An Efficacy and Safety Study of Two Doses of Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

Inclusion Criteria

• Able to provide written informed consent to participate in the study
• Willing and able to comply with all study requirements and instructions of the site study staff
• Male or female, 40 years to 85 years old (inclusive)
• Must be ambulatory
• Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of osteoarthritis (OA) and supported by radiological evidence Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening
• Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at screening
• Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used)
• No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure
• No known clinically significant liver abnormality e.g. cirrhosis, transplant, etc.)

Exclusion Criteria

• As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
• A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion)
• A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
• Presence of tense effusions
• Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the Principal Investigator
• Isolated patella femoral syndrome, also known as chondromalacia
• Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial e.g. cancer, congenital defects, spine OA)
• Major injury to the index knee within the 12 months prior to screening
• Severe hip OA ipsilateral to the index knee
• Any pain that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee)
• Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study
• Use of the following medications:
• No IA injected pain medications in the study knee during the study
• No analgesics containing opioids. NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply
• No topical treatment on osteoarthritis index knee during the study
• No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
• No systemic treatments that may interfere with safety or efficacy assessments during the study
• No immunosuppressants
• No use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable)
• Any human albumin treatment in the 3 months before randomization