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

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.

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Key information

Conditions

Primary Sjögren Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESG206

Drug

ESG206 Low Dose administered by intravenous infusion

Placebo

Drug

Placebo administered by intravenous infusion

Primary outcomes

Change from baseline in ESSDAI score compared with placebo.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qing Zhou, PhD

CONTACT

[email protected]

86 21 5855 6098

Sponsors and collaborators

Lead sponsor

Shanghai Escugen Biotechnology Co., Ltd

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Jan 29, 2026
Registry last updated: Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed