FAQs

The aim of the BE SEEN Study is to evaluate the investigational drug bimekizumab in people with PPP. The main study goal is to test the safety (how well it’s tolerated) and efficacy (how well it works) of bimekizumab in patients with PPP and to see what kind of effect it has on the symptoms of PPP.

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

• Attend study visits – these will be at a study centre or clinic. Some visits can take place at home.
• Allow the collection of blood and urine samples.

The study consists of a main period and an extension period. For each participant, the total time in the study can be up to 122 weeks (approx. 2 years and 4 months).

In the main study period, you will be randomly assigned (like drawing a straw) to either the investigational drug, bimekizumab, or a placebo. A placebo looks like bimekizumab but contains no medicinally active ingredients. For the extension period, all participants will receive bimekizumab.

Please speak to the study team about medications that you cannot take during the study or that are restricted. The study team will discuss these with you in more detail.

There are risks and discomforts in most studies, and these include risks associated with the tests and assessments 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:

• Having blood samples taken from you may cause pain or bruising.
• Having the study medication injected subcutaneously (under the skin) may cause irritation or discomfort around the injection site.
• 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 participation at any time without having to give a reason. Deciding not to take part will not affect your 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 the study treatment, nor any study-related tests and assessments.

The BE SEEN Study is sponsored by UCB, a global biopharma company based in Belgium. UCB is focusing on neurological and immunological disorders, including a number of different autoimmune diseases such as PPP.

All your personal data collected for the study will be “coded” to remove any part of the personal data that could identify you. Using a code to identify you 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 have been analysed 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 up to several years after your participation until this is available. The study sponsor UCB may publish the results in an academic journal, but these will not include any information that can identify individual study participants.