SNAC: Systemic Lupus Erythematosus (SLE) Treatment with N-acetylcysteine (NAC)

Abstract This is a multi-center double-blind placebo-controlled randomized study to determine the clinical efficacy of NAC in patients with SLE. All participants will receive NAC for a 3-month open-label period, titrated up to the individual’s maximally tolerated dosage between 2.4-4.8 g/day. Subjects who tolerate at least 2.4 g/day NAC will be randomized 1:1 to receive either NAC (at the subject’s tolerated dosage) or matching placebo for the remaining 9 months (double-blind period). To minimize the risk of unblinding, NAC will be tapered down in the placebo arm over 1 week (T, taper) (59). The primary endpoint will be the achievement of SRI-4 (yes/no) at Month 12 relative to enrollment at Month 0. Response rates in SRI will be compared between the placebo and NAC arms for primary efficacy outcome.