EVI-01-IT Safety Study

NCT05422976 | Completed

• 1 other identifier: EVI-01-IT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

highly concentrated hyaluronic acid; knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Primary objective of this study is to assess the safety and tolerability of EVI-01 following single intraarticular administration in the knee joint, assessed with adverse events monitoring throughout the follow up duration of six months.

  6 months

Secondary Outcomes (4)

• Change in patient-reported pain intensity

  7 days

• Change in WOMAC index

  6 months

• Patient satisfaction for the overall treatment effect

  6 months

• Physician satisfaction for the overall treatment effect

  6 months

Study Arms (1)

EVI-01 treatment

EXPERIMENTAL

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.

Device: EVI-01

Interventions

EVI-01 DEVICE

High molecular weight Hyaluronic Acid

EVI-01 treatment

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• Concomitant inflammatory joint disorder;
• 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;
• month = 30 days

Sponsors & Collaborators

• Aptissen SA: lead
• Donawa Lifescience: collaborator

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stefano Zaffagnini, MD

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 21, 2022
• Study Start: June 23, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

IT (1)