drugset / Trial / NCT06011733

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis

NCT06011733 ↗

Phase 3 Completed 133 enrolled UCB Biopharma SRL
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with moderate to severe plaque psoriasis (PSO).

Timeline

Start
2023-10-31
Primary completion
2025-02-05
Completion
2025-02-05

Outcome

Met primary endpoint

paper significantly higher primary endpoint response rates versus placebo (Week 16; PASI 90: 94.0% vs. 3.0%; IGA 0/1: 92.0% vs. 3.0%; p < 0.001 PMID 41678327 ↗

registry analysis (superiority test); ITP: Placebo vs ITP: BKZ Dosage Regimen 1; p <0.001 NCT06011733 ↗

release “Chinese study participants with moderate to severe plaque psoriasis (PSO) reported positive results. All primary and secondary endpoints were met” ucb.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bimekizumab Monoclonal antibody 320 mg Subcutaneous

Indications