A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Equillium
- 入组人数
- 158
- 试验地点
- 118
- 主要终点
- The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
研究概览
简要总结
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids
详细描述
This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.
- •Is age ≥12 years and >40kg at informed consent/assent.
- •Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
- •Has evidence of myeloid engraftment
- •Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.
- •Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.
排除标准
- •Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
- •An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
- •Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
- •Evidence of cGVHD or overlap syndrome
- •Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
- •Use of any systemic corticosteroids of >0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.
研究组 & 干预措施
Itolizumab (EQ001)
Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
干预措施: Itolizumab (Biological)
EQ001 Placebo
EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses
干预措施: EQ001 Placebo (Drug)
结局指标
主要结局
The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
时间窗: Day 29
Complete response at Day 29
次要结局
- Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures,(Day 29)
- Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.(Day 99)