A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 29
- 主要终点
- Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study
研究概览
简要总结
The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.
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
- None
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
- •Subject has a diagnosis of primary immune thrombocytopenia (ITP) for a minimum of 3 months prior to Screening Visit
- •Subject has a platelet count <30x10^9/L at Screening and <35x10^9/L at Baseline (Visit 2)
- •Subject has a current or history of a peripheral blood smear consistent with ITP
- •Subject has responded to previous ITP therapy (according to the judgment of the investigator)
排除标准
- •Subject has an immunoglobulin G (IgG) level <=6g/L at Screening Visit
- •Subject has a partial thromboplastin time (PTT) >=1.5x upper limit of normal (ULN) or International Normalized Ratio (INR) >=1.5 at Screening Visit
- •Subject has renal and/or liver impairment defined as:
- •Serum creatinine level of >=1.4 mg/dL for females and >=1.5 mg/dL for males at Screening Visit
- •Subject has planned an elective surgical procedure in the coming 6 months
- •Subject has evidence of a secondary cause of primary immune thrombocytopenia purpura
- •Subject has a history of clinically relevant ongoing chronic infections
- •Subject has a family history of primary immunodeficiency
- •Subject has a clinically relevant active infection or has had a serious infection within 6 weeks prior to the first dose of IMP
- •Subject has a history of known inflammatory bowel disease, diverticular disease, and gastric or esophageal ulceration
- •Subject has experienced gastrointestinal bleed in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis
- •Subject has a medical history of thrombosis
- •Subject has a history of coagulopathy disorders other than ITP
- •Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
- •Subject has had prior treatment with rituximab in the 6 months prior to the Baseline Visit
- •Subject has not completed the washout period for the immunosuppressants, biologics and other therapies
研究组 & 干预措施
UCB7665 4 mg/kg
Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) at 1-week intervals.
干预措施: UCB7665 (Drug)
UCB7665 7 mg/kg
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals.
干预措施: UCB7665 (Drug)
UCB7665 10 mg/kg
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals.
干预措施: UCB7665 (Drug)
UCB7665 15 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.
干预措施: UCB7665 (Drug)
UCB7665 20 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg.
干预措施: UCB7665 (Drug)
结局指标
主要结局
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study
时间窗: From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first investigational medicinal product (IMP) administration)
TEAEs were defined as Adverse Events starting after the time of first Investigational Medicinal Product (IMP) administration up to and including 8 weeks after the final dose.
次要结局
未报告次要终点