protocolSection identificationModule nctId: NCT06293365, orgStudyIdInfo id: CVAY736A2202, secondaryIdInfos id: 2023-508996-35, type: EUDRACT_NUMBER, briefTitle: Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-26, primaryCompletionDateStruct date: 2025-07-29, completionDateStruct date: 2029-02-08, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS., conditionsModule conditions: Sjögrens Disease, conditions: Systemic Lupus Erythematosus, conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: VAY736 1ml PFS, interventions name: VAY736 2 ml PFS, interventions name: VAY736 2ml AI, outcomesModule primaryOutcomes measure: Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab, primaryOutcomes measure: Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab, primaryOutcomes measure: Cohort 2 (optional): Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab, primaryOutcomes measure: Cohort 2 (optional): Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab, secondaryOutcomes measure: Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab, secondaryOutcomes measure: Cohort 2 (optional): Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab, secondaryOutcomes measure: Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab, secondaryOutcomes measure: Cohort 2 (optional): Concentration at the end of a dosing interval (Ctrough) for ianalumab, secondaryOutcomes measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Anti-ianalumab antibodies (ADA), secondaryOutcomes measure: Incidence of ADA positive participants, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False