Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
| Condition | Lupus Erythematosus, Lupus Nephritis |
|---|---|
| Phase | Phase 1 |
| Sponsor | Biocon Limited |
| Status | Completed |
| Enrollment | 52 participants |
| Interventions | Itolizumab [Bmab 600] |
| Start date | Oct 1, 2019 |
| Completion date | Nov 16, 2023 |
| Results posted | Apr 18, 2025 |
Summary
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis
Number of Treatment Emergent Adverse Events
| EQ001 Type A Cohort (0.4mg/kg) | 0 Participants |
|---|---|
| EQ001 for Type B Cohort | 17 Participants |
| EQ001 Type A Cohort (0.8mg/kg) | 2 Participants |
| EQ001 Type A Cohort (1.6mg/kg) | 4 Participants |
| EQ001 Type A Cohort (2.4mg/kg) | 3 Participants |
| EQ001 Type A Cohort (3.2mg/kg) | 8 Participants |
Open in BENITIONS View on ClinicalTrials.gov
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