About the BE CARING Study
The aim of the BE CARING Study is to gather information about the amounts of a drug called bimekizumab in the breast milk of breastfeeding mothers who are taking it for an autoimmune or autoinflammatory disease. The study will also assess the amounts of bimekizumab in the blood of both the mother and (optionally, if the parents or guardians agree to it) her breastfeeding baby.
If you are 18 years of age or older, are already taking bimekizumab and plan to continue taking it, and have decided to breastfeed while taking bimekizumab, then you may be able to take part in this study. The study team will discuss other eligibility criteria with you too.
The study will last a maximum of around 17 weeks (approximately 4 months), with up to 10 study visits. The breast milk and blood sampling will take place mostly over a 2-week period.
Breast milk and blood samples will be taken from you and blood samples will be taken from you and your baby during the BE CARING Study. The blood samples from your baby are completely optional.
Breast milk samples are very important for the BE CARING Study and allow researchers to measure the amount of bimekizumab in your breast milk. Blood samples from you and your baby are also very important for this study and will help researchers measure the amount of bimekizumab in your blood and your baby’s blood. The amount of blood taken from your baby is very small and the study team are trained to take blood as painlessly as possible. A machine records the electrical activity of your heart through small patches attached to your chest, arms and legs.
Around 15–20
participants
Up to 17
weeks*
About 10
study visits
You will visit the study center for tests to see if you can take part.
During this phase of the study, breast milk and blood samples will be taken at study visits.
There will be a phone call approximately 5 weeks after the final breast milk or blood sample is taken.
What happens at the study visits?
Study visits will take around 2 hours. You will have the choice of completing study visits at home in the presence of a qualified nurse or at a clinic, study site, or other healthcare provider office. You will undergo various tests and assessments at these visits. The tests and assessments include (but are not limited to) the following:
Collection of your demographic, health and pregnancy data, such as your age, medical history, what medications you’re taking and how your pregnancy and delivery went
Collection of breast milk with a breast pump to measure the amount of bimekizumab in your breast milk
Collection of a small amount of blood from you (3 times) and your baby (2 times, but is optional)
Physical exam, including measurement of your height and weight
Measurement of your vital signs – blood pressure, pulse rate, and body temperature
Review of what you fed your baby since the last study visit
Review of bimekizumab dosing dates and times since the previous study visit
Review of other medications taken by you or your baby since the previous study visit
If you or your baby are having breastfeeding problems during the study, a lactation professional will be available for assistance.
While you will not receive any payment for your participation in this study, reimbursement for study-related travel costs may be provided.
Before you decide to join the study, the study team will explain everything related to the study in more detail, including the known risks and benefits and you will have the opportunity to ask any questions you may have.
You will not receive any study drugs as part of the study and will continue to take bimekizumab as prescribed by your doctor. Because you made the decision independently of the study to breastfeed while taking bimekizumab, the bimekizumab you take will not be supplied to you during the study.
You can answer the questions in the pre-screener questionnaire to see if you might qualify for the BE CARING Study and you can find a study center near you on the Find a study center page.
You will be told about the study in more detail by the team at the study center, and they will also go through the Informed Consent Form (ICF) with you. An ICF is there to make sure you have all the information you need to make the best decision for yourself and your baby about participating in a clinical study.
