Study of Safety Tolerability Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.

  • STATUS
    Recruiting
  • End date
    Sep 2, 2022
  • participants needed
    133
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 September 2021
body mass index

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).

Description

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). In Part A, this study aims to establish Proof of Concept (PoC), namely regeneration of the articular cartilage, in order to provide information on the potential clinical utility of LNA043, with the ultimate goal of replacing current surgical procedures for cartilage repair with an injectable, less invasive regenerative therapy. In Part B, this study aims at further evaluating the cartilage anabolic activity of LNA043 in a more severe knee OA population, and at testing the potential benefit of a higher dose of LNA043 administered i.a. monthly instead of weekly.

Details
Condition Trauma, Wounds
Treatment Placebo, LNA043
Clinical Study IdentifierNCT03275064
SponsorNovartis Pharmaceuticals
Last Modified on22 September 2021

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