New clinical trial on knee osteoarthritis
Clinical trial for the treatment of knee osteoarthritis
LRX712 versus Placebo
A randomised, placebo-controlled, patient- and investigator-blinded study of the safety, tolerability and preliminary efficacy of an 8-week treatment with intra-articular LRX712 to regenerate articular cartilage in patients with mild/moderate knee osteoarthritis.
Study start date in Austria: May 2022
Study duration: up to 52 weeks
Active substance: LRX712/placebo
Administration: Intra-articular injection
Study phase: II
Over time, joints become overstressed due to excessive strain, accidents or malalignment and osteoarthritis, i.e. painful wear and tear of the joint, can occur. Current drug treatments for osteoarthritis only aim to reduce symptoms and have no significant effect on structural changes in osteoarthritis. To date, there is no approved medication that can regenerate worn joint cartilage and restore the function of the knee joint.
Which drug is being investigated?
The drug investigated in the study is called LRX712. For the application, LRX712 is injected into the knee joint.
LRX712 is a synthetic small molecule that is able to differentiate stem cells towards cartilage cells and promote cartilage regeneration. In preclinical studies, LRX712 has been shown to induce the restoration of articular cartilage. Treatment with LRX712 may also delay surgical procedures (e.g. knee replacement implantation) in patients with osteoarthritis by regenerating cartilage, thereby reducing pain and improving joint function.
LRX712 is a drug that has not yet been approved by a regulatory agency for the treatment of patients with knee osteoarthritis. The study drug is not currently available on the market in any country, so it cannot be purchased or prescribed.
What is the aim of the study?
The aim of the study is to investigate the safety, tolerability, pharmacokinetics and efficacy of 3 intra-articular injections of LRX712 (or placebo) at 4-week intervals into the knee in patients with mild/moderate osteoarthritis. The condition of the cartilage will be assessed by magnetic resonance imaging after 3 injections of LRX712 or placebo.
How is the study proceeding?
The administration of the study medication is preceded by initial examinations, in the course of which you will be examined in detail and your suitability to take part in the study will be checked (so-called "screening"). If this study is suitable for you, you will be randomly assigned to one of the treatment groups, i.e. "randomised". Your chance of receiving LRX712 is 50%. The study duration is a maximum of 52 weeks. During this time, a total of 16 visits to the study centre at specific intervals and 4 appointments for magnetic resonance imaging are necessary to monitor your health and the progress of your cartilage wear in the knee after administration of the study medication. During these visits, blood and urine samples will be taken and physical examinations and ECGs will be performed, among other things, and you will also be required to answer a questionnaire about your knee symptoms. You will be compensated for your time during the visits to the study centre and the magnetic resonance imaging.
Who can participate in this study?
The study might be suitable for you if
- you have mild/moderate osteoarthritis in a knee joint
- you are between 35 and 75 years old
- your BMI is below 35 kg/m²
You can find out about the exact inclusion and exclusion criteria of the study from Prim. Priv.-Doz. DDr. Christian Albrecht or Dr. Adrian Pototschnig, who will decide together with you on your participation in the study.