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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
2026-04-01
Completion Date
2029-05-25
Last Updated
2026-05-11
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 (4)
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Omega Research Debary, LLC
DeBary, Florida, United States
Bolanos Clinical Research
Pembroke Pines, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States