for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Principal Investigator
by Kenneth Kalunian, MD



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

Official Title

A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus 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.


Lupus Erythematosus, Lupus Nephritis, Systemic Lupus Erythematosus, Active Proliferative Lupus Nephritis, Nephritis, Itolizumab [Bmab 600]


For people ages 18-75

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


  • University of California San Diego Perlman Ambulatory Clinic
    La Jolla California 92037 United States
  • California Institute of Renal Research
    Chula Vista California 91910 United States

Lead Scientist at UCSD

  • Kenneth Kalunian, MD
    Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 184 research publications


in progress, not accepting new patients
Start Date
Completion Date
company website
Phase 1 Lupus Research Study
Study Type
Expecting 55 study participants
Last Updated