Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
This study, called NEPTUNUS-2, is looking into a new medicine, ianalumab (also known as VAY736), for people who have active Sjögren's syndrome. Sjögren's syndrome is a condition where your immune system attacks your healthy tissues, often causing dry eyes and mouth. The main goal is to find out if ianalumab is safe and effective in improving symptoms. Participants will be randomly given either the new medicine or a placebo (a dummy medicine with no active ingredients). This is a 'Phase 3' study, which means it involves a larger group of people and is a crucial step before a medicine can be approved for general use. The medicine will be given as an injection under the skin either monthly or every three months.
At a glance
What is this study about?
This study, named NEPTUNUS-2, is designed to carefully look at a new medicine called ianalumab (VAY736) for people living with Sjögren's syndrome. Sjögren's syndrome is an autoimmune condition, meaning your body’s defence system mistakenly attacks its own healthy tissues. This most commonly affects the glands that produce tears and saliva, leading to very dry eyes and mouth, but it can also affect other parts of the body like joints and organs.
The main purpose of this study is to see if ianalumab can help reduce the symptoms of active Sjögren's syndrome and if it is safe for people to use. To do this fairly, the study will involve three groups of people: some will receive ianalumab monthly, some will receive it every three months, and others will receive a 'placebo'. A placebo looks exactly like the real medicine but contains no active ingredients. This helps scientists to truly understand if any improvements are due to the new medicine or other factors. Neither you nor your study doctor will know which treatment group you are in, which is called a 'double-blind' study. This is a common and important way to prevent bias in research.
This is a 'Phase 3' study, which means it's one of the final steps in testing a new medicine before it might become available to everyone. It involves a larger number of patients and aims to confirm the findings from earlier, smaller studies. By taking part, you could be helping to find new and more effective treatments for Sjögren's syndrome in the future.
Key takeaways
- This study is testing a new medicine (ianalumab) for active Sjögren's syndrome.
- It's a 'Phase 3' study, which is a key step in developing new treatments.
- Participants will receive either ianalumab (monthly or every 3 months) or a placebo.
- The medicine is given as an injection under the skin.
- You'll have regular check-ups and medical monitoring.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) and have Sjögren's syndrome that has been diagnosed within the last 7 and a half years, according to specific medical guidelines. Your Sjögren's syndrome also needs to be 'active,' meaning you have specific symptoms or signs of the condition that are being monitored. You'll also need to have certain antibodies in your blood (called anti-Ro/SSA) or, if not, a positive saliva gland biopsy.
There are also some requirements about your current health and medicines you might be taking. For example, your saliva flow rate needs to be at a certain level. If you are taking medicines for your Sjögren's syndrome, such as hydroxychloroquine or methotrexate, you may be able to continue them, but they need to have been at a steady dose for at least a month beforehand. Other specific medications, including some traditional Chinese medicines, might need to be stopped before you can join. You won't be able to join if you have another active autoimmune condition that is your main illness, or if you're taking part in another drug study.
The research team will carry out several checks and tests to make sure the study is a good fit for you and that taking part would be safe. It's important that you can understand the study requirements and are willing to follow them.
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 Sjögren's syndrome confirmed within the last 7.5 years?
- Do you have active Sjögren's symptoms being monitored?
- Are you able to attend regular clinic appointments and follow study instructions?
- Are you not currently involved in another drug study?
What does participation involve?
If you decide to take part in this study, you'll first be asked to sign a consent form, which means you agree to participate after having all your questions answered. You'll then go through a screening process to check if you meet all the requirements. Once enrolled, you'll be randomly assigned to one of three groups: receiving ianalumab monthly, ianalumab every three months, or a placebo (dummy medicine). The medicine will be given as an injection under the skin.
Throughout the study, you'll have regular visits to the clinic for medical check-ups, blood tests, and to discuss any changes in your health or symptoms. These visits are important for the research team to monitor your progress and ensure your safety. The full duration of the study, including follow-up appointments, will be explained by the study team, but it typically involves several months to a year or more. The team will provide you with a detailed schedule of visits and what each visit will involve.
Potential risks and benefits
Locations (146)
- Providence Medical FoundationVerified postcodeFullerton, United States
- Advanced Medical ResearchVerified postcodeLa Palma, United States
- Bay Area Arthritis And OsteoporosisVerified postcodeBrandon, United States
- GNP ResearchVerified postcodeCooper City, United States
- Sarasota Arthritis Res CtrVerified postcodeSarasota, United States
- Augusta University GeorgiaVerified postcodeAugusta, United States
- North Georgia Rheumatology GroupVerified postcodeLawrenceville, United States
- Clin Invest Specialists IncVerified postcodeOrland Park, United States
- Clinic of Robert HozmanVerified postcodeSkokie, United States
- Clinical Investigation Specialists, Inc.Verified postcodeWauconda, United States
- University of Kansas HospitalVerified postcodeKansas City, United States
- Tufts School of Dental MedicineVerified postcodeBoston, United States
Common questions
What is Sjögren's syndrome?
Sjögren's syndrome is a long-lasting condition where your body's immune system mistakenly attacks healthy parts of your body, often leading to dry eyes and mouth.
What is ianalumab?
Ianalumab is the new medicine being tested in this study to see if it can help people with Sjögren's syndrome.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real treatment but doesn't have any active ingredients. It helps researchers compare results fairly.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know whether you are receiving ianalumab or the placebo. This is to ensure the study results are accurate.
Will I have to pay to join the study?
No, you will not have to pay to participate in the study. All study-related treatments and tests are covered by the research sponsor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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