Phase II Trial of RC1416 Injection in Asthma

February 4, 2026 updated by: Nanjing RegeneCore Biotech Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

195

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Suzhou, Anhui, China, 234000
        • Wanbei Coal-Electricity Group General Hospital
        • Contact:
          • Jiang Hui
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • China-Japan Friendship Hospital
        • Contact:
          • Yang Ting
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Gansu Provincial People's Hospital
        • Contact:
          • Zhang Hong
    • Guangdong
      • Qingyuan, Guangdong, China, 511518
        • Qingyuan People's Hospital
        • Contact:
          • Tian Dong Bo
    • Guangxi
      • Liuchow, Guangxi, China, 545005
        • Liuzhou Workers' Hospital
        • Contact:
          • Ming Mo Yu
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • The Third Hospital of Hebei Medical University
        • Contact:
          • Zhao Yun Xia
      • Tangshan, Hebei, China, 063000
        • The Affiliated Hospital of North China University of Science and Technology
        • Contact:
          • Yu Chang Li
      • Xingtai, Hebei, China, 054001
        • Xingtai People's Hospital
        • Contact:
          • Gao Zhi Guo
      • Zhangjiakou, Hebei, China, 075000
        • The First Affiliated Hospital of Hebei North University
        • Contact:
          • Liu Jian Hua
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Daqing Oilfield General Hospital
        • Contact:
          • Li Li
      • Harbin, Heilongjiang, China, 150001
        • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
        • Contact:
          • Yang Shan Jun
      • Qiqihar, Heilongjiang, China, 161000
        • The Third Affiliated Hospital of Qiqihar Medical University
        • Contact:
          • jiang Yun Fei
    • Henan
      • Anyang, Henan, China, 455000
        • Anyang People's Hospital
        • Contact:
          • Jia Ming Yong
      • Kaifeng, Henan, China, 475000
        • The First Affiliated Hospital of Henan University
        • Contact:
          • Huang Zhi Ang
      • Sanmenxia, Henan, China, 472000
        • Sanmenxia Central Hospital
        • Contact:
          • Liu Kuan
      • Xinxiang, Henan, China, 453000
        • Xinxiang First People's Hospital
        • Contact:
          • Li Rong Kai
    • Hubei
      • Yichang, Hubei, China, 443003
        • Yichang Central People's Hospital
        • Contact:
          • Xiong Xiao Qi
    • Hunan
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People's Hospital
        • Contact:
          • Liu Nian
    • Jiangsu
      • Nanjing, Jiangsu, China, 211100
        • Nanjing Jiangning Hospital
        • Contact:
          • Zhang Xiu Wei
      • Xuzhou, Jiangsu, China, 221002
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Zhang Wen Hui
      • Yangzhou, Jiangsu, China, 225001
        • Yangzhou First People's Hospital
        • Contact:
          • Wu Feng
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Ganzhou People's Hospital
        • Contact:
          • Xu Yu Hui
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Zuo Wei
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
        • Contact:
          • Guo Li Ping
      • Jilin, Jilin, China, 132011
        • Jilin Central Hospital
        • Contact:
          • Wang Yu Hong
      • Tonghua, Jilin, China, 134001
        • Tonghua Central Hospital
        • Contact:
          • Jin Guo Yan
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University
        • Contact:
          • Zhao Li
    • Ningxia
      • Yinchuan, Ningxia, China, 750002
        • Ningxia Hui Autonomous Region People's Hospital
        • Contact:
          • Zhuan Bing
    • Shaanxi
      • Xi'an, Shaanxi, China, 710100
        • Xi'an International Medical Center Hospital
        • Contact:
          • Fu En Qing
    • Shandong
      • Heze, Shandong, China, 274031
        • Heze Municipal Hospital
        • Contact:
          • Liu Xun Chao
      • Jinan, Shandong, China, 250022
        • Qilu Second Hospital of Shandong University
        • Contact:
          • Xu Shao Hua
      • Jining, Shandong, China, 272029
        • The Affiliated Hospital of Jining Medical University
        • Contact:
          • jiang Bo
