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

• Conditions: Osteoarthritis, Knee
• Interventions: Genetic: ICM-203; Drug: Placebo

• Registration Number: NCT05752032
• Lead Sponsor: ICM Co. Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-02
• Study Start: 2023-03-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Previous receipt of ICM-203 or matching placebo

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICM-203	ICM-203	Participants who previously received ICM-203 in ICM-203 clinical studies
Placebo	Placebo	Participants who previously received placebo in ICM-203 clinical studies

Primary Outcome Measures

Name	Time	Method
Incidence of delayed adverse events	Up to 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Barwon Health; 🇦🇺 Geelong, Victoria, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia