🏛️ Verified NIH Record • Updated 2026-04-21

Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NCT00775476)

Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC) (SNAC)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: State University of New York - Upstate Medical University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Cedars-Sinai Medical Center — Los Angeles, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (12 Sites)

  • Cedars-Sinai Medical Center — Los Angeles, California
  • Yale Center for Clinical Investigation — New Haven, Connecticut
  • Emory University School of Medicine — Atlanta, Georgia
  • University of Kentucky — Lexington, Kentucky
  • Hospital for Special Surgery — New York, New York
  • University of Columbia — New York, New York
  • SUNY Upstate Medical University — Syracuse, New York
  • The Ohio State University — Columbus, Ohio
  • VA Medical Center — Oklahoma City, Oklahoma
  • St. Luke's University Health Network — Allentown, Pennsylvania
  • Penn State MS Hershey Medical Center — Hershey, Pennsylvania
  • University of Pittsburgh — Pittsburgh, Pennsylvania

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