CQUC398 Study — Osteoarthritis Research (2024)

The CQUC398 trial is a research study testing a new treatment for knee osteoarthritis. The investigational treatment is called QUC398 and is administered as a monthly sub-cutaneous injection (administered under the skin).

CQUC398 is a 16-month study which aims to determine whether the QUC398 injection can relieve osteoarthritis knee pain in your knee and stop the damage to knee cartilage.

In the body, there are several proteins, which are responsible for cartilage damage and pain. The investigational treatment QUC398 is expected to stop one of the most important of these proteins and thereby decreasing cartilage damage and pain.

Currently, there are no approved therapies that stop the progression of osteoarthritis. The available therapies provide symptomatic relief by reducing the pain however are not able to delay the progression of the osteoarthritis. QUC398 is an experimental treatment. This means that it is not an approved treatment for knee osteoarthritis in Australia.

Recruitment for the CQUC398 Study has now closed. If you’d like to be join a current study, please visit our Current Trials page. If you’d like to be notified about future studies, please contact us.

Current trials

Aim 1

To assess the efficacy of QUC398 injections compared with placebo in relieving osteoarthritis knee pain

Aim 2

To assess the efficacy of QUC398 injections compared with placebo in preservation of cartilage in the knee

Aim 3

To assess the efficacy of QUC398 injections compared with placebo in improving knee function

The study is suitable for people who:

• Can speak and read English sufficiently to understand study procedures, complete questionnaires and provide informed consent.

• Have internet access and an active email account.

• Are aged between 40 and 80 years old.

• Weigh more than 50kg and have a BMI between 18 and 35.

• Have moderate to severe knee pain.

• Do not have a needle phobia.

• Have no MRI contraindications (e.g pacemaker, cochlear implant).

• If you are interested in participating in this trial, you will be asked to fill out an online screening survey to see if the study is suitable for you.

• Your study participation will last for about 1 year and 3 months after a screening period of 6 weeks. During this time, you will need to visit the study site approximately 19 times. Most study visits will take 2-4 hours. However, some visits may take longer.

• The first study treatment will be administered on Day 1, followed by administration every 4 weeks until Week 48, inclusive. During the study you will receive a total of 13 sub-cutaneous injections.

• Biological samples including blood and urine will be collected from you while you are in this study.

• You will be required to complete a daily assessment of pain intensity in the target knee and to record any pain medication used.

• You will need to wear a wrist device during the day for select periods during the study. The wrist device is similar to a watch and will monitor your physical activity.

• You are invited to take part in additional and optional blood sample at Week 56 to study how the study treatment is processed by your body and how the study treatment effects your blood markers of your cartilage health.