AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee; Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic
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: 168.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: osteoarthritis; osteoarthritis of the knee; OA; OAK; Kellgren Lawrence (KL)

Summary:

      This is a phase 3 randomized study to confirm the efficacy of an intra-articular injection of
      Ampion™ in adults with pain due to severe 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;

          -  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:

               1. No intra-articular (IA) injected medications in the study knee during the study
                  (or 12 weeks prior to Baseline).

               2. No analgesics containing opioids.

               3. NSAIDs are not permitted during the study; acetaminophen is available as a rescue
                  medication during the study from the provided supply.

               4. No topical treatment on the study knee during the study

               5. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
                  (treatment such as low-dose Aspirin (81 mg) and Plavix are allowed)

               6. No systemic treatments that may interfere with safety or efficacy assessments
                  during the study

               7. No immunosuppressants

               8. 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