N-acetylcysteine treatment for systemic lupus erythematosus

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

This study is testing whether N-acetylcysteine can help people with systemic lupus erythematosus feel better and manage their symptoms.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: State University of New York - Upstate Medical University (other)
• Drugs / interventions: belimumab, anifrolumab, rituximab, methotrexate, cyclophosphamide, prednisone
• Locations: 8 sites (Los Angeles, California and 7 other locations)
• Trial ID: NCT00775476 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of N-acetylcysteine (NAC) as a treatment for systemic lupus erythematosus (SLE), a chronic autoimmune disease. The study involves an initial 3-month open-label period where participants will have their NAC dosage titrated to tolerance, followed by a randomized phase where they will either continue with NAC or switch to a placebo. The primary outcome will be measured by the SLE Responder Index at 12 months, assessing improvements in disease activity and treatment failure rates. The trial aims to evaluate the efficacy and safety of NAC in managing SLE symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who meet specific SLE classification criteria and have stable disease activity.

Not a fit: Patients with severe renal or central nervous system involvement or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for managing systemic lupus erythematosus with potentially fewer side effects than current therapies.

How similar studies have performed: While the use of NAC in SLE is a novel approach, previous studies have shown promise in using NAC for other inflammatory conditions.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18;
* Male or female;
* ≥ 4 ACR SLE classification criteria (104,105);
* Positive ANA at a titer of ≥ 1/80;
* Stable immunosuppressants (MMF ≤ 3 g/day, azathioprine ≤ 150 mg/day; methotrexate ≤ 25 mg/week; leflunomide ≤ 20 mg/week; cyclosporin 100 mg/day; voclosporin 47.4 mg/day) and/or antimalarials (hydroxychloroquine ≤ 400 mg/day) for 30 days prior to screening; stable oral corticosteroids for 2 weeks prior to screening; ≤ 20 mg/day prednisone or equivalent; stable belimumab or anifrolumab for 90 days prior to screening;
* BILAG 2004 index (48) level A disease activity in ≥ 1 organ/system except renal or central nervous system or BILAG 2004 index level B disease activity in ≥ 1 organs/systems if no level A disease activity is present and SLEDAI ≥ 6 (106);
* Enrollment is approved by adjudication committee within 10 days, which may include retesting and communication with study sites, as necessary.
* Patients may be considered for enrollment 12 months after rituximab treatment, or 6 months after rituximab treatment if their B cell counts have normalized.

Participant Exclusion Criteria

* Acute SLE flare threatening vital organs;
* Pregnant or lactating;
* Moderately serious or serious comorbidities (e.g., diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency) that in investigator's opinion confers high risk for adverse events;
* Patients receiving cyclophosphamide within 3 months;
* Active chronic infections (e.g., HIV, hepatitis B virus, hepatitis C virus, mycobacteria); patients with oral steroid-dependent asthma;
* Infections requiring intravenous antibiotics within a month or oral antibiotics within two weeks of screening; Patients taking (unwilling or unable to stop) NAC or other antioxidants within 1 month of screening (which is considered sufficient time to revert GSH to pre-treatment levels (29);
* Patients who participated in the pilot RCT or are taking daily acetaminophen (≤ 1 g/day prn is allowed if documented);
* Patients receiving mTOR inhibitors (rapamycin/sirolimus, everolimus);
* Patients enrolled in other interventional trials.
* Patients should not take medications containing acetaminophen (Tylenol) as it may reduce the effectiveness of NAC. 1 g/day of acetaminophen is allowed if documented.
* Patients should avoid taking more than 500 mg of vitamin C and more than 30 IU of vitamin E daily as both vitamin C and E can confound the study results.

Where this trial is running

Los Angeles, California and 7 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
• Yale Center for Clinical Investigation — New Haven, Connecticut, United States (RECRUITING)
• Hospital for Special Surgery — New York, New York, United States (RECRUITING)
• SUNY Upstate Medical University — Syracuse, New York, United States (RECRUITING)
• The Ohio State University — Columbus, Ohio, United States (RECRUITING)
• VA Medical Center — Oklahoma City, Oklahoma, United States (RECRUITING)
• St. Luke's University Health Network — Allentown, Pennsylvania, United States (RECRUITING)
• Penn State MS Hershey Medical Center — Hershey, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Andras Perl, M.D., Ph.D. — State University of New York - Upstate Medical University
• Study coordinator: Andras Perl, M.D., Ph.D.

Conditions: Systemic Lupus Erythematosus, Systemic lupus erythematosus, an autoimmune disease