      • Qingdao, Shandong, China, 266011
        • Qingdao Municipal Hospital
        • Contact:
          • Han Wei
      • Weifang, Shandong, China, 261041
        • Weifang Second People's Hospital
        • Contact:
          • Yang Guo Ru
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hospital
        • Contact:
          • Zou Shen Chun
      • Zibo, Shandong, China, 255036
        • Zibo Central Hospital
        • Contact:
          • Yin Xin Da
      • Zibo, Shandong, China, 255400
        • Zibo Linzi District People's Hospital
        • Contact:
          • Suo Li Jun
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Shanghai Pulmonary Hospital (Tongji University Affiliated Shanghai Pulmonary Hospital)
        • Contact:
          • Guo Jian
    • Shanxi
      • Yuncheng, Shanxi, China, 044000
        • Yuncheng Central hospital
        • Contact:
          • Zhang Hai Xia
    • Sichuan
      • Chengdu, Sichuan, China, 610031
        • Chengdu Third People's Hospital
        • Contact:
          • Li Guo Ping
      • Chengdu, Sichuan, China, 611130
        • Chengdu Fifth People's Hospital
        • Contact:
          • Liu Xiao
      • Mianyang, Sichuan, China, 621000
        • Mianyang Central Hospital
        • Contact:
          • Xu Wei Guo
      • Panzhihua, Sichuan, China, 617000
        • Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
        • Contact:
          • Hu Qiang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300192
        • Tianjin First Central Hospital
        • Contact:
          • Jiang Ping
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Wu Li Qin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 month 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RC1416
Drug: RC1416
There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
Placebo Comparator: RC1416 Placebo
Drug: RC1416 Placebo
Each subjects will receive the placebo by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1)
Time Frame: During 32 weeks
Mean change from baseline in Pre-BD forced expiratory volume in 1 Second (FEV1)
During 32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe asthma exacerbation
Time Frame: During 32 weeks
Severe asthma exacerbation events, Time to the first asthma exacerbation
During 32 weeks
Pre-BD FEV1
Time Frame: During 32 weeks
During 32 weeks
Morning and evening peak expiratory flow (PEF)
Time Frame: During 32 weeks
Mean change from baseline of absolute value and percentage
During 32 weeks
forced vital capacity (FVC)
Time Frame: During 32 weeks
Mean change from baseline of absolute value and percentage
During 32 weeks
Forced mid-expiratory flow (FEF25-75%) before bronchodilator (BD)
Time Frame: During 32 weeks
Mean change from baseline of absolute value and percentage
During 32 weeks
Asthma loss of control (LOAC)
Time Frame: During 32 weeks
Asthma loss of control (LOAC) events, Time to the first Asthma loss of control
During 32 weeks
Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit
Time Frame: During 32 weeks
Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit events
During 32 weeks
Asthma Control Questionnaire-6 (ACQ-6) score
Time Frame: During 32 weeks
Mean change Mean change from baseline. The proportion of trial participants with a reduction of ≥0.5 points from baseline
During 32 weeks
Asthma Quality of Life Questionnaire (AQLQ-S) score
Time Frame: During 32 weeks
Mean change from baseline
During 32 weeks
weekly Asthma Symptom Diary (ASD) score
Time Frame: During 32 weeks
Mean change in mean weekly from baseline
During 32 weeks
Rescue medication
Time Frame: During 32 weeks
Mean change in mean weekly from baseline
During 32 weeks
Adverse Events
Time Frame: During 32 weeks
During 32 weeks
Pharmacokinetics
Time Frame: During 32 weeks
trough concentration
During 32 weeks
Pharmacodynamics
Time Frame: During 32 weeks
mean changes of Pharmacodynamic Parameter from baseline
During 32 weeks
Anti-Drug antibody
Time Frame: During 32 weeks
number and percentage of subjects tested ADA positive
During 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing RegeneCore Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2026

Primary Completion (Estimated)

October 25, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • RJK-RC1416-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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