NCT07760155Not yet recruitingPhase 2
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus
Shanghai Escugen Biotechnology Co., Ltd20 sites in 1 country40 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 20
- Primary Endpoint
- SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
ESG206 High Dose
Experimental
Intervention: ESG206 (Drug)
ESG206 Low Dose
Experimental
Intervention: ESG206 (Drug)
Outcomes
Primary Outcomes
SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo
Time Frame: Up to approximately 25 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (20)
Loading locations...
Similar Trials
Not yet recruiting
Phase 2
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren SyndromePrimary Sjögren SyndromeNCT07375524Shanghai Escugen Biotechnology Co., Ltd40
Recruiting
Phase 2
Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)Ulcerative ColitisNCT07265570InSilico Medicine Hong Kong Limited80
Recruiting
Phase 2
A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental GlomerulosclerosisMinimal Change Disease (MCD)Focal Segmental Glomerulosclerosis (FSGS)NCT07499700Bio-Thera Solutions192
Not yet recruiting
Phase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 InjectionCOPDNCT07519499Zhejiang Kanova Biopharmaceutical Co., LTD75
Recruiting
Phase 2
ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 OverexpressionHepatocellular Carcinoma (HCC)NCT07327034Abbisko Therapeutics Co, Ltd141