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

RECRUITINGPHASE2/PHASE3

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

NCT05979051•Guangdong Hengrui Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+12 more criteria

Locations (2)

Beijing Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

November 16, 2023

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

December 4, 2025

Enrollment

166

ESTIMATED participants

Conditions

Eosinophilic Granulomatosis With Polyangiitis

Interventions

SHR-1703

DRUG

Mepolizumab Injection

DRUG

Contacts

Siai Sun

CONTACT

0518-82342973 siai.sun@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)

NUCALA® Special Drug Use Investigation (EGPA, Long-term)

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