A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

ESG206: ESG206 Low Dose administered by intravenous infusion

ESG206: ESG206 High Dose administered by intravenous infusion

Placebo: Placebo administered by intravenous infusion

Study summary

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

Primary outcome measure(s)

• Change from baseline in ESSDAI score compared with placebo. — Up to approximately 25 weeks
  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.

Trial sites (21)

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