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

March 25, 2026 updated by: ICM Co. Ltd.
This is an observational study of the long term safety and efficacy of ICM-203.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Barwon Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects who received ICM-203 or matching placebo in clinical studies

Description

Inclusion Criteria:

  • Previous receipt of ICM-203 or matching placebo

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICM-203
Participants who previously received ICM-203 in ICM-203 clinical studies
Genetic: ICM-203
Long term follow-up
Placebo
Participants who previously received placebo in ICM-203 clinical studies
Drug: Placebo
Long term follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of delayed adverse events
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of total knee replacement
Time Frame: Up to 5 years
Up to 5 years
Knee pain
Time Frame: Up to 3 years
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
Knee function
Time Frame: Up to 3 years
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
Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
Time Frame: Up to 3 years
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
Joint space width
Time Frame: Up to 3 years
Evaluation of change from baseline in joint space width in mm as measured on knee radiograph
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ICM Co. Ltd.

Investigators

  • Study Director: Alison Heald, MD, ICM Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM 20-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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