Severe Osteoarthritis of the KneePhase 3NCT03349645

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

A Phase 3 study testing 4 mL injection of AMPION™ in people with Severe Osteoarthritis of the Knee, run by Ampio Pharmaceuticals. Inc. at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Severe Osteoarthritis of the Knee
What is being tested?: 4 mL injection of AMPION™
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 11 sitesUnited States
Study dates: 8 Dec 2017to 4 Oct 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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

Who cannot join

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

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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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Tekton Research
Austin, Texas, 78745
Northwest Clinical Research Center
Bellevue, Washington, 98007
Central Research Associates, Inc.
Birmingham, Alabama, 35205
Healthcare Research Netword
Blue Island, Illinois, 60406
CORE Orthopaedic Medical Center
Encinitas, California, 92024
St. Joseph Heritage
Fullerton, California, 92835
Healthcare Network Research
Hazelwood, Missouri, 63042
Drug Studies America
Marietta, Georgia, 30060
Coastal Carolina Center at Lowcountry Orthopaedics
North Charleston, South Carolina, 29406
Westlake Medical Research
Thousand Oaks, California, 91360
Heartland Research Associates
Wichita, Kansas, 67207

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Severe Osteoarthritis of the Knee
Being tested: 4 mL injection of AMPION™
Keywords: Osteoarthritis, osteoarthritis of the knee
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

4 mL injection of AMPION™Biological
4 mL injection of AMPION™

Study groups in NCT03349645
Study group	Role	What they receive
AMPION™ 4 mL dose	Experimental	4 mL intra-articular injection of AMPION™ Receives: Biological: 4 mL injection of AMPION™

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 20174 Oct 2018

First posted21 Nov 2017
Study start8 Dec 2017
Primary completion4 Oct 2018
Study completion4 Oct 2018

Why it stopped: Study terminated by Sponsor due to absence of significant safety findings.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Severe Osteoarthritis of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open Label
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03349645
Sponsor's protocol ID: AP-003-C-OLE
Status last verified: Aug 2022
First submitted: 17 Nov 2017
Last updated: 3 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Patient Pain and Function in Medial Knee Osteoarthritis After Anteromedial vs Anterolateral Intra-Articular Corticosteroid Injection
Osteoarthitis, Osteoarthritic Knee Pain
RecruitingPhase 1/2
Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
Osteoarthritis of the Knees
Recruiting
Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis
Osteoarthitis
Recruiting
Percutaneous Neurostimulation in Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Neuromodulation
Recruiting
Acute Exercise Responses With Blood Flow Restriction Under Dynamic Pressure Compared to Fixed Pressure in Patients With Severe Gonarthrosis
Severe Knee Osteoarthritis

All Severe Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03349645
Acronym / sponsor ID: AP-003-C-OLE
Conditions: Severe Osteoarthritis of the Knee
Keywords: Osteoarthritis, osteoarthritis of the knee
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated by Sponsor due to absence of significant safety findings.
Enrolment: 94 participants (actual)
Lead sponsor: Ampio Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
Study start: 8 Dec 2017 (actual)
Primary completion: 4 Oct 2018 (actual)
Study completion: 4 Oct 2018 (actual)
First posted: 21 Nov 2017 (actual)
Results: Posted 3 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open Label

Arm	Type	Receives
AMPION™ 4 mL dose	Experimental	Biological: 4 mL injection of AMPION™4 mL intra-articular injection of AMPION™

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
4 mL injection of AMPION™4 mL injection of AMPION™	Biological	AMPION™ 4 mL dose

Primary outcome

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 52 weeks
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).

Results and safety

Results posted to the registry on 3 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ampion 4 mL Dose	94	12

Primary outcome: Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

Time frame: 52 weeks. Number. Unit: Events

Measure	Ampion 4 mL Dose n = 94
Mild treatment-emergent adverse event (TEAE)	21
Moderate treatment-emergent adverse event (TEAE)	11
Severe treatment-emergent adverse event (TEAE)	2

Population analysed: Intent To Treat (ITT)

Adverse events

Time frame: 52 Weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ampion 4 mL Dose	0 of 94 (0%)	22 of 94 (23.4%)	0 of 94

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Severe Osteoarthritis of the Knee

Recruiting
Patient Pain and Function in Medial Knee Osteoarthritis After Anteromedial vs Anterolateral Intra-Articular Corticosteroid Injection
Osteoarthitis, Osteoarthritic Knee Pain
RecruitingPhase 1/2
Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
Osteoarthritis of the Knees
Recruiting
Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis
Osteoarthitis
Recruiting
Percutaneous Neurostimulation in Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Neuromodulation
Recruiting
Acute Exercise Responses With Blood Flow Restriction Under Dynamic Pressure Compared to Fixed Pressure in Patients With Severe Gonarthrosis
Severe Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Howard Levy, MD study director

Ampio Pharmaceuticals. Inc.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 4 mL injection of AMPION™ in people with Severe Osteoarthritis of the Knee, run by Ampio Pharmaceuticals. Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03349645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.