A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

A Multicenter, Single-arm/Randomized, Double-blind, Active-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA

This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.

Study Overview

• Status: Recruiting
• Conditions: Eosinophilic Granulomatosis With Polyangiitis
• Intervention / Treatment: Drug: SHR-1703; Drug: Mepolizumab Injection

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Siai Sun; Phone Number: 0518-82342973; Email: siai.sun@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Beijing Hospital
      • Contact: Xuan Zhang, Doctor; Phone Number: 010-85132266; Email: zxlab@outlook.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Huahao Shen, Doctor; Phone Number: 0571-87783777; Email: huahaoshen@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects age 18 years or older;
2. Diagnosed with EGPA for at least 6 months;
3. History of relapsing or refractory EGPA；
4. Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization;
5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.

Exclusion Criteria:

1. Subjects with other eosinophilic-related diseases;
2. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
3. Life-threatening EGPA within 3 months prior to randomization;
4. Malignancy history within 5 years prior to randomization;
5. Immunodeficiency;
6. Uncontrolled hypertension；
7. Uncontrolled cerebrovascular and cardiovascular disease;
8. parasitic infection within 6 months prior to randomization;
9. Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
10. Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization;
11. Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;
12. Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;
13. Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
14. Rituximab used within 6 months prior to randomization；
15. Surgical plans that might affect the evaluation;
16. Significant laboratory abnormalities；
17. Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
18. History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
19. Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
20. Subjects is pregnant, lactating, or planning to be pregnant;
21. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents or previous failure of IL-5/IL-5R therapy;
22. 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: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; SHR-1703	Drug: SHR-1703; SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
Active Comparator: Mepolizumab Injection; SHR-1703 Placebo	Drug: Mepolizumab Injection; Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in oral glucocorticoid dose (OCS)	Phase 2	Up to week 12
The Proportion of subjects in EGPA remission	Phase 3	week 36 and week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to the first relapse of EGPA	Effectiveness Indicators (Phase 2)	Up to week 48
The time of the first Severe relapse of EGPA	Effectiveness Indicators (Phase 2)	Up to week 48
Changes from baseline in Pre- and post-Bronchodilator FEV1	Effectiveness Indicators (Phase 2)	Up to week 48
Change from baseline in OCS	Effectiveness indicators (Phase 3)	Week 24, Week 48
The proportion of subjects with OCS dosage ≤5 mg/d	Effectiveness indicators (Phase 3)	week 24, week 48
The proportion of subjects with at least 50% reduction of OCS dosage from baseline	Effectiveness indicators (Phase 3)	week 24, week 48
The Proportion of subjects with EGPA relapse	Effectiveness indicators (Phase 3)	week 24, week 48
The Proportion of subjects with Severe relapse of EGPA	Effectiveness indicators (Phase 3)	week 24, week 48
The time to the first relapse of EGPA	Effectiveness indicators (Phase 3)	Up to week 48
The time of the first Severe relapse occurred of EGPA	Effectiveness indicators (Phase 3)	Up to week 48
Change from baseline in oral glucocorticoid dose	Effectiveness Indicators (Phase 2)	Up to week 24, week 48
The proportion of subjects with OCS dosage ≤5 mg/d	Effectiveness Indicators (Phase 2)	week 12, week 24, week 48
The proportion of subjects with at least 50% reduction of OCS dosage from baseline	Effectiveness Indicators (Phase 2)	week 12, week 24, week 48
The Proportion of subjects with EULAR remission	Effectiveness Indicators (Phase 2)	week 12, week 24, week 48
The Proportion of subjects achieving EULAR remission at week 12 and week 24 of treatment and maintaining it up to week 48	Effectiveness Indicators (Phase 2)	week 12, week 24, week 48
The Proportion of subjects with EGPA remission	Effectiveness Indicators (Phase 2)	week 24, week 48
The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48	Effectiveness Indicators (Phase 2)	week 24, week 48
The proportion of subjects with EGPA relapse	Effectiveness Indicators (Phase 2)	week 12, week 24, week 48
The proportion of subjects with Severe relapse of EGPA	Effectiveness Indicators (Phase 2)	week 12, week 24, week 48
The Proportion of subjects with EULAR remission	Effectiveness Indicators (Phase 3)	week 36, week 48
The Proportion of subjects with EGPA remission	Effectiveness Indicators (Phase 3)	week 36, week 48
The Proportion of subjects achieving EULAR remission within 24 weeks of treatment and maintaining it up to week 48	Effectiveness Indicators (Phase 3)	week 24, week 48
The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48	Effectiveness Indicators (Phase 3)	week 24, week 48
Cumulative weeks of EGPA remission through week 48, categorized as 0 weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks; or ≥36 weeks	Effectiveness Indicators (Phase 3)	week 0, week 12, week 24, week 36, week 48

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Skin Diseases, Vascular; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granuloma; Systemic Vasculitis; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Churg-Strauss Syndrome; mepolizumab
• Other Study ID Numbers: SHR-1703-301

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