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

NCT ID: NCT05522439

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-22
• Study Completion Date: 2024-09-12

Brief Summary

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

Conditions

Asthma With Eosinophilic Phenotype

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Subjects receiving SHR-1703 dose 1

Group Type: EXPERIMENTAL

SHR-1703

Intervention Type: DRUG

SHR-1703 will be administered by SC injection.

SHR-1703 Placebo

Intervention Type: DRUG

Matching Placebo will be administered by the SC route.

Subjects receiving SHR-1703 dose 2

Group Type: EXPERIMENTAL

SHR-1703

Intervention Type: DRUG

SHR-1703 will be administered by SC injection.

Subjects receiving SHR-1703 dose 3

Group Type: EXPERIMENTAL

SHR-1703

Intervention Type: DRUG

SHR-1703 will be administered by SC injection.

SHR-1703 Placebo

Intervention Type: DRUG

Matching Placebo will be administered by the SC route.

Placebo

Group Type: PLACEBO_COMPARATOR

SHR-1703 Placebo

Intervention Type: DRUG

Matching Placebo will be administered by the SC route.

Interventions

SHR-1703

SHR-1703 will be administered by SC injection.

Intervention Type: DRUG

SHR-1703 Placebo

Matching Placebo will be administered by the SC route.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

SHR-1703-201

Identifier Type: -

Identifier Source: org_study_id