CTRI/2021/09/036978已完成1 期
A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects with Systemic Lupus with or without Active Proliferative Lupus Nephritis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Incidence of Treatment Emergent Adverse Events. Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
研究概览
简要总结
The study will enroll up to 50 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of 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
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
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.
- •Meets SLICC and/or ACR criteria for SLE
- •Kidney biopsy with a histologic diagnosis of LN Classes III, 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
- •During Screening has adequate hematologic function
- •Most recent eGFR ≥ 40 mL/min/1.73m2
- •Has evidence of serologic activity during Screening.
排除标准
- •Key Exclusion Criteria:
- •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.
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events. Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
时间窗: Type A up to Day 57 or Type B up to Day 253
次要结局
- EQ001 serum concentrations(Type A up to Day 57 or Type B up to Day 253)
- CD6 receptor occupancy. The % levels of free versus EQ001-bound CD6 receptor on T cells(Type A up to Day 57 or Type B up to Day 253)
研究者
研究点 (4)
Loading locations...
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