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The purpose of the BE HEARD Study is to determine how effective and well-tolerated an investigational study drug (called bimekizumab) is for the treatment of people with moderate-to-severe hidradenitis suppurativa.
Just under 1000 participants at approximately 220 study centers across North America, Europe, and Asia Pacific are expected to take part in the BE HEARD program.
Once enrolled, you will receive either the investigational study drug or placebo – a placebo looks similar to the study drug but contains no active medication. You will be randomly allocated (like drawing straws) to one of four groups; you will have a 1 in 7 chance of getting placebo for the first 16 weeks, and then, for the remaining 32 weeks you will receive the investigational study drug, for a total of 48 weeks of treatment.
Neither you nor the study team will know if you are taking the study drug or placebo. This ensures that the results from the tests are handled in the same way.
The study drugs will be given by a subcutaneous (under the skin) injection in your lower abdomen (stomach), thigh, or upper arm. There will be no charge for any study-related treatment or care.
Participants are expected to be in the study for 53 weeks (up to 5 weeks screening plus 48 weeks of study treatment); during this period you will be required to visit the study center approximately 27 times. The study is made up of three parts:
(including the Safety Follow-Up Period for study participants who are not continuing into the Open-label Extension Study)
(28 including the Safety Follow-Up Visit if not continuing into the Open-label Extension Study)
During visits to the study center, you will undergo tests and assessments. The purpose of these tests is to understand how your body is responding to the investigational study drug.
You may have the following tests and assessments at some point in the study:
Physical examination: this is a general assessment of your body and its functions using inspection, palpation (feeling with the hands), percussion (tapping with the fingers), and auscultation (listening). This will be carried out by the study doctor.
ECG, or electrocardiogram: a machine records the electrical activity of your heart through small patches attached to your chest, arms and legs.
Vital signs: your blood pressure, pulse rate and body temperature, along with your height and weight, will be measured.
Blood test: blood samples will be taken via a small needle inserted into your arm. Tests will include a full blood count and routine safety biochemistry and coagulation tests, as well as additional samples taken to determine the level of study drug in your blood.
Urine test: urine samples will be collected for laboratory examination.
Questionnaires: you will be asked a series of questions about your condition and its effect on your everyday life.
Pregnancy test: a sample of serum (that is, a part of your blood) or urine will be tested for participating females who are able to have children to make to confirm sure that you are not pregnant.
Study drug: you will receive the investigational study drug or placebo.
Chest x-ray: a procedure that takes pictures of the inside of your chest; you will be exposed to a low dose of radiation during this procedure.