Phase 3, 56-week, randomised, double-blind, placebo-controlled study utilising patient-reported and radiographic outcomes evaluating the efficacy and safety of a lorecivivint injection in patients with moderate to severe knee osteoarthritis: OA-11 Study
Authors' conclusion
In this study, LOR was well tolerated although it did not meet the primary endpoint of change from baseline in target knee Pain NRS at Week 12.
Study context
- Population
- Patients with ACR criteria-defined knee osteoarthritis (OA), Kellgren-Lawrence (KL) grades 2–3, and medial Joint Space Width (JSW) 1.5–4 mm in the target kneerandomised
- Participants
- 513 patients
- Comparison
- Single intraarticular (IA) injection of 0.07 mg lorecivivint vs vehicle placebo
- Primary endpoint
- Change from baseline in pain Numeric Rating Scale (NRS)
- Follow-up
- Week 12
Methodological detailsphase 3, 56-week, multicentre, double-blind, placebo-controlled
- Phase 3
- 56-week
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Mean change from baseline in weekly average of daily Pain NRS
Lorecivivint (LOR)
−2.24
mean · ± 0.13
Placebo (PBO)
−2.49
mean · ± 0.13
95% CI −0.12 to 0.62; P = 0.185
Further findings
Other endpoints (WOMAC Function, WOMAC Pain, PGA, medial JSW)
- No discernable treatment effects of LOR vs PBO
Medial JSW loss · 52 weeks
- Neither group showed meaningful medial JSW loss
Safety
AEs: incidence, severity and relationship to study treatment
- Similar between LOR and PBO
Original publication
Phase 3, 56-week, randomised, double-blind, placebo-controlled study utilising patient-reported and radiographic outcomes evaluating the efficacy and safety of a lorecivivint injection in patients with moderate to severe knee osteoarthritis: OA-11 Study. Clin Exp Rheumatol. Published 5 March 2024. doi:10.
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