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Enrolling by Invitation

NCT Number: NCT05752032

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

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

Enrolling by Invitation

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous receipt of ICM-203 or matching placebo

Exclusion criteria

  • None

Treatment and study plan

ICM-203

Genetic

Long term follow-up

Placebo

Drug

Long term follow-up

Primary outcomes

  1. Incidence of delayed adverse events

    Time frame: Up to 5 years

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. Incidence of total knee replacement

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

ICM Co. Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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