EVI-01-IT Safety Study

July 20, 2023 updated by: Aptissen SA

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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;
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EVI-01 treatment
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.
Device: EVI-01
High molecular weight Hyaluronic Acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in patient-reported pain intensity
Time Frame: 7 days
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''.
7 days
Change in WOMAC index
Time Frame: 6 months
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
6 months
Patient satisfaction for the overall treatment effect
Time Frame: 6 months
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).
6 months
Physician satisfaction for the overall treatment effect
Time Frame: 6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aptissen SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Donawa Lifescience

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefano Zaffagnini, MD, IRCCS Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EVI-01-IT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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