SIM0718 Treatment of Asthma Clinical Study
NCT Number: NCT06488755
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Asthma; Eosinophilic
Interventions: DRUG: SIM0718 injection|DRUG: SIM0718 injection of placebo
Sponsor: Simcere Pharmaceutical Co., Ltd
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 418
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2027-09-30
Locations: China Japan Friendship Hospital, Beijing, Beijing, 100000, China

Summary:
Phase III clinical study of SIM0718 asthma

Primary Outcome Measures: Annualized rate of severe asthma exacerbation events, Annualized rate of severe asthma exacerbation events within 52 weeks, 52 weeks
Secondary Outcome Measures: Change from baseline in forced expiratory volume in the first second before bronchodilator use, Change from baseline in forced expiratory volume in the first second before within 12 weeks, 12 weeks|Change from baseline in Forced Vital Capacity (FVC), Change from baseline in Forced Vital Capacity (FVC) of during the 52-week treatment period, During the 52-week treatment period|Change from baseline in pre-bronchodilator forced expiratory volume in 1 second, Change from baseline in pre-bronchodilator forced expiratory volume in 1 second of during the 52-week treatment period, During the 52-week treatment period|Change from baseline in Peak Expiratory Flow (PEF), Change from baseline in Peak Expiratory Flow (PEF) of during the 52-week treatment period, During the 52-week treatment period|Time from baseline to the first severe asthma exacerbation event, proportion of subjects with ≥ 1 severe asthma exacerbation, subjects with ≥ 1 severe asthma exacerbation of during the 52-week treatment period, During the 52-week treatment period|Annualized rate of "loss of asthma control" events, time from baseline to "loss of asthma control"event, Annualized rate of "loss of asthma control" events, time from baseline to "loss of asthma control"event of during the 52-week treatment period, During the 52-week treatment period|Change from baseline in annualized rate of hospitalization or emergency department visits, utilization of medical resources, Change from baseline in annualized rate of hospitalization or emergency department visits, utilization of medical resources of during the 52-week treatment period, During the 52-week treatment period|Change from baseline in ASTHMA CONTROL QUESTIONNAIRE(ACQ-5) score, Change from baseline in ASTHMA CONTROL QUESTIONNAIRE(ACQ-5) score (5 questions, 0-6 score, higher score indicated lower asthma control) of during the 52-week treatment period, During the 52-week treatment period|Asthma symptom score, Asthma symptom score (0-4 score, higher score indicated worse asthma symptom) during the 52-week treatment period, During the 52-week treatment period|Use of rescue medication, Use of rescue medication of during the 52-week treatment period, During the 52-week treatment period|Number of days of awakenings due to asthma and number of awakenings due to asthma, Number of days of awakenings due to asthma and number of awakenings due to asthma of during the 52-week treatment period, During the 52-week treatment period|Change from baseline in standardized asthma quality of life questionnaire score ASTHMA QUALITY OF LIFE QUESTIONNAIRES(AQLQ(S)), Change from baseline in standardized asthma quality of life questionnaire score(AQLQ(S)) (32 questions, 1-7 score, higher scores indicate better quality of life) of during the 52-week treatment period, During the 52-week treatment period|Adverse events, Adverse events during 64 week study period, during the 64 week study period|Vital signs, Vital signs during 64 week study period, during the 64 week study period|Electrocardiograph (12-ECG), Electrocardiograph (12-ECG) during 64 week study period, during the 64 week study period|Laboratory tests, Laboratory tests during 64-week study period. Lab tests include hematology, biochemistry, during the 64 week study period|SIM0718 blood concentration, SIM0718 blood concentration of during the 52-week treatment period, During the 52-week treatment period|Positive rate and titer of anti-drug antibodies, positive rate of neutralizing antibodies, Positive rate and titer of anti-drug antibodies, positive rate of neutralizing antibodies of 64 weeks during the study, 64 weeks during the study