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NCT05752032 Clinical Trial

A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo

Osteoarthritis, Knee Clinical Trial

Official title:
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05752032
Other study ID # ICM 20-1002
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 16, 2023
Est. completion date December 2028

Study information
Verified date May 2024
Source ICM Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational study of the long term safety and efficacy of ICM-203.

Description:

Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 16
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Previous receipt of ICM-203 or matching placebo Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• ICM-203
Long term follow-up
Drug:
• Placebo
Long term follow-up

Locations
Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Barwon Health Geelong Victoria

Sponsors (1)
Lead Sponsor Collaborator
ICM Co. Ltd.

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of delayed adverse events Up to 5 years
Secondary Knee pain Evaluation of change from baseline in knee pain as measured using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable) Up to 3 years
Secondary Knee function Evaluation of change from baseline in knee function as measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) function in daily living subscale ranging from 0 (extreme problems) to 100 (no problems) Up to 3 years
Secondary Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) Evaluation of change from baseline in MOAKS, focusing on bone marrow lesions, articular cartilage, and effusion-synovitis, where higher scores reflect worse disease Up to 3 years
Secondary Joint space width Evaluation of change from baseline in joint space width in mm as measured on knee radiograph Up to 3 years
Secondary Incidence of total knee replacement Up to 5 years
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