What are the BE MOBILE studies?
The BE MOBILE 1 and BE MOBILE 2 studies are testing an investigational study drug called bimekizumab to see whether it is safe and effective in treating people with axial spondyloarthritis (axSpA). Bimekizumab is investigational because it has not yet been approved to be prescribed and is still being researched in clinical studies like these. Bimekizumab will be compared with a placebo (a placebo looks like bimekizumab but contains no active medication).
Who can take part?
Approximately 240 people will take part in the BE MOBILE 1 Study and around 300 people will join the BE MOBILE 2 Study. Study centers are located worldwide. Not everyone will be able to join the studies as several inclusion criteria must be met.
What do the studies involve?
Your participation in either study will last up to 73 weeks. The studies are divided into four parts:
- Screening Visit (2 to 5 weeks before Initial Treatment Period) – you will undergo tests and assessments to see whether you are able to participate in one of the studies.
- Initial Treatment Period (16 weeks) – you will be expected to visit the study center 7 times, during which you will receive either bimekizumab OR placebo every 4 weeks and undergo tests.
- Maintenance Treatment Period (36 weeks) – you will be expected to visit the study center 9 times, during which you will receive bimekizumab every 4 weeks and undergo further tests.
- Safety Follow-Up Visit (20 weeks after the last dose of study drug) – when you complete the treatment period, you will need to attend a follow-up visit so that the study team can monitor your health and well-being.
What happens when the studies end?
At the end of the Maintenance Treatment Period, you may be invited to take part in an extension to the BE MOBILE studies, during which you will continue to receive bimekizumab only. If you choose to take part in the extension study, you will not need to attend the Safety Follow-Up Visit. If you choose not to take part in the extension study, you will be asked to attend the Safety Follow-Up Visit as described above. The study team will provide you with further information.
Which study drug will I receive?
Once enrolled, you will be randomly assigned to receive either bimekizumab or placebo. The placebo period lasts the first 16 weeks of the study, after which participants will receive bimekizumab. Neither you nor the study team will know which study drug you are taking. This ensures that the results from the tests and assessments are handled in the same way.
How do I take the study drug?
The study drug will be injected under the skin of your lower stomach area (abdomen/tummy), outside of your upper thigh, or upper arm. Each injection will last approximately 10 to 15 seconds. All injections will be given by the study team at the study center. You will receive 13 injections in total (5 in the Initial Treatment Period and 8 in the Maintenance Treatment Period).
What happens during visits to the study center?
The study team will ask you questions and carry out medical tests to assess your health and determine how your body is responding to the study drug. The following tests and assessments will occur at some point during the study:
- You will be asked questions about your personal life, medical history, current and previous drugs you have been or are taking.
- You will complete questionnaires about how you are feeling and how axSpA affects your life.
- Physical examinations will assess the status of your axSpA.
- Measurements of your blood pressure, pulse, body temperature, height and weight will be taken.
- An ECG (electrocardiogram) will measure the electrical activity of your heart.
- Blood and urine samples will be taken.
- Imaging techniques will be used to take pictures of your joints and spine.
- You will be given the study drug.
Additional visits to the study center may be required. This will be decided by the study doctor.
How do I take part?
If you are interested in taking part in one of the BE MOBILE studies, follow these three steps:
- Check the criteria. You should:
- Be 18 years of age or older
- Have nonradiographic axSpA or ankylosing spondylitis
- Not be responding to treatment
There are additional criteria that must be met to qualify as a study participant.
- Take the pre-qualification screener. If you pre-qualify for one of the BE MOBILE studies, you will be referred to your nearest study center.
- Visit the study center, where the study team 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 medical tests to determine whether you are right for the study and the study is right for you.
Prior to any procedures taking place, you must agree to and sign an Informed Consent Form. This document explains the study in detail, including potential risks and benefits, as well as your rights and responsibilities while taking part in the study.
If you are eligible to participate, all study-related treatment and care will be provided at no cost to you. If you do decide to participate, you may withdraw from the study at any time for any reason.