EG-501 for Cognitive Impairment in Neuropsychiatric SLE (NPSLE): Efficacy and Safety Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Neuropsychiatric Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE), Cognitive Impairment

In brief

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.

Key facts

Study ID
NCT07281105
Run by
Evergreen Therapeutics, Inc.
People needed
131
Starts
2018-08-23
Expected to finish
2025-08-12
Last updated by the study team
2025-12-15

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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