About the BE SEEN Study
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. Bimekizumab has already been approved in a number of countries for use in other autoinflammatory conditions.
If you are at least 18 years old, have been diagnosed with PPP for 6 months or longer, and currently have active disease on the palms of your hands and/or the soles of your feet, you may be able to take part in this study. The study team will discuss other eligibility criteria with you too.
The study consists of a main part and an extension part. The main part will last between 57 weeks (a little over a year) and 65 weeks (approximately 15 months). There’s an extension part that will last a maximum of 60 weeks (14 months). The whole study could last up to 117 weeks (2 years and 3 months).
In the BE SEEN Study, the study medication is given as a subcutaneous (under the skin) injection.
For the first part of the study treatment period, you will be randomly assigned (like drawing a straw) to one of two treatment groups. One group will receive the investigational drug, bimekizumab, the other group will receive a placebo. A placebo looks like bimekizumab but contains no medicinally active ingredients.
For the second part of the treatment period and the extension period, all participants will receive bimekizumab. The study team at the study centre will explain everything you need to know about this process.
Around 300
participants
Up to 117
weeks
About 29
study visits
Study Journey
For each participant, the total time in the study can be up to 117 weeks (2 years and 3 months). The main part of the study is up to 57 weeks (just over a year). If you leave the study at this point, you will then enter a follow-up period, or you may be able to keep receiving the investigational drug for an additional year plus follow-up after the initial 57 weeks in the main study.
What happens at the study visits?
Study visits will take up to 2 hours. You will undergo various assessments and tests at the study visits. The tests and assessments include (but are not limited to) the following:
Collection of your demographic and health data, such as your age, your medical and PPP history, and what medications you’re currently taking
Information about your smoking history or status
A physical examination and assessment of your current PPP disease activity
Measurement of your weight and height
Assessment of your vital signs – pulse rate, blood pressure and temperature
Blood and urine samples
Pregnancy test (if appropriate)
Assessment of your tuberculosis risk
Completion of questionnaires about your PPP and quality of life
Review of other medications taken by you since the previous study visit
You can answer the questions in the pre-screener questionnaire to see if you might qualify for the BE SEEN Study. You will find a study centre near you on the Find a study centre page.
You will be told about the study in more detail by the team at the study centre, 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 about participating in a clinical study. 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. You will have the opportunity to ask any questions you may have.
While you will not receive any payment for your participation in this study, reimbursement for study-related travel costs may be provided.
This website provides information about the BE SEEN Study, a clinical study sponsored by UCB Biopharma SRL. It is evaluating an investigational drug compared with placebo in people with PPP. Information placed on this website is not intended as a substitute for consultation with your healthcare professional. For further information about the disease described on this website or treatment options for PPP, please consult your treating doctor.