Recruitment Complete
Sponsor ID
HZNP-DAZ-301
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants with Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
Study Details
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
Protocol Summary
Primary Outcome Measures
Change from baseline in European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI) Score
Timeframe: At Week 48
Secondary Outcome Measures
Proportion of participants achieving ESSDAI response
Timeframe: At Week 48
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score
Timeframe: At Week 48
Change from baseline in ESSPRI dryness domain score
Timeframe: At Week 48
Change from baseline in DASPRI dryness domain score
Timeframe: At Week 48
Change from baseline in tender and swollen joint counts
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 ESSDAI score
Timeframe: Week 12 and Week 24
Change from baseline in DASPRI total score
Timeframe: At Week 48
Change from baseline in ESSPRI total 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: Up to Week 56
Number of participants With Adverse Events of Special Interest (AESIs)
Timeframe: Up to Week 56
Locations
Location
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan, 350-0495
Status
Recruiting
Location
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, United States, 85392
Status
Recruiting
Location
Hospital General de Agudos Dr. José María Ramos Mejia
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1121ADC
Status
Recruiting
Location
Centro de Investigaciones Reumatológicas
San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
Status
Recruiting
Location
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucuman, Tucumán, Argentina, T4000AXL
Status
Recruiting
Location
Sanatorio Agote - Swiss Medical Group - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1425EOE
Status
Recruiting
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