Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis

The study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of approximately 20 open-label subjects enrolled for Type B-Lupus Nephritis.

Subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (Type A) or 13 (Type B) doses with 4 or 12 weeks of follow-up after the last dose of investigational product.

Type A Cohort Key Inclusion Criteria:

• Is male or female, age ≥ 18 and ≤ 75 years
• 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
• Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
• Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening
• Restricted SLE treatments are stable and/or washed out
• During Screening, has adequate hematologic function

Type B Cohort Key Inclusion Criteria:

• Is male or female, age ≥ 18 and ≤ 75 years
• Has a diagnosis of SLE
• Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V)
• Has a urine protein to creatinine ratio of > 1000 mg/g
• Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment
• Has adequate hematologic function
• Restricted SLE treatments are stable and/or washed out
• Most recent eGFR ≥ 40 mL/min/1.73m2
• Has evidence of serologic activity

Key Exclusion Criteria:

• Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
• Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
• Active TB or a positive TB test