The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).
The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms. This study will include 3 periods: screening (5 weeks), treatment period (48 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized to receive subcutaneous (SC) dose of HZN-1116 or placebo. Acquired from Horizon in 2024.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
209
Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)
Time frame: At Week 48
Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)
Time frame: At Week 24
Change from baseline in ESSDAI (Population #1)
Time frame: At Week 24
Proportion of Participants achieving ESSDAI [5] response (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in ESSPRI pain domain score (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in ESSPRI fatigue domain score (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in DASPRI fatigue domain score (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in ESSPRI dryness domain score (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in DASSPRI dryness domain score (Population #1)
Time frame: At Week 24 and Week 48
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Change from baseline in tender joint count (TJC) (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in swollen joint count (SJC) (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1)
Time frame: At Week 24 and Week 48
Change from baseline in DASPRI (Population #2)
Time frame: At Week 24
Proportion of Participants achieving ESSPRI [1.5] response (Population #2)
Time frame: At Week 24
Change from baseline in ESSPRI pain domain (Population #2)
Time frame: At Week 24
Change from baseline in ESSPRI fatigue domain (Population #2)
Time frame: At Week 24
Change from baseline in ESSPRI dryness domain (Population #2)
Time frame: At Week 24
Change from baseline in SF-36 PCS Score (Population #2)
Time frame: At Week 24
Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2)
Time frame: At Week 24
Change from baseline in PROMIS-Fatigue SF-10a (Population #2)
Time frame: At Week 24
Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2)
Time frame: Up to Week 60
Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2)
Time frame: Up to Week 60