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

NCT05337540 | Completed DMC

• 1 other identifier: EVI-01-BR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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)

  from baseline to 180 days after randomization

• Comparison of treatment-related Adverse Events in the three groups

  Incidence of treatment-emergent adverse events

  from baseline to 180 days after randomization

Secondary Outcomes (4)

• Changes to the WOMAC (Western Ontario and McMaster Universities) Total Numeric 3.1 score

  from baseline to 180 days after randomization

• Changes to the WOMAC (Western Ontario and McMaster Universities) A score

  from Day 1 to Day 7 after randomization

• Response to the Euro Quality of Life Questionnaire

  from baseline to 180 days after randomization

• Response rate, according to OMERACT-OARSI2 international criteria

  from baseline to Days 28, 90 and 180 after randomization

Study Arms (3)

EVI-01 - low dose

EXPERIMENTAL

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

Device: EVI-01

EVI-01 - high dose

EXPERIMENTAL

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

Device: EVI-01

Synvisc-One

ACTIVE COMPARATOR

6 mL, one single intra-articular injection

Device: Active comparator Synvisc-One

Interventions

EVI-01 DEVICE

Single intra-articular injection of high molecular weight hyaluronic acid

EVI-01 - high dose; EVI-01 - low dose

Active comparator Synvisc-One DEVICE

Single intra-articular injection of active comparator Synvisc-One

Synvisc-One

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Aptissen SA: lead
• Azidus Brasil: collaborator

Study Sites (2)

A2Z Clinical

Valinhos, São Paulo, Brazil

Location

Ortocity

São Paulo, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Guilherme Gracitelli, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 20, 2022
• Study Start: January 17, 2024
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

BR (2)