A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome.

Sjögren’s Syndrome

Population #1:Change from baseline in European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI) total score at Week XX, Population #2:Change from baseline in European Alliance of Associations for Rheumatology Sjögren’s Syndrome Patient Reported Index (ESSPRI) total score at Week XX

Population #1: - Change from baseline in ESSDAI total score at Week XX, Population #1: - Proportion of participants achieving ESSDAI[5] response at Week XX and XX without premature discontinuation from treatment and without receiving rescue or potentially confounding therapy, Population #1: - Change from baseline in tender joint count (TJC) and swollen joint count (SJC) at the Week XX and XX time points, Population #1: - Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS) at the Week XX and XX time points, Population #1: - Change from baseline in PROMIS-Fatigue SF-10a at Week XX and Week XX, Population #2: - - Change from baseline in DASPRI total score at Week XX, Population #2: - Proportion of participants achieving ESSPRI[1.5] response without premature discontinuation from treatment and without receiving rescue or potentially confounding therapy at Week XX, Population #2: - Change from baseline in ESSPRI -pain, -fatigue, and -dryness domains at Week XX, Population #2: - Change from baseline in SF-36 PCS and MCS at Week XX, Population #2: - Change from baseline in PROMIS-Fatigue SF-10a at Week XX, Population #1 and #2: - PK of HZN-1116, Population #1 and #2: - Proportion of participants who develop anti-drug antibodies (ADA) over time

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Austria, Bulgaria, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Spain