NCT07281105

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Evergreen Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Protocol EG-501-2.1 is a Phase 2, multi-site, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of EG-501 for the treatment of cognitive impairment in systemic lupus erythematosus (SLE). The primary objective was to assess whether a 12-week EG-501 regimen produces a statistically and clinically significant improvement in the Total Scale Index score of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS®), compared with matched placebo, in a precisely defined SLE population with objective cognitive impairment. Fifty-six (56) patients were randomized treatment, 30 to placebo group and 26 to EG-501 group. All but three patients were female. Median age was 44.0 and 45.5 for placebo and EG-501 groups, respectively. With patients recruited only from the US, racial distribution was about 2/3 white, 1/3 black, with ethnicity reflecting largely non-Hispanic demographics.

Conditions

• Neuropsychiatric Systemic Lupus Erythematosus
• Systemic Lupus Erythematosus (SLE)
• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Placebo	The placebo will match the study drug in appearance, dose, and frequency. It will not contain any active drug (EG-501).
DRUG	EG-501	EG-501/ EG-MNTP-01 is an oral, low-affinity NMDA receptor antagonist.

Timeline

• Start date: 2018-08-23
• Primary completion: 2025-08-12
• Completion: 2025-08-12
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study