A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype

Phase 2

Active, not recruiting

• Conditions: Asthma With Eosinophilic Phenotype
• Interventions: Drug: SHR-1703; Drug: SHR-1703 Placebo

• Registration Number: NCT05522439
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Status Verified: 2022-11
• Study Start: 2022-12-22
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects receiving SHR-1703 dose 1	SHR-1703	-
Subjects receiving SHR-1703 dose 1	SHR-1703 Placebo	-
Subjects receiving SHR-1703 dose 2	SHR-1703	-
Subjects receiving SHR-1703 dose 3	SHR-1703	-
Subjects receiving SHR-1703 dose 3	SHR-1703 Placebo	-
Placebo	SHR-1703 Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Blood Eosinophils	Up to Week 52

Secondary Outcome Measures

Name	Time	Method
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 Pre- and post-Bronchodilator FEV 1% pred	Up to Week 52
Changes from baseline in Pre- and post-Bronchodilator FEV1	Up to Week 52
Changes from baseline in Asthma Control Questionnaire-6(ACQ-6)	Up to Week 52
Changes from baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ)	Up to Week 52
Frequency of use of asthma relievers	Up to Week 24
Changes from baseline in n fractional exhaled nitric oxide (FeNO)	Up to Week 52
Time to first exacerbation of asthma	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 severe exacerbation of asthma	Up to Week 24

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China