Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A prospective, double-blinded, randomized, placebo-controlled phase 1/2a study to assess safety, tolerability, systemic exposure and preliminary efficacy of single intraarticular injections of three dose levels of SYN321 and placebo in patients with symptomatic knee osteoarthritis

This research study is investigating a new treatment called SYN321 for people with knee osteoarthritis. Researchers want to understand how safe SYN321 is and if it causes any side effects. They are also comparing different doses of the medicine to a 'dummy' treatment (a placebo) to see if it helps reduce pain and improve quality of life. The study involves giving a single injection directly into the knee. By carefully monitoring participants, scientists hope to learn more about how SYN321 works in the body and if it could be a useful treatment for knee pain in the future. This type of study is an important step in developing new medications.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Synartro AB

Enrolment target

Start

08 Oct 2024

knee osteoarthritis

What is this study about?

This study is a clinical trial looking into a potential new treatment called SYN321 for people who have knee osteoarthritis. Osteoarthritis is a common condition where the cartilage that cushions your joints wears down, leading to pain, stiffness, and sometimes swelling, particularly in the knees.

The main aim of this study is to see how safe SYN321 is. Researchers also want to understand if it causes any unwanted effects and how well people tolerate it. To do this, they are comparing SYN321 to a 'placebo', which is a dummy treatment that looks just like SYN321 but contains no active medicine. This helps them understand whether any changes are due to the actual medicine or something else.

Another important part of the study is to see if SYN321 can help improve symptoms of knee osteoarthritis, like pain. They will also be looking at how the body handles the medicine and how it moves through your system. The information gathered from this study will be very important in deciding if SYN321 could be a helpful new option for people with knee osteoarthritis in the future.

Key takeaways

This study is testing a new medicine (SYN321) for knee osteoarthritis.
It aims to check the medicine's safety, side effects, and how well it helps with pain.
Participants will receive a single injection into their knee.
It's a 'blinded' study, meaning you won't know if you get the active medicine or a dummy.
Participation involves regular check-ups and tracking your pain for about 8 weeks.
You can withdraw from the study at any time.

Who may be eligible?

This study is for adults generally aged 18 and over who have been diagnosed with knee osteoarthritis and are experiencing symptoms.

Both men and women can take part in this research.

Specific medical conditions or medications might affect whether you can join, so the study team will need to check your full medical history carefully.

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 currently experiencing symptoms from your knee osteoarthritis?
Are you able to attend appointments for about 8 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single injection directly into your affected knee. This injection would be either the study medicine (SYN321) at one of three different dose levels, or a placebo (a dummy injection that looks the same but contains no active medicine). Because this is a 'double-blinded' study, neither you nor the study doctors would know whether you received the active medicine or the placebo.

You would have regular check-ups and assessments, which would include physical examinations, blood tests, and possibly heart scans (ECGs). You would also be asked to keep track of your pain levels daily using a simple rating scale for about 56 days (roughly 8 weeks). You'd also complete questionnaires about your knee function and quality of life. The study team would also track any other medicines you take, including pain relievers, to see if you needed extra help with your knee pain. The total duration of your active participation in the main monitoring part of the study would be about two months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of receiving a new treatment that could improve your knee osteoarthritis symptoms. However, as with any new medicine, there might be risks, including side effects from the injection or the medicine itself. These could range from mild, like soreness at the injection site, to more serious effects. All risks will be fully explained by the study team. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Sweden

Common questions

What is knee osteoarthritis?

It's a condition where the protective cartilage in your knee joint wears down, causing pain, stiffness, and swelling.

What does 'double-blinded' mean?

It means neither you nor the doctors will know if you're getting the new medicine or a dummy treatment, which helps make the study fair.

How is the medicine given?

It's given as a single injection directly into the knee joint.

How long will I be in the study?

Your active participation, including daily pain tracking, will last for about 56 days (roughly 8 weeks).

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, and it won't affect your regular medical care.