A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome
1 other identifier
interventional
40
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2026
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
January 29, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
February 3, 2026
January 1, 2026
1.8 years
January 21, 2026
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in ESSDAI score compared with placebo.
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.
Up to approximately 25 weeks
Study Arms (3)
ESG206 Low Dose
ACTIVE COMPARATORESG206 Low Dose Injection administered by intravenous infusion
ESG206 High Dose
ACTIVE COMPARATORESG206 High Dose Injection administered by intravenous infusion
Placebo
PLACEBO COMPARATORPlacebo Injection administered by intravenous infusion
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
Changde First People's Hospital
Changde, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Huzhou Third People's Hospital
Huzhou, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2026
First Posted
January 29, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
February 3, 2026
Record last verified: 2026-01