A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus
1 other identifier
interventional
40
1 country
20
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 Systemic Lupus Erythematosus (SLE).
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 Sep 2026
20 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
August 7, 2026
CompletedFirst Posted
Study publicly available on registry
August 12, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
Study Completion
Last participant's last visit for all outcomes
September 30, 2028
August 12, 2026
August 1, 2026
1.6 years
August 7, 2026
August 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo
Up to approximately 25 weeks
Study Arms (3)
ESG206 High Dose
EXPERIMENTALESG206 Low Dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adults (≥18 years of age) with a confirmed diagnosis of Systemic Lupus Erythematosus
- Evidence of active disease at screening
- Willing and able to provide written informed consent
You may not qualify if:
- Have other autoimmune diseases that may interfere with the assessment of SLE
- 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 (20)
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
Zhongshan Traditional Chinese Medicine Hospital
Zhongshan, Guangdong, China
Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liupanshui Shougang Shuigang Hospital
Liupanshui, Guizhou, China
Affiliated Hospital of Hebei Engineering University
Handan, Hebei, China
Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Changde First People's Hospital
Changde, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Loudi Central Hospital
Loudi, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Zibo Central Hospital
Zibo, Shandong, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Huzhou Third People's Hospital
Huzhou, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
August 7, 2026
First Posted
August 12, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
August 12, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share