A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
This research is a Phase 2 study investigating a new injection called 4P004. It's for people aged 40 to 80 who have knee osteoarthritis, which is wear and tear of the knee joint, and also inflammation (swelling) inside the knee. The study will test if a single shot of 4P004, given directly into the knee, is safe and effective compared to a 'dummy' injection (placebo). Researchers want to see if 4P004 can help reduce pain and improve how the knee works. This is a blind study, meaning neither the patient nor the doctor will know if they're receiving the active drug or the placebo, to ensure fair results.
At a glance
What is this study about?
This study is exploring a new treatment called 4P004 for people suffering from knee pain. Specifically, it's for those who have both knee osteoarthritis – a common condition where the cartilage in the knee joint wears down – and something called synovitis, which means there's inflammation or swelling inside the knee joint. This inflammation often contributes to the pain and stiffness people feel. The aim is to see if one injection of 4P004 directly into the knee can help reduce these symptoms.
The study is currently in Phase 2, which means it's one of the earlier stages of drug development. At this stage, researchers are mainly focused on finding out if the treatment is safe and if it shows promising signs of being effective for the condition. They are also trying to find the best dose. To make sure the results are reliable, the study compares 4P004 to a 'placebo' – this is a dummy injection, much like what you'd get if you were just having a saltwater solution injected. Neither you nor your doctor would know whether you received the actual drug or the placebo during the study.
The findings from this study will help researchers understand if 4P004 could be a future option for people living with knee pain, especially those with both osteoarthritis and inflammation. It’s an important step in potentially developing new ways to manage these uncomfortable and often debilitating knee conditions.
Key takeaways
- This study is testing a new injection (4P004) for knee pain.
- It's for people aged 40-80 with both knee arthritis and inflammation.
- The study compares 4P004 to a dummy injection (placebo).
- It aims to see if the injection helps reduce pain and improve knee function.
- Participation involves a single injection and several follow-up visits.
- Your safety and well-being would be monitored closely throughout the study.
Who may be eligible?
This study is looking for volunteers between 40 and 80 years old. You need to have knee pain that has lasted at least 6 months, and it should be moderate to severe on most days over the last three months. You also need to have been diagnosed with knee osteoarthritis and have inflammation (swelling) inside your knee joint. We will check this with an ultrasound scan.
To be considered, you should have tried other common pain relief treatments like paracetamol, NSAIDs (like ibuprofen), or even stronger options like certain opioids or steroid injections, but found they didn't help enough, or you couldn't take them. Your body weight and overall health will also be checked to make sure it's safe for you to take part.
There are also some things that would prevent you from joining. For example, if you have severe pain in your other knee, or if you have a BMI (Body Mass Index) outside of a certain range (between 18.5 and 35). Women who could become pregnant would need to use effective birth control throughout the study. You'll need to be able to walk, though using a walking stick or cane is fine.
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 between 40 and 80 years old?
- Do you have knee pain most days, rated as moderate to severe?
- Has your knee pain lasted at least 6 months?
- Have you tried common pain relief options that didn't help enough?
- Can you walk, even if you use a stick or cane?
- Are you able to attend regular study visits?
What does participation involve?
If you take part in this study, you would first have ascreening visit to check if you meet all the requirements. If you do, you would then receive a single injection into your knee – this would be either the study drug 4P004 or a placebo (a dummy injection). You wouldn't know which one you received.
After the injection, you would have several follow-up visits with the study team. These visits would involve checking how your knee pain is, how well your knee works, and making sure you're not having any unexpected side effects. You might also have physical examinations, blood tests, and scans of your knee. You would be asked to keep a diary of your pain levels. The study would last for several months in total, with regular check-ups to monitor your progress and safety.
Potential risks and benefits
Locations (22)
- Tucson Orthopaedic InstituteVerified postcodeTucson, United States· Recruiting
- Northwestern University Feinberg School of MedicineVerified postcodeChicago, United States· Recruiting
- Skylight Health Research BurlingtonVerified postcodeBurlington, United States· Recruiting
- Durham Bone and Joint SpecialistsVerified postcodeAjax, Canada· Recruiting
- SJHC London Rheumatology CentreVerified postcodeLondon, Canada· Recruiting
- G.R.M.O. (Groupe de recherche en maladies osseuses) IncVerified postcodeQuébec, Canada· Not yet recruiting
- Parker Institute Bispebjerg, Frederiksberg HospitalVerified postcodeFrederiksberg, Denmark· Recruiting
- Sanos Clinic HerlevVerified postcodeHerlev, Denmark· Recruiting
- CHU MontpellierVerified postcodeMontpellier, France· Recruiting
- ChU de NiceVerified postcodeNice, France· Recruiting
- Hôpital CochinVerified postcodeParis, France· Recruiting
- Hôpital LariboisièreVerified postcodeParis, France· Recruiting
Common questions
What is osteoarthritis?
Osteoarthritis is a common condition where the smooth cartilage covering the ends of bones in your knee joint gradually wears away, leading to pain, stiffness, and sometimes swelling.
What is synovitis?
Synovitis means there's inflammation or swelling of the lining inside your knee joint. This can cause pain and contribute to the symptoms of arthritis.
What does 'intra-articular' mean?
It means the injection is given directly into the joint space of your knee.
What is a 'placebo'?
A placebo is a 'dummy' treatment, like a saltwater injection, that looks exactly like the actual study drug but contains no active medicine. It helps researchers fairly compare the new treatment's effects.
Will I know if I'm getting the real drug or the placebo?
No, this is a 'blind' study, meaning neither you nor your study doctor will know whether you're receiving 4P004 or the placebo. This helps ensure fair and unbiased results.
How to find out more
Francis Berenbaum, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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