Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
| 适应症 | Lupus Erythematosus, Lupus Nephritis |
|---|---|
| 分期 | 1期 |
| 申办方 | Biocon Limited |
| 状态 | 已完成 |
| 受试者人数 | 52 人 |
| 干预（药物） | Itolizumab [Bmab 600] |
| 开始日期 | 2019年10月1日 |
| 完成日期 | 2023年11月16日 |
| 结果公布日 | 2025年4月18日 |
摘要
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis
Number of Treatment Emergent Adverse Events
| EQ001 Type A Cohort (0.4mg/kg) | 0 Participants |
|---|---|
| EQ001 for Type B Cohort | 17 Participants |
| EQ001 Type A Cohort (0.8mg/kg) | 2 Participants |
| EQ001 Type A Cohort (1.6mg/kg) | 4 Participants |
| EQ001 Type A Cohort (2.4mg/kg) | 3 Participants |
| EQ001 Type A Cohort (3.2mg/kg) | 8 Participants |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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