A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee

Inclusion Criteria

• Male or female, 35 years to 85 years old (inclusive) who are ambulatory but suffering from moderate to moderately severe pain from osteoarthritis in the index knee as evidenced by a rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale at screening.
• Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II, III, IV). Confirmatory x-ray must be taken at Screening and assessed using Kellgren Lawrence grading system.
• Moderate to moderately-severe OA pain in the index knee even with dosing of nonsteroidal anti-inflammatory drug (NSAID) in the 4 weeks prior to screening.
• No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure; and,
• 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.

Exclusion Criteria

• Previous participation in an Ampion™ study.
• 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.
• Presence of tense effusions.
• 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).
• Initiation or change in any pharmacological or non-pharmacological treatment for OA during the 4 weeks prior to randomization or likely to be changed during the duration of the study.
• Use of the following medications anticipated to be required during the study:
• Intra-articular pain medications in the study knee
• 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.)
• Topical treatment on osteoarthritis index knee needed during the study
• Use of significant anticoagulant therapy, oral or injectable, during the study (aspirin and clopidogrel are allowed)
• Systemic treatments that may interfere with safety or efficacy assessments during the study such as immunosuppressants
• Use of corticosteroids >10 mg prednisolone equivalent per day (if ≤10 mg prednisolone, the dose must be stable).
• Use of human albumin treatment in the 3 months before randomization.
• 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).
• Principal Investigator considers the patient unfit for the study based on medical review and screening.