drugset / Trial / NCT07355218
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Phase 3
Recruiting
202 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2026-04-01
- Primary completion
- 2029-05-25
- Completion
- 2029-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enpatoran | Small molecule | — | Oral |