EG-501 for Cognitive Impairment in Neuropsychiatric SLE (NPSLE): Efficacy and Safety Study (NCT07281105) | Clinical Trial Compass
CompletedPhase 2
EG-501 for Cognitive Impairment in Neuropsychiatric SLE (NPSLE): Efficacy and Safety Study
United States131 participantsStarted 2018-08-23
Plain-language summary
Neuropsychiatric systemic lupus erythematosus with cognitive impairment (NPSLE-CI) is a serious, disabling, and potentially life-threatening manifestation of SLE, affecting up to 80% of patients with cognitive impairments ("brain fog"), leading to substantial disability, approximately 2 times higher unemployment risk, reduced health-related quality of life (HRQoL), and mortality 2-14 times higher than the general population (standardized mortality ratio, SMR). No approved therapies exist for NPSLE cognitive dysfunction, representing a high-priority unmet need for this FDA-recognized serious condition with major functional and psychosocial burden. The objective of this study is to evaluate the safety, tolerability and efficacy of EG-501 in a precise patient subset with NPSLE. Participants will complete a full 14-week clinical trial, receiving either EG-501 or a placebo.
Who can participate
Age range
18 Years – 69 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
. Physician diagnosis of SLE;
. Report NPSLE symptoms on the screening survey recommended by EULAR guideline but limited to a subset of the psychiatric manifestations questions and using a cut-off score of at least 5, with a minimum of 2.5 being scored on section 1;
. Score ≤ 85 on the RBANS total index (≤ 1 SD below the normative mean of 100)
Exclusion criteria
. Male and female subjects \<18 or \>69 years;
. Change in medication that may affect mood or cognition including prednisone, antidepressant medications, analgesics including opioids, or stimulants within the last 4 weeks;
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 Phase 2 trial of EG-501 for cognitive impairment in neuropsychiatric lupus has already completed, has the results data been published or presented anywhere, and what did it show about whether EG-501 actually improved thinking and memory scores on the RBANS test?
2Given that this was only a Phase 2 study, what does that mean for how much we can trust the safety and effectiveness data — and would you consider this treatment experimental compared to what's currently available for cognitive issues in lupus?
3My lupus already affects my brain and thinking, so are there any proven standard-of-care treatments I should be trying first before considering something that was tested in a completed early-phase trial like this one?
4The trial measured cognitive improvement using a specific test called the RBANS — do you think that kind of testing would be useful for tracking my own cognitive symptoms, regardless of whether this trial is relevant to me?
5If EG-501 showed promising results in this completed trial, is there a Phase 3 trial planned or already underway that I might actually be eligible to discuss with you as a potential next step?
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
Repeatable Battery for Assessment of Neuropsychological Status (RBANS) Total Index Score at endpoint (Visit 4)
. Metabolic derangement defined as liver function tests \>3x upper limit of normal, or severe renal disease defined as calculated creatinine clearance\<30 mL;
. Severe psychiatric disease including schizophrenia, psychosis, suicidal depression, or substance abuse disorder;
. Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history)\* or prevent the participant from completing the protocol (poor compliance or unpredictable schedule);