Eosinophilic Granulomatosis With Polyangiitis
Conditions
Brief summary
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
Interventions
DRUGSHR-1703
SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in oral glucocorticoid dose | Up to week 24, week 48 | Effectiveness Indicators (Phase 2) |
| The proportion of subjects with OCS dosage ≤5 mg/d | week 12, week 24, week 48 | Effectiveness Indicators (Phase 2) |
| The proportion of subjects with at least 50% reduction of OCS dosage from baseline | week 12, week 24, week 48 | Effectiveness Indicators (Phase 2) |
| The Proportion of subjects with EULAR remission | week 12, week 24, week 48 | Effectiveness Indicators (Phase 2) |
| 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 | Effectiveness Indicators (Phase 2) |
| The Proportion of subjects with EGPA remission | week 24, week 48 | Effectiveness Indicators (Phase 2) |
| The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48 | week 24, week 48 | Effectiveness Indicators (Phase 2) |
| The proportion of subjects with EGPA relapse | week 12, week 24, week 48 | Effectiveness Indicators (Phase 2) |
| The time to the first relapse of EGPA | Up to week 48 | Effectiveness Indicators (Phase 2) |
| The proportion of subjects with Severe relapse of EGPA | week 12, week 24, week 48 | Effectiveness Indicators (Phase 2) |
| 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 2) |
| The Proportion of subjects achieving EULAR remission within 24 weeks of treatment and maintaining it up to week 48 | week 24, week 48 | Effectiveness Indicators (Phase 3) |
| Cumulative weeks of EGPA remission through week 48, categorized as 0 weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks; or ≥36 weeks | week 0, week 12, week 24, week 36, week 48 | Effectiveness Indicators (Phase 3) |
| 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 Proportion of subjects with Severe relapse of EGPA | week 24, week 48 | Effectiveness indicators (Phase 3) |
| The time of the first Severe relapse occurred of EGPA | Up to week 48 | Effectiveness indicators (Phase 3) |
Countries
China
Contacts
Primary ContactSiai Sun
Outcome results
None listed