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Not yet recruitingNCT07375524Updated Feb 3, 2026

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

A Phase 2 interventional study of ESG206 and ESG206 in Primary Sjögren Syndrome, sponsored by Shanghai Escugen Biotechnology Co., Ltd. Not yet recruiting at 21 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Shanghai Escugen Biotechnology Co., Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Sjögren Syndrome
03

In context

Lead sponsor

Shanghai Escugen Biotechnology Co., Ltd is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    ESG206 Low Dose

    ESG206 Low Dose Injection administered by intravenous infusion

    Drug: ESG206

  • Active comparator
    ESG206 High Dose

    ESG206 High Dose Injection administered by intravenous infusion

    Drug: ESG206

  • Placebo comparator
    Placebo

    Placebo Injection administered by intravenous infusion

    Drug: Placebo

Interventions

  • DrugESG206

    ESG206 Low Dose administered by intravenous infusion

  • DrugESG206

    ESG206 High Dose administered by intravenous infusion

  • DrugPlacebo

    Placebo administered by intravenous infusion

06

What researchers measure

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.

    Time frame: Up to approximately 25 weeks

07

Study locations

21 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07375524
Lead sponsor
Shanghai Escugen Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Feb 3, 2026

Study contacts

Qing Zhou, PhD
Contact
zhaoyonggang@escugen.com
86 21 5855 6098

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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