2024-516064-28-00已完成3 期
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
Equillium Inc.61 个研究点 分布在 5 个国家目标入组 99 人开始时间: 2024年8月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 61
- 主要终点
- Complete Response rate at Day 29.
研究概览
简要总结
To assess the efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥12 years and >40 kg at informed consent/assent. Subjects <18 years may only enroll if locally permitted.
- •Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis. NOTE: 2 allogeneic HSCTs may be allowed if GVHD did not occur after the first HSCT.
- •Has evidence of myeloid engraftment, defined as an absolute neutrophil count ≥500/mm3 (or ≥0.5 × 10exp9/L) achieved and sustained for 3 laboratory values obtained on different days. Laboratory values prior to Screening may be used.
- •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 - at Screening and randomization. Biopsies to confirm aGVHD should be obtained but are not required and should not delay entry into the study.
- •Began initial systemic corticosteroid treatment with ≥ 1mg/kg/day methylprednisolone or equivalent 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
- •Has evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
- •Has an unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
- •Has evidence of persistent molecular disease requiring treatment (eg, standard chemotherapy or tyrosine kinase inhibitors) that was not specified prior to HSCT.
- •Has evidence of cGVHD or overlap syndrome, as defined by 2014 NIH Consensus Criteria.
- •Is using immunosuppressants other than corticosteroids for the treatment of aGVHD. Continued use of immunosuppressants as GVHD prophylaxis agents is permitted.
- •Has received 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. Systemic corticosteroids administered as premedication before blood product transfusions or IV medications to prevent infusion-related reactions are allowed.
- •Has a clinically active, uncontrolled bacterial, viral, or fungal infection, despite adequate treatment. No signs of progression of the infection can be present at randomization. Asymptomatic cytomegalovirus (CMV), Epstein–Barr virus (EBV), or human Herpesvirus 6 (HHV-6) viremia based on viral load or a viral load that is declining with treatment does not constitute a clinically active infection.
- •Other Protocol-defined criteria apply.
结局指标
主要结局
Complete Response rate at Day 29.
Complete Response rate at Day 29.
次要结局
- 1. Overall response rate at Day 29.
- 2. Durable complete response rate from Day 29 through Day 99.
研究者
Clinical Trials Information
Scientific
Equillium Inc.
研究点 (61)
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