Efficacy and safety of LEVI-04 in patients with osteoarthritis of the knee: a randomised, double-blind, placebo-controlled, phase 2 trial
Authors' conclusion
LEVI-04 was well tolerated and showed significant improvements in pain and function.
Study context
- Population
- Painful (WOMAC pain ≥4/10) and radiographic knee OA; Denmark, Hong Kong, Poland, Moldova and the Czech Republic292 female, 226 male
- Participants
- 518 participants
- Comparison
- Monthly intravenous LEVI-04 0.3 mg/kg, 1.0 mg/kg or 2.0 mg/kg vs placebo through to week 16
- LEVI-04 0.3 mg/kgn = 130
- LEVI-04 1.0 mg/kgn = 130
- LEVI-04 2.0 mg/kgn = 129
- Placebon = 129reference
- Primary endpoint
- Change in WOMAC pain from randomisation to week 17
- Follow-up
- Week 17
Methodological detailsdouble-blind, placebo-controlled, phase 2, Safety follow-up to week 30
- Double-blind
- Placebo-controlled
- Phase 2
- Safety follow-up to week 30
Primary result
As reported in the abstract
Change in WOMAC pain, least squares MD vs placebo
Each group vs placeboLeast squares mean difference (95% CI)P value
LEVI-04 0.3 mg/kg
−0.51(−0.96 to −0.07)
P = 0.023LEVI-04 1.0 mg/kg
−0.62(−1.07 to −0.17)
P = 0.015LEVI-04 2.0 mg/kg
−0.79(−1.24 to −0.35)
P = 0.0024Further findings
| Outcome | SMD (95% CI) |
|---|---|
| WOMAC pain effect size (SMD) · week 17LEVI-04 0.3 mg/kg vs Placebo | 0.28 (0.52–0.04) |
| WOMAC pain effect size (SMD) · week 17LEVI-04 1.0 mg/kg vs Placebo | 0.33 (0.58–0.09) |
| WOMAC pain effect size (SMD) · week 17LEVI-04 2.0 mg/kg vs Placebo | 0.43 (0.68–0.19) |
Safety
Treatment-emergent adverse events
- Treatment-emergent adverse events: One person who did not receive study treatment excluded from safety analysis
Treatment-emergent adverse events
- No increased incidence of serious adverse events or joint pathologies, including rapidly progressive OA
Original publication
Efficacy and safety of LEVI-04 in patients with osteoarthritis of the knee: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. Published 28 March 2026. doi:10.
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