A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of PPV-06 Active Immunotherapy in Patients with Inflammatory Knee Osteoarthritis (KOA).
This research study is looking into a new treatment called PPV-06 for people with knee osteoarthritis. This condition causes pain and stiffness in the knee joints. The study will compare PPV-06 with a placebo (a dummy treatment that looks just like the real one but contains no active medicine) to see how safe and effective it is. They will measure changes in knee pain and how well people can move over 54 weeks. The study is a 'Phase 2' trial, which means they are exploring whether the treatment works and is safe before moving to larger studies. This helps researchers understand if PPV-06 could be a future option for managing knee osteoarthritis.
At a glance
What is this study about?
This study is investigating a new treatment called PPV-06 for common knee pain caused by osteoarthritis. Osteoarthritis is a condition where the cartilage protecting your joints wears down, leading to pain, stiffness, and sometimes swelling. It's a very common problem, especially as people get older.
The main goal of this study is to find out if PPV-06 can help reduce pain and improve how well people can move their knee. They'll also be looking at overall safety. To do this, some participants will receive the new treatment, while others will receive a 'placebo.' A placebo looks exactly like the treatment but contains no active medicine. This helps researchers compare the true effects of the new treatment against doing nothing. Neither the patients nor their doctors will know who is getting which treatment until the study ends. This is called a 'double-blind' study and helps ensure the results are as fair and accurate as possible.
Throughout the study, patients will be regularly assessed. Researchers will use special questionnaires to measure changes in pain and physical function. They will also use MRI scans to look at inflammation and cartilage over time. The information gathered from this study will help us understand if PPV-06 could be a valuable new way to help people manage their knee osteoarthritis in the future.
Key takeaways
- Tests a new treatment for knee osteoarthritis.
- Compares it to a dummy treatment (placebo).
- Focuses on reducing pain and improving movement.
- Involves regular visits and health checks over about a year.
- Both men and women aged 18 and over can be considered.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older, who has been diagnosed with knee osteoarthritis. Both men and women are welcome to participate.
There might be other specific health requirements or conditions that would prevent someone from joining, even if they meet the basic age and diagnosis criteria. These are in place to ensure the study is safe for everyone involved and that the results are clear.
If you're interested, it's really important to discuss all your health conditions and any medicines you are taking with the study doctor. They will carefully check if this study is right for you.
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?
- Have you been diagnosed with knee osteoarthritis?
- Are you able to attend regular clinic visits?
- Are you willing to potentially receive an active treatment or a placebo?
What does participation involve?
If you decide to take part, you'll be assigned to either receive the new treatment (PPV-06) or a dummy treatment (placebo). There's also another existing medication (Panodil) being used for comparison in some parts of the study. You won't know which one you're getting, and neither will your study doctor, until the study is over. You'll need to attend regular visits at your local study clinic over a period of 54 weeks, which is about a year. During these visits, the study team will carry out health checks, ask you questions about your knee pain and how you're moving, and you'll likely have some blood tests. You'll also have MRI scans of your knee, possibly at the start, during, and at the very end of the study (up to 2 years after starting) to check for changes in inflammation and cartilage. The total duration for some assessments, like cartilage changes, could be up to 2 years.
Potential risks and benefits
Locations (5)
- —UnverifiedRomania
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedDenmark
- —UnverifiedCzechia
Common questions
What is knee osteoarthritis?
It's a common condition where the protective cartilage in your knee joint wears down over time, causing pain, stiffness, and sometimes swelling.
What is PPV-06?
PPV-06 is a new treatment being tested to see if it can help reduce pain and improve movement for people with knee osteoarthritis.
What is a 'placebo'?
A placebo is a dummy treatment that looks identical to the active medicine but contains no active ingredients. It helps researchers fairly compare the new treatment's effects.
How long will the study last for me?
The main part of monitoring your pain and function will last about 54 weeks (just over a year), but some detailed checks like MRI scans might continue for up to 2 years.
Will I know if I'm getting the real treatment?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know whether you're receiving PPV-06 or the placebo until the study has finished.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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