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

Phase 2

Recruiting

• Conditions: Eosinophilic Granulomatosis With Polyangiitis
• Interventions: Drug: SHR-1703 Placebo; Drug: SHR-1703

• Registration Number: NCT05979051
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-07-30
• Study First Posted: 2023-08-07
• Study Start: 2023-11-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2026-03-21
• Study Completion: 2027-05-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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 or alemtuzumab used within 12 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;
22. Other conditions unsuitable for participation in the study per investigator judgement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group B	SHR-1703 Placebo	SHR-1703 Placebo
Treatment group A	SHR-1703	SHR-1703

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The time of the first Severe relapse of EGPA	Up to week 48	Effectiveness Indicators (Phase 2)
Changes from baseline in Pre- and post-Bronchodilator FEV1	Up to week 48	Effectiveness indicators (Phase 3)
The Proportion of subjects with Severe relapse of EGPA	week 24, week 48	Effectiveness indicators (Phase 3)
Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred	Up to week 48	Effectiveness indicators (Phase 3)
Changes from baseline in Pre- and post-Bronchodilator FVC	Up to week 48	Effectiveness indicators (Phase 3)
Change from baseline in oral glucocorticoid dose	Up to week 24	Effectiveness Indicators (Phase 2)
The Proportion of subjects in EULAR remission	week 12 through week 24	Effectiveness Indicators (Phase 2)
The Proportion of subjects with EGPA remission	week 12, week 24	Effectiveness Indicators (Phase 2)
Change from baseline in OCS	Week 24, Week 48	Effectiveness indicators (Phase 3)
The Proportion of subjects with EGPA relapse	week 24, week 48	Effectiveness indicators (Phase 3)
The time to the first relapse of EGPA	Up to week 48	Effectiveness indicators (Phase 3)
The proportion of subjects with OCS dosage ≤5 mg/d	week 24, week 48	Effectiveness indicators (Phase 3)
The total accrued duration of remission	up to week 48	Effectiveness indicators (Phase 3)
The time of the first Severe relapse occurred of EGPA	Up to week 48	Effectiveness indicators (Phase 3)
The Proportion of subjects in EGPA remission	week 24 through week 48	Effectiveness indicators (Phase 3)
The proportion of subjects with at least 50% reduction of OCS dosage from baseline	week 24, week 48	Effectiveness indicators (Phase 3)

Trial Locations

Locations (2)

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China