Severe Osteoarthritis of the KneePhase 3NCT03988023
Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.
A Phase 3 study testing Ampion and Saline in people with Severe Osteoarthritis of the Knee, run by Ampio Pharmaceuticals. Inc. at 1 site in United States.
Trial summary
The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with 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?
- Ampion and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,043 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 13 Jul 2021
- 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
- Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OAK and supported by radiological evidence (Kellgren-Lawrence Grade 4) that is not older than 6 months prior to the date of screening
- Moderate to moderately-severe osteoarthritis (OA) pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 as measured by 5-point Likert Pain Subscale) assessed at screening
- Ability to temporarily discontinue nonsteroidal anti-inflammatory drug (NSAID) for 48 hours prior to scheduled clinical efficacy evaluations
- No analgesia (including acetaminophen [paracetamol]) taken 12 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 patient 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 index knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)
- Major injury to the index knee within the 12 months prior to screening
- Severe hip osteoarthritis ipsilateral to the index knee
- Any pain that could interfere with the assessment of index 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
- Use of the following medications:
- No IA injected pain medications in the study knee during the study
- No analgesics containing opioids. NSAIDs may be continued at levels preceding the study, however may not be used 48 hours prior to efficacy evaluations, and acetaminophen is available as a rescue medication during the study from the provided supply
- No topical treatment on osteoarthritis index 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 > 10 mg prednisolone equivalent per day
- If corticosteroid use is ≤ 10 mg prednisolone equivalent per day, and if clinically indicated, subjects should be allowed to decrease their corticosteroid use. Additionally, some subjects may need to increase their steroid dose to treat worsened symptoms in the treated knee, and subjects who increase their corticosteroid dose above their starting dose of corticosteroid during the study will be treated as "treatment failures" for efficacy analysis
- No human albumin treatment in the 3 months before randomization or throughout the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee.
The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee.
Read the detailed description
This study is a randomized, double-blind, single dose design.
The co-primary trial objectives are to evaluate the greater efficacy for pain improvement and function improvement of 4 mL Ampion versus saline intra-articular (IA) injection when applied to patients suffering from severe osteoarthritis of the knee (OAK). Efficacy will primarily be assessed with WOMAC A pain and WOMAC C function scores.
Mean change in the WOMAC A weekly pain scores from Baseline to Week 12 will be compared between Ampion and saline control. Mean change in WOMAC C function score will be compared between Ampion and saline control. This will test whether Ampion is superior to saline in improving pain and function.
- Conditions
- Severe Osteoarthritis of the Knee
- Being tested
- Ampion, Saline
- 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.
AmpionBiological
4 mL injection of Ampion
SalineDrug
Also called 0.9% Saline
Saline solution, 4 mL, single intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| AMPION™ 4 mL dose | Experimental | 4 mL injection of Ampion Receives: Biological: Ampion |
| Saline | Placebo comparator | 4 mL injection of placebo Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Pain
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Measured: Scored at Baseline and 12 Week
Change in Knee Function
Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.
Measured: Scored at Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start24 Jun 2019
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Why it stopped: The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ampio Pharmaceuticals. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Levy, M.D., Study director, Ampio Pharmaceuticals. Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988023
- Sponsor's protocol ID
- AP-013
- Status last verified
- Aug 2022
- First submitted
- 13 Jun 2019
- Last updated
- 5 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT03988023
- Acronym / sponsor ID
- AP-013
- Conditions
- Severe Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, osteoarthritis of the knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.
- Enrolment
- 1,043 participants (actual)
- Lead sponsor
- Ampio Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 5 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee.
Detailed description
This study is a randomized, double-blind, single dose design.
The co-primary trial objectives are to evaluate the greater efficacy for pain improvement and function improvement of 4 mL Ampion versus saline intra-articular (IA) injection when applied to patients suffering from severe osteoarthritis of the knee (OAK). Efficacy will primarily be assessed with WOMAC A pain and WOMAC C function scores.
Mean change in the WOMAC A weekly pain scores from Baseline to Week 12 will be compared between Ampion and saline control. Mean change in WOMAC C function score will be compared between Ampion and saline control. This will test whether Ampion is superior to saline in improving pain and function.
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: Ampion4 mL injection of Ampion |
| Saline | Placebo comparator | Drug: Saline4 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 (8 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
- Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OAK and supported by radiological evidence (Kellgren-Lawrence Grade 4) that is not older than 6 months prior to the date of screening
- Moderate to moderately-severe osteoarthritis (OA) pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 as measured by 5-point Likert Pain Subscale) assessed at screening
Key exclusion criteria (21 listed)
- As a result of medical review and screening investigation, the Principal Investigator considers the patient 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 |
|---|---|---|
| Ampion4 mL injection of Ampion | Biological | AMPION™ 4 mL dose |
| SalineAlso: 0.9% SalineSaline solution, 4 mL, single intra-articular injection | Drug | Saline |
Primary outcome
Change in Knee Pain
Time frame: Scored at Baseline and 12 Week
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Change in Knee Function
Time frame: Scored at Baseline and 12 weeks.
Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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, M.D. study director
Ampio Pharmaceuticals. Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ampion and Saline in people with Severe Osteoarthritis of the Knee, run by Ampio Pharmaceuticals. Inc. at 1 site 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 8 inclusion and 21 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 5 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 1 site 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 5 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?
Change in Knee Pain (time frame: Scored at Baseline and 12 Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2022.