OsteoarthritisNCT05337540
A Study to Evaluate the Efficacy, Safety and Tolerability of EVI-01 Intra-Articular Injection in Osteoarthritis of the Knee
A study testing EVI-01 and Active comparator Synvisc-One in people with Osteoarthritis and Osteoarthritis, Knee, run by Aptissen SA at 2 sites in Brazil.
Trial summary
Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product. Study design: Interventional, dose-finding, three arms, randomized (1:1:1), parallel assignment, double-blind, controlled by an active comparator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee
- What is being tested?
- EVI-01 and Active comparator Synvisc-One
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesBrazil
- Study dates
- 17 Jan 2024to 29 Oct 2025
- 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
- Patients of both genders aged 18 years or older;
- Body Mass Index (BMI) < 35 kg/m2;
- Diagnosis of primary knee osteoarthritis, Kellgren-Lawrence Grade 2 to 4, according to American College of Rheumatology (ACR) criteria and confirmed radiologically within the previous 12 months, for which an intraarticular treatment is indicated;
- Moderate to severe pain measured by VAS (0-100mm) and >40mm in the knee to be treated, partially responsive to chronic doses of nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or weak opioids (codeine and tramadol);
- Ability to understand and provide signed consent through the Informed Consent Form (ICF).
Who cannot join
- History of hypersensitivity/allergy to hyaluronic acid (HA) or other excipients of the IP or product;
- Pregnant or breastfeeding women;
- Women at menace who do not agree to use acceptable contraceptive methods (oral contraceptive, injectable contraceptive, IUD, hormonal implant, barrier methods, sexual abstinence, hormone transdermal patch and tubal ligation); except those who are surgically sterile (bilateral oophorectomy or hysterectomy);
- Emotional problems or any situation that, at the Investigator's discretion, places the safety of subjects at risk;
- Application of visco-supplementation to the knee less than four months prior to randomization;
- Corticosteroid IA injection less than 4 months prior to randomization and/or schedule during the course of the study;
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- Knee infection and/or inflammation (e.g., bursitis), skin infection at or around the IA injection;
- Swelling, redness, warmth, or other clinically relevant inflammatory signs in the knee in the investigator's description
- Knee injury or trauma;
- Patients with bleeding diathesis or on anticoagulant therapy;
- Major knee malformations or deformities that the investigator deems pertinent;
- Active cancer at the Investigator's discretion;
- Continuous or frequent use (use for more than 2 weeks in the last 2 months) of corticosteroids by any route of administration (oral, IM, IV)
- Concomitant use of chondroprotective drugs such as glucosamine, chondroitin, or collagen. These medications should not be introduced during the study, but if the patient is already taking them may be included, but the medication will not change.
- Need for the use of strong opioids (methadone, fentanyl, morphine, and oxycodone) for pain management;
- Participation in a clinical trial within the last twelve months prior to enrollment (CNS Resolution 251, dated 07 August 1997, item III, item J), unless the investigator believes that there may be a benefit to the patient.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Double-Blind, Randomized, Controlled, Three Parallel Arm, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of One Single Intra-Articular Injection of EVI-01 in Patients With Symptomatic Osteoarthritis of the Knee
Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product.
Study design: Interventional, dose-finding, three arms, randomized (1:1:1), parallel assignment, double-blind, controlled by an active comparator.
Read the detailed description
Phase II, dose-finding, interventional, three-arm, randomized (1:1:1), double-blind, parallel, active-comparator-controlled clinical trial.
- Conditions
- Osteoarthritis, Osteoarthritis, Knee
- Being tested
- EVI-01, Active comparator Synvisc-One
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVI-01Device
Single intra-articular injection of high molecular weight hyaluronic acid
Active comparator Synvisc-OneDevice
Single intra-articular injection of active comparator Synvisc-One
| Study group | Role | What they receive |
|---|---|---|
| EVI-01 - low dose | Experimental | 4 mL, one single EVI-01 intra-articular injection Receives: Device: EVI-01 |
| EVI-01 - high dose | Experimental | 6 mL, one single EVI-01 intra-articular injection Receives: Device: EVI-01 |
| Synvisc-One | Active comparator | 6 mL, one single intra-articular injection Receives: Device: Active comparator Synvisc-One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to the questionnaire WOMAC A (Western Ontario and McMaster Universities) Numeric 3.1
Questionnaire WOMAC A (Western Ontario and McMaster Universities) numeric scale, version 3.1, total knee pain score (pain, stiffness and physical function assessment)
Measured: from baseline to 180 days after randomization
Comparison of treatment-related Adverse Events in the three groups
Incidence of treatment-emergent adverse events
Measured: from baseline to 180 days after randomization
Secondary outcomes (4)
Changes to the WOMAC (Western Ontario and McMaster Universities) Total Numeric 3.1 score
WOMAC (Western Ontario and McMaster Universities) numeric scale, version 3.1 (pain, stiffness and physical function assessment)
Measured: from baseline to 180 days after randomization
Changes to the WOMAC (Western Ontario and McMaster Universities) A score
WOMAC (Western Ontario and McMaster Universities) A numeric scale, version 3.1, total knee pain score (pain, stiffness and physical function assessment)
Measured: from Day 1 to Day 7 after randomization
Response to the Euro Quality of Life Questionnaire
Euro Quality of Life Questionnaire version EQ-5D-5L
Measured: from baseline to 180 days after randomization
Response rate, according to OMERACT-OARSI2 international criteria
OMERACT-OARSI2 (Outcome Measures in Rheumatology Committee - Osteoarthritis Research Society International)
Measured: from baseline to Days 28, 90 and 180 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start17 Jan 2024
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptissen SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Azidus Brasil
- Responsible party
- Sponsor
- Investigators
- Guilherme Gracitelli, MD, Principal investigator, C.E.P.O.T. - Centro de Estudos e Pesquisas em Ortopedia e Traumatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337540
- Sponsor's protocol ID
- EVI-01-BR
- Status last verified
- Dec 2025
- First submitted
- 14 Apr 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Controlled, Three Parallel Arm, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of One Single Intra-Articular Injection of EVI-01 in Patients With Symptomatic Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT05337540
- Acronym / sponsor ID
- EVI-01-BR
- Conditions
- Osteoarthritis, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aptissen SAIndustry (pharma, biotech, devices)
- Collaborators
- Azidus Brasil
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 20 Apr 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.
Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product.
Study design: Interventional, dose-finding, three arms, randomized (1:1:1), parallel assignment, double-blind, controlled by an active comparator.
Detailed description
Phase II, dose-finding, interventional, three-arm, randomized (1:1:1), double-blind, parallel, active-comparator-controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVI-01 - low dose | Experimental | Device: EVI-014 mL, one single EVI-01 intra-articular injection |
| EVI-01 - high dose | Experimental | Device: EVI-016 mL, one single EVI-01 intra-articular injection |
| Synvisc-One | Active comparator | Device: Active comparator Synvisc-One6 mL, one single intra-articular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both genders aged 18 years or older;
- Body Mass Index (BMI) < 35 kg/m2;
- Diagnosis of primary knee osteoarthritis, Kellgren-Lawrence Grade 2 to 4, according to American College of Rheumatology (ACR) criteria and confirmed radiologically within the previous 12 months, for which an intraarticular treatment is indicated;
- Moderate to severe pain measured by VAS (0-100mm) and >40mm in the knee to be treated, partially responsive to chronic doses of nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or weak opioids (codeine and tramadol);
- Ability to understand and provide signed consent through the Informed Consent Form (ICF).
Key exclusion criteria (16 listed)
- History of hypersensitivity/allergy to hyaluronic acid (HA) or other excipients of the IP or product;
- Pregnant or breastfeeding women;
- Women at menace who do not agree to use acceptable contraceptive methods (oral contraceptive, injectable contraceptive, IUD, hormonal implant, barrier methods, sexual abstinence, hormone transdermal patch and tubal ligation); except those who are surgically sterile (bilateral oophorectomy or hysterectomy);
- Emotional problems or any situation that, at the Investigator's discretion, places the safety of subjects at risk;
- Application of visco-supplementation to the knee less than four months prior to randomization;
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-01Single intra-articular injection of high molecular weight hyaluronic acid | Device | EVI-01 - high dose, EVI-01 - low dose |
| Active comparator Synvisc-OneSingle intra-articular injection of active comparator Synvisc-One | Device | Synvisc-One |
Primary outcome
Changes to the questionnaire WOMAC A (Western Ontario and McMaster Universities) Numeric 3.1
Time frame: from baseline to 180 days after randomization
Questionnaire WOMAC A (Western Ontario and McMaster Universities) numeric scale, version 3.1, total knee pain score (pain, stiffness and physical function assessment)
Comparison of treatment-related Adverse Events in the three groups
Time frame: from baseline to 180 days after randomization
Incidence of treatment-emergent adverse events
4 secondary outcomes
Changes to the WOMAC (Western Ontario and McMaster Universities) Total Numeric 3.1 score
Time frame: from baseline to 180 days after randomization
Changes to the WOMAC (Western Ontario and McMaster Universities) A score
Time frame: from Day 1 to Day 7 after randomization
Response to the Euro Quality of Life Questionnaire
Time frame: from baseline to 180 days after randomization
Response rate, according to OMERACT-OARSI2 international criteria
Time frame: from baseline to Days 28, 90 and 180 after randomization
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 8 Dec 2025.
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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.
Guilherme Gracitelli, MD principal investigator
C.E.P.O.T. - Centro de Estudos e Pesquisas em Ortopedia e Traumatologia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVI-01 and Active comparator Synvisc-One in people with Osteoarthritis and Osteoarthritis, Knee, run by Aptissen SA at 2 sites in Brazil.
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 5 inclusion and 16 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Changes to the questionnaire WOMAC A (Western Ontario and McMaster Universities) Numeric 3.1 (time frame: from baseline to 180 days after randomization). 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 8 Dec 2025.