A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: 4 mL injection of AMPION™; 4 mL injection of Placebo
Intervention description: 4 mL Injection of Ampion; 4 mL Injection of Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 480.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Osteoarthritis of the Knee

Summary:

      This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™
      in adults with pain due to osteoarthritis of the knee
    

Eligibility criteria:

        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 (Kellgren Lawrence Grade II, III, or IV)
             read by a central reader;

          -  WOMAC 5-point Likert pain subscale <1.5 in the contralateral knee;

          -  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);

          -  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);

          -  Ability to discontinue 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 is allowed
             during the study);

          -  No analgesia (including acetaminophen [paracetamol]) 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 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
             osteoarthritis)

          -  Major injury to the index knee within the 12 months prior to screening

          -  Severe hip osteoarthritis 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

          -  Pregnancy or planning to become pregnant during the study.

          -  Use of the following medications:

          -  No IA injected pain medications in the study knee during the study

          -  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 osteoarthritis index knee during the study

          -  No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
             (treatment such as low dose 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

          -  No human albumin treatment in the 3 months before randomization or throughout the
             duration of the study