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Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens Syndrome
Clinicaltrials.gov:
EU CTIS:
#2024-513965-38-00
Other:
#80202135SJS3001
Trials at a glance
Status
Enrolling
Condition
Sjogrens Syndrome
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Nipocalimab
Placebo
Standard of care treatment
Age
18+ years old
Biological sex
All
Placebo?
Yes
Trial start date
December 4, 2024
Trial end date
August 2, 2029
CT.gov ID
#NCT06741969
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
Nipocalimab in Moderate to Severe Sjogren's Disease
The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab
in participants with moderate to severe Sjogren's disease (SjD).
Primary outcome measures
- Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
Secondary outcome measures
- Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
- Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
- Change from Baseline in ClinESSDAI Score at Week 8
- Change from Baseline in Stimulated Salivary Flow Rate at Week 48
- Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
- Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48
- Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48
- Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48
Access detailed information on the trial:
Clinical trials information
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