A Study to Evaluate the Placental Transfer of Dapirolizumab Pegol to the Infant(s) From Pregnant Study Participants With Active Systemic Lupus Erythematosus Who Are Administered Dapirolizumab Pegol
A Prospective, Open-Label, Single-Arm, Multicenter Pharmacokinetic Study Evaluating the Placental Transfer of Dapirolizumab Pegol to the Infant(s) From Pregnant Study Participants With Active Systemic Lupus Erythematosus Who Are Administered Dapirolizumab Pegol
The purpose of the study is to assess transfer of dapirolizumab pegol (DZP) across the placenta to infants from mothers who are administered DZP
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：UCB Cares
- 电话号码：001 844 599 2273
研究联系人备份
- 姓名：UCB Cares
- 电话号码：+18445992273
- 邮箱：ucbcares@ucb.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participant must be greater than or equal to (≥)18 to less than or equal to (≤) 45 years of age at the time of signing the informed consent form (ICF)
- Participant must be considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the investigator
- Participant is pregnant and at ≥14 gestational week (GW) and 0 days and <28 GW and 0 days at the time of the first dose of DZP in the study. An ultrasound examination and the last menstrual period (LMP) will be used to determine the estimated date of delivery, to document the gestational age for the study, and to document a viable intrauterine pregnancy
- Participant has not been previously exposed to DZP
- Participant has been diagnosed with SLE by a qualified physician (eg, rheumatologist, internal medicine expert, immunologist, nephrologist, or dermatologist) as confirmed by meeting the 2019 SLE EULAR/ACR classification criteria for SLE
- Participant has an unmet medical need for a treatment intervention for SLE during their pregnancy as determined by the investigator based on the following criteria:
Maternal disease activity score as measured by a SLEPDAI score without serology ≥1 AND at least one of the risk factors specified in the protocol for SLE-associated maternal and/or fetal complications during pregnancy
- Body weight ≥40 kilograms (kg) and ≤150kg
Exclusion Criteria:
- Study participant has any evidence or medical history of a known non-autoimmune obstetrical condition with a high likelihood for pregnancy loss, or her fetus has any medical or surgical condition or history that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study or the outcome of the pregnancy
- Study participant has a history of chronic alcohol or drug abuse within the previous 24 weeks
- Study participant has a known hypersensitivity to any components of DZP including polyethylene glycol (PEG) or comparative drugs (and/or an investigational device) as stated in this protocol
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dapirolizumab pegol (DZP)
Pregnant women will receive DZP by intravenous (iv) administration during 2nd and 3rd trimester and after delivery they may continue for up to 1 year (if not breastfeeding). |
Study participants will receive DZP at pre-specified timepoints
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Plasma concentration of DZP in the infants at birth
大体时间：At Birth during this study
|
Plasma concentration of DZP will be reported in infants at birth. |
At Birth during this study
|
|
Plasma concentration of DZP in mothers at delivery
大体时间：At Delivery during this study
|
Plasma concentration of DZP in mothers at delivery will be reported. |
At Delivery during this study
|
|
Ratio between plasma concentration of DZP between the infants and mother at birth/delivery
大体时间：Infants: At Birth; Mothers: At Delivery during this study
|
Ratio of plasma concentration of DZP between the infants and mother at birth/delivery will be reported. |
Infants: At Birth; Mothers: At Delivery during this study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum
大体时间：At 4 weeks, 8 weeks, and 12 weeks after birth
|
Plasma concentration of DZP at 4 weeks or 8 weeks, and at 12 weeks after birth in the infants from mothers continuing DZP treatment postpartum will be reported. |
At 4 weeks, 8 weeks, and 12 weeks after birth
|
|
Predose and postdose plasma concentrations of DZP in mothers during pregnancy
大体时间：Predose and postdose during second and third trimester
|
Predose and postdose plasma concentrations of DZP in mothers during pregnancy will be reported. |
Predose and postdose during second and third trimester
|
|
DZP plasma concentrations at 12 and 14 Weeks postpartum in mothers continuing DZP treatment postpartum
大体时间：Predose and postdose at Week 12 and Week 14 postpartum
|
