Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04128579 | Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis | PHASE1 | COMPLETED | 52 | — | — | Oct 1, 2019 | Jan 18, 2024 | Apr 18, 2025 | 25 | United States, India +1 |
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
| Arm | Type | Description |
|---|---|---|
| EQ001 Type A cohort | EXPERIMENTAL | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg). |
| EQ001 for Type B cohort | EXPERIMENTAL | EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg). |
| Name | Type | Description |
|---|---|---|
| Itolizumab [Bmab 600] | DRUG | EQ001 |
Type A Cohort Key Inclusion Criteria: 1. Is male or female, age ≥ 18 and ≤ 75 years 2. Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE 3. Received at least 1 immun...