FAQs

The BE CARING Study is taking place to gather information on bimekizumab in the breast milk of mothers who are breastfeeding and taking bimekizumab. This study will also look at the levels of bimekizumab in the blood of both the mother and her breastfeeding baby. The information that researchers learn in this study might be able to help other women in the future who are facing the difficult decision of whether to take bimekizumab while they are breastfeeding.

If you join the study, here are some of the things you will be asked to do:

• Attend study visits – some of these can be in your own home and/or at a study center or clinic.
• Allow the collection of breast milk using an electronic breast pump that will be provided to you by the study team.
• Allow the collection of blood from you and, if consent is given, your baby.
• Fill in a study diary – this will be provided to you by the study team.

If you decide to join the BE CARING Study, your participation will last for a maximum of 17 weeks (this is about 4 months). Your breast milk will be collected up to 10 times – this will be mostly over a period of 2 weeks. How long you are part of the study also depends on your individual bimekizumab dosing schedule.

The BE CARING Study is for women who are already taking bimekizumab as prescribed by their treating physician for an autoimmune or autoinflammatory disease. This decision will have been made before joining the study and independently of the study. You will not be provided any medication as part of this study, including the bimekizumab you are currently taking.

No, participants will not have to return the breast pump at the end of the study.

Study participants and their babies can continue on their prescribed medications that they were already taking when they joined the study, with the exception of any biologic treatments other than bimekizumab, which are not allowed. Certain medications should be discussed with the study team before starting to take them, such as antibiotics or medications or herbal treatments that have an effect on breast milk production. The study team will discuss this with you in more detail.

There are risks and discomforts in most studies, and these include risks associated with the procedures done as part of study visits. Your study team will inform you in detail about potential risks and benefits before you decide to join the study. Some known risks and discomforts in this study are:

• Using the electronic breast pump may cause breast pain, soreness, discomfort, or infection (but this is rare).
• Having blood samples taken from you and your baby may cause pain or bruising.
• Having your blood pressure taken using an inflatable cuff may cause mild discomfort in your arm.

Joining in a clinical study is a very personal and individual decision, and you should consider if this is the right choice for you and your family. You can stop your or your baby’s participation at any time without having to give a reason. Deciding not to take part will not affect your or your baby’s medical care now or in the future.

You will not receive any payment for participation in the study, but reasonable travel expenses can be reimbursed. Please speak to your study team about how this works. You will not have to pay for any study-related tests and assessments.

The BE CARING Study is sponsored by UCB, a global biopharma company based in Belgium that is focusing on neurology and immunology disorders, including a number of different autoimmune diseases.

All your personal data and your breastfeeding baby’s personal data collected for the study that can identify you will be “coded” to remove any part of the personal data that could identify you or your baby. Using a code to identify you or your baby helps researchers keep your information confidential.

The overall results of this study will be available on https://www.clinicaltrials.gov after all participants have left the study, all study data has been analyzed and the final study report has been written. A summary of the results in plain language will be shared on the UCB website, but please note that it could take years until this is available. The study sponsor UCB may publish the results in an academic journal, but it will not include any information that can identify individual study participants.