NCT04875754

A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis

A Phase 1/2a, Double-Blind, Placebo-Controlled Single Dose Escalation Study of Intra-Articular ICM 203 in Subjects With Kellgren-Lawrence Grade 2 or Grade 3 Osteoarthritis of the Knee

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: ICM Biotech Australia Pty Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 or matching placebo into the knee of subjects with mild to moderate knee osteoarthritis (OA).

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
GENETIC	ICM-203	Intra-articular injection
DRUG	Placebo	Intra-articular injection

Timeline

• Start date: 2022-03-17
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2021-05-06
• Last updated: 2025-05-01

Locations

2 sites across 1 country: Australia