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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Primary Sjögren Syndrome

In brief

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.

Key facts

Study ID

NCT07375524

Run by

Shanghai Escugen Biotechnology Co., Ltd

People needed

40

Starts

2026-03-01

Expected to finish

2028-06-30

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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