NCT07281105CompletedPhase 2
EG-501 for Cognitive Impairment in Neuropsychiatric SLE (NPSLE): Efficacy and Safety Study
A Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Clinical Trial of EG-501 for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 131 (actual)
- First submitted
- 2 Dec 2025
- Start date
- 23 Aug 2018
- Primary completion date
- 12 Aug 2025
- Lead sponsor
- Evergreen Therapeutics, Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT07281105
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 131
- From 23 Aug 2018 to the primary completion date, 12 Aug 2025
- 3 sites in 1 country
- 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.
Prior treatment
- Change in medication that may affect mood or cognition including prednisone, antidepressant medications, analgesics including opioids, or stimulants within the last 4 weeks;
Other illness
- 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);
Lab values
- Metabolic derangement defined as liver function tests \>3x upper limit of normal, or severe renal disease defined as calculated creatinine clearance\<30 mL;
Age
- Male and female subjects \<18 or \>69 years;
Who the study is looking for
- 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)
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| UT Health Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.