Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative … (NCT04128579) | Clinical Trial Compass
CompletedPhase 1
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
United States, India, Poland52 participantsStarted 2019-10-01
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
. Is male or female, age ≥ 18 and ≤ 75 years
. Has a diagnosis of SLE
Exclusion criteria
. Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this was a Phase 1 trial primarily designed to measure safety and side effects of itolizumab (EQ001) rather than whether it works, what do the results tell us about how safe this drug was for people with lupus or lupus nephritis?
2Now that this trial is completed, has any data been published showing what kinds of treatment-emergent adverse events were reported, and are any of those risks relevant to my specific situation?
3Because this was an early-phase study, is there a follow-up Phase 2 or Phase 3 trial of itolizumab for lupus that I might be eligible to discuss, and would that be worth exploring given where my disease currently stands?
4Given that this trial included patients both with and without active proliferative lupus nephritis, can you help me understand whether my type of lupus would have fit the profile of patients studied, and what that means for how relevant these findings are to me?
5Before considering any experimental options like this, should we first talk about whether my current or standard treatment options have been fully explored, and how itolizumab would compare to those approaches?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Treatment Emergent Adverse Events
Timeframe: Type A up to Day 57 or Type B up to Day 253