Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, two-arm, placebo-controlled, participant, investigator and sponsor-blinded, proof-of-concept study investigating the efficacy, safety and tolerability of QUC398 in patients with symptomatic knee osteoarthritis

This research study is looking into a new treatment called QUC398 for people experiencing pain from knee osteoarthritis. Osteoarthritis is a common condition where the cartilage in your joints wears down, causing pain and stiffness. The main goal of this study is to find out if QUC398 can effectively reduce knee pain and if it’s safe for patients to use. Participants will be randomly given either QUC398 (an injection) or a 'dummy' injection (placebo), alongside common pain relief like paracetamol or paracetamol/codeine tablets. The study is 'blinded', meaning neither you nor the research team will know which treatment you are receiving. This is a common way to make sure the results are as fair and accurate as possible. We will closely monitor how your pain changes and check for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

Start

26 Apr 2024

Knee osteoarthritis

What is this study about?

This clinical trial is designed to investigate a new medication, QUC398, for individuals who have pain due to knee osteoarthritis. Knee osteoarthritis is a condition where the protective cartilage that cushions your joints wears away over time, leading to pain, stiffness, and sometimes swelling. Finding new ways to manage this pain is really important for improving people's daily lives.

The study is trying to understand if QUC398 can effectively reduce the pain caused by knee osteoarthritis and if it's safe to use. To do this, some people will receive QUC398, while others will receive a 'placebo' – which looks identical but contains no active medicine. This helps the researchers compare the new medicine to not having it, to see if any improvements are genuinely due to QUC398. Everyone in the study will also have access to standard pain relievers like paracetamol or paracetamol and codeine tablets.

This is a 'Phase II' study, which means it's an early stage of testing. We're exploring if the medicine works and learning more about the right dose and how safe it is. The research team will be carefully monitoring your knee pain, checking how your knee moves, and overall how you are feeling throughout the study. We will also be looking at detailed scans of your knee joint to see if there are any changes to the cartilage.

Key takeaways

This study is testing a new injection, QUC398, for knee pain from osteoarthritis.
It aims to see if QUC398 reduces pain and is safe.
Participants will receive QUC398 or a dummy injection, plus standard pain relief.
The study lasts about one year and involves clinic visits and scans.
Your safety is a priority, and all participation is voluntary.

Who may be eligible?

This study is looking for adults aged 18 years and older who have been diagnosed with painful knee osteoarthritis. Both men and women are welcome to take part.

To make sure the study results are clear and reliable, there are certain health conditions or medications that might mean you can't join. This is not because of anything you've done, but simply to protect your safety and ensure the study can properly evaluate the new treatment.

If you are interested, the study team will ask you a series of questions about your health and medical history to confirm if this study is suitable for you. It's important to be open and honest during this process to ensure your safety and the accuracy of the trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have knee osteoarthritis that causes you pain?
Are you able to attend regular clinic visits for about a year?
Are you comfortable with receiving injections and having MRI scans?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your involvement will last for about 52 weeks (roughly one year). You'll have several visits to the study clinic, particularly in the first few weeks, and then less frequently towards the end. During these visits, you'll have physical examinations, blood tests, and we'll ask you to complete questionnaires about your pain and how your knee affects your daily life. You will receive either the investigational medicine (QUC398) or the placebo as an injection. You will also be given either paracetamol or paracetamol and codeine tablets to help manage your pain as needed.

Throughout the study, the research team will closely monitor your health and any changes in your knee pain. You'll also have special MRI scans of your knee at certain times to look at your joint cartilage. You'll be asked to keep track of your medication and any side effects you experience. Your commitment is crucial for the success of the study.

Potential risks and benefits

Participating in a clinical trial has potential benefits and risks. You might benefit from closer medical attention and access to a new treatment that isn’t widely available, which could potentially improve your knee pain. However, there's no guarantee the new medicine will work for you, and you might experience side effects from the study medication or the injections. These can include discomfort at the injection site or other effects that the study team will explain in detail. All procedures, like blood tests and scans, also carry very small risks. Your safety is our top priority, and you will be closely monitored throughout the study. Remember, joining a trial is completely voluntary, and you are free to withdraw at any time without giving a reason, and it will not affect your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark
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Unverified
Spain
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Unverified
France

Common questions

What is knee osteoarthritis?

Knee osteoarthritis is a common condition where the protective cartilage in your knee joint gradually wears away, leading to pain, stiffness, and sometimes swelling.

What does 'placebo-controlled' mean?

It means some participants will receive the new medicine, while others will get a 'dummy' treatment (placebo) that looks the same but has no active ingredients. This helps researchers compare the effects accurately.

Will I know if I'm getting the new medicine?

No, this study is 'blinded', meaning neither you nor the doctors will know whether you are receiving QUC398 or the placebo. This helps ensure the study results are fair.

How long will I be in the study?

If you join, your participation will last for approximately one year (52 weeks).

Can I leave the study at any time?

Yes, your participation is completely voluntary. You can choose to leave the study at any point without needing to give a reason, and it won't affect your regular medical care.