A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 45
- 主要终点
- Number of Treatment Emergent Adverse Events
研究概览
简要总结
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
详细描述
The study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of approximately 20 open-label subjects enrolled for Type B-Lupus Nephritis.
Subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (Type A) or 13 (Type B) doses with 4 or 12 weeks of follow-up after the last dose of investigational product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Type A and Type B are open-label.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type A Cohort Key Inclusion Criteria:
- •Is male or female, age ≥ 18 and ≤ 75 years
- •Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE
- •Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
- •Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening
- •Restricted SLE treatments are stable and/or washed out
- •During Screening, has adequate hematologic function
- •Type B Cohort Key Inclusion Criteria:
- •Is male or female, age ≥ 18 and ≤ 75 years
- •Has a diagnosis of SLE
- •Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V)
- •Has a urine protein to creatinine ratio of > 1000 mg/g
- •Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment
- •Has adequate hematologic function
- •Restricted SLE treatments are stable and/or washed out
- •Most recent eGFR ≥ 40 mL/min/1.73m2
- •Has evidence of serologic activity
排除标准
- •Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
- •Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
- •Active TB or a positive TB test
研究组 & 干预措施
EQ001 for Type B cohort
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
干预措施: Itolizumab [Bmab 600] (Drug)
EQ001 Type A cohort
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg).
干预措施: Itolizumab [Bmab 600] (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events
时间窗: Type A up to Day 57 or Type B up to Day 253
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
次要结局
- To Characterize the PK of Itolizumab(Type A up to Day 57 or Type B up to Day 253)
- CD6 Receptor Occupancy(Type A up to Day 57 or Type B up to Day 253)