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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-16

Study Completion Date

2028-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Eosinophilic Granulomatosis With Polyangiitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment group A

SHR-1703

Group Type EXPERIMENTAL

SHR-1703

Intervention Type DRUG

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

Mepolizumab Injection

SHR-1703 Placebo

Group Type ACTIVE_COMPARATOR

Mepolizumab Injection

Intervention Type DRUG

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

Interventions

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SHR-1703

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

Intervention Type DRUG

Mepolizumab Injection

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No