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

ClinicalTrials.gov Identifier: NCT04097379

Novartis Reference Number: CLRX712A12201

See if you pre-qualify

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.

Condition 
Osteoarthritis (OA)
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
40 participants
Start date 
Jul 20, 2020
Completion date 
Jun 27, 2022
Gender 
All
Age(s)
35 Years - 65 Years (Adult, Older Adult)

Interventions

Drug
LRX712
LRX712 intra-articular injections
Drug
Placebo
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 -30 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 and equal or less than 2 in the contralateral knee, as confirmed by radiography
Patient must have radiographic confirmation of a joint space width of 2 to 4 mm 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) ≥ 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)
Positive SARS-CoV-2 polymerase chain reaction (PCR) test at Day -1, prior to first study drug administration

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

Netherlands
Novartis Investigative Site
Recruiting
Leiden, 2333 CL
-
Netherlands

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]