drugset / Trial / NCT07355218

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

NCT07355218

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo. Intervention Form: Film-coated tablet.

Timeline

Start
2026-04-01
Primary completion
2029-05-25
Completion
2029-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Enpatoran Small molecule Oral