Study is designed to evaluate the safety and effectiveness of a drug called CX-011 to treat pain in patients with osteoarthritis of the knee. Osteoarthritis produces pain in the knee (and other joints) that typically is worsened by activities such as long distance walking and is alleviated by rest.
Written consent to participate in the study.
Males or females 18 years of age or less than 75 years old.
Diagnosis OA of the index knee by a combination of clinical and radiographic findings wherein the index knee is self-identified by the patient as the more severe knee and symptoms have persisted for 3 months.
Radiographic evidence of OA in the tibiofemoral compartment of the index knee (Kellgren-Lawrence grades II or III) within 6 months prior to Screening or during the Screening period.
Daily use of assistive devices (e.g. cane or walker) or presence of comorbidities that would limit the patient's ability to walk.
History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis.
Unstable joint (such as a torn anterior cruciate ligament)
Inability to undergo Magnetic Resonance Imaging (MRI) due to presence of surgical hardware or other foreign body in the index knee, or because of patient's claustrophobia