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Recruiting Phase 1 NCT06888193

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

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Trial Parameters

Condition Moderate to Severe Plaque Psoriasis
Sponsor UCB Biopharma SRL
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-11-05
Completion 2027-05-03
Interventions
Bimekizumab

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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 Investigat

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