Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Wounds and Injuries
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03275064
- Collaborators
- Not Provided
- Investigators
- Not Provided
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