NCT07332481

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Cutaneous Lupus Erythematosus (CLE)

Interventions

Type	Name	Description
DRUG	Enpatoran	Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
DRUG	Placebo	Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
DRUG	Standard of care (SoC)	Participants will receive Investigator-recommended SoC.

Timeline

• Start date: 2026-03-10
• Primary completion: 2029-05-24
• Completion: 2029-05-24
• First posted: 2026-01-12
• Last updated: 2026-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study