Two arm, double blind, Phase III study assessing efficacy and safety of ianalumab versus placebo, in participants with Sjogrens disease with high symptom burden

INTERVENTION: Intervention1: ianalumab: ianalumab 300 mg/2 mL Solution for injection in autoinjector (AI) every 4 weeks for 152 weeks Control Intervention1: Placebo: Matching placebo 0 mg/2 mL Solution for injection in autoinjector (AI) every 4 weeks for 52 weeks CONDITION: Health Condition 1: M350‐ Sicca syndrome [Sjogren] PRIMARY OUTCOME: To demonstrate superiority of ianalumab over placebo based on the change from baseline in the Sjogren Syndrome Symptom Diary (SSSD) oral dryness score at Week 52Timepoint: Change from baseline in SSSD oral dryness score at Week 52 INCLUSION CRITERIA: ‐Male or female participants greater than equal to 18 years of age or as per country specific legal adult age, whichever is higher. ‐Classification of Sjogren disease according to ACR‐EULAR 2016 criteria. ‐Seropositive for anti‐Ro‐SSA antibodies at screening. ‐SSSD oral dryness score greater than equal to 5 and overall SSSD summary score greater than equal to 5 collected over 14 consecutive days during the Screening 2 period. ‐Screening ESSDAI biologic and or hematologic domain greater than 0. Note: laboratory abnormalities for scoring must be confirmed as associated with Sjogren disease and not be due to other underlying conditions. .If during screening visit cryoglobulins are being assessed locally as part of standard clinical practice they can be included in the ESSDAI scoring, but patients may be enrolled without screening results of cryoglobulins, provided all inclusion criteria and no exclusion crite SECONDARY OUTCOME: To assess safety and tolerability of ianalumabTimepoint: ‐Incidence of treatment‐emergent adverse events (TEAEs)/serious adverse events (SAEs) till end of study ; ‐Routine hematology and clinical chemistry laboratory test results till end of study ; ‐Vital signs till end of study ; To demonstrate superiority of ianalumab over placebo based on change from baseline in Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐Fatigue) score at Week 52Timepoint: Change from baseline in FACIT‐Fatigue score at Week 52 To demonstrate superiority of ianalumab over placebo based on change from baseline in Sjogren‐related quality of life (SRQoL) score at Week 52Timepoint: Change from baseline in SRQoL score at Week 52 To demonstrate superiority of ianalumab over placebo based on the change from baseline in ESSPRI score at Week 52Timepoint: Change from baseline in ESSPRI score at Week 52 To demonstrate superiority of ianalumab over placebo based on the change from baseline in Patient Global Assessment (PaGA) NRS score at Week 52Timepoint: Change from baseline in PaGA NRS score at Week 52 To demonstrate superiority of ianalumab over placebo based on the change from baseline in SSSD eye dryness at Week 52Timepoint: Change from baseline in SSSD eye dryness at Week 52 To demonstrate superiority of ianalumab over placebo based on the change from baseline in SSSD summary score at Week 52Timepoint: Change from baseline in SSSD summary score at Week 52 To demonstrate superiority of ianalumab over placebo based on the change from baseline in stimulated whole salivary flow (sSF) at Week 52Timepoint: Change from baseline in sSF at Week 52 To demonstrate superiority of ianalumab over placebo based on the proportion of participants achieving meaningful improvement in ESSPRI score at Week 52Timepoint: Achieving ESSPRI response at Week 52 To demonstrate superiority of ianalumab over placebo based on the proportion of participants achieving meaningful improvement in SSSD summary score at Week 52Timepoint: Achieving SSSD response at Week 52