NCT05979051招募中2 期
A Multicenter, Single-arm/Randomized, Double-blind, Active-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA
Guangdong Hengrui Pharmaceutical Co., Ltd2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2023年11月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Change from baseline in oral glucocorticoid dose (OCS)
研究概览
简要总结
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects age 18 years or older;
- •Diagnosed with EGPA for at least 6 months;
- •History of relapsing or refractory EGPA；
- •Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization;
- •If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.
排除标准
- •Subjects with other eosinophilic-related diseases;
- •Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
- •Life-threatening EGPA within 3 months prior to randomization;
- •Malignancy history within 5 years prior to randomization;
- •Immunodeficiency;
- •Uncontrolled hypertension；
- •Uncontrolled cerebrovascular and cardiovascular disease;
- •parasitic infection within 6 months prior to randomization;
- •Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
- •Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization;
- •Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;
- •Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;
- •Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
- •Rituximab used within 6 months prior to randomization；
- •Surgical plans that might affect the evaluation;
- •Significant laboratory abnormalities；
- •Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
- •History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
- •Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
- •Subjects is pregnant, lactating, or planning to be pregnant;
- •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;
- •Other conditions unsuitable for participation in the study per investigator judgement.
研究组 & 干预措施
Treatment group A
Experimental
SHR-1703
干预措施: SHR-1703 (Drug)
Mepolizumab Injection
Active Comparator
SHR-1703 Placebo
干预措施: Mepolizumab Injection (Drug)
结局指标
主要结局
Change from baseline in oral glucocorticoid dose (OCS)
时间窗: Up to week 12
Phase 2
The Proportion of subjects in EGPA remission
时间窗: week 36 and week 48
Phase 3
次要结局
- Change from baseline in oral glucocorticoid dose(Up to week 24, week 48)
- The proportion of subjects with OCS dosage ≤5 mg/d(week 24, week 48)
- The proportion of subjects with at least 50% reduction of OCS dosage from baseline(week 24, week 48)
- The Proportion of subjects with EULAR remission(week 36, week 48)
- 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)
- The Proportion of subjects with EGPA remission(week 36, week 48)
- The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48(week 24, week 48)
- The proportion of subjects with EGPA relapse(week 12, week 24, week 48)
- The time to the first relapse of EGPA(Up to week 48)
- The proportion of subjects with Severe relapse of EGPA(week 12, week 24, week 48)
- The time of the first Severe relapse of EGPA(Up to week 48)
- Changes from baseline in Pre- and post-Bronchodilator FEV1(Up to week 48)
- The Proportion of subjects achieving EULAR remission within 24 weeks of treatment and maintaining it up to week 48(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(week 0, week 12, week 24, week 36, week 48)
- Change from baseline in OCS(Week 24, Week 48)
- The Proportion of subjects with EGPA relapse(week 24, week 48)
- The Proportion of subjects with Severe relapse of EGPA(week 24, week 48)
- The time of the first Severe relapse occurred of EGPA(Up to week 48)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
3 期
A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic SurgeryPostoperative Pain Of Laparoscopic SurgeryNCT05459220Jiangsu HengRui Medicine Co., Ltd.357
已完成
3 期
A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower AbdominalPainNCT04852003Jiangsu HengRui Medicine Co., Ltd.228
已完成
2 期
A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil PhenotypeAsthma With Eosinophilic PhenotypeNCT05522439Jiangsu HengRui Medicine Co., Ltd.85
进行中（未招募）
2 期
A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLCNon-Small-Cell Lung CancerNCT04580498Jiangsu HengRui Medicine Co., Ltd.107
进行中（未招募）
3 期
A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic AsthmaAsthma With Eosinophilic PhenotypeNCT06653322Guangdong Hengrui Pharmaceutical Co., Ltd401