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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337540
• Other study ID #: EVI-01-BR
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: February 2025

Study information

• Verified date: December 2023
• Source: Aptissen SA
• Contact: Eduard Vidovic, MD
• Phone: +41 22 552 21 04
• Email: clinic[@]aptissen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Phase II, dose-finding, interventional, three-arm, randomized (1:1:1), double-blind, parallel, active-comparator-controlled clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients of both genders aged 18 years or older;

2. Body Mass Index (BMI) < 35 kg/m2;

3. 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;

4. 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);

5. Ability to understand and provide signed consent through the Informed Consent Form (ICF).

Exclusion Criteria:

1. History of hypersensitivity/allergy to hyaluronic acid (HA) or other excipients of the IP or product;

2. Pregnant or breastfeeding women;

3. 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);

4. Emotional problems or any situation that, at the Investigator's discretion, places the safety of subjects at risk;

5. Application of visco-supplementation to the knee less than four months prior to randomization;

6. Corticosteroid IA injection less than 4 months prior to randomization and/or schedule during the course of the study;

7. Knee infection and/or inflammation (e.g., bursitis), skin infection at or around the IA injection;

8. Swelling, redness, warmth, or other clinically relevant inflammatory signs in the knee in the investigator's description

9. Knee injury or trauma;

10. Patients with bleeding diathesis or on anticoagulant therapy;

11. Major knee malformations or deformities that the investigator deems pertinent;

12. Active cancer at the Investigator's discretion;

13. 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)

14. 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.

15. Need for the use of strong opioids (methadone, fentanyl, morphine, and oxycodone) for pain management;

16. Participation in a clinical trial within the last twelve months prior to enrollment (CNS Resolution 251, dated 07 August 1997, item III, item J), unless the investigator believes that there may be a benefit to the patient.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• EVI-01
Single intra-articular injection of high molecular weight hyaluronic acid
• Active comparator Synvisc-One
Single intra-articular injection of active comparator Synvisc-One

Locations

Country	Name	City	State
Brazil	Ortocity	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Aptissen SA	Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Comparison of treatment-related Adverse Events in the three groups	Incidence of treatment-emergent adverse events	from baseline to 180 days after randomization
Secondary	Changes to the WOMAC (Western Ontario and McMaster Universities) Total Numeric 3.1 score	WOMAC (Western Ontario and McMaster Universities) numeric scale, version 3.1 (pain, stiffness and physical function assessment)	from baseline to 180 days after randomization
Secondary	Changes to the WOMAC (Western Ontario and McMaster Universities) A score	WOMAC (Western Ontario and McMaster Universities) A numeric scale, version 3.1, total knee pain score (pain, stiffness and physical function assessment)	from Day 1 to Day 7 after randomization
Secondary	Response to the Euro Quality of Life Questionnaire	Euro Quality of Life Questionnaire version EQ-5D-5L	from baseline to 180 days after randomization
Secondary	Response rate, according to OMERACT-OARSI2 international criteria	OMERACT-OARSI2 (Outcome Measures in Rheumatology Committee - Osteoarthritis Research Society International)	from baseline to Days 28, 90 and 180 after randomization