A Phase 3, 28-week, multicentre, randomised, double-blind, placebo-controlled trial (OA-10) to evaluate the efficacy and safety of a single injection of lorecivivint in the target knee joint of moderately to severely symptomatic osteoarthritis patients.

研究概要

Four hundred ninety-eight patients with moderate to severe symptomatic knee osteoarthritis were randomized to receive either a single intra-articular injection of lorecivivint 0.07 mg (n=243) or placebo (n=253). The primary outcome of interest was the change in Pain Numeric Rating Scale (NRS) at Week 12. Secondary outcomes included changes in WOMAC Function and Pain subscores, Patient Global Assessment (PtGA), and safety assessments. Outcomes were assessed at Weeks 12 and 24. Overall, the results of the study revealed no statistically significant difference in pain reduction or function improvement between lorecivivint and placebo. However, a post-hoc subgroup analysis suggested nominal benefits of lorecivivint in patients with less advanced radiographic disease (KL Grade 2). These findings suggest that while lorecivivint was safe, its potential benefits may be limited to patients with earlier-stage knee osteoarthritis.