A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)
EMD Serono Research & Development Institute, Inc.
202 participants
Mar 10, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
Participants will receive Investigator-recommended SoC.
Locations(45)
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NCT07332481