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

  • STATUS
    Recruiting
  • End date
    Jan 11, 2024
  • participants needed
    45
  • sponsor
    Novartis Pharmaceuticals
Updated on 4 August 2021
x-rays

Summary

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.

Description

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of multiple intra-articular injections of LRX712 in the knee when treating patients with knee osteoarthritis of mild/moderate severity, in order to support the further clinical development. This study will also allow refinement of the systemic and local pharmacokinetics of LRX712 and the exploration of drug effects on biomarkers of cartilage breakdown and regeneration in OA patients.

Details
Condition Arthritis, Osteoarthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), degenerative arthritis
Treatment Placebo, LRX712
Clinical Study IdentifierNCT04097379
SponsorNovartis Pharmaceuticals
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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