (ACQ-6) score

    Mean change Mean change from baseline. The proportion of trial participants with a reduction of ≥0.5 points from baseline

    Measured: During 32 weeks

  9. Asthma Quality of Life Questionnaire (AQLQ-S) score

    Mean change from baseline

    Measured: During 32 weeks

  10. weekly Asthma Symptom Diary (ASD) score

    Mean change in mean weekly from baseline

    Measured: During 32 weeks

  11. Rescue medication

    Mean change in mean weekly from baseline

    Measured: During 32 weeks

  12. Adverse Events

    Measured: During 32 weeks

  13. Pharmacokinetics

    trough concentration

    Measured: During 32 weeks

  14. Pharmacodynamics

    mean changes of Pharmacodynamic Parameter from baseline

    Measured: During 32 weeks

  15. Anti-Drug antibody

    number and percentage of subjects tested ADA positive

    Measured: During 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start10 Mar 2026
  3. Primary completion25 Oct 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
195 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07403487
Sponsor's protocol ID
RJK-RC1416-103
Status last verified
Sep 2026
First submitted
27 Jan 2026
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC1416 in people with Moderate to Severe Asthma, run by Nanjing RegeneCore Biotech Co., Ltd. at 44 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 7 inclusion and 12 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 10 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 44 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 Guo Qian (+86-025-58608860, guoqian@regenecore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1) (time frame: During 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07403487.

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 10 Sep 2026.

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