Osteoarthritis, KneePhase 3NCT03182686
AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee
A Phase 3 study testing 4 mL injection of Ampion in people with Osteoarthritis, Knee and Knee Osteoarthritis, run by Ampio Pharmaceuticals. Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee, Knee Osteoarthritis, Knee Arthritis
- What is being tested?
- 4 mL injection of Ampion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 13 sitesUnited States
- Study dates
- 19 Jun 2017to 7 Dec 2017
- 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
- 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);
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- 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.).
Who cannot join
- 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
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- 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.
- 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 low-dose Aspirin (81 mg) and Plavix are allowed)
- No systemic treatments that may interfere with safety or efficacy assessments during the study
- No immunosuppressants
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 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
Arthritis Treatment Center
Frederick, Maryland, 21702
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
Artemis Institute for Clinical Research
San Diego, California, 92103
Westlake Medical Research
Thousand Oaks, California, 91360
Heartland Research Associates
Wichita, Kansas, 67207
About this study
Official title: 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
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.
Read the 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.
- Being tested
- 4 mL injection of Ampion, 4 mL Injection of Placebo
- Keywords
- osteoarthritis, osteoarthritis of the knee, OA, OAK, Kellgren Lawrence (KL)
- 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 AmpionBiological
4 mL injection of Ampion
4 mL Injection of PlaceboDrug
Also called 0.9% Saline
4 mL Injection of Placebo
| Study group | Role | What they receive |
|---|---|---|
| AMPION™ 4 mL dose | Experimental | 4 mL injection of Ampion Receives: Biological: 4 mL injection of Ampion |
| Placebo 4 mL dose | Placebo comparator | 4 mL injection of Placebo Receives: Drug: 4 mL Injection of Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Determined from Baseline to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start19 Jun 2017
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ampio Pharmaceuticals. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Levy, MD, Study director, Ampio Pharmaceuticals. Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182686
- Sponsor's protocol ID
- AP-003-C
- Status last verified
- Aug 2022
- First submitted
- 6 Jun 2017
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29910837
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03182686
- Acronym / sponsor ID
- AP-003-C
- Keywords
- osteoarthritis, osteoarthritis of the knee, OA, OAK, Kellgren Lawrence (KL)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Ampio Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Posted 8 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMPION™ 4 mL dose | Experimental | Biological: 4 mL injection of Ampion4 mL injection of Ampion |
| Placebo 4 mL dose | Placebo comparator | Drug: 4 mL Injection of Placebo4 mL injection of Placebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (22 listed)
- 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
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 Ampion4 mL injection of Ampion | Biological | AMPION™ 4 mL dose |
| 4 mL Injection of PlaceboAlso: 0.9% Saline4 mL Injection of Placebo | Drug | Placebo 4 mL dose |
Primary outcome
Number of Participants Classified as Responders
Time frame: Determined from Baseline to 12 Weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29910837Salottolo 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.
- Individual participant dataSharing planned: No
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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.
13 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 Osteoarthritis, Knee and Knee Osteoarthritis, run by Ampio Pharmaceuticals. Inc. at 13 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 10 inclusion and 22 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: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. Some participants in this study may receive a placebo. 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 8 Aug 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?
Number of Participants Classified as Responders (time frame: Determined from Baseline to 12 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 NCT03182686, which also lists 1 linked publication.
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 9 Aug 2022.