A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 5
- 主要终点
- Number of Participants With Treatment Related Adverse Events as Defined by CTCAE 5.0
研究概览
简要总结
The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.
详细描述
This study is a single-arm, open-label, multicenter study of RLYB212 in HPA-1b/b pregnant participants at higher risk for the occurrence of HPA-1a alloimmunization and FNAIT. A laboratory testing paradigm will be applied at screening to identify women at higher risk for HPA-1a alloimmunization. Study IPA2202 is comprised of three phases: a two-part screening phase, an antenatal treatment phase, and a postpartum follow-up phase. Study duration for each participant is anticipated to be ~44 weeks, inclusive of the screening visits through the Week 10 postpartum visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who present at Gestational Week 6 or after and confirmed to be: HPA-1b/b (HPA-1a negative), HLA-DRB3*01:01 positive, Anti-HPA-1a alloantibody negative, Carrying an HPA-1a/b (HPA-1a positive) fetus
排除标准
- •Prior history of HPA-1a related fetal and neonatal alloimmune thrombocytopenia
- •Multiple pregnancy (more than 1 fetus)
- •Prior history of platelet transfusion or other blood transfusions
- •Known sensitivity and/or immediate hypersensitivity to any components of RLYB212 or its formulation
- •Any co-morbid medical or obstetric condition(s), laboratory abnormality, concomitant treatment, or other reason that, in the investigator's opinion, could adversely affect the safety of the participant and/or fetus, impair the assessment of study results, or preclude compliance with the study
研究组 & 干预措施
RLYB212
RLYB212 Subcutaneous injection
干预措施: Anti-(integrin beta-3) human monoclonal antibody (Drug)
结局指标
主要结局
Number of Participants With Treatment Related Adverse Events as Defined by CTCAE 5.0
时间窗: Approx. Gestational Week (GW) <16, 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38; at birth (~40), Post Partum (PP) Week 4, 10 week
Adverse Events will be collected throughout the study from the time of screening part 2 and beyond until the end of study visit (10 weeks postpartum for the maternal participant and 4-6 weeks of age for the neonate/infant). MedDRA version 27.0 or above will be used to code the AEs. All maternal AEs will be graded according to the National Cancer Institute of Common Terminology Criteria for AEs (CTCAE version 5.0 or higher) and Maternal and Fetal Adverse Event Terminology (MFAET version 1.0 or higher).
Maternal Exposure to RLYB212 as Measured in Serum
时间窗: Approx. GW 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38, at birth (~40), PP Week 4
The PK profile of RLYB212 during pregnancy following repeat SC administration was evaluated. Results reported in concentration only.
次要结局
- Frequency of Neonatal Thrombocytopenia as Measured by Platelet Count Within 72 Hours of Delivery(At birth (~GW 40))
- Neonatal Exposure to RLYB212 as Measured in Cord Blood(At birth (~GW 40))
- Number of HPA-1a Positive Neonates With Treatment Related Adverse Events as Defined by CTCAE v5.0(At birth (~GW 40), Approx. PP Week 4)
- Pregnancy Outcomes: Incidence of Live Births, Spontaneous Abortions, Elective Abortions, Still Births or Premature Births(At birth (~GW 40))
- Frequency of HPA-1a Alloimmunization as Measured by Anti-HPA-1a Alloantibodies(Approx. PP Week 10)
- Neonatal Outcomes: General Health and Overall Status as Defined by Absolute Values and Percentiles(4-6 weeks following delivery)
- Participants That Test Positive for Anti-RLYB212 Antibodies as Measured in Their Serum(16, 20, 24, 28, 32, 36, at birth (~40), PP Week 4)