What is the BE INVOLVED Study?
The BE INVOLVED Study is researching an alternative way to administer bimekizumab—through an intravenous (IV) infusion—to see how it compares to the approved subcutaneous (SC) injection administration form in adults who have been diagnosed with psoriatic arthritis (PsA) and/or axial spondyloarthritis (AxSpA).
What happens during the BE INVOLVED Study?
- Following a ≤4-week Screening Period, eligible participants will be randomized in a 1:1 ratio to receive bimekizumab either as an SC injection or through an IV infusion during the Study Treatment Period that will last approximately 20 weeks.
Participants will then return to the study center for a final check-up approximately 17 weeks after their final dose of bimekizumab for follow-up health checks.
Who can take part?
Around 392 participants in study centers across Europe and the USA are expected to take part. Eligible participants must fulfill the following criteria:
- ≥18 years of age at time of screening
- Diagnosis of active PsA and/or active axSpA (ankylosing spondylitis or non-radiographic axSpA) with no contraindications for receiving biologic disease-modifying anti-rheumatic drugs (bDMARDs). bDMARD-naive patients will be allowed.
- Negative for rheumatoid factor and anti-cyclic citrullinated peptide antibodies.
- Weight ≥50 kg for male participants and ≥45 kg for female participants, but ≤100 kg for all participants at the Screening Visit.
- No known active tuberculosis (TB) infection, positive or double indeterminate result on TB test, high risk of acquiring a TB infection, current or history of latent TB infection or non-TB mycobacterium infection.
- No history or presence of cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal (including inflammatory bowel disease), endocrinological, hematological, or neurological disorders.
- No active infection within 14 days of dosing, or serious infection requiring hospitalization or IV antibiotics within 2 months of dosing.
- No use of any bDMARD within 3 months or 5 half-lives prior to the first administration of the study drug.
If your clinic is interested in joining the BE INVOLVED Study or you know of a patient who may be a suitable candidate, please contact BeInvolved@parexel.com.
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