Phase 3 trial of bimekizumab versus placebo in 435 adults with moderate to severe plaque psoriasis
This was a phase 3 randomized controlled trial involving 435 adult subjects with moderate to severe chronic plaque psoriasis. The study compared the interleukin-17A and 17F inhibitor bimekizumab against placebo. The co-primary endpoints were the percentage of participants achieving a Psoriasis Area and Severity Index 90 (PASI90) response and an Investigator's Global Assessment (IGA) response at week 16. The trial had a follow-up period of 10.7 months. The specific efficacy results, including response rates, effect sizes, and statistical significance for these endpoints, were not reported in the provided data. No secondary outcomes were detailed. No safety or tolerability data, including rates of adverse events, serious adverse events, or discontinuations, were reported. The study was funded by the drug's manufacturer, UCB Biopharma SRL. Key limitations include the absence of reported results, which prevents assessment of efficacy and safety. The practice relevance cannot be determined until complete trial data are published and peer-reviewed. Clinicians should await the full publication of this phase 3 trial to understand the magnitude of benefit and safety profile of bimekizumab in this population.