Status:
COMPLETED
Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Osteoarthritis (OA)
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
Brief Summary
This study explored 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 was...
Detailed Description
This was an exploratory study, with a 7-week screening period, an 8-week treatment period, and a 44-week follow-up period, using a 3-treatment arm, parallel-group, randomized, double-blind, placebo-co...
Eligibility Criteria
Inclusion
- 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
- 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 other than OA.
- 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.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04097379
Start Date
July 20 2020
End Date
January 17 2025
Last Update
January 7 2026
Active Locations (1)
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1
Novartis Investigative Site
Leiden, South Holland, Netherlands, 2333 CL