A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This research is a Phase 2 study investigating a new treatment, NVG-2089, for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a condition where the body's immune system attacks nerves, leading to weakness and numbness. The main goal of this study is to check how safe the new medicine is and if there are any side effects. Researchers will also look at how well people tolerate the treatment and if it helps improve their symptoms. The study includes adults aged 18 and over, and both men and women can participate. They are studying people newly diagnosed with CIDP and those who have been living with the condition for a while and may have already tried other treatments.
At a glance
What is this study about?
This study is about a new medicine called NVG-2089, which is being tested for a condition called Chronic Inflammatory Demyelinating Polyneuropathy, often shortened to CIDP. CIDP is a long-term condition where your body's immune system mistakenly attacks its own nerves. This can cause muscle weakness, numbness, tingling, and problems with balance, usually affecting both sides of the body. Finding effective treatments is very important for people living with CIDP.
This is a 'Phase 2' study, which means the medicine has already been tested in a small number of people and shown some promise. Now, researchers want to learn more about its safety and effectiveness in a larger group. They're particularly interested in seeing how people react to NVG-2089, if they experience any side effects, and if it helps improve their CIDP symptoms. This involves carefully looking at changes in muscle strength and how easily people can move around.
The study also aims to understand how NVG-2089 behaves in the body and if the body develops any antibodies against the medicine. They're comparing how the medicine works in people who are newly diagnosed with CIDP and haven't had much treatment before, with those who have had CIDP for some time and might have already tried other therapies. This will help doctors understand who might benefit most from this new treatment in the future.
Key takeaways
- Tests a new medicine (NVG-2089) for CIDP.
- Aims to understand safety, tolerability, and effectiveness.
- Includes adults aged 18 and older, both men and women.
- You would receive the new medicine via a drip.
- Involves regular clinic visits for health checks and tests.
- You can leave the study at any time.
Who may be eligible?
To be able to join this study, you must be at least 18 years old. There's no upper age limit, meaning older adults are welcome to participate as long as they meet the other study requirements.
Both men and women can take part in this research. The study is open to anyone over the age of 18, regardless of their gender.
Beyond age and gender, there will be other specific health checks and medical history reviews to make sure the study medicine is safe and suitable for you. These will be discussed in detail by the study team.
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 a diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)?
- Are you able to attend regular clinic appointments?
- Are you willing to receive the study medicine through an intravenous drip?
What does participation involve?
If you decide to join this study, you would receive the new medicine, NVG-2089, through an intravenous drip, meaning it goes directly into your vein. The study includes regular visits to a clinic over a period of weeks, where doctors and nurses will monitor your health very closely. These visits will involve various assessments, such as physical examinations, checking your vital signs (like blood pressure and heart rate), taking blood and urine samples for lab tests, and possibly getting an electrocardiogram (ECG) to check your heart.
You'll also have tests to measure your muscle strength, grip strength, and how easily you can carry out daily activities. These help the researchers see if the treatment is making a difference to your CIDP symptoms. The study will look at how your body handles the medicine and if there are any side effects. You'll also be followed up for a period after the main treatment to ensure your well-being. The total duration of your participation will be explained fully by the study team.
Potential risks and benefits
Locations (6)
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Common questions
What is CIDP?
CIDP is a long-term condition where your body's immune system attacks its own nerves, leading to weakness, numbness, and tingling, usually on both sides of your body.
What is NVG-2089?
NVG-2089 is a new medicine being tested in this study to see if it can help people with CIDP.
What does 'Phase 2' mean?
Phase 2 means the medicine has already been tried in a small group, and now researchers want to learn more about its safety and how well it works in a larger group of people with CIDP.
Will I get the new medicine or a dummy treatment?
This study is 'open-label', which means everyone who joins will receive the new medicine, NVG-2089.
How long will I need to be in the study?
The full duration of your participation, including treatment and follow-up visits, will be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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