Actively Recruiting
A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2026-05-05
316
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
CONDITIONS
Official Title
A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosis of systemic lupus erythematosus by European League Against Rheumatism/American College of Rheumatology criteria
- Positive antinuclear antibodies (ANA) at 1:80 or higher, or positive anti-double stranded DNA antibodies at screening
- High disease activity with SLEDAI-2000 score 8 or more (excluding alopecia)
- On stable dose of one or more standard SLE treatments prior to first dose
- Able and willing to provide written informed consent and follow study protocol
You will not qualify if you...
- Insufficient organ function
- Received rituximab or any B-cell depleting drug within 9 months before first dose
- CD4+ T lymphocyte count less than 200 cells per microliter
- Received cyclophosphamide within 8 weeks before first dose
- Received calcineurin inhibitors (except topical use) or plasma exchange therapy within 4 weeks before first dose
- Received B-cell stimulating factor inhibitors such as Belimumab or Telitacicept within 8 weeks before first dose
- Received TNF inhibitors, interleukin monoclonal antibodies, JAK inhibitors, BTK inhibitors, TYK2 inhibitors, or thalidomide within 4 weeks before first dose
- Received live or attenuated vaccines within 28 days before first dose
- Participated in other clinical trials within 28 days before first dose
- Have other serious diseases
- Positive for hepatitis B surface antigen or core antibody with high HBV DNA, or positive for hepatitis C virus antibody, or positive for HIV
- History of severe allergic reactions to MIL62
- Breastfeeding or pregnant
- Women of childbearing potential unwilling or unable to use acceptable birth control
- Other conditions making participation unsuitable as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
Z
Zhanguo Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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