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
DRUGSHR-1703
SHR-1703 will be administered by SC injection.
DRUGSHR-1703 Placebo
Matching Placebo will be administered by the SC route.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 75years (inclusive). 2. Weight ≥40 kg. 3. History of asthma≥ 1 year. 4. Documented treatment with Medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization. 5. Previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization. 6. Blood eosinophils of ≥150 cells/µL at screening and baseline. 7. Pre-Bronchodilator FEV1% pred≥40% and\<80% at screening and baseline. 8. Asthma Control Questionnaire-6 score≥1.5. 9. Use highly effective contraceptive measures. 10. Willing to sign the informed consent form to participate in this study.
Exclusion criteria
1. Subjects with Clinically significant pulmonary diseases； 2. Subjects with other diseases that could lead to elevated eosinophils； 3. Subjects with Immunodeficiency； 4. Poorly controlled hypertension; 5. Subjects with severe cerebrovascular disease; 6. Subjects with infection history requiring clinical intervention； 7. Subjects with parasitic infection； 8. Diagnosed Malignant tumor within 5 years prior to randomization; 9. Used non-selective β-blockers within 1 week prior to randomization; 10. Used either 5-lipoxygenase inhibitor or Phosphodiesterase-4 inhibitor within 1 week prior to randomization; 11. Blood donation or massive blood loss, or transfusion of blood products or immunoglobulins within 4 weeks prior to randomization; 12. Live attenuated vaccine inoculated within 4 weeks before randomization; 13. Allergen Immunotherapy within 8 weeks prior to randomization； 14. Used systemic immunosuppressants or immunomodulators, or biologics or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug; 15. Bronchial thermoplasty within 1 year prior to randomization； 16. Subjects have planned Surgery or other medical procedures that may affect evaluation during the study period; 17. Subjects with significant laboratory abnormality at screening； 18. Subjects have prolonged QTc interval or other electrocardiogram abnormality with significant safety risk at screening; 19. Current smokers or ex-smokers who have given up smoking for \<6 months ，or positive smoke test, and/or have a smoking pack history of \> 10 pack years; 20. History of drug or substance abuse or alcohol abuse within 1 year prior to screening; 21. Subjects participated another clinical studies and received active drug within 30 days or 5 half-lives prior to screening; 22. Subjects is pregnant, lactating,or planning to become pregnant; 23. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents; 24. Other conditions unsuitable for participation in the study per investigator judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in Blood Eosinophils | Up to Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred | Up to Week 52 |
| Changes from baseline in Pre- and post-Bronchodilator FVC | Up to Week 52 |
| Changes from baseline in Pre- and post-Bronchodilator PEF | Up to Week 52 |
| Changes from baseline in n fractional exhaled nitric oxide (FeNO) | Up to Week 52 |
| Changes from baseline in Asthma Control Questionnaire-6(ACQ-6) | Up to Week 52 |
| Changes from baseline in Pre- and post-Bronchodilator FEV1 | Up to Week 52 |
| Frequency of use of asthma relievers | Up to Week 24 |
| Frequency of exacerbations of asthma | Up to Week 24 |
| Frequency of severe exacerbations of asthma | Up to Week 24 |
| Time to first exacerbation of asthma | Up to Week 24 |
| Time to first severe exacerbation of asthma | Up to Week 24 |
| Changes from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) | Up to Week 52 |
Countries
China
Outcome results
None listed