Asthma With Eosinophilic Phenotype
Conditions
Brief summary
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
Interventions
DRUGHR-1703
HR-1703 will be administered by SC injection.
DRUGPlacebo
Matching Placebo will be administered by the SC injection.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 12 years of age 2. A minimum weight of 40kg 3. A medical history of at least 1 year that meets the diagnosis of asthma; 4. Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months 5. Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month 6. Absolute count of blood eosinophils suggests eosinophilic asthma 7. During the screening period and baseline, pre- BD FEV1% \< 80% 8. During the screening period and baseline, ACQ-6 score indicates asthma poor control 9. History of severe asthma exacerbation within the past 12 months prior to screening 10. Good compliance with eDiary completion 11. Take efficient contraceptive measures 12. Voluntarily sign the informed consent form to participate in this study
Exclusion criteria
1. With other condition that could lead to elevated eosinophils 2. With Clinically significant pulmonary diseases 3. With existing immunodeficiency disease 4. With other clinically significant diseases that may affect lung function 5. With uncontrolled severe cardiovascular and cerebrovascular diseases 6. With uncontrolled hypertension and/or diabetes 7. With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization 8. Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation 9. Existing parasitic infections 10. Diagnosed as malignant tumor within the first 5 years of randomization 11. Significant abnormalities in screening period or baseline laboratory tests 12. Screening period or baseline ECG QTc prolongation 13. Prohibited drugs using during the pre randomization period 14. Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening 15. Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years 16. History of drug use, alcoholism, or substance abuse within the past year prior to screening 17. Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents 18. Pregnant or lactating subjects 19. Other reasons why the researcher deemed it unsuitable for conducting this experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualised asthma exacerbation rate，about 48weeks | about 48weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean number of days with oral corticosteroids taken for exacerbation，about 48weeks | about 48weeks |
| Frequency of exacerbations requiring hospitalisation，about 48weeks | about 48weeks |
| Time to first exacerbation requiring hospitalisation，about 48weeks | about 48weeks |
| Mean change from baseline in clinic pre- and post-BD FEV1，about 64 weeks | about 64 weeks |
| Mean change from baseline in clinic pre- and post-BD FEV1%，about 64weeks | about 64weeks |
| Mean change from baseline in clinic pre- and post-BD FVC，about 64 weeks | about 64 weeks |
| Mean change from baseline in clinic pre- and post-BD PEF，about 64 weeks | about 64 weeks |
| Mean change from baseline in FeNO，about 64weeks | about 64weeks |
| Mean change from baseline in asthma control questionnaire (ACQ-6) score，about 64 weeks | about 64 weeks |
| Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score，about 64weeks | about 64weeks |
| Mean change from baseline in Asthma symptom score at week 12/24/36/48/60，about 64weeks | at week 12/24/36/48/60，about 64weeks |
| Mean change from baseline in daily rescue medication use at week 12/24/36/48/60，about 64weeks | at week 12/24/36/48/60，about 64weeks |
| Mean change from baseline in awakening at night due to asthma symptoms requiring rescue medication use at week 12/24/36/48/60，about 64weeks | at week 12/24/36/48/60，about 64weeks |
| Mean change from baseline in morning and evening PEF at week 12/24/36/48/60，about 64weeks | at week 12/24/36/48/60，about 64weeks |
| Mean change from baseline in IgE，about 64weeks | about 64weeks |
| Adverse events，about 64weeks | about 64weeks |
Countries
China
Outcome results
None listed