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Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Sponsor: Biocon Limited
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2019-10-01
Completion Date
2024-01-18
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
Itolizumab [Bmab 600]
EQ001
Locations (25)
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