Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

NCT05771948 | Completed

• 1 other identifier: CLD-0000616
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate the Efficacy and Safety of CCoat Intra-Articular Injection in Mild to Moderate Knee Osteoarthritis. The main questions it aims to answer are:

• To demonstrate superior efficacy of CCoat administered via intra-articular injection versus placebo during the study period.
• To evaluate the efficacy of two different concentrations of CCoat, administered via single IA injection as compared to control group (placebo) One IA injection of CCoat or Placebo will be injected to participants' knee. Follow up will take place up to six months.
• To evaluate the safety of the repeated CCoat injection administered at six months.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Osteoarthritis Outcome Score (KOOS) PAIN

  Change from baseline in patients KOOS pain over the course of the 12-week initial treatment period as measured by using the Knee injury and Osteoarthritis Outcome Score (KOOS) in following subscore: Pain- \[Time Frame: Day 0, up to week 12\] The responses for the KOOS Pain subscale are then summed and transformed into a score ranging from 0 to 100, where: 0 represents extreme problems (maximum pain) 100 represents no problems (no pain)

  Baseline up to 12 weeks

Secondary Outcomes (5)

• Numerical Rating Scale (NRS) Pain Score

  Assessed at1, 6, 12, and 26 weeks from baseline.

• PGA

  Baseline to 6,12 and26 weeks

• Knee Injury and Osteoarthritis Outcome Score Responder Rates

  Baseline to 12 weeks

• Subscores-Specific KOOS Improvements

  Baseline to 6,12 and26 weeks

• Safety Adverse events, including serious adverse events

  baseline to 6 month

Study Arms (2)

Group 1 (Control)

PLACEBO COMPARATOR

1 IA injection of 4 ml Normal Saline solution.

Device: CCoat

Group 2 (Study)

EXPERIMENTAL

1 IA injection of 4 ml CCoat

Device: CCoat

Interventions

CCoat DEVICE

CCoat is a new intra-articular (IA) injectable joint lubricant for patients suffering from joint pain developed by Liposphere LTD. CCoat is a liposomal boundary lubricant which coats the cartilage surface and protects it from further damage and degradation.

Group 1 (Control); Group 2 (Study)

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed and dated the informed consent form
• Age ≥30 and ≤ 85 years old
• Pain in the intended study knee with an average VAS score (active) of ≥3 over the last week before screening.
• Degenerative changes in the intended study knee that can be categorized as grade I -III- Kellgren Lawrence based upon standing anterior- posterior and lateral radiographsof the knee
• Body Mass Index (BMI) between 18.5 and 38
• A negative urine pregnancy test female patient with childbearing potential at Visit 1 prior to intra-articular injection of AqueousJoint.
• If female, the subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential using at least 2 methods of birth control that are effective from at least 30 days before Visit 1 through visit 26w (26 weeks post injection).
• Are willing or able to comply with procedures required in this protocol.

You may not qualify if:

• Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
• History of significant knee trauma or previous surgery of the intended study knee within the last 3 months preceding the screening
• Pain in both knees with a VAS score of ≥5
• Intra-articular injection to the intended study knee within 3 months before Screening
• Significant instability of the index knee
• Malalignment more than 10 degrees varus OR 10 degrees valgus according to standing X-ray
• Intake of chronic pain medications (especially opioid pain relievers) without an option to pause for the period of the study
• History of Psoriatic Arthritis, Rheumatoid Arthritis, or any other inflammatory condition associated with arthritis
• Wound in the area of the intended study knee
• Any known tumor of the index knee
• Any known history of intra-articular or osseous infection of the index knee
• Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, provided that two consecutive cultures are negative (taken within at least 2 weeks of each other)
• Any known history of inflammatory arthropathy or crystal-deposition arthropathy
• Any known systemic cartilage and/or bone disorder, such as but not limited to, chondrodysplasia or osteogenesis imperfecta
• Body Mass Index (BMI) \> 38

Sponsors & Collaborators

• Lipo-Sphere: lead

Study Sites (3)

Assuta

Ashdod, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Drexler, Prof.

  Orthopedic department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: March 16, 2023
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 27, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)