For Healthcare Professionals

A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis.

clipboard-pencil

About the study

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 formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 into the knee of subjects with mild to moderate knee osteoarthritis (OA). Approximately 6 to 18 subjects will be enrolled into 3 successive dose-escalating groups in a 3+3 study design, whereby 3 study subjects in each group will be dosed sequentially with ICM-203 and 3 additional subjects will be dosed at the same dose level if a dose limiting toxicity (DLT) occurs in any of the first 3 subjects.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening.
  2. Kellgren-Lawrence grade 2 or grade 3 OA of target knee.
  3. Target knee pain between 4 and 9, inclusive, on an NRS ranging from 0 (no pain) to 10 (worst pain imaginable), at the time of screening.
  4. KOOS function in daily living score >25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems), at the time of screening .
  5. A stable treatment regimen for symptomatic relief of OA, including NSAIDs, for 4 weeks prior to screening.

EXCLUSION CRITERIA

  1. 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.
  2. Injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1.
  3. Major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening.
  4. Disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk.
  5. Surgery on the target knee within 180 days prior to day 1.
  6. Total knee arthroplasty or other knee surgery planned in the next 12 months.
  7. Active joint infection or other concurrent medical or psychiatric condition that, in the opinion of the Investigator, would make the subject unsuitable for the study.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1 (206) 465-3912Email iconEmail Study Center

Study’s details


Contition

Osteoarthritis, Knee

Age (in years)

50 - 80

Phase

Phase 1/Phase 2

Participants needed

18

Est. Completion Date

Nov 2025

Treatment type

Interventional


Sponsor

ICM Co. Ltd.

ClinicalTrials.gov identifier

NCT05454566

Study number

ICM 20-1003

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.