Status:
COMPLETED
EVI-01-IT Safety Study
Lead Sponsor:
Aptissen SA
Collaborating Sponsors:
Donawa Lifescience
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05422976
Start Date
June 23 2022
End Date
May 31 2023
Last Update
July 21 2023
Active Locations (1)
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1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136