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MIL62 in Systemic Lupus Erythematosus
NCT07405970Phase 3
Key facts
- Status
- Recruiting
- Start
- Apr 2026
- Primary completion
- Dec 2028
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- Bejescin
- Conditions
- systemic lupus erythematosus (SLE)
01
Overview
Phase 3, randomised, double-blind trial in systemic lupus erythematosus (SLE) comparing MIL62 + Standard Treatment with Placebo + Standard Treatment (2 arms). Primary endpoint: Systemic Lupus Erythematosus Responder Index 4 at 52 weeks. Started Apr 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
MIL62 + Standard Treatment
MIL62 1000 mg IV infusion at W1, W3, W25, W27 plus stable standard SLE treatment.
Placebo + Standard Treatment
Placebo 1000 mg IV infusion at W1, W3, W25, W27 plus stable standard SLE treatment.
03
Who it enrols
Adults aged 18-80 with active systemic lupus erythematosus (SLEDAI-2000 >= 8) and positive ANA or anti-dsDNA, currently on stable standard SLE treatment. Excludes patients with recent use of B-cell targeted therapies, severe organ dysfunction, or active viral infections (HBV, HCV, HIV).
04
Endpoints
Primary
Systemic Lupus Erythematosus Responder Index 4
Secondary
Systemic Lupus Erythematosus Responder Index 4
Changes in 24-hour urine protein
Percentage of participants who achieved or maintained a prednisone dose of <=7.5 mg/day
EuroQol 5-Dimensional Questionnaire
Change From Baseline in Serum Immunoglobulin Levels
Change From Baseline in biomarkers associated with disease
Adverse Events
Pharmacodynamics characteristics of peripheral blood CD19+ B cells
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