AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee, Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic

In brief

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.

Key facts

Study ID

NCT03182686

Run by

Ampio Pharmaceuticals. Inc.

People needed

168

Starts

2017-06-19

Expected to finish

2017-12-07

Last updated by the study team

2022-08-09

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.).

You may not qualify if…

• 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:
• No intra-articular (IA) injected medications in the study knee during the study (or 12 weeks prior to Baseline).
• 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 the study knee during the study
• No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as low-dose Aspirin (81 mg) and Plavix are allowed)
• No systemic treatments that may interfere with safety or efficacy assessments during the study
• No immunosuppressants
• 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

Where it is running

• Central Research Associates, Inc. — Birmingham, Alabama, United States
• CORE Orthopaedic Medical Center — Encinitas, California, United States
• St. Joseph Heritage — Fullerton, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Westlake Medical Research — Thousand Oaks, California, United States
• Drug Studies America — Marietta, Georgia, United States
• Healthcare Research Netword — Blue Island, Illinois, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Arthritis Treatment Center — Frederick, Maryland, United States
• Healthcare Network Research — Hazelwood, Missouri, United States
• Coastal Carolina Center at Lowcountry Orthopaedics — North Charleston, South Carolina, United States
• Tekton Research — Austin, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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