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RECRUITING
NCT07355218
PHASE3

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.

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-2)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2026-03-27

Completion Date

2029-05-25

Last Updated

2026-04-06

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 (2)

Bolanos Clinical Research

Pembroke Pines, Florida, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States