A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
Study Details
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
Protocol Summary
Change from baseline in ESSPRI score
Timeframe: At Week 48
Change from baseline in Diary for Assessing Sjogren’s Patient Reported Index (DASPRI ) score
Timeframe: At week 48
Proportion of participants achieving meaningful improvement in DASPRI
Timeframe: At Week 48
Proportion of participants achieving ESSPRI [1.5] response
Timeframe: At Week 48
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a)
Timeframe: At Week 48
Change from baseline in DASPRI Dryness
Timeframe: At Week 48
Change from baseline in ESSPRI Dryness
Timeframe: At Week 48
Change from baseline in DASPRI Pain
Timeframe: At Week 48
Change from baseline in ESSPRI Pain
Timeframe: At Week 48
Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score
Timeframe: At Week 48
Change from baseline in DASPRI total score
Timeframe: At week 12 and week 24
Change from baseline in ESSPRI total score
Timeframe: At week 12, Week 24
Change from baseline in DASPRI Fatigue
Timeframe: At Week 48
Change from baseline in ESSPRI fatigue domain score
Timeframe: At Week 48
Change from baseline in total stimulated salivary flow
Timeframe: At Week 48
Number of participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: Baseline (Day 1) to Week 56
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)
Timeframe: Baseline (Day 1) to Week 56
Number of participants With Adverse Events of Special Interest (AESIs)
Timeframe: Baseline (Day 1) to Week 56