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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Sjögren Syndrome
• Intervention / Treatment: Drug: ESG206; Drug: ESG206; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qing Zhou, PhD; Phone Number: 86 21 5855 6098; Email: zhaoyonggang@escugen.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China
      • Peking University Shougang Hospital
  • Fujian
    • Xiamen, Fujian, China
      • The First Affiliated Hospital of Xiamen University
  • Guangxi
    • Guilin, Guangxi, China
      • The Second Affiliated Hospital of Guilin Medical University
  • Hebei
    • Langfang, Hebei, China
      • Hebei Petro China Central Hospital
  • Hunan
    • Changde, Hunan, China
      • Changde First People's Hospital
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University
    • Zhuzhou, Hunan, China
      • Zhuzhou Central Hospital
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Xuzhou Central Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
    • Pingxiang, Jiangxi, China
      • Pingxiang People's Hospital
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University
    • Jining, Shandong, China
      • Affiliated Hospital of Jining Medical University
    • Zaozhuang, Shandong, China
      • Zaozhuang Municipal Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Contact: Leading PI; Phone Number: 86 21 58752345; Email: Fuqiong5@163.com
      • Contact: co Leading PI; Email: hongjunzhao2015@sina.com
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital
    • Nanchong, Sichuan, China
      • Affiliated Hospital of North Sichuan Medical College
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital
    • Huzhou, Zhejiang, China
      • Huzhou third people's Hospital
    • Jinhua, Zhejiang, China
      • Jinhua Municipal Central Hospital
    • Wenzhou, Zhejiang, China
      • Wenzhou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESG206 Low Dose; ESG206 Low Dose Injection administered by intravenous infusion	Drug: ESG206; ESG206 Low Dose administered by intravenous infusion; Drug: ESG206; ESG206 High Dose administered by intravenous infusion
Active Comparator: ESG206 High Dose; ESG206 High Dose Injection administered by intravenous infusion	Drug: ESG206; ESG206 Low Dose administered by intravenous infusion; Drug: ESG206; ESG206 High Dose administered by intravenous infusion
Placebo Comparator: Placebo; Placebo Injection administered by intravenous infusion	Drug: Placebo; Placebo administered by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Escugen Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ESG206-PSS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No