protocolSection identificationModule nctId: NCT06312020, orgStudyIdInfo id: HZNP-HZN-1116-201, briefTitle: A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-09-03, completionDateStruct date: 2026-11-26, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Horizon Therapeutics Ireland DAC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS)., conditionsModule conditions: Sjogren's Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 262, type: ESTIMATED, armsInterventionsModule interventions name: HZN-1116, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1), primaryOutcomes measure: Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2), secondaryOutcomes measure: Change from baseline in ESSDAI (Population #1), secondaryOutcomes measure: Proportion of Participants achieving ESSDAI [5] response (Population #1), secondaryOutcomes measure: Change from baseline in ESSPRI pain domain score (Population #1), secondaryOutcomes measure: Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1), secondaryOutcomes measure: Change from baseline in ESSPRI fatigue domain score (Population #1), secondaryOutcomes measure: Change from baseline in DASPRI fatigue domain score (Population #1), secondaryOutcomes measure: Change from baseline in ESSPRI dryness domain score (Population #1), secondaryOutcomes measure: Change from baseline in DASSPRI dryness domain score (Population #1), secondaryOutcomes measure: Change from baseline in tender joint count (TJC) (Population #1), secondaryOutcomes measure: Change from baseline in swollen joint count (SJC) (Population #1), secondaryOutcomes measure: Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1), secondaryOutcomes measure: Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1), secondaryOutcomes measure: Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1), secondaryOutcomes measure: Change from baseline in DASPRI (Population #2), secondaryOutcomes measure: Proportion of Participants achieving ESSPRI [1.5] response (Population #2), secondaryOutcomes measure: Change from baseline in ESSPRI pain domain (Population #2), secondaryOutcomes measure: Change from baseline in ESSPRI fatigue domain (Population #2), secondaryOutcomes measure: Change from baseline in ESSPRI dryness domain (Population #2), secondaryOutcomes measure: Change from baseline in SF-36 PCS Score (Population #2), secondaryOutcomes measure: Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2), secondaryOutcomes measure: Change from baseline in PROMIS-Fatigue SF-10a (Population #2), secondaryOutcomes measure: Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2), secondaryOutcomes measure: Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False