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

NCT ID: NCT03182686

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-19
• Study Completion Date: 2017-12-07

Brief 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.

Detailed Description

A Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

There will be a 7-day screening period for each subject followed by a 12-week participation period.

The primary trial objective is to evaluate the clinical efficacy of Ampion using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) (using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) 3.1 Index and Patient's Global Assessment as assessments).

The secondary trial objectives are to evaluate the safety of a single intra-articular injection (4 mL) of Ampion.

Conditions

Osteoarthritis, Knee; Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AMPION™ 4 mL dose

4 mL injection of Ampion

Group Type: EXPERIMENTAL

4 mL injection of Ampion

Intervention Type: BIOLOGICAL

4 mL injection of Ampion

Placebo 4 mL dose

4 mL injection of Placebo

Group Type: PLACEBO_COMPARATOR

4 mL Injection of Placebo

Intervention Type: DRUG

4 mL Injection of Placebo

Interventions

4 mL injection of Ampion

4 mL injection of Ampion

Intervention Type: BIOLOGICAL

4 mL Injection of Placebo

4 mL Injection of Placebo

Intervention Type: DRUG

Other Intervention Names

0.9% Saline

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ampio Pharmaceuticals. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Levy, MD

Role: STUDY_DIRECTOR

Ampio Pharmaceuticals. Inc.

Locations

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

Countries

United States

References

Salottolo K, Cole B, Bar-Or D. Intra-articular injection of the anti-inflammatory compound LMWF-5A in adults with severe osteoarthritis: a double-blind prospective randomized controlled multi-center safety and efficacy trial. Patient Saf Surg. 2018 Jun 18;12:11. doi: 10.1186/s13037-018-0158-0. eCollection 2018.

Reference Type: RESULT

PMID: 29910837 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AP-003-C

Identifier Type: -

Identifier Source: org_study_id