This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with primary Sjögren's syndrome.
Adults (≥18 years of age) with a confirmed diagnosis of primary Sjögren's syndrome according to the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
Evidence of active disease at screening
Willing and able to provide written informed consent
Secondary Sjögren's syndrome or other clinically significant autoimmune or inflammatory diseases
Prior or recent use of prohibited immunomodulatory therapies
Clinically significant infections, malignancies, or uncontrolled medical conditions
Pregnancy or breastfeeding
Parallel
ESG206
DrugESG206 Low Dose administered by intravenous infusion
ESG206
DrugESG206 High Dose administered by intravenous infusion
Placebo
DrugPlacebo administered by intravenous infusion
Change from baseline in ESSDAI score compared with placebo.
ESSDAI is a validated clinical disease activity index for Sjögren's syndrome. It includes 12 organ-specific domains, each scored by the investigator according to severity using 3- or 4-level scales. Weighted domain scores are summed to generate a total score (maximum score: 123). Domains include constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological, and biological domains. Higher scores on the ESSDAI scale are associated with poorer health states.
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This trial is not recruiting at the moment. You can still explore other options:
