Recruitment Complete
Sponsor ID
HZNP-DAZ-303

A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

Sponsor ID
HZNP-DAZ-303
Clinicaltrials.gov ID
NCT06245408
EUCTIS ID
N/A
EudraCT ID
N/A

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

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
434
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan, 350-0495
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
Sanatorio Guemes
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1425EUG
Status
Recruiting
Location
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
Status
Recruiting
Location
Sanatorio Agote - Swiss Medical Group - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1425EOE
Status
Recruiting
Location
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, San Juan, Argentina, J5400DIL
Status
Recruiting
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