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

Eosinophilic Granulomatosis With Polyangiitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979051
• Other study ID #: SHR-1703-301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 16, 2023
• Est. completion date: May 16, 2027

Study information

• Verified date: December 2023
• Source: Guangdong Hengrui Pharmaceutical Co., Ltd
• Contact: Siai Sun
• Phone: 0518-82342973
• Email: siai.sun[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: May 16, 2027
• Est. primary completion date: March 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Eosinophilic Granulomatosis With Polyangiitis
• Granulomatosis with Polyangiitis
• Systemic Vasculitis

Intervention

Drug:
• SHR-1703
SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
• SHR-1703 Placebo
SHR-1703 Placebo will be administered by Subcutaneous injection in Phase 3.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Hengrui Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in oral glucocorticoid dose (OCS)	Phase 2	Up to week 12
Primary	The Proportion of subjects in EGPA remission	Phase 3	week 36 and week 48
Secondary	Change from baseline in oral glucocorticoid dose	Effectiveness Indicators (Phase 2)	Up to week 24
Secondary	The proportion of subjects with OCS dosage =5 mg/d	Effectiveness Indicators (Phase 2)	week 12, week 24
Secondary	The proportion of subjects with at least 50% reduction of OCS dosage from baseline	Effectiveness Indicators (Phase 2)	week 12, week 24
Secondary	The Proportion of subjects with EGPA remission	Effectiveness Indicators (Phase 2)	week 12, week 24
Secondary	The Proportion of subjects with EGPA relapse	Effectiveness Indicators (Phase 2)	week 12, week 24
Secondary	The Proportion of subjects with Severe relapse of EGPA	Effectiveness Indicators (Phase 2)	week 12, week 24
Secondary	The Proportion of subjects in EULAR remission	Effectiveness Indicators (Phase 2)	week 12 through week 24
Secondary	The time to the first relapse of EGPA	Effectiveness Indicators (Phase 2)	Up to week 48
Secondary	The time of the first Severe relapse of EGPA	Effectiveness Indicators (Phase 2)	Up to week 48
Secondary	Changes from baseline in Pre- and post-Bronchodilator FEV1	Effectiveness Indicators (Phase 2)	Up to week 48
Secondary	Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred	Effectiveness Indicators (Phase 2)	Up to week 48
Secondary	Changes from baseline in Pre- and post-Bronchodilator FVC	Effectiveness Indicators (Phase 2)	Up to week 48
Secondary	Change from baseline in OCS	Effectiveness indicators (Phase 3)	Week 24, Week 48
Secondary	The proportion of subjects with OCS dosage =5 mg/d	Effectiveness indicators (Phase 3)	week 24, week 48
Secondary	The proportion of subjects with at least 50% reduction of OCS dosage from baseline	Effectiveness indicators (Phase 3)	week 24, week 48
Secondary	The total accrued duration of remission	Effectiveness indicators (Phase 3)	up to week 48
Secondary	The Proportion of subjects with EGPA relapse	Effectiveness indicators (Phase 3)	week 24, week 48
Secondary	The Proportion of subjects with Severe relapse of EGPA	Effectiveness indicators (Phase 3)	week 24, week 48
Secondary	The time to the first relapse of EGPA	Effectiveness indicators (Phase 3)	Up to week 48
Secondary	The time of the first Severe relapse occurred of EGPA	Effectiveness indicators (Phase 3)	Up to week 48
Secondary	The Proportion of subjects in EGPA remission	Effectiveness indicators (Phase 3)	week 24 through week 48
Secondary	Changes from baseline in Pre- and post-Bronchodilator FEV1	Effectiveness indicators (Phase 3)	Up to week 48
Secondary	Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred	Effectiveness indicators (Phase 3)	Up to week 48
Secondary	Changes from baseline in Pre- and post-Bronchodilator FVC	Effectiveness indicators (Phase 3)	Up to week 48