AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

A Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

There will be a 7-day screening period for each subject followed by a 12-week participation period.

The primary trial objective is to evaluate the clinical efficacy of Ampion using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) (using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) 3.1 Index and Patient's Global Assessment as assessments).

The secondary trial objectives are to evaluate the safety of a single intra-articular injection (4 mL) of Ampion.

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;
• Must be ambulatory;
• Study knee must have a clinical diagnosis of osteoarthritis (OA) supported by radiological evidence (Kellgren Lawrence Grade IV) which is assessed locally (x-rays within the past 6 months of screening are acceptable);
• Moderate to moderately-severe OA pain in the study knee (rating of at least 1.5 on the WOMAC A, 5-point Likert Pain Subscale);
• Moderate to moderately-severe OA function in the study knee (rating of at least 1.5 on the WOMAC C, 5-point Likert Function Subscale);
• WOMAC A, 5-point Likert pain subscale <1.5 in the contralateral knee;
• Ability to discontinue non-steroidal anti-inflammatory drug (NSAID) use at Screening visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical study (low-dose aspirin (81 mg) is allowed during the study);
• No analgesia (including acetaminophen) taken 24 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 subject 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 study knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)
• Major injury to the study knee within the 12 months prior to screening
• Severe hip osteoarthritis ipsilateral to the study knee
• Any pain that could interfere with the assessment of study 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
• Pregnancy or planning to become pregnant during the study
• Use of the following medications:

• No intra-articular (IA) injected medications in the study knee during the study (or 12 weeks prior to Baseline).
• No analgesics containing opioids.
• NSAIDs are not permitted during the study; acetaminophen is available as a rescue medication during the study from the provided supply.
• No topical treatment on the study knee during the study
• No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as low-dose Aspirin (81 mg) and Plavix are allowed)
• No systemic treatments that may interfere with safety or efficacy assessments during the study
• No immunosuppressants
• No use of systemic or intra-articular corticosteroids
• No human albumin treatment in the 3 months before randomization or throughout the duration of the study