Ianalumab compared with placebo in adults with Sjögren's disease and heavy symptoms
Tests ianalumab against placebo in adults with Sjögren's disease and high symptom burden.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Almelo, Groningen, Leeuwarden, and Rotterdam, NetherlandsSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Sjögren's disease who have a high burden of symptoms. It tests ianalumab against placebo, given by injection under the skin each month for 52 weeks.
- Age
- 18 years or older, or the legal adult age in the country if that is higher.
- Sex
- Men and women can join.
- Disease stage
- Sjögren's disease by ACR/EULAR 2016 criteria, with high symptom scores (oral dryness score ≥ 5 and overall summary score ≥5 over 14 days). ESSDAI biologic and/or hematologic domain > 0. Stimulated saliva flow > 0.3 mL/min.
- Earlier treatment
- Hydroxychloroquine (≤ 400 mg/day) can continue if the dose was stable for at least 4 weeks. Predniso(lo)ne ≤ 5 mg/day is allowed for up to 16 weeks after randomization. Earlier B-cell-depleting therapy, ianalumab, and several biologic or immunosuppressant drugs must be stopped for set periods before screening.
- Biomarker or test result
- Positive for anti-Ro/SSA antibodies at screening.
Main reasons for not taking part
- Another active autoimmune rheumatic disease as the main illness, such as systemic sclerosis
- Fibromyalgia or overlapping inflammatory diseases, now or in the past
- Earlier B-cell-depleting therapy such as rituximab within 36 weeks, or while B-cell count is still low
- Earlier treatment with ianalumab
- Allergy to the study drugs or their ingredients
Read by machine on 10 November 2026.
Where in Netherlands
- Ziekenhuisgroep Twente StichtingAlmelo, NetherlandsNot yet recruiting
- Universitair Medisch Centrum GroningenGroningen, NetherlandsNot yet recruiting
- Frisius MCLeeuwarden, NetherlandsNot yet recruiting
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsNot yet recruiting
- Maasstad Ziekenhuis StichtingRotterdam, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07621809EU 2025-522271-29-00
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)
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.
Inclusion: 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: Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases; Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:; 36 weeks prior to randomization, or; Prior treatment with ianalumab; Prior treatment with any of the following within the given period prior to Screening:; Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease; Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors); Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:; 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; History of hypersensitivity to any of the study drugs or their excipients, or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/L-histidine, polysorbate 20); As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening; Systemic sclerosis (SSc).