LEVI-04 (NCT05618782), a phase 2, randomised trial enrolling participants with symptomatic knee osteoarthritis (WOMAC pain ≥4/10 and Kellgren-Lawrence grade ≥2) who received intravenous LEVI-04 0.3, 1, or 2 mg/kg every 2 weeks or placebo. The analysis focused on the effect of treatment on bone marrow lesions (assessed by MRI). In total, 518 participants were enrolled in the trial.
Between 70% and 77% of participants presented with a bone marrow lesion at baseline. Following 20 weeks of treatment, significantly fewer participants with LEVI-04 1 mg/kg (46%) and 2 mg/kg (39%) had bone marrow lesions, compared with no change in the placebo group (72%). Furthermore, there was a significant, dose-dependent decrease in the total average bone marrow lesion area with LEVI-04 compared with placebo. Finally, this dose-dependent decrease in bone marrow lesion area was observed across all Kellgren-Lawrence grade subgroups (2, 3, and 4).
“Our phase 2 data showed statistically significant effects on analgesia and notable effects on stiffness and pain, but also demonstrated that a proportion of the analgesia and stiffness improvement is associated with the regression of bone marrow lesions,” concluded Dr Westbrook. “LEVI-04 holds promise as potentially the first therapy to modify structural signs and symptoms of osteoarthritis.”
- Conaghan P, et al. LEVI-04, a novel neurotrophin-3 inhibitor, substantially improves pain and function without deleterious effects on joint structure in people with knee osteoarthritis: A randomized controlled phase II trial. ACR Convergence, 14–19 November 2024, Washington, DC, USA.
- Westbrook S, et al. LEVI-04 significantly reduces bone marrow lesions and symptoms in knee osteoarthritis: Results from a phase II RCT ACR Convergence, 24–29 October 2025, Chicago, IL, USA.
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