Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

Study SM04690-OA-06 was a multicenter, randomized, double-blind, placebo-controlled, parallel group study of a single concentration of 0.07 mg SM04690 per 2 mL injection injected into the target knee joint of moderately to severely symptomatic OA subjects at Day 1 and Week 24 (Phase A). Subjects who completed Phase A were eligible to enter the single-blind extension phase, Phase B, for an additional 52 weeks of study treatment, receiving the randomized Phase A treatment at Week 52 and again at Week 76. The study was primarily designed to assess the safety and tolerability of repeated SM04690 injections, focusing not only on AEs but also several assessments of bone density in the knee.