Actively Recruiting
A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2026-05-05
316
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of a drug called MIL62 compared with a placebo in adults with systemic lupus erythematosus (SLE), a chronic autoimmune disease. This phase 3 clinical trial aims to better understand how well MIL62 works to reduce disease activity and improve symptoms in people diagnosed with SLE based on established classification criteria. Participants will receive MIL62 or placebo through intravenous infusions at a dose of 1000 mg on specific days: Week 1 Day 1, Week 3 Day 1, Week 25 Day 1, and Week 27 Day 1. The study involves random assignment to one of these two groups, and the treatment process is double-blinded, meaning neither participants nor researchers know who receives which infusion. During the trial, participants will be monitored closely for changes in disease activity using measures like the SLE Responder Index (SRI-4) at Weeks 24 and 52, urine protein levels, prednisone dose adjustments, quality of life questionnaires, and serum biomarkers related to SLE. Safety is tracked by recording adverse events and immune response markers. The trial lasts up to 52 weeks, with regular assessments to evaluate the treatment's impact and participant health.
CONDITIONS
Brief Title
A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosis of systemic lupus erythematosus according to EULAR/ACR classification criteria
- Positive antinuclear antibodies (ANA) at least 1:80 or positive anti-dsDNA at screening
- High disease activity with SLEDAI-2000 score of 8 or higher (excluding alopecia)
- On stable doses of one or more standard SLE treatments before 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 below 200 cells/µL
- Received cyclophosphamide within 8 weeks before first dose
- Received calcineurin inhibitors (except topical) or plasma exchange therapy within 4 weeks before first dose
- Received B-cell stimulating factor inhibitors like Belimumab or Telitacicept within 8 weeks before first dose
- Received TNF inhibitors, interleukin monoclonal antibodies, JAK, BTK, 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 serious other diseases
- Positive for hepatitis B surface antigen/core antibody with elevated HBV DNA, hepatitis C antibody, or HIV
- History of severe allergic reactions to MIL62
- Pregnant or breastfeeding women
- Childbearing potential without willingness or ability to use acceptable birth control
- Other conditions deemed unsuitable by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive intravenous infusions of MIL62 or placebo at specified intervals as part of the trial treatment.
4 infusion visits at Week 1 Day 1, Week 3 Day 1, Week 25 Day 1, and Week 27 Day 1
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
Z
Zhanguo Li
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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