About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ESG206
- ESG206
- Placebo