Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
Acquired from Horizon in 2024.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
434
IV infusion
IV infusion
Change from baseline in ESSPRI score
Time frame: At Week 48
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score
Time frame: At week 48
Proportion of participants achieving meaningful improvement in DASPRI
Time frame: At Week 48
Proportion of participants achieving ESSPRI [1.5] response
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 DASPRI Dryness
Time frame: At Week 48
Change from baseline in ESSPRI Dryness
Time frame: At Week 48
Change from baseline in DASPRI Pain
Time frame: At Week 48
Change from baseline in ESSPRI Pain
Time frame: At Week 48
Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score
Time frame: At Week 48
Change from baseline in DASPRI total score
Time frame: At week 12 and week 24
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Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Tucson, Arizona, United States
Medvin Clinical Research - Covina
Covina, California, United States
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, United States
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States
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Whittier, California, United States
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Change from baseline in ESSPRI total score
Time frame: At week 12, Week 24
Change from baseline in DASPRI Fatigue
Time frame: At Week 48
Change from baseline in ESSPRI fatigue domain score
Time frame: At Week 48
Change from baseline in total stimulated salivary flow
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: Baseline (Day 1) to Week 56
Number of participants With Adverse Events of Special Interest (AESIs)
Time frame: Baseline (Day 1) to Week 56