Phase II Trial of RC1416 Injection in Asthma
Recruiting · NCT07403487 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
RC1416RC1416 Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
44 locations listed.
- Anqiing Municipal Hospital - Anqing, Anhui, China
- Wanbei Coal-Electricity Group General Hospital - Suzhou, Anhui, China
- China-Japan Friendship Hospital - Beijing, Beijing Municipality, China
- The Affiliated Yongchuan Hospital of Chongqing Medical University - Chongqing, Chongqing Municipality, China
- Gansu Provincial People's Hospital - Lanzhou, Gansu, China
- The Third Hospital of Hebei Medical University - Shijiazhuang, Hebei, China
- The Affiliated Hospital of North China University of Science and Technology - Tangshan, Hebei, China
- Xingtai People's Hospital - Xingtai, Hebei, China
- The First Affiliated Hospital of Hebei North University - Zhangjiakou, Hebei, China
- Daqing Oilfield General Hospital - Daqing, Heilongjiang, China
- The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine - Harbin, Heilongjiang, China
- The Third Affiliated Hospital of Qiqihar Medical University - Qiqihar, Heilongjiang, China
- Anyang People's Hospital - Anyang, Henan, China
- The First Affiliated Hospital of Henan University - Kaifeng, Henan, China
- Sanmenxia Central Hospital - Sanmenxia, Henan, China
- Xinxiang First People's Hospital - Xinxiang, Henan, China
- Yichang Central People's Hospital - Yichang, Hubei, China
- Huhhot First Hospital - Hohhot, Inner Mongolia, China
- The Affiliated Hospital of Inner Mongolia - Hohhot, Inner Mongolia, China
- Nanjing Jiangning Hospital - Nanjing, Jiangsu, China
- The Affiliated Hospital of Xuzhou Medical University - Xuzhou, Jiangsu, China
- Xuzhou Mining Group General Hospital - Xuzhou, Jiangsu, China
- Xuzhou Central Hospital - Xuzhou, Jiangsu, China
- The First Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, China
- The First Hospital of Jilin University - Changchun, Jilin, China
- Jilin Central Hospital - Jilin City, Jilin, China
- Shengjing Hospital of China Medical University - Shenyang, Liaoning, China
- The Fourth Affiliated Hospital of China Medical University - Shenyang, Liaoning, China
- Ningxia Hui Autonomous Region People's Hospital - Yinchuan, Ningxia, China
- Xi'an International Medical Center Hospital - Xi'an, Shaanxi, China
- Heze Municipal Hospital - Heze, Shandong, China
- Qilu Second Hospital of Shandong University - Jinan, Shandong, China
- The Affiliated Hospital of Jining Medical University - Jining, Shandong, China
- Qingdao Municipal Hospital - Qingdao, Shandong, China
- Yantai Yuhuangding Hospital - Yantai, Shandong, China
- Zibo Central Hospital - Zibo, Shandong, China
- Shanghai Pulmonary Hospital (Tongji University Affiliated Shanghai Pulmonary Hospital) - Shanghai, Shanghai Municipality, China
- Yuncheng Central Hospital - Yuncheng, Shanxi, China
- Chengdu Third People's Hospital - Chengdu, Sichuan, China
- Chengdu Fifth People's Hospital - Chengdu, Sichuan, China
- Mianyang Central Hospital - Mianyang, Sichuan, China
- Affiliated Hangzhou First People's Hospital - Hangzhou, Zhejiang, China
- The First Affiliated Hospital of Ningbo University - Ningbo, Zhejiang, China
- The Second Affiliated Hospital of Wenzhou Medical University - Wenzhou, Zhejiang, China