A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

ClinicalTrials.gov ID NCT07355218
Sponsor EMD Serono Research & Development Institute, Inc.
Information provided by EMD Serono (EMD Serono Research & Development Institute, Inc.) (Responsible Party)
Last Update Posted 2026-08-17

Study Overview

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.

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)

Conditions 

Systematic Lupus ErythematosusCutaneous Lupus Erythematosus

Intervention/Treatment 

• Drug: Enpatoran
• Drug: Placebo
• Drug: Standard of care (SoC)

Other Study ID Numbers 

• MS504908_0008
• 2025-524855-30-00 ( EU Trial (CTIS) Number )
• 169831 ( Other Identifier ) (OTHER: IND)
• CTR20261950 ( Other Identifier ) (OTHER: ChinaDrugTrials.org.cn)
• 2025 ( U.S. NIH Grant/Contract )

Obsolete Identifiers

• NCT07470970

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