Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA

A Randomized, Placebo-controlled, Subject and Investigator Blinded Study Investigating the Safety, Tolerability and Preliminary Efficacy of 8-week Treatment With Intra-articular LRX712 to Regenerate Articular Cartilage in Patients With Mild/Moderate Knee Osteoarthritis Identifier: NCT04097379

Novartis Reference Number: CLRX712A12201

Last Update: Mar 14, 2023

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study will explore the preliminary efficacy of multiple intra-articular injections of LRX712 by evaluating the ability of the drug to restore structural integrity of articular cartilage. Efficacy will be evaluated in the context of the systemic safety and local tolerability of the investigational drug.

Osteoarthritis (OA)
Phase 2
Overall status 
Start date 
Jul 20, 2020
Completion date 
Mar 03, 2025
35 Years - 75 Years (Adult, Older Adult)


LRX712 intra-articular injections
Placebo intra-articular injections

Eligibility Criteria

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.

To be eligible for inclusion in this study patients must meet all of the following criteria:

Patient must have a BMI between 18 -35 kg/m2
Patient must have symptomatic knee osteoarthritis predominantly in one knee (index knee)
Patient must have knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) in the index knee, as confirmed by radiography
Patient must have radiographic confirmation of a medial joint space width of 1.5 to 3.5 mm for females, or 2 to 4 mm for males within the medial tibio-femoral compartment of the index knee

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for inclusion in this study:

Patient has a known autoimmune disease, inflammatory or chronic arthropathy
Patient had partial or complete joint replacement in one or both knees
Patient has symptomatic, isolated patello-femoral pain in the index knee as per the Investigator's examination
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
Previous use of LRX712 or use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
Patient has malalignment (valgus- or varus-deformity) ≥ 7.5° in the index knee as per anatomic PA axis measured by weight-bearing short knee radiography
History of significant cardiac conduction/electrophysiological disorder, e.g. familial long QT syndrome or known family history of Torsades de Pointes or prolonged QT syndrome or QTcF ≥ 450 msec (Fridericia Correction) for males and ≥ 460 msec for females at screening or baseline (by local 12-lead digitized ECG reading)
Signs or symptoms, in the judgment of the investigator, of a clinically significant systemic viral, bacterial or fungal infection within 30 days prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

Novartis Investigative Site
Wien, 1130
Novartis Investigative Site
Leiden, 2333 CL
Novartis Investigative Site
Maastricht, 6229 HX


Novartis Pharmaceuticals

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