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NCT Number: NCT06888193

A 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.

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Key information

Conditions

Moderate to Severe Plaque Psoriasis Ankylosis Arthritis Arthritis, Psoriatic Axial Spondyloarthritis Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Hidradenitis Hidradenitis Suppurativa Infections Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Up0122 202, Calgary, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bimekizumab

Drug

Bimekizumab under the care of their treating physician.

Other names: Bimzelx®

Primary outcomes

  1. Concentration of bimekizumab in the breast milk on Day 1

    Time frame: Day 1

    Breast milk samples will be collected predose on Day 1.

  2. Concentration of bimekizumab in the breast milk on Day 2

    Time frame: Day 2

    Breast milk samples will be collected predose on Day 2.

  3. Concentration of bimekizumab in the breast milk on Day 3

    Time frame: Day 3

    Breast milk samples will be collected predose on Day 3.

  4. Concentration of bimekizumab in the breast milk on Day 5

    Time frame: Day 5

    Breast milk samples will be collected predose on Day 5.

  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.

  6. Concentration of bimekizumab in the breast milk on Day 9

    Time frame: Day 9

    Breast milk samples will be collected predose on Day 9.

  7. Concentration of bimekizumab in the breast milk on Day 11

    Time frame: Day 11

    Breast milk samples will be collected predose on Day 11.

  8. Concentration of bimekizumab in the breast milk on Day 13

    Time frame: Day 13

    Breast milk samples will be collected predose on Day 13.

  9. Concentration of bimekizumab in the breast milk on Day 15

    Time frame: Day 15

    Breast milk samples will be collected predose on Day 15.

  10. 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.

  11. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

UCB Cares

CONTACT

[email protected]

1-844-599-2273 (USA)

UCB Cares

CONTACT

[email protected]

001 844 599 2273 (USA)

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

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

Acronym: BE CARING

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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