NCT05752032

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
31mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Mar 2023Dec 2028

First Submitted

Initial submission to the registry

February 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 16, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

February 21, 2023

Last Update Submit

March 25, 2026

Conditions

Osteoarthritis, Knee

Keywords

Adeno-associated virusGene therapyICM-203Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Incidence of delayed adverse events

    Up to 5 years

Secondary Outcomes (5)

  • Knee pain

    Up to 3 years

  • Knee function

    Up to 3 years

  • Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)

    Up to 3 years

  • Joint space width

    Up to 3 years

  • Incidence of total knee replacement

    Up to 5 years

Study Arms (2)

ICM-203

Participants who previously received ICM-203 in ICM-203 clinical studies

Genetic: ICM-203

Placebo

Participants who previously received placebo in ICM-203 clinical studies

Drug: Placebo

Interventions

ICM-203GENETIC

Long term follow-up

ICM-203
PlaceboDRUG

Long term follow-up

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Previous receipt of ICM-203 or matching placebo

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Alison Heald, MD

    ICM Co. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 2, 2023

Study Start

March 16, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)