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About the study

What is the BE SURE study?

The BE SURE study is a clinical research study. It is testing whether an investigational medication called bimekizumab is safe and effective for treating moderate to severe chronic plaque psoriasis. Bimekizumab is described as investigational because it has not been approved to be prescribed by doctors and other medical professionals and is still being researched in clinical studies like this one.

What does the study involve?
The study will compare three different treatment groups:

bimekizumab every 4 weeks throughout the study

bimekizumab every 4 weeks during the initial treatment period, then every 8 weeks through the maintenance treatment period and

adalimumab (comparator medication).

Neither you nor your study doctor will decide or know to which treatment group you are assigned. This information can be made available in an emergency.

The study will last for a maximum of 76 weeks and will consist of:

  • A 2 to 4 week screening period
  • A 16 week initial treatment period
  • A 40 week maintenance treatment period, and
  • A 20 week safety follow-up period after the last dose of study medication.

If eligible, you may be able to participate in an open label extension study after the maintenance treatment period.

Who can take part?
450 participants in approximately 10 countries across Europe, North America, and Asia Pacific will take part in this study. Not everyone will be able to join the study as several criteria must be met. It is voluntary to join the study. You can leave at any time for any reason without having to explain why. Leaving the study will have no impact on your primary care.

Can I take part?
You may qualify for participation if you:

  • Are 18 years of age or older
  • Have moderate to severe chronic plaque psoriasis, and
  • Have had this condition for at least six months.

There are additional medical criteria that must be met to qualify as a participant.

If you wish to take part in the study, you will need to give informed consent. Your study center will discuss the informed consent form with you if you qualify.

What medication will I receive?
If you join the study, you will be placed randomly into one of three treatment groups. Neither you nor your study team will know the group to which you have been assigned, and what medication you will receive.

How will the study medication be given?
You will receive injections under the skin every 1 to 2 weeks starting at Day 1 (Baseline Visit) through Week 24. Then you will receive injections every 4 weeks until the end of the study.

How long will I be in the study?
Your participation in the study will last up to 76 weeks. The study is divided into four parts:

Screening period (2 to 4 weeks) – the study doctor will check using several tests to see whether you are able to participate in the study.

Initial Treatment period (16 weeks) – you will be expected to visit the study center 13 times and you will receive the study medication at each of the visits.

Maintenance Treatment period (40 weeks) — you will be expected to visit the study center 14 times, receive the study medication at 13 of the 14 visits, and undertake a variety of tests.

Safety follow-up period (20 weeks after the last dose of study medication) – when you complete the treatment period (or discontinue treatment early), you will need to attend a follow-up visit to monitor your health and well-being.

What happens at each visit?
When you visit the study center, the study team will ask you several questions and carry out a number of medical tests to determine how the study medication affects your health and well-being. The following tests and examinations are examples of what may occur at different times throughout the study:

  • Physical examination
  • Measurements of your blood pressure, heart rate, weight and temperature
  • Blood and urine tests
  • Tuberculosis (TB) questionnaires and evaluations
  • An electrocardiogram (ECG), which measures the electrical activity of your heart
  • Questionnaires about chronic plaque psoriasis and how it is affecting your life
  • Pregnancy tests (if appropriate).

How do I take part?

If you are interested in taking part in the BE SURE study, just follow these 3 simple steps:

1. Check the criteria. Participants should:

  • Be 18 years of age or older
  • Have moderate to severe chronic plaque psoriasis, and
  • Have had this condition for at least six months.

There are additional medical criteria that must be met to qualify as a participant.

2. Find your nearest participating study center.

3. Call to find out more and to make an appointment.

At your visit, study staff will:

  • Discuss the study in more detail and explain what participation would mean for you.
  • Talk through the potential benefits and risks of being involved in the study.
  • Ask questions and carry out several medical tests to determine whether you are right for the study, and the study is right for you.
  • If you are eligible to participate, study medication and all study-related care will be provided without charge.
  • If you do decide to participate, you may withdraw from the study at any time without giving a reason and with no impact to your primary care.

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