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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Escugen Biotechnology Co., Ltd

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

Treatment groups

40 Participants
are divided into 3 treatment groups