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 40 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 subject as the more severe knee (if both knees qualified) 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 subject'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 subject's claustrophobia or other MRI contraindication, including intolerance of or allergic reaction to IV contrast
Parallel
CX-011
DrugCX-011 is a hydrophobic small molecule for intra-articular (IA) administration that is being developed for the treatment of subjects with osteoarthritis of the knee.
Determine tolerability by monitoring the frequency of treatment-emergent adverse events
Tolerability will be measured by the incidence and severity of dose-limiting toxicity events as well as the incidence and severity of local and systemic adverse events (AEs)
Composite safety profile of CX-011 based on change from baseline in clinical laboratory parameters
The incidence and severity of clinically-significant laboratory findings determined by change from baseline in blood chemistry, hematology and urinalysis as indicators of blood, liver and kidney function, respectively.
Pain (Visual Analog Scale, VAS)
Determine the change from baseline to 4, 12 and 24 weeks in the Visual Analog Scale (VAS), with scores ranging from 0-100; lower scores represent better outcomes.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Determine the percent improvement in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function subscales at 4, 12 and 24 weeks. Scores for the pain subscale range from 0-20, while scores for the function subscale range from 0-68; lower scores reflect better outcomes.
Click on the lead sponsor to view all of their trials.
