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

ovartis Pharma AG0 个研究点目标入组 45 人开始时间: 2019年10月9日最近更新: 2022年3月2日

适应症

试验速览

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•- Patient must weigh at least 50 kg and have a BMI within 18-35
•- 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 joint space width of 1.5 to 3.5 mm (females) or 2 to 4 mm (males) within the medial tibio-femoral compartment of the affected knee
•Other protocol-defined inclusion/exclusion criteria may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- 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) in the index knee = 7.5° 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 ECG reading)
•- Signs or Symptoms, in the judgement of the Investigator, of a clinically significant systemic viral, bacterial or fungal infection within 30 days prios to screening
•Other protocol-defined inclusion/exclusion criteria may apply.

发起方