Summary

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

Description

Summary

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

Details

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.

Keywords

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

Eligibility

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

Locations

  • University of California San Diego Perlman Ambulatory Clinic not yet accepting 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Equillium
Links
company website
ID
NCT04128579
Phase
Phase 1
Study Type
Interventional
Last Updated