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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07375524

Enrollment

Registered

2026-01-29

Start date

2026-03-01

Completion date

2028-06-30

Last updated

2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren Syndrome

Brief 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.

Interventions

DRUGESG206

ESG206 Low Dose administered by intravenous infusion

DRUGPlacebo

Placebo administered by intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

CONTACTQing Zhou, PhD

zhaoyonggang@escugen.com86 21 5855 6098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026