This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
GR1802 will be administered SC.
GR1802 will be administered SC.
The placebo will be administered SC.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGChange from baseline in pre-bronchodilator FEV1 (forced expiratory volume in 1 second) at 12 weeks.
Absolute change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of GR1802 treatment compared with placebo.
Time frame: 12weeks
Change from baseline in pre-bronchodilator FEV1 at 24 weeks.
Absolute change from baseline in pre-bronchodilator FEV1 at e24 weeks.
Time frame: 24weeks
Percent change from baseline in pre-bronchodilator FEV1 at 12 and 24 weeks.
Percent change from baseline in pre-bronchodilator FEV1 at 12 and 24 weeks.
Time frame: 12weeks and 24weeks
Annualized rate of subjects experiencing severe asthma exacerbations.
Annualized rate of subjects experiencing severe asthma exacerbations during the 24-week randomized treatment and throughout the trial period.
Time frame: 24weeks and 32weeks
Time to the first onset of the severe asthma exacerbation event.
Time from baseline to the first onset of the severe asthma exacerbation event.
Time frame: 32weeks
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC).
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) during the 24-week randomized treatment and throughout the trial period.
Time frame: 24weeks and 32weeks
Time to the onset of the first event of LOAC.
Time from baseline to the onset of the first event of LOAC.
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Time frame: 32weeks
Change from baseline in other lung function measures.
Changes from baseline in FEV1 percentage of predicted value (FEV1% Pred) and Peak diurnal and nocturnal expiratory flow (PEF)
Time frame: 24weeks
Changes from baseline in the Asthma Control Questionnaire-5 (ACQ-5)score and ACQ-7 score at each evaluation time point.
The ACQ-5 is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 (on a 7-point scale) according to its severity. The higher the score, the less satisfactory symptom control is.
Time frame: 2、4、8、12、16、20、24、28 、32weeks
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score at 12weeks and 24 weeks.
The AQLQ is a disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range 1-7, with higher scores indicating better quality of life.
Time frame: 12weeks and 24weeks
Total daily use of asthma reliever
Total daily use of asthma relief medication
Time frame: 24weeks
Safety evaluation indicators
Safety evaluation indicators: Adverse Events, Laboratory Tests, Vital Signs, Electrocardiograms, Physical Examination, etc.
Time frame: 32weeks
Concentration of GR1802 at each evaluation time point.
To evaluate the trough concentration at steady-state of GR1802 for each dose group. Population pharmacokinetic analysis is performed using a nonlinear mixed-effects model.
Time frame: Baseline up to week 32
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs).
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable).
Time frame: Baseline up to week 32