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.
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
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.
Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases
36 weeks prior to randomization, or
Parallel
VAY736
DrugVAY736 once monthly solution for injection for subcutaneous use.
Placebo
DrugPlacebo once monthly solution for injection for subcutaneous use.
Change from baseline in SSSD oral dryness score
The Sjögren's Syndrome Symptom Diary (SSSD) oral dryness score is a patient-reported measure assessing severity of mouth dryness. The mouth dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Change from baseline in SSSD summary score
The SSSD summary score is calculated over a defined time window. Each symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Change from baseline in ESSPRI score
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score is a validated patient-reported outcome assessing three symptom domains: dryness, pain and fatigue. Scores range from 0 (no symptoms) to 10 (worst imaginable symptoms).
Change from baseline in stimulated whole salivary flow (sSF)
The stimulated whole salivary flow rate, is an objective functional assessment of salivary gland activity, measuring saliva production under stimulation. Higher values indicate better salivary gland function.
Change from baseline in Patient's Global Assessment (PaGA) NRS score
The Patient's Global Assessment of disease activity captures the patient's overall perception of disease activity. It is assessed using a Numerical Rating Scale (NRS) from 0 to 10. Higher scores indicate worse perceived disease activity.
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