A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis
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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 342.0
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 of three intra-articular injections, given 2 weeks
      apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to provide written informed consent to participate in the study.

          2. Willing and able to comply with all study requirements and instructions of the site
             study staff.

          3. Male or female, 40 years to 85 years old (inclusive).

          4. Must be ambulatory.

          5. 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.

          6. 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.

          7. 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).

          8. No analgesia taken 24 hours before efficacy measure.

        Exclusion Criteria:

          1. As a result of medical review and screening investigation, the Principal Investigator
             considers the subject unfit for the study.

          2. Previous Ampion™ injection in the index knee.

          3. Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc).

          4. A history of allergic reactions to human albumin (reaction to non-human albumin such
             as egg albumin is not an exclusion criterion).

          5. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan,
             sodium caprylate).

          6. Presence of tense effusions in the index knee.

          7. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or
             joint replacement in the index knee, as assessed locally by the Principal
             Investigator.

          8. Isolated patella femoral syndrome, also known as chondromalacia, in the index knee.

          9. 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).

         10. Major injury to the index knee within the 12 months prior to screening.

         11. Severe hip OA ipsilateral to the index knee.

         12. 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).

         13. 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.

         14. Use of the following medications are exclusionary:

               1. IA injected pain medications in the study knee during the study;

               2. 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;

               3. Topical treatment on osteoarthritis index knee during the study;

               4. Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study
                  (treatment such as Aspirin and Plavix are allowed);

               5. Systemic treatments that may interfere with safety or efficacy assessments during
                  the study;

               6. Immunosuppressants;

               7. Use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg
                  prednisolone, the dose must be stable).

         15. Any human albumin treatment in the 3 months before randomization.