Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
Status:
Not yet recruiting
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
Summary
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has
debilitating and potentially life-threatening consequences. The cause of SLE is unknown and
current therapies lack specificity and carry significant side-effects. We previously
discovered the depletion of glutathione in lymphocytes of patients with SLE and associated
this metabolic change with the elevation of the mitochondrial transmembrane potential.
This study will titrate to tolerance during an initial 3 month open label period and then
subjects will be randomized to one of 2 arms.
It was determined by statistical analysis that each group must have 105 subjects. All
subjects will be enrolled and evaluated for tolerance of NAC between dosages of 2.4 g/day and
4.8 g/day for 3 months. After A 3-month open-label dose-titration phase, SLE subjects will be
randomized into 2 groups of 105 subjects either to continue the tolerated dosage of NAC or
switched to equal number of placebo capsules. There will be up to seven study visits per SLE
subject, including the screening and wash out visits. Visits 2-6 will be scheduled three
months apart. The study will last 13 months with the wash-out visit. Each subject will donate
approximately 100 ml of blood for biomarker studies at each visit. Healthy control subjects
will donate blood at the same time. They will be matched to the SLE subjects by gender, age
within 10 years, and ethnicity. Their blood will be used as reference for biomarker assays.
There is a consent form required to participate in the phase II study.
Phase:
Phase 2
Details
Lead Sponsor:
State University of New York - Upstate Medical University