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Efficacy and Safety of AqueousJoint Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
AqueousJoint
Sponsored by
Lipo-Sphere
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 Active malignances, excluding BCC. Chemotherapy and/or radiation in the past 12 months Known history of a severe allergic reaction Patient who is pregnant or intends to become pregnant during the study History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies A Known substance or alcohol abuse Participation in other clinical trials within 60 days to before the study or concurrent with the study Known insulin dependent diabetes mellitus Unable to undergo X-ray

Sites / Locations

  • AssutaRecruiting
  • Sheba Medical CenterRecruiting
  • Kaplan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group 1 (Control)

Group 2 (Study)

Group 3 (Study)

Arm Description

1 IA injection of 4 ml Normal Saline solution.

1 IA injection of 4 ml AqueousJoint low conc (15mM)

1 IA injection of 4 ml AqueousJoint high conc (30mM)

Outcomes

Primary Outcome Measures

Efficacy Endpoint
Change in pain score by VAS. VAS score is between 0 to 10, which higher score means worse pain (worse pain).
Efficacy Endpoint
Change in KOOS over the course of the 12-week initial treatment period as measured by participants using the Knee injury and Osteoarthritis Outcome Score (KOOS). KOOS score is between 0 to 100 - higher score means better outcome.

Secondary Outcome Measures

Change in KOOS sub scores
Change in KOOS Symptoms/ Sport / ADL / QOL sub score. KOOS score is between 0 to 100 - higher score means better outcome.
Overall KOOS
Overall KOOS responder rate. KOOS score is between 0 to 100 - higher score means better outcome.
PGA/EGA
Change in Patient's / Evaluators' Global Assessment (PGA/EGA). PGA/ EGA assessment includes 5 options to answer - between 1 to 5 - which 1 means 'very good' , and 5 means 'very poor'.
Safety Endpoint
Adverse events, including serious adverse events

Full Information

First Posted
March 5, 2023
Last Updated
October 8, 2023
Sponsor
Lipo-Sphere
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1. Study Identification

Unique Protocol Identification Number
NCT05771948
Brief Title
Efficacy and Safety of AqueousJoint Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis
Official Title
Efficacy and Safety of AqueousJoint Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: Prospective, Placebo Controlled, Randomized, Double-Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lipo-Sphere

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the Efficacy and Safety of AqueousJoint Intra-Articular Injection in Mild to Moderate Knee Osteoarthritis of AqueousJoint. The main questions it aims to answer are: To demonstrate superior efficacy of AqueousJoint administered via intra-articular injection versus placebo during the study period. To evaluate the efficacy of two different concentrations of AqueousJoint, administered via single IA injection as compared to control group (placebo) One IA injection of AqueousJoint or Placebo will be injected to participants' knee. Follow up will take place up to six months.
Detailed Description
This study aims to assess the efficacy and safety of intra-articular injection of Aqueous Joint at two different concentrations administered via a single injection in osteoarthritic patients up to 26 weeks of follow-up in a double-blind, randomized clinical study. Primary Efficacy Objective The primary objective is to demonstrate the superior efficacy of AqueousJoint administered via intra-articular injection versus placebo during the study period in terms of pain reduction. Pain and functional outcomes will be assessed using VAS and KOOS at each FU visit (up to and including 12 weeks) and compared to the baseline levels. Secondary Efficacy Objective The secondary objective is to assess changes from baseline to 26 weeks in KOOS Pain, symptoms, QOL, ADL and sport subscores. Change from Baseline in Patient's Global Assessment (PGA) and Evaluators' Global Assessment (EGA) of Osteoarthritis at Week 26 will be evaluated. Safety Objectives Safety will be evaluated by the occurrence of Adverse Events during the study. Adverse Events will be reported in terms of incidence, severity, and frequency of all Adverse Events (AE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Control)
Arm Type
Placebo Comparator
Arm Description
1 IA injection of 4 ml Normal Saline solution.
Arm Title
Group 2 (Study)
Arm Type
Experimental
Arm Description
1 IA injection of 4 ml AqueousJoint low conc (15mM)
Arm Title
Group 3 (Study)
Arm Type
Experimental
Arm Description
1 IA injection of 4 ml AqueousJoint high conc (30mM)
Intervention Type
Device
Intervention Name(s)
AqueousJoint
Intervention Description
AqueousJoint is a new intra-articular (IA) injectable joint lubricant for patients suffering from joint pain developed by Liposphere LTD. AqueousJoint is a liposomal boundary lubricant which coats the cartilage surface and protects it from further damage and degradation.
Primary Outcome Measure Information:
Title
Efficacy Endpoint
Description
Change in pain score by VAS. VAS score is between 0 to 10, which higher score means worse pain (worse pain).
Time Frame
Baseline up to 12 weeks
Title
Efficacy Endpoint
Description
Change in KOOS over the course of the 12-week initial treatment period as measured by participants using the Knee injury and Osteoarthritis Outcome Score (KOOS). KOOS score is between 0 to 100 - higher score means better outcome.
Time Frame
Day 0, up to week 12
Secondary Outcome Measure Information:
Title
Change in KOOS sub scores
Description
Change in KOOS Symptoms/ Sport / ADL / QOL sub score. KOOS score is between 0 to 100 - higher score means better outcome.
Time Frame
Baseline to 26 weeks
Title
Overall KOOS
Description
Overall KOOS responder rate. KOOS score is between 0 to 100 - higher score means better outcome.
Time Frame
Baseline to 26 weeks
Title
PGA/EGA
Description
Change in Patient's / Evaluators' Global Assessment (PGA/EGA). PGA/ EGA assessment includes 5 options to answer - between 1 to 5 - which 1 means 'very good' , and 5 means 'very poor'.
Time Frame
Baseline to 26 weeks
Title
Safety Endpoint
Description
Adverse events, including serious adverse events
Time Frame
Baseline to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Active malignances, excluding BCC. Chemotherapy and/or radiation in the past 12 months Known history of a severe allergic reaction Patient who is pregnant or intends to become pregnant during the study History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies A Known substance or alcohol abuse Participation in other clinical trials within 60 days to before the study or concurrent with the study Known insulin dependent diabetes mellitus Unable to undergo X-ray
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisa Yelisov, SC
Phone
972-54-5803409
Email
alisay@assuta.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Drexler, Prof.
Organizational Affiliation
Orthopedic department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta
City
Ashdod
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Drexler, MD
Email
michaeldre@assuta.co.il
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tehila Belfer
Email
tehila.biton@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Merav Lidar, Prof.
Facility Name
Kaplan Medical Center
City
Reẖovot
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiran Rogof
Email
shiranro1@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Amir Herman, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of AqueousJoint Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

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