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
Authors' conclusion
LOR was well tolerated despite not meeting the primary endpoint. Efficacy signals were identified in patients with less severe structural knee OA disease
Study context
- Population
- Patients with ACR-defined knee osteoarthritis (OA), Kellgren-Lawrence (KL) grades 2–3, and pain Numeric Rating Scale (NRS) ≥4 and ≤8 in the target knee51.9% KL Grade 3
- Participants
- 498 patients
- Comparison
- Single intra-articular (IA) injection of lorecivivint 0.07 mg vs vehicle placebo
- Primary endpoint
- Change from baseline in Pain NRS, LOR vs PBO
- Follow-up
- Week 12
Methodological detailsPhase 3, multicentre, double-blind, placebo-controlled, 1:1 randomisation, 28-week
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- 1:1 randomisation
- 28-week
Primary result
As reported in the abstract
Change from baseline in Pain NRS
- Lorecivivint (LOR) failed to meet the primary endpoint when compared to placebo (PBO) (full analysis set (FAS))
- Full analysis set (FAS)
Further findings
| Outcome | P value |
|---|---|
| Weekly Pain NRS, KL Grade 2 subgroup · Week 4Nominal statistical significance · post-hoc analysis | P < 0.05 |
Other efficacy endpoints (WOMAC Function, WOMAC Pain, PGA)
- No significant treatment differences
Weekly Pain NRS, KL Grade 2 subgroup · Week 4
- Positive treatment effect of LOR relative to PBO
Safety
Adverse events (incidence, seriousness, severity)
- Similar across the treatment groups
Original publication
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. Clin Exp Rheumatol. Published 3 March 2024. doi:10.
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