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

NCT05979051 | Recruiting Phase 2

• 1 other identifier: SHR-1703-301
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Eosinophilic Granulomatosis With Polyangiitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• Change from baseline in oral glucocorticoid dose

  Up to week 24, week 48

• The proportion of subjects with OCS dosage ≤5 mg/d

  week 12, week 24, week 48

• The proportion of subjects with at least 50% reduction of OCS dosage from baseline

  week 12, week 24, week 48

• The Proportion of subjects with EULAR remission

  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

  week 12, week 24, week 48

Study Arms (2)

Treatment group A

EXPERIMENTAL

SHR-1703

Drug: SHR-1703

Mepolizumab Injection

ACTIVE COMPARATOR

SHR-1703 Placebo

Drug: Mepolizumab Injection

Interventions

SHR-1703 DRUG

SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.

Treatment group A

Mepolizumab Injection DRUG

Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3

Mepolizumab Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects with other eosinophilic-related diseases;
• Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
• Life-threatening EGPA within 3 months prior to randomization;
• Malignancy history within 5 years prior to randomization;
• Immunodeficiency;
• Uncontrolled hypertension；
• Uncontrolled cerebrovascular and cardiovascular disease;
• parasitic infection within 6 months prior to randomization;
• Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
• Subjects with a dose of oral prednisone of \>50 mg/day within 4 weeks prior to randomization;
• Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;
• Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;
• Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
• Rituximab used within 6 months prior to randomization；
• Surgical plans that might affect the evaluation;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (2)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Churg-Strauss Syndrome

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Siai Sun

CONTACT

0518-82342973; siai.sun@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: November 16, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

CN (2)