Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo,… (NCT07621809) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
570 participantsStarted 2026-07-15
Plain-language summary
The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
Who can participate
Age range
18 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.
Inclusion Criteria:
* Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher
* Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.
* Seropositive for anti-Ro/SSA antibodies at screening
* SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period
* Screening ESSDAI biologic and/or hematologic domain \> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.
* Stimulated whole salivary flow (sSF) rate \> 0.3 mL/min at screening
* Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period.
* Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.
Exclusion Criteria:
* Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
* Systemic sclerosis (SSc)
* Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments.
*…
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.
1Since this trial is measuring the change in oral dryness specifically, and that's my main symptom, is that enough to know whether ianalumab might also help my other Sjögren's symptoms like fatigue or eye dryness?
2This is a Phase III trial, which means ianalumab has already been through earlier testing — what does my doctor know about the safety signals seen in those earlier phases, and are there any risks I should be weighing before considering this?
3Because this trial is double-blind and placebo-controlled, there's a chance I'd receive a placebo rather than the active drug — given where my symptoms are right now, would it be better for me to try available standard treatments first instead of waiting to find out which arm I'd be in?
4The trial isn't recruiting yet — how long might it realistically be before I could even enroll, and is that waiting period something my current symptom burden can tolerate without other treatment changes?
5What would my doctor need to know about my specific disease activity or lab results to determine whether I might even be a good candidate to discuss with the trial team once enrollment opens?
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.