A Study to Evaluate the Efficacy, Safety and Tolerability of EVI-01 Intra-Articular Injection in Osteoarthritis of the Knee

NCT ID: NCT05337540

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2025-10-29

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EVI-01 - low dose

4 mL, one single EVI-01 intra-articular injection

Group Type: EXPERIMENTAL

EVI-01

Intervention Type: DEVICE

Single intra-articular injection of high molecular weight hyaluronic acid

EVI-01 - high dose

6 mL, one single EVI-01 intra-articular injection

Group Type: EXPERIMENTAL

EVI-01

Intervention Type: DEVICE

Single intra-articular injection of high molecular weight hyaluronic acid

Synvisc-One

6 mL, one single intra-articular injection

Group Type: ACTIVE_COMPARATOR

Active comparator Synvisc-One

Intervention Type: DEVICE

Single intra-articular injection of active comparator Synvisc-One

Interventions

EVI-01

Single intra-articular injection of high molecular weight hyaluronic acid

Intervention Type: DEVICE

Active comparator Synvisc-One

Single intra-articular injection of active comparator Synvisc-One

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients of both genders aged 18 years or older;

2. Body Mass Index (BMI) < 35 kg/m2;

3. 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;

4. 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);

5. Ability to understand and provide signed consent through the Informed Consent Form (ICF).

Exclusion Criteria

1. History of hypersensitivity/allergy to hyaluronic acid (HA) or other excipients of the IP or product;

2. Pregnant or breastfeeding women;

3. 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);

4. Emotional problems or any situation that, at the Investigator's discretion, places the safety of subjects at risk;

5. Application of visco-supplementation to the knee less than four months prior to randomization;

6. Corticosteroid IA injection less than 4 months prior to randomization and/or schedule during the course of the study;

7. Knee infection and/or inflammation (e.g., bursitis), skin infection at or around the IA injection;

8. Swelling, redness, warmth, or other clinically relevant inflammatory signs in the knee in the investigator's description

9. Knee injury or trauma;

10. Patients with bleeding diathesis or on anticoagulant therapy;

11. Major knee malformations or deformities that the investigator deems pertinent;

12. Active cancer at the Investigator's discretion;

13. 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)

14. 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.

15. Need for the use of strong opioids (methadone, fentanyl, morphine, and oxycodone) for pain management;

16. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aptissen SA

INDUSTRY

Sponsor Role: lead

Azidus Brasil

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guilherme Gracitelli, MD

Role: PRINCIPAL_INVESTIGATOR

C.E.P.O.T. - Centro de Estudos e Pesquisas em Ortopedia e Traumatologia

Locations

A2Z Clinical

Valinhos, São Paulo, Brazil

Ortocity

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

EVI-01-BR

Identifier Type: -

Identifier Source: org_study_id