A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Iltoo Pharma
- 入组人数
- 100
- 试验地点
- 25
- 主要终点
- SRI-4 (SLE responder index)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus erythematosus.
详细描述
Interleukin 2 (IL-2) plays an important role on immune homeostasis by acting on T lymphocytes. In systemic lupus erythematosus, there is a so called "insufficiency" in a subpopulation of T lymphocytes, the regulatory T cells (Tregs) leading to altered immune balance between regulatory and effector T cells. These cells seem to play a major role in the physiopathology of the disease. Many researches enlighten the fact that this Tregs/Teffs balance can be restored by administering low dose of IL-2. It is thus assumed that treatment with low dose of IL-2 may impact positively the progression of the disease and thus help patients improving their clinical outcomes.
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
- Double (Participant, Investigator)
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
- •Confirmed diagnosis of SLE
- •Active SLE
- •On stable background therapy for 1 month
- •Using highly effective contraception
排除标准
- •Serious organ failure (renal functional impairment, severe central nervous system manifestations, severe heart failure, liver failure)
- •Any clinical evidence of active chronic infection HIV, hepatitis B, hepatitis C
- •Clinical significant pleuritis or pericarditis
- •Type1 Diabetes and/or CROHN's disease
- •Use of Benlysta (belimumab) in the past 4 weeks
- •Use of Rituximab in the past 6 months
- •Vaccination with live attenuated virus in the last month
研究组 & 干预措施
ILT-101
Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
干预措施: ILT-101 (Drug)
Placebo
Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
干预措施: Placebo (Drug)
结局指标
主要结局
SRI-4 (SLE responder index)
时间窗: at week 12
Number of participants with SRI-4
次要结局
- Incidence of adverse events(From baseline up to week 24 or 36)
- Number of participants able to reduce oral steroid dose of 25 and 50%(From baseline to week 12 or 24)
- Anti ds-DNA by immunology-based assay(From baseline to week 12 or 24)
- %Tregs(From baseline to week 12 or 24)