Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
NCT ID: NCT04128579
Last Updated: 2025-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2019-10-01
2024-01-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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EQ001 Type A cohort
EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg).
Itolizumab [Bmab 600]
EQ001
EQ001 for Type B cohort
EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg).
Itolizumab [Bmab 600]
EQ001
Interventions
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Itolizumab [Bmab 600]
EQ001
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
Exclusion Criteria
2. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
3. Active TB or a positive TB test
18 Years
75 Years
ALL
No
Sponsors
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Biocon Limited
INDUSTRY
Equillium
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Kalunian, MD
Role: PRINCIPAL_INVESTIGATOR
UCSD
Locations
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AKDHC Medical Research Services, LLC
Sun City, Arizona, United States
California Institute of Renal Research
Chula Vista, California, United States
University of California San Diego Perlman Ambulatory Clinic
La Jolla, California, United States
Clinical Research of West Florida - Clearwater
Clearwater, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
University of Florida, Division of Rheumatology
Gainesville, Florida, United States
Clinical Site Partners Leesburg, LLC
Leesburg, Florida, United States
SouthCoast Research Center Inc
Miami, Florida, United States
Hope Clinical Trials
Miami, Florida, United States
Omega Research Maitland, LLC
Orlando, Florida, United States
Clinical Research of West Florida - Tampa
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Georgia Nephrology
Lawrenceville, Georgia, United States
Northwell Health / Division of Rheumatology
Great Neck, New York, United States
Columbia University Medical Center, Div of Nephrology
New York, New York, United States
Albert Einstein College of Medicine, Montefiore Medical Center
The Bronx, New York, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States
Dallas Renal Group
Dallas, Texas, United States
Prolato Clinical Research Center (PCRC)
Houston, Texas, United States
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, , India
Medanta - The Medicity Hospital
Gurugramam, , India
MAX Super Specialty Hospital
New Delhi, , India
Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, , India
SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii
Lodz, , Poland
Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ
Warsaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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company website
Other Identifiers
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EQ001-19-002
Identifier Type: -
Identifier Source: org_study_id
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