Clinical Research Directory

The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis

This will be a 26-week, prospective, international, multi-center, randomized, active-controlled, double-blinded (to subject and Investigator) study in subjects with mild to moderate OA in the knees to assess safety and efficacy of 2107 Injection following a single intra-articular injection as compared to DUROLANE® (the active comparator). A total of 286 subjects from approximately 15 sites and at least three (3) countries will be enrolled and randomized at a 1:1 ratio into the 2107 Injection arm or DUROLANE® arm. One (1) target knee of each subject (only one \[1\] knee to be treated) will receive a single intra-articular dose of 3 mL of 2107 Injection (16 mg/mL HA, i.e. 48 mg per dose) or 3 mL of DUROLANE® (20 mg/mL HA, i.e. 60 mg per dose). Subjects will be followed for 26 weeks after the intra-articular injection for safety and efficacy assessments. The study will consist of six (6) visits (see Table 1. Schedule of Assessments). Subjects who withdraw from the study will have an early termination visit. The primary efficacy endpoint will be the mean change in the Western Ontario and McMaster Universities (WOMAC) Pain sub-score on 100-mm Visual Analog Scale (VAS) from baseline to 13 weeks after intra-articular injection. The secondary efficacy endpoints include the changes in WOMAC sub-score and total score, PGA/IGA, the percentage of subjects taking rescue medication, the level of swelling and tenderness of the target knee and the Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. The safety endpoint includes systemic and local safety profile.