A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis

A randomized, placebo-controlled, double-blinded study to evaluate the efficacy and safety of repeated intra-articular injections of Ampion™ in adult subjects with advanced osteoarthritis of the knee.

The primary study objective was to evaluate the efficacy and safety from Baseline to Week 20 of 3 Ampion™ 4 mL intra-articular (IA) injections vs saline administered 2 weeks apart in improving knee pain in subjects suffering from osteoarthritis (OA) of the knee (OAK).

The secondary study objective was to analyze the effect of Ampion 4 mL vs saline on a change in Patient's Global Assessment (PGA) and knee function from Baseline to Week 20.

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 OA and supported by radiological evidence (x-ray) acquired at screening and assessed by a central reader. Subjects must have a Kellgren Lawrence Grade of III or IV for inclusion in the study.
• 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 and confirmed at randomization.
• Moderate to moderately-severe OA pain in the index knee (even if chronic doses of non-steroidal anti-inflammatory drug [NSAID], which have not changed in the 4 weeks prior to screening, have been/are being used).
• No analgesia taken 24 hours before efficacy measure.

Exclusion criteria

• As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
• Previous Ampion™ injection in the index knee.
• Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc).
• 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 in the index knee.
• Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the index knee, as assessed locally by the Principal Investigator.
• Isolated patella femoral syndrome, also known as chondromalacia, in the index knee.
• 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 treatment or likely to be changed during the duration of the study.
• Use of the following medications are exclusionary:

• IA injected pain medications in the study knee during the study;
• 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 during the study;
• Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed);
• Systemic treatments that may interfere with safety or efficacy assessments during the study;
• Immunosuppressants;
• 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.