EVI-01-IT Safety Study

Aptissen

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: EVI-01

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05422976

EVI-01-IT

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

EVI-01 treatment

Experimental group

Description:

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.

Treatment:

Device: EVI-01