A randomized, double-blind, placebo controlled, 2-armmulticenter phase 3 study to assess the efficacy and safetyof ianalumab in patients with active Sjögren’s syndrome(NEPTUNUS-1)
This study, called NEPTUNUS-1, is looking into a new medicine called ianalumab for people who have active Sjögren's syndrome. Sjögren's syndrome is a long-term condition that mainly affects the glands that produce tears and saliva, leading to dry eyes and mouth. The study wants to find out if ianalumab is safe and effective in reducing the symptoms of Sjögren's. Participants will either receive the new medicine or a 'dummy' medicine (placebo) by injection. Researchers will closely monitor changes in symptoms and overall well-being. This is a Phase 3 study, which means it’s one of the final steps before a medicine might be approved for wider use.
At a glance
What is this study about?
This research study is called NEPTUNUS-1, and it's looking into a new medicine for people who have Sjögren's syndrome. Sjögren's syndrome is a condition where your body's immune system mistakenly attacks its own healthy cells, especially those in glands that make moisture, like tears and saliva. This can cause very dry eyes and mouth, and sometimes other parts of the body can be affected too, leading to pain and tiredness.
The main goal of this particular study is to see if a new medicine, called ianalumab (also known as VAY736), can help improve the symptoms and overall health of people with active Sjögren's syndrome. 'Active' means your symptoms are currently flaring up or causing significant problems. The study will compare ianalumab to a 'placebo', which looks exactly like the real medicine but contains no active drug. This helps researchers work out if any improvements are truly due to the new medicine or if they might have happened anyway.
Researchers will be looking at how your symptoms change over time, using specific ways of measuring disease activity and your quality of life. This includes checking things like how tired you feel, your pain levels, and how the disease affects your daily life. The study is a 'Phase 3' trial, which means it's a big, important step to gather enough information about the medicine's safety and effectiveness before it can potentially be made available to more people.
Key takeaways
- This study is testing a new medicine, ianalumab, for active Sjögren's syndrome.
- It compares the new medicine to a dummy treatment (placebo).
- Participants will receive the medicine by injection.
- The study hopes to see if the new medicine improves symptoms and quality of life.
- It's a 'Phase 3' study, a crucial step for new medicines.
- You will have regular clinic visits and health checks.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
Beyond these basic requirements, there will be other specific health checks to make sure the study is right for you. For example, the study is looking for people whose Sjögren's syndrome is 'active', meaning you are currently experiencing symptoms or your condition is causing issues.
The research team will carefully review your medical history and conduct some tests to confirm if you meet all the necessary criteria. It's important to remember that not everyone with Sjögren's syndrome will be able to join, even if they meet the age requirement.
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 Sjögren's syndrome?
- Is your Sjögren's syndrome currently 'active' or causing ongoing problems?
- Are you willing to attend regular clinic appointments?
- Are you able to receive injections?
What does participation involve?
If you decide to take part in this study, you will be given either the new medicine (ianalumab) or a placebo (a dummy medicine) through an injection under your skin. Neither you nor your study doctor will know which one you are receiving during the study, as this helps prevent any bias when assessing the treatment's effects.
You will have regular visits to the study clinic over a period of time, likely over a year. At these visits, doctors and nurses will carry out various checks. This will include physical examinations, blood tests, and questionnaires to see how your symptoms are changing and how you are feeling generally. They will also make sure the medicine is not causing any problems.
Throughout the study, your health will be closely monitored. The total duration of your participation in the study, including all treatments and follow-up appointments, will be clearly explained to you if you decide to consider joining.
Potential risks and benefits
Locations (9)
- —UnverifiedBelgium
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedPoland
- —UnverifiedPortugal
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedLithuania
Common questions
What is Sjögren's syndrome?
It's a long-term condition where your body's immune system attacks healthy cells, leading to dryness, particularly in your eyes and mouth.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the new medicine fairly.
What does 'Phase 3' mean for a study?
Phase 3 is an important stage where a medicine is tested in a larger number of people to check its effectiveness and safety before it might be approved for general use.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know, as this helps ensure the study results are as accurate as possible.
How long will I be in the study for?
The full duration of the study, including all visits and follow-ups, will be clearly explained to you by the research 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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