Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 9 -> 13 locations 2026-07-19
notable Trial sites expanded: 4 -> 9 locations 2026-07-03
critical Recruitment opened 2026-04-07
Trial Details
NCT Number NCT07355218
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Enrollment 202 participants
Start Date 2026-04-01
Primary Completion 2029-05-25 (estimated)
Study Completion 2029-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-17