Clinical trial NCT05522439: A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Pharmacodynamic, Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1703 in Asthma Patients With Eosinophil Phenotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma With Eosinophilic Phenotype
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-31
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in Blood Eosinophils
timeFrame: Up to Week 52
Secondary outcomes:
measure: Changes from baseline in Pre- and post-Bronchodilator FEV1
timeFrame: Up to Week 52
measure: Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
timeFrame: Up to Week 52
measure: Changes from baseline in Pre- and post-Bronchodilator FVC
timeFrame: Up to Week 52
measure: Changes from baseline in Pre- and post-Bronchodilator PEF
timeFrame: Up to Week 52
measure: Changes from baseline in n fractional exhaled nitric oxide (FeNO)
timeFrame: Up to Week 52
measure: Changes from baseline in Asthma Control Questionnaire-6(ACQ-6)
timeFrame: Up to Week 52
measure: Changes from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Up to Week 52
measure: Frequency of use of asthma relievers
timeFrame: Up to Week 24
measure: Frequency of exacerbations of asthma
timeFrame: Up to Week 24
measure: Frequency of severe exacerbations of asthma
timeFrame: Up to Week 24
measure: Time to first exacerbation of asthma
timeFrame: Up to Week 24
measure: Time to first severe exacerbation of asthma
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: