Enpatoran for Skin Symptoms of Lupus

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

Recruiting Phase 3 Interventional Study
Systemic Lupus Erythematosus (SLE) Cutaneous Lupus Erythematosus (CLE)
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 skin problems related to lupus. If you join, you'll take a treatment called enpatoran for 24 weeks and have visits every 4 weeks.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with cutaneous lupus erythematosus or systemic lupus erythematosus.
  • I have active skin lupus symptoms for at least 6 weeks.
  • I meet specific criteria for lupus diagnosis as outlined by medical guidelines.
  • I have been living with the condition for at least 6 months.
  • I have a specific score indicating my skin symptoms.

You may not be able to join if

  • I have another autoimmune disease like rheumatoid arthritis.
  • I have a serious uncontrolled health condition.
  • I have drug-induced lupus.
  • I have active lupus kidney disease that needs treatment.
  • I have signs 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.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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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