Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis

Summary

This was a multicenter, randomized, double-blind, placebo-controlled Phase IIb study evaluating intra-articular LNA043 in patients with knee osteoarthritis.

Timeline

Start

2021-05-31

Primary completion

2024-09-29

Completion

2025-05-29

Outcome

Missed primary endpoint

Stopped: “Study early terminated due to lack of effect (did not meet primary/ secondary endpoints). This decision was not linked to safety concerns”

registry analysis (superiority test); Arm 1: LNA043 40 mg x3, Q6m vs Placebo x3, Q6m; p = 0.5001; NCT04864392 ↗

registry analysis (superiority test); Arm 2: LNA043 40 mg x3, Q12m vs Placebo x3, Q6m; p = 0.5080; NCT04864392 ↗

Publications

• Gerwin N, Scotti C, Halleux C, Fornaro M, Elliott J, Zhang Y, Johnson K, Shi J, Walter S, Li Y, Jacobi C, Laplanche N, Belaud M, Paul J, Glowacki G, Peters T, Wharton KA Jr, Vostiar I, Polus F, Kramer I, Guth S, Seroutou A, Choudhury S, Laurent D, Gimbel J, Goldhahn J, Schieker M, Brachat S, Roubenoff R, Kneissel M. Angiopoietin-like 3-derivative LNA043 for cartilage regeneration in osteoarthritis: a randomized phase 1 trial. Nat Med. 2022 Dec;28(12):2633-2645. doi: 10.1038/s41591-022-02059-9. Epub 2022 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LNA043	Unknown	20 mg	Other
Subject	LNA043	Unknown	40 mg	Other

Indications