2024-518689-29-00招募中1 期
A multicenter, open-label, prospective study to assess the concentration of bimekizumab in mature breast milk from mothers receiving treatment with Bimzelx® (bimekizumab)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 5
- 主要终点
- Concentration of bimekizumab in the breast milk predose on Day 1 and on Days 2, 3, 5, 7, 9, 11, 13, and 15 (predose for mothers on Q2W dosing regimen), and in addition, predose on Day 29 or Day 57 for mothers on Q4W or Q8W dosing regimen, respectively
研究概览
简要总结
To assess the concentration of bimekizumab in mature human breast milk
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Study participant must be at least 18 years of age at the time of signing the informed consent.
- •Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician.
- •Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period.
- •The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study.
- •Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to sampling (prior to start of the Sampling Period).
- •A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.
排除标准
- •Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study.
- •The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation.
- •Study participant has a history of chronic alcohol or drug abuse within the previous last year.
- •Study participant has history of breast implants, breast augmentation, or breast reduction surgery.
- •Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation).
- •Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and/or an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study.
- •Study participant or her infant has previously participated (ie, entered the sampling period) in this study.
结局指标
主要结局
Concentration of bimekizumab in the breast milk predose on Day 1 and on Days 2, 3, 5, 7, 9, 11, 13, and 15 (predose for mothers on Q2W dosing regimen), and in addition, predose on Day 29 or Day 57 for mothers on Q4W or Q8W dosing regimen, respectively
Concentration of bimekizumab in the breast milk predose on Day 1 and on Days 2, 3, 5, 7, 9, 11, 13, and 15 (predose for mothers on Q2W dosing regimen), and in addition, predose on Day 29 or Day 57 for mothers on Q4W or Q8W dosing regimen, respectively
次要结局
- Estimated Infant Dosage of bimekizumab from breast milk
- Relative Infant Dose of bimekizumab from breast milk
- Treatment-emergent adverse events (TEAEs) of the mother from time of informed consent through Safety Follow-Up (SFU) contact
研究者
UCB Cares
Scientific
UCB Biopharma
研究点 (5)
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