Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogr… (NCT05349214) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
United States, Argentina, Australia506 participantsStarted 2022-08-04
Plain-language summary
A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Within 12 weeks prior to randomization: i.v. or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors) unless explicitly allowed by protocol
. HBV DNA is negative
. hepatitis B monitoring is implemented - in these subjects, monthly testing of HBsAg and HBV DNA must be performed while on study treatment and at least every 12 weeks after end of treatment for the entire duration of safety follow-up.
. Antiviral prophylaxis must be implemented before the first administration of the study treatment, and continued up to 12 months after end of study treatment. If antiviral therapy cannot be given or if the patient is not willing to comply with the antiviral treatment requirement, the patient is not eligible for the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial for Sjögren's syndrome — does that mean there's already enough earlier-phase safety data on ianalumab that we have a reasonably clear picture of its risks, and how does that compare to what I might expect from my current or standard treatment options?
2The trial is active but no longer enrolling new patients — does that mean I can't participate, and if so, is there any way to access ianalumab outside of a trial, such as through a compassionate use or expanded access program?
3The trial measures change in something called the ESSDAI score over 48 weeks — can you explain what that score tracks about Sjögren's activity, and whether improving on that scale would likely match the symptoms I personally find most limiting?
4Since the study has three arms, meaning participants receive different treatments or doses, is it worth discussing with you what arm someone would likely be assigned to and whether one of those options would realistically suit my specific disease picture?
5Given that this trial runs for 48 weeks and is already in its active phase, are there other ongoing or upcoming Sjögren's trials I should know about, or would starting a standard treatment now make more sense while we wait to see what results this study produces?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plan A and B - Change from baseline in ESSDAI score at Week 48