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Taking people in SwitzerlandPhase 1

Measures bimekizumab levels in breast milk of mothers taking it

Tests how much bimekizumab passes into breast milk in women treated for psoriasis or arthritis.

Key facts

Who runs it
UCB Biopharma SRL
Where
Lausanne and Sankt Gallen, SwitzerlandSee the 2 sitesAlso in 4 other countries, 12 sites
Trial code
Registry title
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Status
Recruiting
Phase
Phase 1
People taking part
20 people, planned
Started
5 Nov 2025
Expected to end
31 Dec 2027
Type of study
Interventional
Treatments tested
  • Bimekizumab
Record updated
18 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for breastfeeding women, aged 18 or older, who are already treated with bimekizumab (Bimzelx). It measures how much of the drug is in their breast milk.

Age
18 years or older
Sex
Women only
Disease stage
The record lists moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and hidradenitis suppurativa as the conditions studied.
Earlier treatment
Must be treated with commercial bimekizumab for at least 12 weeks after delivery and since starting, restarting or continuing it, before sampling begins.

Main reasons for not taking part

  • Pregnant, or plans to become pregnant during the study
  • History of breast implants, breast augmentation or breast reduction surgery
  • History of chronic alcohol or drug abuse within the last year
  • Planned surgery during the screening or sampling period (tubal ligation is not counted)
  • Took part in another study of an investigational medicine or device within the previous 6 months

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Study participant has a history of chronic alcohol or drug abuse within the previous last year
  • 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
  • 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
  • Study participant has history of breast implants, breast augmentation, or breast reduction surgery
  • 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

Where in Switzerland

Also in 4 other countries, 12 sites

  • Up0122 602Lausanne, SwitzerlandContact: UCB CaresTaking people
  • Up0122 601Sankt Gallen, SwitzerlandContact: UCB CaresTaking people

About the trial

What the trial wants to find out

Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.

The group in the trial

  • BimekizumabTreatment being tested

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Plain-language title
Measures bimekizumab levels in breast milk of mothers taking itGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
18 September 2026