NCT04128579CompletedPhase 1
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 30 Sept 2019
- Start date
- 1 Oct 2019
- Primary completion date
- 16 Nov 2023
- Lead sponsor
- Biocon Limited
- Diseases
- Lupus (SLE)
- NCT number
- NCT04128579
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 52
- From 1 Oct 2019 to the primary completion date, 16 Nov 2023
- 25 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
- Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
Other
- Active TB or a positive TB test
Criteria the registry did not label
- Type A Cohort Key Inclusion Criteria:
- 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 Inclusion Criteria:
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Post Graduate Institute of Medical Education and Research (PGIMER) Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| Medanta - The Medicity Hospital Coordinator of this site? Confirm its status | Gurugramam | India | Unknown status |
| Max Super Specialty Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER) Coordinator of this site? Confirm its status | Puducherry | India | Unknown status |
| SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Northeast Clinical Research Center, LLC Coordinator of this site? Confirm its status | Bethlehem | United States | Unknown status |
| California Institute of Renal Research Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| Clinical Research of West Florida - Clearwater Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Dallas Renal Group Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Centre for Rheumatology, Immunology and Arthritis Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| University of Florida, Division of Rheumatology Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Northwell Health Division of Rheumatology Coordinator of this site? Confirm its status | Great Neck | United States | Unknown status |
| Prolato Clinical Research Center (PCRC) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of California San Diego Perlman Ambulatory Clinic Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Georgia Nephrology Coordinator of this site? Confirm its status | Lawrenceville | United States | Unknown status |
| Clinical Site Partners Leesburg, LLC Coordinator of this site? Confirm its status | Leesburg | United States | Unknown status |
| SouthCoast Research Center, Inc. Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Hope Clinical Trials Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Columbia University Medical Center, Div of Nephrology Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Omega Research Maitland, LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AKDHC Medical Research Services, LLC Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Clinical Research of West Florida - Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Albert Einstein College of Medicine - Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.