A Multicenter, Phase 2a, Open-label, Non-randomized Study Evaluating the Efficacy, Safety, and Tolerability of BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 9
- 主要终点
- Percentage of Participants With a Durable Platelet Response
研究概览
简要总结
Primary Objective:
- To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP)
Secondary Objectives:
- To assess the safety and tolerability of BIVV020
- To assess the pharmacokinetics of BIVV020
- To assess the response rate of treatment with BIVV020
- To assess the time to response
- To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy
- To assess the immunogenicity of BIVV020
详细描述
Study duration:
- Screening period: up to 56 days
- Transition period between last sutimlimab dose and first dose of BIVV020 (for participants who were previously receiving sutimlimab): 14 days, included as part of the 56-day Screening period. Treatment duration: Minimum 52 weeks.
Visit frequency:
- Day 1
- Day 4
- Weeks 1 to 6: Weekly
- Weeks 7 to 12: Every other week
- Weeks 13 to 24: Every 4 weeks
- Weeks 25+: At least every 8 weeks
- End of Study visit: 22 weeks after the last dose of BIVV020
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR445088
Participants received SAR445088 (BIVV020).
干预措施: SAR445088 (BIVV020) (Drug)
结局指标
主要结局
Percentage of Participants With a Durable Platelet Response
时间窗: From Week 3 to Week 24
A naive participant was a participant who did not use sutimlimab prior to enrollment. A switcher was a participant who used sutimlimab prior to enrollment. A naive participant was a responder if the platelet count was \>=50 × 10\^9/liter (L) at \>=50 percent (%) of scheduled visits, or for participants with baseline platelet count \<15 × 10\^9/L, a \>=20 × 10\^9/L increase in platelet count from baseline at \>=50% of scheduled visits, without receiving rescue immune thrombocytopenia (ITP) therapy. A switcher was a responder if the maintenance platelet count was \>=30 × 10\^9/L at \>=50% of scheduled visits, without receiving rescue ITP therapy.
次要结局
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Urinalysis(On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103))
- Plasma Concentrations of SAR445088 (BIVV020)(1-hour post-dose on Day 1, on Days 8, 15, 29, 43, at Weeks 12, 16, 24, 32, 40, 48, 56, 64, 72, 80 and EOS visit, up to 103 weeks)
- Number of Responders to SAR445088 (BIVV020)(At Weeks 24 and 56)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (SAE)(From first study treatment administration (Day 1) up to Week 103)
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematology(On Days 1, 15, 29, at Weeks 8, 12, 24, and then every 8 weeks until the end of study (EOS) (Week 103))
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Clinical Chemistry(On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103))
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Coagulation(On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103))
- Number of Participants With Anti-Drug Antibody (ADAs) Response to SAR445088 (BIVV020)(Up to Week 103)
- Time to First Platelet Response(From Baseline (Day 1) up to Week 56)
- Percentage of Participants Who Did Not Require Rescue Therapy for an Acute Episode of Thrombocytopenia After Week 3(Up to Week 84)