Status:
ACTIVE_NOT_RECRUITING
A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis
Lead Sponsor:
ICM Biotech Australia Pty Ltd.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening.
- Kellgren-Lawrence grade 2 or grade 3 OA of target knee.
- Target knee pain between 4 and 9, inclusive, on an NRS ranging from 0 (no pain) to 10 (worst pain imaginable).
- KOOS function in daily living score \>25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems).
- A stable treatment regimen for symptomatic relief of OA, including NSAIDs, for 4 weeks prior to screening.
Exclusion
- History of rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, autoimmune OA, chondrocalcinosis, hemochromatosis, villonodular synovitis, and synovial chondromatosis or other disorder that in the opinion of the Investigator could cause inflammation of the knee.
- Injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1.
- Major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening.
- Disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk.
- Surgery on the target knee within 180 days prior to day 1
- Total knee arthroplasty or other knee surgery planned in the next 12 months.
- Active joint infection or other concurrent medical (diabetes, uncontrolled hypertension, severe osteoporosis, glaucoma) or psychiatric condition that, in the opinion of the Investigator, would make the subject unsuitable for the study.
Key Trial Info
Start Date :
March 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04875754
Start Date
March 17 2022
End Date
December 1 2026
Last Update
May 1 2025
Active Locations (2)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Barwon Health
Geelong, Victoria, Australia, 3220