Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

Main Inclusion Criteria: * Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions * Male or female \>=40 years of age * Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening * Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA * Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray * Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale) * Body mass index (BMI) ≤ 40 kg/m2 * Willingness to abstain from use of restricted medications Main Exclusion Criteria: * Ipsilateral hip OA * Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee * History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis * History of arthritides due to crystals (e.g., gout, pseudogout) * History or clinical signs and symptoms of infection in the index joint * Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification) * Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain * IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening * IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening * Intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening * Oral corticosteroids (investigational or marketed) within 1 month of Screening * Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening * Any other IA investigational drug/biologic within 6 months of Screening * Prior use of FX006 * Women of child-bearing potential not using effective contraception or who are pregnant or nursing