Phase 3 Study of Enpatoran Tablets for Active Skin Lupus With or Without Systemic Disease

What this Trial Is About

Researchers are investigating the effects of enpatoran in adults with active cutaneous lupus erythematosus, with or without systemic lupus erythematosus SLE. This global, multicenter Phase 3 study aims to evaluate the efficacy and safety of enpatoran over a 24-week treatment period, focusing on skin manifestations of lupus. The study is designed as a randomized, double-blind, placebo-controlled trial to assess how well enpatoran works alongside standard care in this population. Participants will receive either enpatoran tablets or placebo tablets twice daily for 24 weeks while continuing their investigator-recommended standard of care. Dosing occurs orally from Day 1 to Day 168. Visits are scheduled every four weeks, except for a televisit at Week 2. The study includes treatment and follow-up visits throughout the treatment period, which lasts up to 35 weeks in total. During the study, participants will undergo regular assessments including evaluation of skin disease severity using the Cutaneous Lupus Erythematosus Disease Area and Severity Index CLASI, and other lupus activity measures. Safety will be monitored by tracking adverse events and laboratory results. Researchers will also assess symptoms such as itch and skin changes. The main outcome is the reduction of skin disease severity at Week 24. Participants may expect scheduled clinic visits and evaluations over the study course until completion in May 2029.

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease