This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
166
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
Beijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGChange from baseline in oral glucocorticoid dose (OCS)
Phase 2
Time frame: Up to week 12
The Proportion of subjects in EGPA remission
Phase 3
Time frame: week 36 and week 48
Change from baseline in oral glucocorticoid dose
Effectiveness Indicators (Phase 2)
Time frame: Up to week 24, week 48
The proportion of subjects with OCS dosage ≤5 mg/d
Effectiveness Indicators (Phase 2)
Time frame: week 12, week 24, week 48
The proportion of subjects with at least 50% reduction of OCS dosage from baseline
Effectiveness Indicators (Phase 2)
Time frame: week 12, week 24, week 48
The Proportion of subjects with EULAR remission
Effectiveness Indicators (Phase 2)
Time frame: 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)
Time frame: week 12, week 24, week 48
The Proportion of subjects with EGPA remission
Effectiveness Indicators (Phase 2)
Time frame: week 24, week 48
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The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48
Effectiveness Indicators (Phase 2)
Time frame: week 24, week 48
The proportion of subjects with EGPA relapse
Effectiveness Indicators (Phase 2)
Time frame: week 12, week 24, week 48
The time to the first relapse of EGPA
Effectiveness Indicators (Phase 2)
Time frame: Up to week 48
The proportion of subjects with Severe relapse of EGPA
Effectiveness Indicators (Phase 2)
Time frame: week 12, week 24, week 48
The time of the first Severe relapse of EGPA
Effectiveness Indicators (Phase 2)
Time frame: Up to week 48
Changes from baseline in Pre- and post-Bronchodilator FEV1
Effectiveness Indicators (Phase 2)
Time frame: Up to week 48
The Proportion of subjects with EULAR remission
Effectiveness Indicators (Phase 3)
Time frame: week 36, week 48
The Proportion of subjects with EGPA remission
Effectiveness Indicators (Phase 3)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: week 0, week 12, week 24, week 36, week 48
Change from baseline in OCS
Effectiveness indicators (Phase 3)
Time frame: Week 24, Week 48
The proportion of subjects with OCS dosage ≤5 mg/d
Effectiveness indicators (Phase 3)
Time frame: week 24, week 48
The proportion of subjects with at least 50% reduction of OCS dosage from baseline
Effectiveness indicators (Phase 3)
Time frame: week 24, week 48
The Proportion of subjects with EGPA relapse
Effectiveness indicators (Phase 3)
Time frame: week 24, week 48
The Proportion of subjects with Severe relapse of EGPA
Effectiveness indicators (Phase 3)
Time frame: week 24, week 48
The time to the first relapse of EGPA
Effectiveness indicators (Phase 3)
Time frame: Up to week 48
The time of the first Severe relapse occurred of EGPA
Effectiveness indicators (Phase 3)
Time frame: Up to week 48