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A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
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.
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: 2024-03-11
Primary completion: 2026-05-01
Study completion finish: 2026-05-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06245408
Intervention or treatment
DRUG: Dazodalibep
DRUG: Placebo
Conditions
- • Sjögren's Syndrome (SS)
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 ESSPRI score | Not Specified | At Week 48 |
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score | Not Specified | At week 48 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Proportion of participants achieving meaningful improvement in DASPRI | Not Specified | At Week 48 |
Proportion of participants achieving ESSPRI [1.5] response | 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 DASPRI Dryness | Not Specified | At Week 48 |
Change from baseline in ESSPRI Dryness | Not Specified | At Week 48 |
Change from baseline in DASPRI Pain | Not Specified | At Week 48 |
Change from baseline in ESSPRI Pain | Not Specified | At Week 48 |
Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score | Not Specified | At Week 48 |
Change from baseline in DASPRI total score | Not Specified | At week 12 and week 24 |
Change from baseline in ESSPRI total score | Not Specified | At week 12, Week 24 |
Change from baseline in DASPRI Fatigue | Not Specified | At Week 48 |
Change from baseline in ESSPRI fatigue domain 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 | Baseline (Day 1) to Week 56 |
Number of participants With Adverse Events of Special Interest (AESIs) | Not Specified | Baseline (Day 1) to Week 56 |
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