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RECRUITING
NCT07332481
PHASE3

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

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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

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.

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