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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma With Eosinophilic Phenotype
• Intervention / Treatment: Drug: SHR-1703; Drug: SHR-1703 Placebo

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: SHR-1703 Placebo; Matching Placebo will be administered by the SC route.
Experimental: Subjects receiving SHR-1703 dose 1	Drug: SHR-1703; SHR-1703 will be administered by SC injection.; Drug: SHR-1703 Placebo; Matching Placebo will be administered by the SC route.
Experimental: Subjects receiving SHR-1703 dose 2	Drug: SHR-1703; SHR-1703 will be administered by SC injection.
Experimental: Subjects receiving SHR-1703 dose 3	Drug: SHR-1703; SHR-1703 will be administered by SC injection.; Drug: SHR-1703 Placebo; Matching Placebo will be administered by the SC route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in Blood Eosinophils	Up to Week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in Pre- and post-Bronchodilator FEV1	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 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 Standardized Asthma Quality of Life Questionnaire (AQLQ)	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Actual): September 12, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: SHR-1703-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No