UCB announced positive results from the phase 3 BE VIVID trial of bimekizumab for the treatment of adults with moderate-to-severe chronic plaque psoriasis. Bimekizumab is an investigational humanized monoclonal IgG1 antibody that inhibits IL-17A and IL-17F.
BE VIVID is a 52-week, double-blind, placebo- and active-controlled study that compared the efficacy and safety of bimekizumab vs placebo in 570 patients with moderate-to-severe chronic plaque psoriasis. Patients were randomized to receive bimekizumab, ustekinumab, or placebo at pre-specified time intervals. The co-primary end points included Psoriasis Area and Severity Index 90 (PASI 90) response (defined as achieving a 90% reduction from baseline in the PASI score) at Week 16, and the Investigator’s Global Assessment (IGA) response (defined as clear or almost clear with a ≥2-category improvement relative to baseline) at Week 16.
Results demonstrated bimekizumab to meet both co-primary end points of at least 90% improvement in PASI 90 and an IGA response of clear or almost clear (IGA 0/1). Additionally, key secondary end points were met with bimekizumab showing superiority to ustekinumab in PASI 90 and IGA 0/1; bimekizumab was also found to be superior to placebo in total skin clearance (PASI 100 or IGA 0) at Week 16.
The overall safety profile of bimekizumab was consistent with previous phase 2 BE ABLE studies. Full detailed results will be presented in the near future.
“These encouraging first results provide strong evidence that bimekizumab has the potential to raise the bar for achieving skin clearance rates for patients. Achieving clear skin is of critical importance in positively impacting the lives of psoriasis patients. Today’s announcement marks an important milestone in the extensive clinical development of bimekizumab,” said Mark Lebwohl, M.D., Lead Study Investigator, Waldman Professor of Dermatology and Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, New York.
The Company is also investigating the safety and efficacy of bimekizumab in psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
For more information visit ucb.com.