Interim results were announced from a phase 3 study evaluating bimekizumab, an investigational interleukin (IL)-17A and IL-17F inhibitor, in adults with active ankylosing spondylitis.
The ongoing multicenter, randomized, double-blind, placebo-controlled BE MOBILE 2 study (ClinicalTrials.gov Identifier: NCT03928743) compared the efficacy and safety of bimekizumab to placebo in 332 adults with active ankylosing spondylitis who had no response to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for a total of 4 weeks or had a history of intolerance to or a contraindication to NSAID therapy. Patients who had an inadequate response or intolerance to a tumor necrosis factor alpha inhibitor were also included in the study.
Results showed that the study met the primary endpoint with a greater proportion of patients in the bimekizumab treatment arm achieving at least a 40% improvement in the Assessment of SpondyloArthritis International Society (ASAS40) criteria response at week 16 compared with the placebo arm.
Bimekizumab also met all ranked secondary endpoints at week 16, including significant improvements in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), achievement of ASAS partial-remission and Ankylosing Spondylitis Disease Activity Score (ASDAS) major improvement, and the nocturnal spinal pain score.
The safety profile of bimekizumab was consistent with that seen in previous studies. There were no new safety signals reported.
“The encouraging top-line phase 3 results reported today are consistent with the phase 2 findings and suggest that bimekizumab has the potential to deliver clinically meaningful improvements in the key signs and symptoms of the disease,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.
The Company is also evaluating bimekizumab for active nonradiographic-axial spondyloarthritis in the phase 3 BE MOBILE 1 study (ClinicalTrials.gov Identifier: NCT03928704).
The Biologics License Application for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults is currently under review by the Food and Drug Administration.
Positive top-line results for bimekizumab in phase 3 ankylosing spondylitis trial. News release. UCB. Accessed December 16, 2021. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/positive-top-line-results-bimekizumab-phase-3-ankylosing.