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Phase 3 trial compares bimekizumab to placebo and ustekinumab for moderate to severe plaque psoriasis
Photo by Charl Durand / Unsplash

Phase 3 trial compares bimekizumab to placebo and ustekinumab for moderate to severe plaque psoriasis

Key Takeaway
Await full publication of phase 3 bimekizumab psoriasis trial results for efficacy and safety data.

This was a phase 3 randomized controlled trial involving 567 adult subjects with moderate to severe chronic plaque psoriasis. The study compared the efficacy and safety of bimekizumab against both placebo and the active comparator ustekinumab. The primary outcomes were the percentage of participants achieving a Psoriasis Area and Severity Index 90 (PASI90) response and an Investigator's Global Assessment (IGA) response of clear or almost clear at week 16. The trial had a follow-up period of 13.1 months.

No specific efficacy results, including absolute numbers, effect sizes, or statistical significance for the primary or any secondary outcomes, were reported in the provided data. Similarly, detailed safety data on adverse events, serious adverse events, discontinuations, and tolerability were not available. The funding source was UCB Biopharma SRL, the lead sponsor.

Key limitations include the absence of reported results, which prevents any assessment of the intervention's comparative efficacy or safety profile. The practice relevance cannot be determined without the complete trial findings. Clinicians should await the full, peer-reviewed publication of this trial's results to understand the magnitude of benefit, safety signals, and how bimekizumab may fit into the treatment landscape for plaque psoriasis.

View Original Abstract ↓
Status: COMPLETED | Phase: PHASE3 Condition(s): Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, Psoriatic Arthritis Intervention(s): Bimekizumab (DRUG), Ustekinumab (DRUG), Placebo (OTHER) This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO). Primary Outcome(s): Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16; Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16 Enrollment: 567 (ACTUAL) Lead Sponsor: UCB Biopharma SRL Start: 2017-12-06 | Primary Completion: 2019-01-08 Results posted: 2022-02-03