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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
195
There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
Each subjects will receive the placebo by subcutaneous injection
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)
Time frame: During 32 weeks
Severe asthma exacerbation
Severe asthma exacerbation events, Time to the first asthma exacerbation
Time frame: During 32 weeks
Pre-BD FEV1
Time frame: During 32 weeks
Morning and evening peak expiratory flow (PEF)
Mean change from baseline of absolute value and percentage
Time frame: During 32 weeks
forced vital capacity (FVC)
Mean change from baseline of absolute value and percentage
Time frame: During 32 weeks
Forced mid-expiratory flow (FEF25-75%) before bronchodilator (BD)
Mean change from baseline of absolute value and percentage
Time frame: During 32 weeks
Asthma loss of control (LOAC)
Asthma loss of control (LOAC) events, Time to the first Asthma loss of control
Time frame: During 32 weeks
Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit
Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit events
Time frame: During 32 weeks
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Anqiing Municipal Hospital
Anqing, Anhui, China
NOT_YET_RECRUITINGWanbei Coal-Electricity Group General Hospital
Suzhou, Anhui, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Affiliated Yongchuan Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGGansu Provincial People's Hospital
Lanzhou, Gansu, China
RECRUITINGThe Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei, China
RECRUITINGXingtai People's Hospital
Xingtai, Hebei, China
RECRUITINGThe First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, China
RECRUITINGDaqing Oilfield General Hospital
Daqing, Heilongjiang, China
RECRUITING...and 34 more locations
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
Time frame: During 32 weeks
Asthma Quality of Life Questionnaire (AQLQ-S) score
Mean change from baseline
Time frame: During 32 weeks
weekly Asthma Symptom Diary (ASD) score
Mean change in mean weekly from baseline
Time frame: During 32 weeks
Rescue medication
Mean change in mean weekly from baseline
Time frame: During 32 weeks
Adverse Events
Time frame: During 32 weeks
Pharmacokinetics
trough concentration
Time frame: During 32 weeks
Pharmacodynamics
mean changes of Pharmacodynamic Parameter from baseline
Time frame: During 32 weeks
Anti-Drug antibody
number and percentage of subjects tested ADA positive
Time frame: During 32 weeks