A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Gusacitinib in Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Adverse Events severity (as defined by AEs equal or greater than grade 3 as per the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0) and frequency as compared to placebo at week 12
研究概览
简要总结
Background:
Systemic lupus erythematosus (SLE), also called lupus, is a disease that causes the body s immune system to attack healthy tissue. Lupus causes swelling and inflammation in the skin, skin, joints, kidneys, brain, blood vessels, and other organs. There is no cure for lupus. Current treatments do not help everyone and may have adverse effects. Better treatments are needed.
Objective:
To test a study drug (Gusacitinib) in people with lupus.
Eligibility:
People aged 18 years and older with lupus.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. They will have a chest X-ray. They will have tests that use blood pressure cuffs to measure blood flow and pressure throughout the body.
Participants will have 9 clinic visits and 6 phone visits over about 7 months.
The study has 3 parts.
Part 1: Gusacitinib is a tablet taken by mouth. Participants will be divided into 3 groups. One group will receive the study drug, and a second group will get a placebo. The placebo looks like the study drug but does not contain any medicine. Both of these groups will take their tablets once a day for 12 weeks. The third group will continue to take their usual medications for lupus throughout the study.
Part 2: All participants who took the study drug or placebo in part 1 will take the study drug once a day for 12 weeks.
Part 3: All participants who took the study drug will stop taking it for 4 weeks.
详细描述
STUDY DESCRIPTION:
This is a phase Ib study of Gusacitinib a dual inhibitor of JAK and SYK kinases, that can simultaneously target multiple signaling pathways responsible for the SLE disease pathogenesis. This study will compare the safety of Gusacitinib 80 mg with placebo initially in a double-blind period and then 80 mg daily in an open label period, followed by an off-drug period.
In addition, we will have a comparator group of SLE subjects receiving standard of care treatment. We hypothesize that Gusacitinib will be safe and well tolerated in subjects with SLE.
OBJECTIVES:
Primary Objective: The primary Objective of the study is to determine safety and tolerability of Gusacitinib 80 mg in subjects with SLE.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects will receive a placebo that looks similar to the interventional drug.
干预措施: Gusacitinib (Drug)
结局指标
主要结局
Adverse Events severity (as defined by AEs equal or greater than grade 3 as per the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0) and frequency as compared to placebo at week 12
时间窗: Week 12
Adverse Events severity (as defined by AEs equal or greater than grade 3 as per the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE) v5.0) and frequency as compared to placebo
次要结局
- Change in the proportion of patients achieving SLE Responder Index-4 (SRI 4) response at week 24 compared to baseline. Another efficacy analysis will be done by comparing subjects treated with Gusacitinib vs. placebo at week 12.(Week 12)