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

Primary Purpose

Severe Osteoarthritis of the Knee

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
4 mL injection of AMPION™
Sponsored by
Ampio Pharmaceuticals. Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Osteoarthritis of the Knee focused on measuring Osteoarthritis, osteoarthritis of the knee

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects who completed the AP-003-C Main study and have not developed any exclusionary criteria
  2. Able to provide written informed consent to participate in the study
  3. Willing and able to comply with all study requirements and instructions of the site study staff
  4. Male or female, 40 years to 85 years old (inclusive), as assessed in the AP-003-C Main Study
  5. Must be ambulatory, as assessed in the AP-003-C Main Study
  6. 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.
  7. 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
  8. 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
  9. WOMAC A, 5-point Likert pain subscale <1.5 in the contralateral knee, as assessed in the AP-003-C Main Study
  10. 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.
  11. No analgesia (including acetaminophen [paracetamol]) taken 24 hours prior to an efficacy measure

Exclusion Criteria:

  1. As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
  2. Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc.)
  3. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion)
  4. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
  5. Presence of tense effusions
  6. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee
  7. Isolated patella femoral syndrome, also known as chondromalacia
  8. 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)
  9. Major injury to the index knee within the last 12 months
  10. Severe hip osteoarthritis ipsilateral to the index knee
  11. 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)
  12. 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
  13. Pregnancy or planning to become pregnant during the study
  14. Use of the following medications:

    1. 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.
    2. No analgesics containing opioids
    3. NSAIDs are not permitted ± 72 hours before/after injections at in-office visits; 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 Aspirin 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 corticosteroids
    9. No human albumin treatment in the 3 months prior to the AP-003-C Main Study or interim period prior to enrollment into the OLE study. No human albumin treatment throughout the duration of the OLE study

Sites / Locations

  • Central Research Associates, Inc.
  • CORE Orthopaedic Medical Center
  • St. Joseph Heritage
  • Westlake Medical Research
  • Drug Studies America
  • Healthcare Research Netword
  • Heartland Research Associates
  • Healthcare Network Research
  • Coastal Carolina Center at Lowcountry Orthopaedics
  • Tekton Research
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMPION™ 4 mL dose

Arm Description

4 mL intra-articular injection of AMPION™

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 17, 2017
Last Updated
September 21, 2022
Sponsor
Ampio Pharmaceuticals. Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03349645
Brief Title
Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee
Official Title
An Open Label Extension Study to 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Study terminated by Sponsor due to absence of significant safety findings.
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
October 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ampio Pharmaceuticals. Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
An 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. The primary trial objective was to evaluate the safety of a 4-mL intra-articular (IA) injection of Ampion with repeat dosing every 12 weeks for 52 weeks with five total injections of Ampion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Osteoarthritis of the Knee
Keywords
Osteoarthritis, osteoarthritis of the knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open Label
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMPION™ 4 mL dose
Arm Type
Experimental
Arm Description
4 mL intra-articular injection of AMPION™
Intervention Type
Biological
Intervention Name(s)
4 mL injection of AMPION™
Intervention Description
4 mL injection of AMPION™
Primary Outcome Measure Information:
Title
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Description
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).
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who completed the AP-003-C Main study and have not developed any exclusionary 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 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 Exclusion Criteria: 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 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 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 NSAIDs are not permitted ± 72 hours before/after injections at in-office visits; 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 Aspirin and Plavix are allowed) No systemic treatments that may interfere with safety or efficacy assessments during the study No immunosuppressants No use of corticosteroids No human albumin treatment in the 3 months prior to the AP-003-C Main Study or interim period prior to enrollment into the OLE study. No human albumin treatment throughout the duration of the OLE study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Levy, MD
Organizational Affiliation
Ampio Pharmaceuticals. Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
CORE Orthopaedic Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
St. Joseph Heritage
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Westlake Medical Research
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Healthcare Research Netword
City
Blue Island
State/Province
Illinois
ZIP/Postal Code
60406
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Healthcare Network Research
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Coastal Carolina Center at Lowcountry Orthopaedics
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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