Study on Safety, Tolerability and Prelimenary Efficacy of LNA043 in Patients Undergoing Autologous Chondrocyte Implantation
Summary
The purpose of this study was to assess safety, tolerability, pharmacokinetics and preliminary efficacy of a single intra-articular (i.a.) administration of LNA043 in regenerating the articular cartilage of the knee, in a standardized clinical scenario of acute cartilage defect. The study aimed at characterizing the mechanism of action of LNA043
Timeline
- Start
- 2017-10-18
- Primary completion
- 2019-04-05
- Completion
- 2019-04-05
Outcome
Missed primary endpoint
Stopped: “This study was terminated early based on an interim analysis of 14 subjects, which demonstrated a favorable safety and tolerability profile.”
registry analysis (superiority test); LNA043 20mg vs Matching Placebo to 20mg; p = 0.1219; Mean Difference (Net) 0.18 (95% CI -0.15 to 0.51) NCT03334812 ↗
registry analysis (superiority test); LNA043 20mg vs Matching Placebo to 20mg; p = 0.3067; Mean Difference (Final Values) 0.06 (95% CI -0.19 to 0.31) NCT03334812 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LNA043 | Unknown | 20 mg | Other |
| Subject | LNA043 | Unknown | 40 mg | Other |