clinical trial · NCT07332481
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
EMD Serono Research & Development Institute, Inc.·phase3·recruiting·n = 202
Systemic Lupus Erythematosus (SLE)Cutaneous Lupus Erythematosus (CLE)EnpatoranPlaceboStandard of care (SoC)
brief 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.
started
Mar 10, 2026
primary completion
May 24, 2029
completion
May 24, 2029
last updated
Apr 6, 2026
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol