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NCT00775476 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Systemic Lupus Erythematosus, sponsored by State University of New York - Upstate Medical University.

Recruiting
Registry status
Phase 2
Development phase
290
Enrollment target
8
Study locations

NCT00775476: Recruiting Phase 2 study of Systemic Lupus Erythematosus, sponsored by State University of New York - Upstate Medical University.

NCT00775476 is a Phase 2 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by State University of New York - Upstate Medical University. The registered enrollment target is 290 participants, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (23% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00775476, a Phase 2 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by State University of New York - Upstate Medical University.

RECRUITING
Registry status
Phase 2
Development phase
290 participants
Enrollment target
8
Study locations

Study 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.

Primary Outcome

Positive response on the SLE Responder Index (SRI) in the NAC arm vs placebo

Conditions Studied

Systemic Lupus Erythematosus

Interventions

  • DRUG Placebo
  • DRUG N-acetylcysteine

Study Locations (8)

New York

  • Hospital for Special Surgery - New York
  • SUNY Upstate Medical University - Syracuse

Pennsylvania

  • St. Luke's University Health Network - Allentown
  • Penn State MS Hershey Medical Center - Hershey

California

  • Cedars-Sinai Medical Center - Los Angeles

Connecticut

  • Yale Center for Clinical Investigation - New Haven

Ohio

  • The Ohio State University - Columbus

Oklahoma

  • VA Medical Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 290 participants
Start Date 2022-05-05
Est. Completion 2028-09-30
Phase Phase 2
State University of New York - Upstate Medical University

113 total trials

What NCT00775476 shows while recruiting

NCT00775476 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (23% lower).

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00775476 lists 8 locations in 6 states (New York, Pennsylvania, California).

Frequently Asked Questions

What is clinical trial NCT00775476 about?

NCT00775476 is a clinical study titled "Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine". 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 glutathion...

What is the current status of trial NCT00775476?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 290 participants. The study started on 2022-05-05. Estimated completion is 2028-09-30.

What conditions does trial NCT00775476 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus.

What interventions are being tested in trial NCT00775476?

The interventions under investigation include: Placebo (DRUG), N-acetylcysteine (DRUG).

Who is sponsoring clinical trial NCT00775476?

This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00775476 being conducted?

This trial has 8 study locations across California, Connecticut, New York, Ohio, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Systemic Lupus Erythematosus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00775476's enrollment target sits among peer trials

290 31st of 99 higher than 69 of 99 other Systemic Lupus Erythematosus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT00775476

Source: ClinicalTrials.gov NCT00775476, the US trial registry maintained by the National Library of Medicine. NCT00775476 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.