Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
This research study is looking into a new treatment called ianalumab (VAY736) for people living with active Sjogren's Syndrome. It's designed to see how well ianalumab works and if it's safe when compared to a 'dummy' treatment (placebo). Participants will receive either the study medicine or the placebo by injection under the skin every month. Doctors and participants won't know who is getting which treatment. The study aims to find out if ianalumab can help improve symptoms of Sjogren's Syndrome and ensure it doesn't cause too many side effects. This is a crucial step in developing new medicines.
At a glance
What is this study about?
You might be reading this because you or someone you know has Sjogren's Syndrome and you're interested in new treatments. This study is testing a medicine called ianalumab (also known as VAY736). Sjogren's Syndrome is a long-term condition that affects parts of the body that produce fluids, like tears and saliva, leading to dryness in the eyes and mouth. It can also cause problems in other parts of the body, such as the joints, skin, and kidneys. Currently, there isn't a cure, so treatments focus on managing symptoms and preventing complications.
This study, called NEPTUNUS-1, is a 'Phase 3' trial, which means it's one of the final steps before a medicine might be made available to everyone. Researchers want to understand if ianalumab can effectively reduce the symptoms of active Sjogren's Syndrome and if it's safe for people to use. They will compare it to a 'placebo', which looks exactly like the study medicine but doesn't contain any active drug. This helps them truly see the effects of ianalumab.
Participants will be placed into one of two groups by chance (randomised): one group will receive ianalumab, and the other will receive the placebo. Neither the patient nor the doctor will know which treatment is being given, which helps keep the study fair and unbiased. The main goal is to find out if ianalumab improves the symptoms and overall well-being of people with Sjogren's Syndrome, ultimately hoping to offer a new treatment option.
Key takeaways
- This study is testing a new medicine (ianalumab) for active Sjogren's Syndrome.
- It's a Phase 3 study, meaning it's a key step in approving a new medicine.
- Participants will receive either ianalumab or a 'dummy' treatment (placebo) by monthly injections.
- The study aims to see if ianalumab is effective and safe for treating Sjogren's symptoms.
- Close medical monitoring will be provided throughout the study.
- Participation is voluntary, and you can leave the study at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a confirmed diagnosis of Sjogren's Syndrome based on specific medical tests (ACR/EULAR 2016 criteria). Your Sjogren's diagnosis should have been made within the last 7 and a half years at most. You also need to have certain antibodies in your blood (anti-Ro/SSA positive). If you don't have these specific antibodies, you might still be able to join if a special biopsy confirms your diagnosis, but only a small number of people without the antibodies can be included.
The study is looking for people whose Sjogren's Syndrome is 'active', meaning you have certain symptoms or signs of the condition that meet a specific score (ESSDAI score of 5 or more) in areas like tiredness, swollen glands, joint pain, skin issues, or blood changes. You also need to produce a certain amount of saliva. If you're currently taking medicines like hydroxychloroquine, methotrexate or azathioprine, you might still be able to join, but you would need to be on a steady dose for at least one month before the study starts. The same applies if you're taking steroid tablets, but the dose must be low (10mg or less of prednisone or similar).
There are also reasons why you might not be able to join. For example, if you have another serious autoimmune disease that is causing your main health problems, or if you've recently taken other experimental drugs. The research team will carefully check all your medical information to see if this study is right 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.
- Are you 18 years old or older?
- Do you have a confirmed Sjogren's Syndrome diagnosis within the last 7.5 years?
- Does your Sjogren's Syndrome currently have active symptoms?
- Do you have positive anti-Ro/SSA antibodies or a confirmed salivary gland biopsy?
- Are you on stable doses of certain Sjogren's medications (if applicable)?
- Are you willing to have monthly injections and attend regular study visits?
What does participation involve?
If you decide to take part in this study, you'll first have several appointments where blood tests, physical exams, and other checks will happen to make sure you meet all the requirements. Once confirmed, you'll receive either the study medicine (ianalumab) or a dummy medicine (placebo) by an injection under your skin, which will happen every month. You'll have regular follow-up visits with the study team for blood tests, to discuss your symptoms, and to check for any side effects. Each of these monthly visits will include giving you the injection. The exact number of visits and the total length of time you'll be involved will be explained in detail by the study team. They will monitor your health closely throughout the entire study period.
Potential risks and benefits
Locations (77)
- Medvin Clinical ResearchVerified postcodeVan Nuys, United States
- West Broward Rheumatology Associates IncVerified postcodeTamarac, United States
- Indiana Univ School of DentistryVerified postcodeIndianapolis, United States
- Ochsner Health SystemVerified postcodeBaton Rouge, United States
- The John Hopkins Jerome L Greene SjogrenVerified postcodeBaltimore, United States
- Winthrop University HospitalVerified postcodeMineola, United States
- Carolina Arthritis AssociatesVerified postcodeWilmington, United States
- STAT Research IncVerified postcodeDayton, United States
- Altoona Center for Clin ResVerified postcodeDuncansville, United States
- Precision Comprehensive ResearchVerified postcodeColleyville, United States
- Metroplex Clinical ResearchVerified postcodeDallas, United States
- Baylor College Of MedicineVerified postcodeHouston, United States
Common questions
What is Sjogren's Syndrome?
Sjogren's Syndrome is a long-term condition where the body's immune system mistakenly attacks healthy cells, especially those that produce tears and saliva, leading to dryness in the eyes and mouth. It can also affect other parts of the body.
What is ianalumab (VAY736)?
Ianalumab is the name of the new medicine being tested in this study for Sjogren's Syndrome. It works in a specific way to try and calm down the immune system.
What does 'placebo' mean?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is actually working, or if improvements might be due to other factors.
Will I know if I'm getting the active medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving ianalumab or the placebo. This helps ensure the study results are fair.
How will the medicine be given?
The study medicine (ianalumab or placebo) will be given as an injection under the skin every month.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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