A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07760155

Enrollment

Registered

2026-08-12

Start date

2026-09-01

Completion date

2028-09-30

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus (SLE)

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).

Interventions

DRUGESG206

Anti-BAFF-R Monoclonal Antibody

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo	Up to approximately 25 weeks

Countries

China

Contacts

CONTACTQiuyue Shan Qiuyue shan

zhaoyonggang@escugen.com86 21 5855 6098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026