What are the BE OPTIMAL and BE COMPLETE studies?
BE OPTIMAL and BE COMPLETE are clinical research studies. They are testing whether an investigational study drug called bimekizumab is safe and effective for treating active psoriatic arthritis. 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 these.
What do the studies involve?
Screening: the study site staff will ask you about your health and run some tests to make sure that you are right for one of the studies and confirm that the study is right for you. This is known as screening.
Randomization: if you pass screening and decide to enroll in a study, you will be assigned to one of the study treatment groups. This is chosen randomly, purely by chance, like the flip of a coin. This is called randomization. Neither you nor your study doctor will decide or know which treatment group you are assigned. This information can be made available in an emergency.
Study treatment: after randomization, you will enter the study treatment period. You will receive the study drug(s) by injection(s) by the study team at the study center. The length of the treatment period is different for each study, but it could be up to 1 year.
Study visits: you will visit the study center every 2–4 weeks during these studies. You will be given the study drug at most of these visits. Your health and well-being will also be monitored.
Study end: You may also be eligible to participate in an open-label extension study after the treatment period.
Who can take part?
The BE OPTIMAL Study will involve about 840 participants and the BE COMPLETE Study will involve about 390 participants in countries across Europe, North America, and Asia Pacific. Not everyone will be able to join these studies as several criteria must be met. It is voluntary to join either of these studies. You can leave at any time for any reason without having to explain why. Leaving the studies 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 active psoriatic arthritis
- Have had this condition for at least 6 months
- Have at least 1 psoriatic lesion and/or a history of psoriasis.
There are additional medical criteria that must be met to qualify as a participant.
If you wish to take part in one of these studies, you will need to give informed consent. Your study staff will discuss the Informed Consent Form and the study with you if you qualify.
What study drug will I receive?
If you join either of the studies, you will be placed randomly into one of the study treatment groups – you might receive the investigational study drug bimekizumab, a placebo, or adalimumab (a comparator drug). Neither you nor your study team will know the group to which you have been assigned, and what study drug you will receive.
How will the study drug be given?
You will receive injections of the study drug under the skin. The injections will be given by the study team, at the study center. The number and timing of injections will differ depending on which study you are eligible for.
How long will I be in the study?
Participation in the BE OPTIMAL Study will last for a maximum of 73 weeks, with approximately 29 visits to the study clinic. Participation in the BE COMPLETE Study will last for a maximum of 37 weeks, with approximately 7 visits to the study clinic.
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 specific to the study, to determine how the study drug affects your health and well-being. The following tests and examinations are examples of what may occur at different times throughout each of the studies:
- 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 psoriatic arthritis and how it is affecting your life
- Pregnancy tests (if appropriate)