A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
Study Details
Study Description
Brief Summary
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group A SHR-1703 |
Drug: SHR-1703
SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
|
| Placebo Comparator: Treatment group B SHR-1703 Placebo |
Drug: SHR-1703 Placebo
SHR-1703 Placebo will be administered by Subcutaneous injection in Phase 3.
|
Outcome Measures
Primary Outcome Measures
- 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
- Change from baseline in oral glucocorticoid dose [Up to week 24]
Effectiveness Indicators (Phase 2)
- The proportion of subjects with OCS dosage ≤5 mg/d [week 12, week 24]
Effectiveness Indicators (Phase 2)
- The proportion of subjects with at least 50% reduction of OCS dosage from baseline [week 12, week 24]
Effectiveness Indicators (Phase 2)
- The Proportion of subjects with EGPA remission [week 12, week 24]
Effectiveness Indicators (Phase 2)
- The Proportion of subjects with EGPA relapse [week 12, week 24]
Effectiveness Indicators (Phase 2)
- The Proportion of subjects with Severe relapse of EGPA [week 12, week 24]
Effectiveness Indicators (Phase 2)
- The Proportion of subjects in EULAR remission [week 12 through week 24]
Effectiveness Indicators (Phase 2)
- The time to the first relapse of EGPA [Up to 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)
- Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred [Up to week 48]
Effectiveness Indicators (Phase 2)
- Changes from baseline in Pre- and post-Bronchodilator FVC [Up to week 48]
Effectiveness Indicators (Phase 2)
- Change from baseline in OCS [Week 24, 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 proportion of subjects with at least 50% reduction of OCS dosage from baseline [week 24, week 48]
Effectiveness indicators (Phase 3)
- The total accrued duration of remission [up to 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 to the first relapse of EGPA [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)
- Changes from baseline in Pre- and post-Bronchodilator FEV1 [Up to 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects age 18 years or older;
-
Diagnosed with EGPA for at least 6 months;
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History of relapsing or refractory EGPA；
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Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization;
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If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.
Exclusion Criteria:
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Subjects with other eosinophilic-related diseases;
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Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
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Life-threatening EGPA within 3 months prior to randomization;
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Malignancy history within 5 years prior to randomization;
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Immunodeficiency;
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Uncontrolled hypertension；
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Uncontrolled cerebrovascular and cardiovascular disease;
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parasitic infection within 6 months prior to randomization;
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Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
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Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization;
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Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;
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Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;
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Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
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Rituximab or alemtuzumab used within 12 months prior to randomization；
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Surgical plans that might affect the evaluation;
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Significant laboratory abnormalities；
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Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
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History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
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Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
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Subjects is pregnant, lactating, or planning to be pregnant;
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Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents;
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Other conditions unsuitable for participation in the study per investigator judgement.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guangdong Hengrui Pharmaceutical Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1703-301