A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
NCT ID: NCT06888193
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-11-05
2027-05-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Bimekizumab
Breastfeeding mothers who are already receiving commercial bimekizumab per locally approved prescribing information and in consultation and agreement with their treating physicians will participate in this study. Study participants will continue receiving commercially available bimekizumab under the care of their treating physician.
Bimekizumab
Bimekizumab under the care of their treating physician.
Interventions
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Bimekizumab
Bimekizumab under the care of their treating physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Up0122 105
Santa Monica, California, United States
Up0122 103
South Miami, Florida, United States
Up0122 102
Durham, North Carolina, United States
Up0122 202
Calgary, , Canada
Up0122 201
Vancouver, , Canada
Up0122 502
Barcelona, , Spain
Up0122 602
Lausanne, , Switzerland
Up0122 601
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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2024-518689-29
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1318-5063
Identifier Type: OTHER
Identifier Source: secondary_id
UP0122
Identifier Type: -
Identifier Source: org_study_id