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

NCT03182686 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AP-003-C
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 13

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.

Conditions

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

Keywords

osteoarthritis; osteoarthritis of the knee; OA; OAK; Kellgren Lawrence (KL)

Outcome Measures

Primary Outcomes (1)

• Number of Participants Classified as Responders

  Using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria of WOMAC A Pain subscore, WOMAC C Function subscore, and PGA as composite endpoints. A patient in this study will be considered a responder for the purpose of efficacy analysis if the following criteria are met: (1) demonstration of ≥ 50% improvement AND a 1.0-unit change in pain OR 1.0-unit change in function OR If the patient does not meet this criterion, then the patient must demonstrate at least 2 of the following: * Improvement in pain (WOMAC A) ≥20% and a 0.5 point absolute change in pain from Baseline on the 5-point Likert scale * Improvement in function (WOMAC C) ≥20% and a 0.5 point absolute change in function from Baseline on the 5-point Likert scale * Improvement in patient global assessment (PGA) ≥20% and a 0.5 point absolute change in function from Baseline on the 5-point Likert scale

  Determined from Baseline to 12 Weeks

Study Arms (2)

AMPION™ 4 mL dose

EXPERIMENTAL

4 mL injection of Ampion

Biological: 4 mL injection of Ampion

Placebo 4 mL dose

PLACEBO COMPARATOR

4 mL injection of Placebo

Drug: 4 mL Injection of Placebo

Interventions

4 mL injection of Ampion BIOLOGICAL

4 mL injection of Ampion

AMPION™ 4 mL dose

4 mL Injection of Placebo DRUG

4 mL Injection of Placebo

Also known as: 0.9% Saline

Placebo 4 mL dose

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (13)

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

St. Joseph Heritage

Fullerton, California, 92835, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Westlake Medical Research

Thousand Oaks, California, 91360, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Healthcare Research Netword

Blue Island, Illinois, 60406, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Arthritis Treatment Center

Frederick, Maryland, 21702, United States

Location

Healthcare Network Research

Hazelwood, Missouri, 63042, United States

Location

Coastal Carolina Center at Lowcountry Orthopaedics

North Charleston, South Carolina, 29406, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Related Publications (1)

• 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.

  PMID: 29910837 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Howard Levy / Chief Medical Officer
• Organization: Ampio Pharmaceuticals

clinicaltrials@ampiopharma.com

7204376500

Study Officials

• Howard Levy, MD

  Ampio Pharmaceuticals. Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 9, 2017
• Study Start: June 19, 2017
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: August 9, 2022
• Results First Posted: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)