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NCT07355218 · ClinicalTrials.gov registry record · Phase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
A Phase 3 study, sponsored by EMD Serono Research & Development Institute.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 202
- Enrollment target
NCT07355218: Recruiting Phase 3 study, sponsored by EMD Serono Research & Development Institute.
NCT07355218 is a Phase 3 study that is actively recruiting participants, run by EMD Serono Research & Development Institute. The registered enrollment target is 202 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07355218, a Phase 3 study, is actively recruiting participants, sponsored by EMD Serono Research & Development Institute.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 202 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Enpatoran
- DRUG Standard of care (SoC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2029-05-25 |
| Phase | Phase 3 |
What NCT07355218 shows while recruiting
NCT07355218 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07355218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07355218 about?
NCT07355218 is a clinical study titled "A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)". 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 Dur...
What is the current status of trial NCT07355218?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2026-04-01. Estimated completion is 2029-05-25.
What interventions are being tested in trial NCT07355218?
The interventions under investigation include: Placebo (DRUG), Enpatoran (DRUG), Standard of care (SoC) (DRUG).
Who is sponsoring clinical trial NCT07355218?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07355218's enrollment target sits among peer trials
202 1353rd of 2000 higher than 648 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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