A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2)
Sjögren's syndrome is an autoimmune condition where the body's defence system mistakenly attacks its own moisture-producing glands, leading to dry eyes, a dry mouth, joint pain, and deep fatigue. Right now, treatments mainly focus on soothing symptoms rather than tackling the root cause. This Phase 3 clinical trial, known as NEPTUNUS-2, looks at whether an experimental drug called ianalumab (VAY736) can reduce overall disease activity. Adults taking part will receive either the study medicine or a dummy injection (placebo) using a pre-filled syringe. Researchers will follow participants for at least 48 weeks. They will monitor changes in body-wide inflammation, tiredness, and dryness using standard medical checks and questionnaires. The goal is to discover whether ianalumab is safe and effective enough to become a helpful new treatment option in the UK and worldwide.
At a glance
What is this study about?
Sjögren's syndrome is a long-term condition that occurs when the immune system gets confused and attacks healthy parts of the body. It most commonly damages the glands that produce saliva and tears, leaving people with uncomfortable dryness in their eyes and mouth. Many people also struggle with aching joints, muscle pain, and overwhelming exhaustion that makes everyday life difficult.
At present, doctors often prescribe artificial tears, saliva sprays, or general painkillers to help people manage day-to-day. While these can offer relief, they do not stop the underlying inflammation. This trial focuses on a new drug called ianalumab, which is designed to calm specific white blood cells that drive inflammation in Sjögren's syndrome.
The trial is in Phase 3, which is usually the final testing stage before a medicine can be approved for general use. Researchers will compare ianalumab directly against a placebo (an identical-looking injection with no active drug) to prove whether the new medicine truly works and to check for any unexpected side effects.
By gathering detailed information from clinical checks and patient questionnaires over 48 weeks, this study aims to show whether ianalumab can lower disease activity across the whole body and improve daily quality of life for people living with Sjögren's.
Key takeaways
- Tests whether a new injection called ianalumab can reduce Sjögren's syndrome activity.
- A Phase 3 study comparing the active drug against an inactive dummy injection (placebo).
- Open to adults aged 18 and over with active symptoms.
- Involves regular clinic visits and health assessments over at least 48 weeks.
- Participation is voluntary and you can withdraw at any time.
Who may be eligible?
This trial is open to men and women aged 18 and over who have been diagnosed with active Sjögren's syndrome. Active means you are currently experiencing symptoms or inflammation that can be measured by medical tests, rather than mild or settled disease.
People of any gender may take part, provided they meet the health and safety checks set by the study doctors. For instance, your kidneys, liver, and heart will need to be working reasonably well to ensure it is safe for you to take an experimental drug.
You might not be able to join if you have certain other serious autoimmune conditions, active severe infections, or a recent history of cancer. The study team will carry out a thorough screening visit to discuss your medical history and confirm whether this trial is a good match 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.
- I am aged 18 or older.
- I have a confirmed diagnosis of Sjögren's syndrome.
- My condition is currently active, causing ongoing symptoms like severe dryness, fatigue, or joint pain.
- I am able and willing to attend regular hospital appointments for around a year.
- I am comfortable receiving injections under the skin.
What does participation involve?
If you take part, your journey will begin with a screening appointment where doctors run blood tests, eye tests, and general health checks to make sure the trial is safe for you. If you are eligible, you will be randomly placed into a group to receive either the study drug (ianalumab) or an inactive dummy treatment (placebo). Neither you nor your doctor will know which one you are receiving, ensuring the results are completely fair.
The treatment is given as an injection under the skin using a pre-filled syringe. You will need to visit the hospital clinic regularly over roughly 48 weeks. During these visits, the medical team will check your blood, measure your tear and saliva production, and ask you to fill in surveys about your pain, dryness, and energy levels. The total study duration may also include extra follow-up visits to monitor your health after your last dose.
Potential risks and benefits
Locations (11)
- —UnverifiedSweden
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedFrance
- —UnverifiedSlovakia
- —UnverifiedGreece
- —UnverifiedRomania
Common questions
What is a placebo and why is it used?
A placebo is an inactive dummy treatment that looks identical to the real drug. It allows researchers to see whether improvements or side effects are truly caused by the study medicine rather than other factors.
How is the trial medication given?
It is given as an injection just under the skin (subcutaneous injection) using a pre-filled syringe, similar to how insulin is administered.
Will I have to pay for the study treatment?
No. The trial medicine, tests, and doctor visits are provided free of charge, and many trials also help cover travel expenses to the clinic.
Can I carry on taking my usual medicines?
In many cases, yes, but some specific medications that affect the immune system may need to be adjusted or paused. The study doctor will review all your current prescriptions.
What happens if I change my mind later on?
Joining a clinical trial is entirely voluntary. You can choose to leave the study at any point without giving an explanation, and your regular medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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