A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in 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: 538.0
Sex: All
Minimum age: 35 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoarthritis; osteoarthritis of the knee

Summary:

      This study will evaluate the efficacy of an Intra-Articular Injection of Ampion™ in Adults
      with pain due to osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 35 years to 85 years old (inclusive) who are ambulatory but suffering
             from moderate to moderately severe pain from osteoarthritis in the index knee as
             evidenced by a rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain
             Subscale at screening.

          2. 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, IV).
             Confirmatory x-ray must be taken at Screening and assessed using Kellgren Lawrence
             grading system.

          3. Moderate to moderately-severe OA pain in the index knee even with dosing of
             nonsteroidal anti-inflammatory drug (NSAID) in the 4 weeks prior to screening.

          4. No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an
             efficacy measure; and,

          5. Able to provide written informed consent to participate in the study.

          6. Willing and able to comply with all study requirements and instructions of the site
             study staff.

        Exclusion Criteria:

          1. Previous participation in an Ampion™ study.

          2. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or
             joint replacement in the affected knee, as assessed locally by the principal
             investigator.

          3. Isolated patella femoral syndrome, also known as chondromalacia.

          4. 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).

          5. Major injury to the index knee within the 12 months prior to screening.

          6. Severe hip OA ipsilateral to the index knee.

          7. Presence of tense effusions.

          8. 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).

          9. Initiation or change in any pharmacological or non-pharmacological treatment for OA
             during the 4 weeks prior to randomization or likely to be changed during the duration
             of the study.

         10. Use of the following medications anticipated to be required during the study:

               -  Intra-articular pain medications in the study knee

               -  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 needed during the study

               -  Use of significant anticoagulant therapy, oral or injectable, during the study
                  (aspirin and clopidogrel are allowed)

               -  Systemic treatments that may interfere with safety or efficacy assessments during
                  the study such as immunosuppressants

         11. Use of corticosteroids >10 mg prednisolone equivalent per day (if ≤10 mg prednisolone,
             the dose must be stable).

         12. Use of human albumin treatment in the 3 months before randomization.

         13. A history of allergic reactions to human albumin (reaction to non-human albumin such
             as egg albumin is not an exclusion criterion).

         14. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan,
             sodium caprylate).

         15. Principal Investigator considers the patient unfit for the study based on medical
             review and screening.