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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: EMD Serono Research & Development Institute, Inc. • ClinicalTrials.gov ID: NCT07355218

Registry updated: 2026-10-06
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Description

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

  • Enpatoran (Drug)
    Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
  • Placebo (Drug)
    Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
  • Standard of care (SoC) (Drug)
    Participants will receive Investigator-recommended SoC.

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 medical history, with or without Systemic Lupus Erythematosus (SLE). * Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit. * Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE. For participants with SLE: * Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria. * Participants with disease duration (cutaneous disease and, where applicable, SLE) of \>= 6 months from time of diagnosis to Screening. * Participants with CLASI-A score \>= 8 at Screening and Day 1 visits. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria * Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE. * Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation. * Participants with drug-induced lupus (SLE or CLE). * Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed). * Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation. * Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures. * Other protocol-defined exclusion criteria may apply.

Conditions

Systematic Lupus Erythematosus Cutaneous Lupus Erythematosus

Locations

  • Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
  • Omega Research Debary, LLC — DeBary, Florida, United States
  • Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
  • South Florida Rheumatology — Hollywood, Florida, United States
  • GTL Medical And Research Group — Miami, Florida, United States
  • Bolanos Clinical Research — Pembroke Pines, Florida, United States
  • Vantage Clinical Trials — Tampa, Florida, United States
  • Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
  • Accurate Clinical Research Inc. - Lake Charles — Lake Charles, Louisiana, United States
  • Oakland Hills Dermatology — Auburn Hills, Michigan, United States
  • Arthritis and Osteoporosis Consultants of the Carolinas II, LLC — Charlotte, North Carolina, United States
  • Superior Clinical Research, LLC — Smithfield, North Carolina, United States
  • North Texas Center for Clinical Research — Frisco, Texas, United States
  • Accurate Clinical Research — Humble, Texas, United States
  • Monash Medical Centre Clayton — Clayton, Victoria, Australia
  • L2IP - Instituto de Pesquisas Clínicas Ltda. — Brasília, Federal District, Brazil
  • A2Z Clinical Centro Avancado de Pesquisa Clinica — Campinas, São Paulo, Brazil
  • Hospital Alemão Oswaldo Cruz — São Paulo, Brazil
  • RDSS Ricardo Diaz Scientific Solution — São Paulo, Brazil
  • DCC 1 Sevlievo EOOD — Sevlievo, Bulgaria
  • DCC "Alexandrovska", EOOD — Sofia, Bulgaria
  • The Medical Arts Health Research Group - 300128547 — Kelowna, British Columbia, Canada
  • Fujian Provincial Hospital — Fuzhou, Fujian, China
  • Nanfang Hospital of Southern Medical University - 300165627 — Guangzhou, Guangdong, China
  • The Second Hospital of Hebei Medical University - 300184836 — Shijiazhuang, Hebei, China
  • The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China
  • The First Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia, China
  • Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China
  • The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
  • The First Hospital of Jilin University — Changchun, Jilin, China
  • Qilu Hospital of Shandong University - 300163463 — Jinan, Shandong, China
  • West China Hospital, Sichuan University — Chengdu, Sichuan, China
  • Prof.MUDr.Petr Arenberger,DrSc.MBA — Prague, Czechia
  • MEDICAL PLUS s.r.o. — Uherské Hradiště, Czechia
  • Universitaetsklinikum Tuebingen - Hautklinik — Tübingen, Baden-Wurttemberg, Germany
  • Klinikum Oldenburg AoeR - Universitatsklinik f Dermatologie u. Allergologie — Oldenburg, Lower Saxony, Germany
  • Helios Klinikum Wuppertal - Klinik fuer Dermatologie, Venerologie — Wuppertal, North Rhine-Westphalia, Germany
  • Universitaetsklinikum Leipzig AoeR - Klinik u. Polikl. f.Dermatol.,Venerol. u. Allergol — Leipzig, Saxony, Germany
  • Tel Aviv Sourasky Medical Center-Derma - 150314762 — Tel Aviv, Israel
  • Tel Aviv Sourasky Medical Center - Neurosurgery — Tel Aviv, Israel
  • Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri - Parent — Rome, Italy
  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - Dip. Medicina - U.O.C. Reumatologia — Verona, Italy
  • Centrum Medyczne Plejady — Kraków, Poland
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. — Szczecin, Poland
  • Pratia Poznan — Warsaw, Poland
  • S.C Neurocity S.R.L — Bucharest, Romania
  • Kyung Hee University Hospital at Gangdong — Seoul, Gangwon-do, South Korea
  • Chung-ang University Gwangmyeong Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • Hospital Universitario Rio Hortega - Servicio de Medicina Interna — Valladolid, Cantabria, Spain
  • Hospital General de Castellon - Servicio de Reumatologia — Castellón, Castellón, Spain
  • Hospital Universitario Reina Sofia - Dermatology Dep — Córdoba, Spain
  • Hospital Universitario La Paz - Internal Medicine Department — Madrid, Spain
  • Dermatotomi AG — Weinfelden, Switzerland
  • IZZ Immunologie-Zentrum Zuerich - Innere Medizin, Allergologie, Immunologie — Zurich, Switzerland
  • Kaohsiung Veterans General Hospital - Internal Medicine — Kaohsiung City, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
  • Doncaster Royal Infirmary - Dept of Rheumatology — Doncaster, South Yorkshire, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record