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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR-1703 |
|
| Mepolizumab Injection | Active Comparator | SHR-1703 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1703 | Drug | SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in oral glucocorticoid dose (OCS) | Phase 2 | Up to week 12 |
| The Proportion of subjects in EGPA remission | Phase 3 | week 36 and week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in oral glucocorticoid dose | Effectiveness Indicators (Phase 2) | Up to week 24, week 48 |
| The proportion of subjects with OCS dosage ≤5 mg/d | Effectiveness Indicators (Phase 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siai Sun | Contact | 0518-82342973 | siai.sun@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.
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| Mepolizumab Injection | Drug | Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3 |
|
| week 12, week 24, week 48 |
| The proportion of subjects with at least 50% reduction of OCS dosage from baseline | Effectiveness Indicators (Phase 2) | week 12, week 24, week 48 |
| The Proportion of subjects with EULAR remission | Effectiveness Indicators (Phase 2) | week 12, week 24, week 48 |
| The Proportion of subjects achieving EULAR remission at week 12 and week 24 of treatment and maintaining it up to week 48 | Effectiveness Indicators (Phase 2) | week 12, week 24, week 48 |
| The Proportion of subjects with EGPA remission | Effectiveness Indicators (Phase 2) | week 24, week 48 |
| The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48 | Effectiveness Indicators (Phase 2) | week 24, week 48 |
| The proportion of subjects with EGPA relapse | Effectiveness Indicators (Phase 2) | week 12, week 24, week 48 |
| The time to the first relapse of EGPA | Effectiveness Indicators (Phase 2) | Up to week 48 |
| The proportion of subjects with Severe relapse of EGPA | Effectiveness Indicators (Phase 2) | week 12, week 24, week 48 |
| The time of the first Severe relapse of EGPA | Effectiveness Indicators (Phase 2) | Up to week 48 |
| Changes from baseline in Pre- and post-Bronchodilator FEV1 | Effectiveness Indicators (Phase 2) | Up to week 48 |
| The Proportion of subjects with EULAR remission | Effectiveness Indicators (Phase 3) | week 36, week 48 |
| The Proportion of subjects with EGPA remission | Effectiveness Indicators (Phase 3) | week 36, week 48 |
| The Proportion of subjects achieving EULAR remission within 24 weeks of treatment and maintaining it up to week 48 | Effectiveness Indicators (Phase 3) | week 24, week 48 |
| The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48 | Effectiveness Indicators (Phase 3) | week 24, week 48 |
| 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 | Effectiveness Indicators (Phase 3) | week 0, week 12, week 24, week 36, week 48 |
| Change from baseline in OCS | Effectiveness indicators (Phase 3) | Week 24, Week 48 |
| The proportion of subjects with OCS dosage ≤5 mg/d | Effectiveness indicators (Phase 3) | week 24, week 48 |
| The proportion of subjects with at least 50% reduction of OCS dosage from baseline | Effectiveness indicators (Phase 3) | week 24, week 48 |
| The Proportion of subjects with EGPA relapse | Effectiveness indicators (Phase 3) | week 24, week 48 |
| The Proportion of subjects with Severe relapse of EGPA | Effectiveness indicators (Phase 3) | week 24, week 48 |
| The time to the first relapse of EGPA | Effectiveness indicators (Phase 3) | Up to week 48 |
| The time of the first Severe relapse occurred of EGPA | Effectiveness indicators (Phase 3) | Up to week 48 |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
|
| ID | Term |
|---|---|
| D015267 | Churg-Strauss Syndrome |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006099 | Granuloma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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