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 up to 48 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and 3 dose escalating cohorts of 6 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 Lupus Erythematosus, Systemic 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. Meets SLICC and/or ACR criteria for 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. Meets criterion a and/or b
  6. Has previously completed induction treatment for active proliferative LN and is currently receiving one of the following: mycophenolate mofetil (MMF), mycophenolic acid (MPA), azathioprine or a calcineurin inhibitor.
  7. Has been receiving induction treatment with MMF/MPA and has a < 50% reduction in proteinuria at or after 12 weeks of induction
  8. During Screening has adequate hematologic function
  9. Restricted SLE treatments are stable and/or washed out
  10. Most recent eGFR ≥ 40 mL/min/1.73m2
  11. Has evidence of serologic activity during Screening

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 accepting new patients
    La Jolla California 92037 United States
  • AKDHC Medical Research Services, LLC accepting new patients
    Sun City Arizona 85351 United States

Lead Scientist at UCSD

  • Kenneth Kalunian, MD
    Research Interests - Innovative strategies for the treatment of patients with rheumatoid arthritis and other rheumatic diseases - Prognostic and predictive factors for outcomes in rheumatic diseases Collapse Websites [IMAGE] Clinical Profile [IMAGE] Division of Rheumatology, Allergy & Immunology


accepting new patients
Start Date
Completion Date
company website
Phase 1
Study Type
Last Updated