Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS. 2. To evaluate the safety and tolerability of dazodalibep in participants with SS
Acquired from Horizon in 2024.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
651
IV infusion
IV infusion
Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score
Time frame: At Week 48
Proportion of participants achieving ESSDAI response
Time frame: At Week 48
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score
Time frame: At Week 48
Change from baseline in ESSPRI dryness domain score
Time frame: At Week 48
Change from baseline in DASPRI dryness domain score
Time frame: At Week 48
Change from baseline in tender and swollen joint counts
Time frame: At Week 48
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a)
Time frame: At Week 48
Change from baseline in ESSDAI score
Time frame: Week 12 and Week 24
Change from baseline in DASPRI total score
Time frame: At Week 48
Change from baseline in ESSPRI total score
Time frame: At Week 48
Change from baseline in total stimulated salivary flow
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Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States
Arizona Research Clinic PLLC
Chandler, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, Arizona, United States
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, United States
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado, United States
Bradenton Research Center Inc
Bradenton, Florida, United States
...and 206 more locations
Time frame: At Week 48
Number of participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline (Day 1) to Week 56
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Up to Week 56
Number of participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to Week 56