NCT05337540

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

A Double-Blind, Randomized, Controlled, Three Parallel Arm, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of One Single Intra-Articular Injection of EVI-01 in Patients With Symptomatic Osteoarthritis of the Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Aptissen SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	EVI-01	Single intra-articular injection of high molecular weight hyaluronic acid
DEVICE	Active comparator Synvisc-One	Single intra-articular injection of active comparator Synvisc-One

Timeline

• Start date: 2024-01-17
• Primary completion: 2025-10-29
• Completion: 2025-10-29
• First posted: 2022-04-20
• Last updated: 2025-12-08

Locations

2 sites across 1 country: Brazil