NCT06888193 A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
| NCT ID | NCT06888193 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | UCB Biopharma SRL |
| Condition | Moderate to Severe Plaque Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2027-05-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-11-05 with a primary completion date of 2027-05-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
UCB Cares
STUDY DIRECTOR
001 844 599 2273
Frequently Asked Questions
Who can join the NCT06888193 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Moderate to Severe Plaque Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06888193 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06888193 currently recruiting?
Yes, NCT06888193 is actively recruiting participants. Contact the research team at ucbcares@ucb.com for enrollment information.
Where is the NCT06888193 trial being conducted?
This trial is being conducted at Santa Monica, United States, South Miami, United States, Durham, United States, Milwaukee, United States and 8 additional locations.
Who is sponsoring the NCT06888193 clinical trial?
NCT06888193 is sponsored by UCB Biopharma SRL. The principal investigator is UCB Cares at 001 844 599 2273. The trial plans to enroll 20 participants.
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