Bimekizumab (UCB), an investigational treatment for moderate-to-severe plaque psoriasis, met its two primary end points in a second phase 3 trial.
The trial, BE READY, included 435 patients with chronic plaque psoriasis for at least 6 months with an affected body surface area of at least 10% and a Psoriasis Area Severity Index (PASI) of ≥12. Patients were randomized to receive bimekizumab or placebo for 16 weeks; those who reached a certain response criteria were re-randomized to bimekizumab or placebo for an additional 40 weeks (randomized-withdrawal period). The co-primary end points were PASI 90 response (defined as a patient that achieved a 90% reduction from baseline in the PASI score) and Investigator’s Global Assessment (IGA) response (defined as clear or almost clear with at least a 2-category improvement relative to baseline).
Results showed that at Week 16, the trial met both co-primary end points as well as key secondary end points (PASI100 response at Week 16, PASI75 response at Week 4, change from baseline in the patient symptom diary responses for itch, pain and scaling; IGA response in patients with scalp psoriasis). In addition, a statistically significant response was observed at Week 56 with continued use of bimekizumab during the randomized-withdrawal period.
Full results from BE READY will be presented at a future scientific congress in 2020. The results are in line with those from the phase 3 BE VIVID study, which found that bimekizumab was superior to placebo and ustekinumab in achieving skin clearance. The Company plans to submit a New Drug Application to the FDA for bimekizumab in mid-2020.
“Clinical trial results with bimekizumab continue to show both robust skin clearance rates as well as improvements in itch, pain and scaling – critically important elements for people living with this disease,” said Andrew Blauvelt, MD, MBA, Lead Study Investigator and President, Oregon Medical Research Center in Portland, Oregon.
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