Study on Knee Osteoarthritis

NCT06097988 | Completed DMC

• 1 other identifier: CLIN2301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and synovitis. It is also characterized by a decrease of the concentration and molecular weight of the hyaluronic acid in the synovial fluid which ultimately leads to poor viscoelastic properties of synovial fluid and induction of proinflammatory pathways. The intra-articular injection of viscosupplementation gel (mainly exogenous hyaluronic acid) represents one of the most used therapeutic strategies to treat osteoarthritis symptoms. Several studies on knee Osteoarthritis, have shown that one or more weekly injection of viscosupplementation gel significantly relieves articular pain and ameliorates mobility and joint function for at least 6 months and more. Repeated courses of intra-articular injections are an effective and safe treatment for knee osteoarthritis symptoms. Based on studies conducted on intra-articular viscosupplementation gels, the most common side effects expected are local transient and short-lived adverse events such as pain, swelling and arthralgia in the site of administration, which are fully reversible in the days following the injection. Furthermore, such local effects may occur in a minority of cases and are usually treated conservatively with ice, non-steroidal anti-inflammatory drugs, and relative rest.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse device effects related to ABIO34199 treatment [tolerability] at 3 months

  Assessment by the investigators of the occurrence of adverse device effects related to ABIO3419 from the first injection up to the 3-month follow-up

  Month 3 after the last injection

Secondary Outcomes (9)

• Incidence of Treatment-Emergent Adverse Events [Safety]

  Immediately after first injection, before and immediately after the injections at 1 week and 2 weeks, then at 2 weeks, 1 month, 3 months and 6 months after the last injection

• Evaluation of the pain of the treated knee when walking on a flat ground.

  Baseline (before initial injection), 1 week and 2 weeks after the first injection (before 2nd and 3rd injections) then 2 weeks, 1 month and 3 months after the last injection.

• Device related complication rates

  Immediately after first injection, before and immediately after the injections at 1 week and 2 weeks, then at 2 weeks, 1 month, 3 months and 6 months after the last injection

• General health status of the treated knee

  Baseline (before initial injection), 1 week and 2 weeks after the first injection (before 2nd and 3rd injections) then 2 weeks, 1 month and 3 months after the last injection.

• Concomitant analgesic consumption

  1 week before the first injection, 1 week and 2 weeks after the first injection then 2 weeks, 1 month and 3 months after the last injection.

Study Arms (1)

ABIO3419

EXPERIMENTAL

Patients will be included consecutively to receive ABIO3419 by intra-articular injection

Device: ABIO3419

Interventions

ABIO3419 DEVICE

Intra-articular injection

ABIO3419

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
• Male and female subjects, aged 35 to 85 years (inclusive).
• Subjects affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for osteoarthritis of the knee, and meeting the following conditions:
• Kellgren-Lawrence Grade 2 to 3 severity osteoarthritis of the knee confirmed by an extension face X-rays shot, supported by flexion face X-rays shot (optional) obtained within 6 months from the screening visit.
• Subjects suffering from osteoarthritis symptoms of the target knee for at least 6 months prior to the screening visit.
• Pain during walking on flat ground in the target knee of at least 40 mm and maximum 80 mm on a 0-100 mm Visual Analogic Scale at the baseline visit (Visit 2).
• Women of childbearing potential must have a negative urine pregnancy test prior to each injection.
• Subject who is able to comply with the study requirements, at the Investigator's appreciation.
• Subject being affiliated to a health social security system

You may not qualify if:

• Pregnant and breastfeeding women
• Subject with bilateral osteoarthritis of the knees is excluded if one of the following point is present on the non-targeted knee has:
• a visual analog scale score greater than 30mm (\> 30mm),
• a Kellgren-Lawrence score is greater than 2 (\>2)
• a dedicated antalgic consumption.
• Subject suffering from a severe or progressive disease or any other pathology which, according to the investigator, may interfere with evaluation of the results of the study: diabetes, autoimmune pathology, cardiac pathologies, hepatic deficiency, epilepsy, porphyria, rheumatoid arthritis or other systemic inflammatory process.
• Subject who has a known history of severe multiple allergies, angioedema or anaphylactic shock according to the investigator opinion.
• Subject with a known allergy or hypersensitivity to Hyaluronic Acid or bovine collagen.
• Subject with a past history of severe streptococcal disease or an active streptococcus infection according to the investigator opinion.
• Subject with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
• Subject having received chemotherapy agents, immunosuppressive medications within the past 3 months.
• Subject with bleeding disorders or subject received medication (anti-platelet agents and anticoagulant) that will likely increase the risk of bleeding within the past 24 hours before injections.
• Subjects having received:
• Intra-articular knee corticosteroids within 60 days prior to the baseline visit.
• Chondroitinsulphate, glucosamine sulphate, diacereine, bisphosphonates or matrix metalloproteinase inhibitors within 30 days prior to the baseline visit.

Sponsors & Collaborators

• Symatese: lead

Study Sites (2)

Knohenfelds

Riga, Rīga, 1039, Latvia

Location

KRASTINS

Riga, Rīga, 1050, Latvia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristaps KNOHENFELDS

  Veselibas Centrs ZIN

  PRINCIPAL INVESTIGATOR

• Kalvis KRASTINS

  Private Office Centrs

  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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 24, 2023
• Study Start: February 2, 2024
• Primary Completion: June 19, 2024
• Study Completion: September 16, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

LA (2)