Knee OsteoarthritisNCT05422976
EVI-01-IT Safety Study
A study testing EVI-01 in people with Knee Osteoarthritis, run by Aptissen SA at 1 site in Italy.
Trial summary
Prospective, single arm, pilot study to assess the safety and tolerability of a single intra-articular injection of EVI-01 for the treatment of symptomatic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- EVI-01
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jun 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen (18) years old or above;
- Patient signed informed consent form;
- Patients with stable symptoms related to knee osteoarthritis for at least 3 months prior to screening;
- Failure, inadequate response or intolerance to analgesics and/or NSAIDs or low-grade opioids;
- Kellgren-Lawrence radiographic stage: II-III diagnosed in the previous 12 months;
- WOMAC average pain index score > 40 mm and < 90 (on a VAS 0-100 mm) on the knee to be treated;
- Difference ≥ 10 mm between the WOMAC average pain score of the knee to be treated and WOMAC average pain score of the contralateral knee at screening;
- Body Mass Index (BMI) inferior to 35 kg/m2 (weight/height).
Who cannot join
- Concomitant inflammatory joint disorder;
- Had received previous visco-supplementation treatment in the study knee within 6 months or intra articular corticosteroids within 3 months* prior to inclusion;
- Infection in or around the study knee;
- Relevant skin disease in the area of injection site;
- Documented presence of injury or trauma of the study knee at screening, including evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments in the study knee;
- History of allergy or intolerance to sodium hyaluronate;
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- Documented presence of osteonecrosis in one or both knees;
- Inability to understand the study procedure;
- Participation in another clinical trial within 30 days prior to screening;
- Ongoing therapy with daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment. If dose < 101 mg, it must be maintained during the study;
- Pregnant or breast-feeding at inclusion.
- 1 month = 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Tolerability of a Single Intra-articular Highly Concentrated Hyaluronic Acid Injection in the Treatment of Symptomatic Knee Osteoarthritis : Pilot, 6-months, Open-label, Single-arm Investigation
Prospective, single arm, pilot study to assess the safety and tolerability of a single intra-articular injection of EVI-01 for the treatment of symptomatic knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- EVI-01
- Keywords
- highly concentrated hyaluronic acid, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVI-01Device
High molecular weight Hyaluronic Acid
| Study group | Role | What they receive |
|---|---|---|
| EVI-01 treatment | Experimental | EVI-01 should be injected within the synovial cavity using standard procedures for intra-articular (IA) injections by a physician skilled in performing IA injections. Receives: Device: EVI-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Primary objective of this study is to assess the safety and tolerability of EVI-01 following single intraarticular administration in the knee joint, assessed with adverse events monitoring throughout the follow up duration of six months.
Measured: 6 months
Secondary outcomes (4)
Change in patient-reported pain intensity
Change in patient-reported pain intensity at Days 1 to 7 compared to baseline will be assess using a 0-100 mm Visual Analogue Scale (VAS), in which 0 means ''no pain at all'' and 100 means ''the worst possible pain''.
Measured: 7 days
Change in WOMAC index
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) consists of a total of 24 questions divided in 5 questions related to pain, 2 questions related to stiffness and 17 questions related to difficulties in performing activities of daily living in relation to physical function. Each question refers to a 0-100 mm Visual Analogue Scale (VAS) in which 0 means ''no pain at all'' and 100 means ''the worst possible pain''. Change in WOMAC pain, stiffness, function and total score will be assess using WOMAC index at Day 7, Day 14, Day 30, Day 90 and Day 180 compared to baseline
Measured: 6 months
Patient satisfaction for the overall treatment effect
Measurements of relief satisfaction by the patient will be assess using a 7 points Likert scale at Day 180. A 7 point Likert scale offers 7 different answer options related to an agreement that would be distinct enough for the respondents (Very good, Good, Fairly good, Same as before, Fairly bad, Bad, Very bad).
Measured: 6 months
Physician satisfaction for the overall treatment effect
Measurements of relief satisfaction by the physician will be assess using a 7 points Likert scale at Day 180. A 7 point Likert scale offers 7 different answer options related to an agreement that would be distinct enough for the respondents (Very good, Good, Fairly good, Same as before, Fairly bad, Bad, Very bad).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start23 Jun 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptissen SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
- Investigators
- Stefano Zaffagnini, MD, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422976
- Sponsor's protocol ID
- EVI-01-IT
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of a Single Intra-articular Highly Concentrated Hyaluronic Acid Injection in the Treatment of Symptomatic Knee Osteoarthritis : Pilot, 6-months, Open-label, Single-arm Investigation
- ClinicalTrials.gov ID
- NCT05422976
- Acronym / sponsor ID
- EVI-01-IT
- Conditions
- Knee Osteoarthritis
- Keywords
- highly concentrated hyaluronic acid, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aptissen SAIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single arm, pilot study to assess the safety and tolerability of a single intra-articular injection of EVI-01 for the treatment of symptomatic knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVI-01 treatment | Experimental | Device: EVI-01EVI-01 should be injected within the synovial cavity using standard procedures for intra-articular (IA) injections by a physician skilled in performing IA injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eighteen (18) years old or above;
- Patient signed informed consent form;
- Patients with stable symptoms related to knee osteoarthritis for at least 3 months prior to screening;
- Failure, inadequate response or intolerance to analgesics and/or NSAIDs or low-grade opioids;
- Kellgren-Lawrence radiographic stage: II-III diagnosed in the previous 12 months;
Key exclusion criteria (12 listed)
- Concomitant inflammatory joint disorder;
- Had received previous visco-supplementation treatment in the study knee within 6 months or intra articular corticosteroids within 3 months* prior to inclusion;
- Infection in or around the study knee;
- Relevant skin disease in the area of injection site;
- Documented presence of injury or trauma of the study knee at screening, including evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments in the study knee;
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 |
|---|---|---|
| EVI-01High molecular weight Hyaluronic Acid | Device | EVI-01 treatment |
Primary outcome
Safety and tolerability
Time frame: 6 months
Primary objective of this study is to assess the safety and tolerability of EVI-01 following single intraarticular administration in the knee joint, assessed with adverse events monitoring throughout the follow up duration of six months.
4 secondary outcomes
Change in patient-reported pain intensity
Time frame: 7 days
Change in WOMAC index
Time frame: 6 months
Patient satisfaction for the overall treatment effect
Time frame: 6 months
Physician satisfaction for the overall treatment effect
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
Stefano Zaffagnini, MD principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVI-01 in people with Knee Osteoarthritis, run by Aptissen SA at 1 site in Italy.
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 12 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 21 Jul 2023. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability (time frame: 6 months). 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 21 Jul 2023.