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

July 16, 2026 updated by: UCB Biopharma SRL

A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Calgary, Canada
        • Recruiting
        • Up0122 202
      • Vancouver, Canada
        • Recruiting
        • Up0122 201
  • Germany
      • Freiburg im Breisgau, Germany
        • Recruiting
        • Up0122 301
      • Herne, Germany
        • Recruiting
        • Up0122 303
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Up0122 502
      • Barcelona, Spain
        • Recruiting
        • Up0122 501
  • Switzerland
      • Lausanne, Switzerland
        • Recruiting
        • Up0122 602
      • Sankt Gallen, Switzerland
        • Recruiting
        • Up0122 601
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Up0122 105
    • Florida
      • South Miami, Florida, United States, 33155
        • Recruiting
        • Up0122 103
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Up0122 104
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Recruiting
        • Up0122 106
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Up0122 102
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Up0122 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Bimekizumab
Bimekizumab under the care of their treating physician.
Other Names:
  • Bimzelx®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of bimekizumab in the breast milk on Day 1
Time Frame: Day 1
Breast milk samples will be collected predose on Day 1.
Day 1
Concentration of bimekizumab in the breast milk on Day 2
Time Frame: Day 2
Breast milk samples will be collected predose on Day 2.
Day 2
Concentration of bimekizumab in the breast milk on Day 3
Time Frame: Day 3
Breast milk samples will be collected predose on Day 3.
Day 3
Concentration of bimekizumab in the breast milk on Day 5
Time Frame: Day 5
Breast milk samples will be collected predose on Day 5.
Day 5
Concentration of bimekizumab in the breast milk on Day 7
Time Frame: Day 7
Breast milk samples will be collected predose on Day 7.
Day 7
Concentration of bimekizumab in the breast milk on Day 9
Time Frame: Day 9
Breast milk samples will be collected predose on Day 9.
Day 9
Concentration of bimekizumab in the breast milk on Day 11
Time Frame: Day 11
Breast milk samples will be collected predose on Day 11.
Day 11
Concentration of bimekizumab in the breast milk on Day 13
Time Frame: Day 13
Breast milk samples will be collected predose on Day 13.
Day 13
Concentration of bimekizumab in the breast milk on Day 15
Time Frame: Day 15
Breast milk samples will be collected predose on Day 15.
Day 15
Concentration of bimekizumab in the breast milk on Day 29
Time Frame: Day 29
Breast milk samples will be collected predose on Day 29 for mothers on every 4 weeks (Q4W) dosing regimen.
Day 29
Concentration of bimekizumab in the breast milk on Day 57
Time Frame: Day 57
Breast milk samples will be collected predose on Day 57 for mothers on every 8 weeks (Q8W) dosing regimen.
Day 57

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Infant Dosage of bimekizumab from breast milk
Time Frame: Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57
Breast milk samples will be collected predose on Day 1 (bimekizumab dosing day), Days 2, 3, 5, 7, 9, 11, 13, and 15 for all study participants (Day 15 predose if every 2 weeks (Q2W) dosing regimen), predose on Day 29 (if Q4W dosing regimen) or Day 57 (if Q8W dosing regimen).
Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57
Relative Infant Dose of bimekizumab from breast milk
Time Frame: Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57
Breast milk samples will be collected predose on Day 1 (bimekizumab dosing day), Days 2, 3, 5, 7, 9, 11, 13, and 15 for all study participants (Day 15 predose if every 2 weeks (Q2W) dosing regimen), predose on Day 29 (if Q4W dosing regimen) or Day 57 (if Q8W dosing regimen).
Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57
Treatment-emergent Adverse Events (TEAEs) of the mother from time of informed consent through SFU contact
Time Frame: From time of informed consent up to approximately 17 weeks
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
From time of informed consent up to approximately 17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2025

Primary Completion (Estimated)

May 3, 2027

Study Completion (Estimated)

May 3, 2027

Study Registration Dates

First Submitted

March 15, 2025

First Submitted That Met QC Criteria

March 15, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP0122
  • 2024-518689-29 (Registry Identifier: EU Clinical Trials)
  • U1111-1318-5063 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized as there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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