Status:
COMPLETED
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Lead Sponsor:
Equillium
Collaborating Sponsors:
Biocon Limited
Conditions:
Lupus Erythematosus
Lupus Nephritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 Proliferativ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Type A Cohort Key
- 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
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04128579
Start Date
October 1 2019
End Date
January 18 2024
Last Update
April 18 2025
Active Locations (25)
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1
AKDHC Medical Research Services, LLC
Sun City, Arizona, United States, 85351
2
California Institute of Renal Research
Chula Vista, California, United States, 91910
3
University of California San Diego Perlman Ambulatory Clinic
La Jolla, California, United States, 92037
4
Clinical Research of West Florida - Clearwater
Clearwater, Florida, United States, 33765-2616