Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
Summary
The purpose of this two-part study is to assess the efficacy, safety and tolerability of multiple intra-articular (i.a.) injections of LNA043, in regenerating the articular surface in patients with cartilage lesions of the knee (Part A) and knee osteoarthritis (Part B).
Timeline
- Start
- 2017-09-12
- Primary completion
- 2022-09-06
- Completion
- 2022-09-06
Outcome
Mixed primary results
registry analysis (superiority test); LNA043 20 mg Part B vs Placebo Part B; p = 0.0131; Mean Difference (Net) 200.18 (90% CI 54.53 to 345.83); Mixed Models Analysis NCT03275064 ↗
registry analysis (superiority test); LNA043 40 mg Part B vs Placebo Part B; p = 0.0544; Mean Difference (Net) 141.87 (90% CI -3.83 to 287.56); Mixed Models Analysis NCT03275064 ↗
registry analysis (superiority test); LNA043 40 mg Part B vs Placebo Part B; p = 0.0248; Mean Difference (Net) 0.06 (90% CI 0.01 to 0.11); Mixed Models Analysis NCT03275064 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LNA043 | Unknown | 20 mg | Other |
| Subject | LNA043 | Unknown | 40 mg | Other |