DZP plasma concentrations at 12 weeks (predose and postdose) and 14 weeks postpartum in mothers continuing DZP treatment postpartum will be reported. |
Predose and postdose at Week 12 and Week 14 postpartum
|
|
DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum
大体时间：At Week 12 postpartum
|
DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum will be reported. |
At Week 12 postpartum
|
|
Treatment-emergent adverse events (TEAEs) of mothers
大体时间：From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs for the mothers will be considered TEAEs if they occur after the start of DZP treatment in this study. |
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
|
Serious TEAEs of mothers
大体时间：From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
An SAE is any untoward medical occurrence that at any dose:
|
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
|
TEAEs of special interest of mothers
大体时间：From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
An AE of special interest is any AE that a regulatory authority has mandated to be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a UCB product/compound. |
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
|
TEAEs of special monitoring of mothers
大体时间：From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
An AE of special monitoring is a product-specific AE, adverse reaction, or safety topic requiring special monitoring by UCB. |
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
|
AEs of infants
大体时间：From birth to End of Safety Follow-Up (Up to 12 months)
|
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
From birth to End of Safety Follow-Up (Up to 12 months)
|
|
Serious AEs of infants
大体时间：From birth to End of Safety Follow-Up (Up to 12 months)
|
An SAE is any untoward medical occurrence that at any dose:
|
From birth to End of Safety Follow-Up (Up to 12 months)
|
|
AEs of special interest of infants
大体时间：From birth to End of Safety Follow-Up (Up to 12 months)
|
An AE of special interest is any AE that a regulatory authority has mandated to be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a UCB product/compound. |
From birth to End of Safety Follow-Up (Up to 12 months)
|
|
AEs of special monitoring of infants
大体时间：From birth to End of Safety Follow-Up (Up to 12 months)
|
An AE of special monitoring is a product-specific AE, adverse reaction, or safety topic requiring special monitoring by UCB. |
From birth to End of Safety Follow-Up (Up to 12 months)
|
|
Pregnancy outcome
大体时间：At the end of pregnancy during the study
|
Pregnancy outcome at the end of pregnancy during the study will be reported |
At the end of pregnancy during the study
|
|
Predicted area under the curve (AUC) over the dosing interval at steady state across the second and third trimesters of pregnancy
大体时间：Second and Third Trimesters
|
Predicted AUC over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported. |
Second and Third Trimesters
|
|
Predicted trough plasma concentration (Ctrough) over the dosing interval at steady state across the second and third trimesters of pregnancy
大体时间：Second and Third Trimesters
|
Predicted Ctrough over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported. |
Second and Third Trimesters
|
|
Predicted maximum plasma concentration (Cmax) over the dosing interval at steady state across the second and third trimesters of pregnancy
大体时间：Second and Third Trimesters
|
Predicted Cmax over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported. |
Second and Third Trimesters
|
|
Predicted AUC over the dosing interval at steady state across the postpartum
大体时间：Up to 14 weeks of postpartum
|
Predicted AUC over the dosing interval at steady state across the postpartum will be reported. |
Up to 14 weeks of postpartum
|
|
Predicted Ctrough over the dosing interval at steady state across the postpartum
大体时间：Up to 14 weeks of postpartum
|
Predicted Ctrough over the dosing interval at steady state across the postpartum will be reported. |
Up to 14 weeks of postpartum
|
|
Predicted Cmax over the dosing interval at steady state across the postpartum
大体时间：Up to 14 weeks of postpartum
|
Predicted Cmax over the dosing interval at steady state across the postpartum will be reported. |
Up to 14 weeks of postpartum
|
合作者和调查者
调查人员
- 研究主任：UCB Cares、001 844 599 22733 (UCB)
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- UP0155
- 2025 (美国 NIH 拨款/合同)
- 2025-524595-37 (注册表标识符：EU Clinical Trials)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized as there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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