What is this study about?
ONWARDS is a research study aiming to find out if a new treatment, called LNA043, promotes the regeneration of the cartilage tissue in the knee joint and is safe and well tolerated when administered at different doses and frequencies in patients with knee osteoarthritis.
LNA043 is injected into the knee and has the potential to promote healing of the inner portion of the joint. ONWARDS will compare the effects of different doses of LNA043 with a placebo over a period of 5 years. A placebo is a water-based solution with no active medicine inside. A placebo is used to make sure that the changes you might experience are not happening just by chance.
LNA043 has previously been tested on knee osteoarthritis and knee cartilage injury in 4 studies but it is currently an experimental treatment and does not have TGA approval, so we are conducting this study to understand the potential role of LNA043 in providing pain relief for people with knee osteoarthritis.
If the study is suitable for you, you will be randomised into either one of the four different dose/regimen combinations for LNA043 or placebo by chance. It is like flipping a coin. A computer will randomly assign the group you are put in.
The study is suitable for people who:
- are aged between 40 and 75 years of age
- are able to give written informed consent and to participate fully in the interventions and follow-up procedures
- are able to travel to Royal North Shore Hospital for study treatments and follow-up assessments
- suffer moderate osteoarthritis knee pain on most days for at least 6 months
- have a Body Mass Index (BMI) <40Kg/m2
- have no contraindications for MRI imaging
- have no symptomatic hip osteoarthritis
This study has been approved by the Central Adelaide Local Health Network Human Research Ethics Committee (HREC) – 2021/HRE00123 and locally by the Northern Sydney Local Health District Research Office – 2021/STE02368
Am I eligible?
If you have knee pain due to osteoarthritis and would like to learn more please complete the online screening survey available at ONWARDS-study to assess your eligibility.