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A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
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-1)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2026-03-10
Completion Date
2029-05-24
Last Updated
2026-05-08
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 (5)
Dermatology Research Associates - 300204025
Los Angeles, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Allen Arthritis
Allen, Texas, United States
Arthritis and Rheumatology Research Institute PLLC
Allen, Texas, United States