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A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
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.
Study details:
Acquired from Horizon in 2024.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-01-24
Primary completion: 2026-07-29
Study completion finish: 2026-07-29
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06104124
Intervention or treatment
DRUG: Dazodalibep
DRUG: Placebo
Conditions
- • Sjogren's Syndrome
Find a site
Closest Location:
The Queen Elizabeth Hospital
Research sites nearby
Select from list below to view details:
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dazodalibep Dose 1
| DRUG: Dazodalibep
|
EXPERIMENTAL: Dazodalibep Dose 2
| DRUG: Dazodalibep
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score | Not Specified | At Week 48 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Proportion of participants achieving ESSDAI response | Not Specified | At Week 48 |
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score | Not Specified | At Week 48 |
Change from baseline in ESSPRI dryness domain score | Not Specified | At Week 48 |
Change from baseline in DASPRI dryness domain score | Not Specified | At Week 48 |
Change from baseline in tender and swollen joint counts | Not Specified | At Week 48 |
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a) | Not Specified | At Week 48 |
Change from baseline in ESSDAI score | Not Specified | Week 12 and Week 24 |
Change from baseline in DASPRI total score | Not Specified | At Week 48 |
Change from baseline in ESSPRI total score | Not Specified | At Week 48 |
Change from baseline in total stimulated salivary flow | Not Specified | At Week 48 |
Number of participants With Treatment Emergent Adverse Events (TEAEs) | Not Specified | Baseline (Day 1) to Week 56 |
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs) | Not Specified | Up to Week 56 |
Number of participants With Adverse Events of Special Interest (AESIs) | Not Specified | Up to Week 56 |
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