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

Sponsor ID
HZNP-DAZ-301
Clinicaltrials.gov ID
NCT06104124
EUCTIS ID
N/A
EudraCT ID
N/A

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

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
651
Additional Study Details

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
Status
Contact Us
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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