Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee

NCT03349645 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: AP-003-C-OLE
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 11

Brief Summary

This Open Label Extension (OLE) study will assess the safety of long-term treatment with a 4 mL intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee

Conditions

Severe Osteoarthritis of the Knee

Keywords

Osteoarthritis; osteoarthritis of the knee

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

  Incidence and severity of treatment emergent adverse events (TEAEs) evaluated up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).

  52 weeks

Study Arms (1)

AMPION™ 4 mL dose

EXPERIMENTAL

4 mL intra-articular injection of AMPION™

Biological: 4 mL injection of AMPION™

Interventions

4 mL injection of AMPION™ BIOLOGICAL

4 mL injection of AMPION™

AMPION™ 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
• Male or female, 40 years to 85 years old (inclusive), as assessed in the AP-003-C Main Study
• Must be ambulatory, as assessed in the AP-003-C Main Study
• Study knee must have a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade IV) as assessed in the AP-003-C Main Study.
• Moderate to moderately-severe OA pain in the study knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale), as assessed in the AP-003-C Main Study
• Moderate to moderately-severe OA function in the study knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Function Subscale), as assessed in the AP-003-C Main Study
• WOMAC A, 5-point Likert pain subscale \<1.5 in the contralateral knee, as assessed in the AP-003-C Main Study
• Ability to discontinue NSAID ± 72 hours before/after injections (in-office visits). Low-dose Aspirin (81 mg) is allowed during the study but must not be taken at least 24 hours prior to in-office visits.
• No analgesia (including acetaminophen \[paracetamol\]) taken 24 hours prior to an efficacy measure

You may not qualify if:

• As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
• Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc.)
• 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
• Isolated patella femoral syndrome, also known as chondromalacia
• 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 osteoarthritis)
• Major injury to the index knee within the last 12 months
• Severe hip osteoarthritis ipsilateral to the index 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 4 weeks prior to entry into the OLE study, or likely to be changed during the duration of the OLE study
• Pregnancy or planning to become pregnant during the study
• Use of the following medications:
• No IA injected pain medications in the study knee during the study. No Hyaluronic Acid (HA) or steroid injections in the study knee at least 12 weeks prior to Day 84 of the Extension Study. HA and steroid injections in the contralateral knee (non-study knee) are acceptable while on study except ± 14 days of an Ampion injection in the study knee.
• No analgesics containing opioids

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (11)

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

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

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

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: December 8, 2017
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: October 3, 2022
• Results First Posted: October 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)