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A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Sponsor: EMD Serono Research & Development Institute, Inc.
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.
Official title: 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-2)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2026-03-27
Completion Date
2029-05-25
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
Enpatoran
Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
Placebo
Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
Standard of care (SoC)
Participants will receive Investigator-recommended SoC.
Locations (2)
Bolanos Clinical Research
Pembroke Pines, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States