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.

• Itolizumab [Bmab 600] (Drug), also known as Bmab600, Itolizumab: EQ001

Primary outcomes

• Number of Treatment Emergent Adverse Events [Type A up to Day 57 or Type B up to Day 253]: Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary outcomes

• To Characterize the PK of Itolizumab [Type A up to Day 57 or Type B up to Day 253]: To characterize the pharmacokinetics of itolizumab
• CD6 Receptor Occupancy [Type A up to Day 57 or Type B up to Day 253]: the % levels of free versus EQ001-bound CD6 receptor on T cells

Sex: All, ages: 18 Years to 75 Years

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 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
4. Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening
5. Restricted SLE treatments are stable and/or washed out
6. During Screening, has adequate hematologic function

Type B Cohort Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Participant flow

Outcome results

• Number of Treatment Emergent Adverse Events (Primary), Count of participants, Participants: EQ001 Type A Cohort (0.4mg/kg) 0; EQ001 for Type B Cohort 17; EQ001 Type A Cohort (0.8mg/kg) 2; EQ001 Type A Cohort (1.6mg/kg) 4; EQ001 Type A Cohort (2.4mg/kg) 3; EQ001 Type A Cohort (3.2mg/kg) 8
• To Characterize the PK of Itolizumab (Secondary)
• CD6 Receptor Occupancy (Secondary)

Adverse events

Time frame: The AEs that occurred after the first dose of itolizumab or during the study treatment and safety Follow-up Periods (Type A through Day 57; Type B through Day 253) were documented on the AE eCRF.

Serious adverse events by term

Other adverse events by term

17 more terms not shown.

• Study Protocol (PDF, 2022-03-03)
• Statistical Analysis Plan (PDF, 2024-01-17)

• Kenneth Kalunian, MD, Principal investigator, UCSD