Ivarmacitinib Versus Glucocorticoids in Mild-to-Moderate Systemic Lupus Erythematosus

This randomized, double‐blind, parallel‐group, noninferiority clinical trial willevaluate the efficacy and safety of ivarmacitinib compared with oral prednisone inparticipants with mild‐to‐moderate active systemic lupus erythematosus (SLE) withoutactive major organ involvement. Approximately 294 participants will be randomized in a1:1 ratio to receive either ivarmacitinib 8 mg once daily or oral prednisone starting at30 mg/day with a prespecified tapering schedule, together with the corresponding matchingplacebo, for 24 weeks. The study will assess whether ivarmacitinib is noninferior to oralprednisone in achieving the primary efficacy outcome. The primary outcome is theproportion of participants achieving remission of arthritis and/or rash, as defined bythe Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI‐2K), at Week 12.Safety and secondary efficacy outcomes will be evaluated throughout the 24‐week treatmentperiod.