Enpatoran for Skin Symptoms of Lupus

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

Recruiting Phase 3 Interventional Study
Systematic Lupus Erythematosus Cutaneous Lupus Erythematosus
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
202 (estimated)
Sponsor
EMD Serono Research & Development Institute, Inc. · Industry
Who this trial is looking for

This trial is looking for people with active skin symptoms of lupus, with or without other types of lupus disease. If you join, you will take a medication called enpatoran for 24 weeks and visit the study site every 4 weeks.

Are You a Good Fit for This Trial?
Rules you out Systemic sclerosisDrug-induced lupus

You may be able to join if

  • I have a diagnosis of Discoid Lupus Erythematosus or Subacute Cutaneous Lupus Erythematosus.
  • I have had active Acute Cutaneous Lupus Erythematosus for at least 6 weeks.
  • I have a diagnosis of Systemic Lupus Erythematosus and have active skin symptoms.
  • My lupus disease has lasted for at least 6 months.
  • I have a CLASI-A score of 8 or more at the Screening visit.

You may not be able to join if

  • I have another autoimmune disease like rheumatoid arthritis.
  • I have active lupus nephritis and have received induction therapy in the last 3 months.
  • I have any uncontrolled disease, such as severe asthma.
  • I have had any signs or symptoms related to Central Nervous System lupus in the past 3 months.
  • I have a history of uncontrolled seizures.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 I…
Trial Locations
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Eligibility Criteria
Inclusion Criteria * Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory. * Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medic…
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