BE CARING: A Prospective Study of Breast Milk Concentration of Bimekizumab in Mothers Taking Bimzelx® (Bimekizumab)

Overview 

This study aims to assess the amount of bimekizumab that is transferred through breast milk for breastfeeding mothers. We are assessing and evaluating:

• The concentrations of bimekizumab within breast milk
• The safety of bimekizumab in the mother
  • Evaluating concentrations in both plasma and breast milk comparatively
  • Exploring the amount of anti-bimekizumab antibodies in plasma and milk
• The safety of transfer to the infant
  • By evaluating infant plasma concentrations after ingestion
• Different dosing regimens of bimekizumab

You can find more information here.

This study is sponsored by UCB Biopharma SRL.

What will be done?

This study is called a  Post-Authorization Safety Study (PASS) as it assesses the risk of bimekizumab usage by breastfeeding mothers, since safety information is limited.

It is also considered interventional as there are study procedures including sample collection, which are not deemed standard of care practices.

All mothers in this study will have already decided on bimekizumab as a treatment with their physician prior to enrollment, and to continue treatment while breastfeeding.

Only approved dosing regiments will be utilized, and participation varies based on frequency of dosing. The maximum duration of participation within the study is about 17 weeks.

Participation includes:

• A screening period of up to 4 weeks,
• A sampling period of 2, 4, or 8 weeks (depending on expected bimekizumab dosing regimens)
• A safety follow up contact for 5 weeks (±5 days) after the final sample is obtained

The following data will be obtained:

• Demographic information
• Medical history
• Pregnancy outcomes
• Physical assessments for both the mother and infant
• Samples
  • Breast milk
  • Maternal blood samples
  • Infant blood samples
    • Infant blood draws are optional; parents will have to consent to this specific blood draw in addition to the main consent for this study

Who can participate?

You may be eligible if you:

• Are 19 years of age or older
• Are being treated with commercial bimekizumab per locally approved prescribing information, in accordance with your treating physician
• Are breastfeeding and intend to breastfeed throughout the sampling period
• Are on bimekizumab at leasst 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to sampling
• A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study
• Your decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study

Want to find out more?

Talk to your rheumatologist to get involved. Ask your rheumatologist about the possibility of participating in the breastfeeding clinical trial with Dr. Neda Amiri.

If you have questions, you can contact the study team at clinicaltrials@arthritisresearch.ca

This study has been approved by the UBC Clinical Research Ethics Board, under application number [H24-03862].