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.
Level 2 - randomized trial
Multicenter randomized double-blind placebo-controlled Phase 3 clinical trial
PubMed 39808288 · doi:10.55563/clinexprheumatol/gskbin
What was done
This Phase 3, 28-week, multicentre, double-blind, placebo-controlled trial evaluated the efficacy and safety of a single intra-articular injection of lorecivivint (0.07 mg) versus vehicle placebo in 498 patients with ACR-defined knee osteoarthritis (Kellgren-Lawrence grades 2–3, baseline pain Numeric Rating Scale 4–8). The primary outcome was the change from baseline in pain Numeric Rating Scale at week 12. Secondary outcomes included WOMAC Function, WOMAC Pain, Patient Global Assessment, and adverse events.
What was found
In the full analysis set, lorecivivint failed to meet the primary endpoint compared with placebo at week 12, and no statistically significant differences were noted in the other efficacy endpoints (numerical values were not reported in the abstract). Incidence, seriousness, and severity of adverse events were similar between groups. A post-hoc analysis in the Kellgren-Lawrence grade 2 subgroup showed a nominally significant difference in weekly pain Numeric Rating Scale favoring lorecivivint at week 4 (p < 0.05).
Why it matters
Despite biological rationale and acceptable safety, lorecivivint did not demonstrate symptom improvement over placebo in a broad Phase 3 population with moderate-to-severe knee osteoarthritis.
Limits
The abstract reports no numerical values, effect sizes, or confidence intervals for primary or secondary outcomes. The positive finding in the Kellgren-Lawrence grade 2 subgroup was derived from a post-hoc analysis with nominal significance, carrying a high risk of false-positive results. The trial evaluated only a single injection with 28 weeks of follow-up.
Cited by
- contradicts Biosplice's osteoarthritis treatment is a single injection that regrows all tendons in 11 months to the state of 16-year-old tendons.