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NCT07332481RecruitingPhase 3

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

A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
202 (estimated)
First submitted
9 Jan 2026
Start date
10 Mar 2026
Primary completion date
24 May 2029
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Diseases
Lupus (SLE)
NCT number
NCT07332481
EU CT number
2025-523871-44-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 202
  • From 10 Mar 2026 to the primary completion date, 24 May 2029
  • 92 sites in 21 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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 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.

Lab values

  • 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.

Other

  • Other protocol-defined exclusion criteria may apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (92)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rheumatology Research Unit Sunshine Coast
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MaroochydoreAustraliaRecruiting
The Alfred Hospital - PARENT
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MelbourneAustraliaRecruiting
John Hunter Hospital - PARENT
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New Lambton HeightsAustraliaRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
DCC 'Sveti Georgi' EOOD
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HaskovoBulgariaRecruiting
DCC V Plovdiv Sv. Archbishop Luka EOOD
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PlovdivBulgariaRecruiting
Medical Center Hera EOOD
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SofiyaBulgariaRecruiting
ASMC IPSMC Skin And Venereal Diseases
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SofiyaBulgariaRecruiting
Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor de Barretos
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BarretosBrazilRecruiting
Freire Pesquisa Clinica
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Belo HorizonteBrazilRecruiting
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
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CuiabáBrazilRecruiting
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
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FortalezaBrazilRecruiting
Clínica SER da Bahia
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SalvadorBrazilRecruiting
Universitaetsspital Basel - Klinik fuer Dermatologie
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BaselSwitzerlandRecruiting
Kantonsspital St. Gallen - Klinik f. Dermatologie, Venerologie u Allergologie
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Sankt GallenSwitzerlandRecruiting
Ganzhou People's Hospital - 300165192
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GanzhouChinaRecruiting
Guangdong Provincial People's Hospital
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GuangzhouChinaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Elbe Kliniken Stade-Buxtehude gGmbH
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BuxtehudeGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyRecruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
HELIOS St. Elisabeth Klinik Oberhausen GmbH
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OberhausenGermanyRecruiting
Hospital Quironsalud Malaga
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MálagaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceNot yet recruiting
Hospital Edouard Herriot
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LyonFranceNot yet recruiting
Hopital Tenon
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Paris Cedex 20FranceNot yet recruiting
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceNot yet recruiting
Centre Hospitalier Universitaire De Saint Etienne
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St Etienne Cedex 2FranceNot yet recruiting
Whipps Cross University Hospital - Dept of Rheumatology
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LondonUnited KingdomRecruiting
Freeman Hospital - Dept of Rheumatology
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Newcastle upon TyneUnited KingdomRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceNot yet recruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceNot yet recruiting
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceNot yet recruiting
Chaim Sheba Medical Center - pt
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Ramat GanIsraelRecruiting
Azienda USL Toscana Centro
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FlorenceItalyNot yet recruiting
IRCCS Azienda Ospedaliera Metropolitana
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GenoaItalyNot yet recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyNot yet recruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyNot yet recruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyNot yet recruiting
NHO Asahikawa Medical Center - Dept of Gastroenterology
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Asahikawa-shiJapanRecruiting
Institute of Science Tokyo Hospital - Dept of Dermatology
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Bunkyo-kuJapanRecruiting
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
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ChibaJapanRecruiting
University of Yamanashi Hospital - Dept of Rheumatology/Immunology
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ChūōJapanRecruiting
St. Luke's International Hospital - Dept of Immunology/Allergy
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ChūōkuJapanRecruiting
Fukushima Medical University Hospital - Dept of Rheumatology/Immunology
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FukushimaJapanRecruiting
Kanazawa University Hospital - Dept of Rheumatology/Immunology
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KanazawaJapanRecruiting
Hospital of the University of Occupational and Environmental Health - Dept of Dermatology
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Kitakyushu-shiJapanRecruiting
Kobe University Hospital - Dept of Immunology/Rheumatology
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KobeJapanRecruiting
JCHO Chukyo Hospital - Dept of Dermatology
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NagoyaJapanRecruiting
Okayama University Hospital - Dept of Rheumatology/Immunology
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OkayamaJapanRecruiting
Sapporo City General Hospital - Dept of Rheumatology/Immunology
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SapporoJapanRecruiting
Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology
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SendaiJapanRecruiting
The University of Osaka Hospital - Dept of Dermatology
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Suita-shiJapanRecruiting
Nihon University Itabashi Hospital - Dept of Hematology/Immunology
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tabashi CityJapanRecruiting
Yokohama City University Hospital - Dept of Dermatology
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YokohamaJapanRecruiting
Korea University Ansan Hospital - 300133335
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Ansan-siSouth KoreaRecruiting
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaRecruiting
Hanyang University Seoul Hospital - 300186741
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SeoulSouth KoreaRecruiting
BIF-MED
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BytomPolandRecruiting
Jagiellonskie Centrum Innowacji Sp. z o.o.
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CracowPolandRecruiting
ETG Lublin Sp. z o.o.
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LublinPolandRecruiting
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o
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MalborkPolandRecruiting
Somed Cr Sp. z o.o. sp.k.
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RzeszowPolandRecruiting
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
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RzeszówPolandRecruiting
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n.med. Jakub Trefler
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WarszawaPolandRecruiting
Velocity Nova Sp. z o.o.
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ZamośćPolandRecruiting
Futuremeds S R L.
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BrasovRomaniaRecruiting
Spitalul Clinic Dr. I. Cantacuzino
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BucharestRomaniaRecruiting
F D Roosevelt University General Hospital Of Banska Bystrica
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Banska BystricaSlovakiaNot yet recruiting
University Hospital Bratislava
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BratislavaSlovakiaNot yet recruiting
Artromac n.o.
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KošiceSlovakiaNot yet recruiting
Thammasat University Hospital
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Amphur KlongluangThailandRecruiting
Ramathibodi Hospital - 300195177
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BangkokThailandRecruiting
China Medical University Hospital
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TaichungTaiwanRecruiting
Chi Mei Medical Center - 300192662
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TainanTaiwanRecruiting
Arthritis and Rheumatology Research Institute, PLLC
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AllenUnited StatesRecruiting
Allen Arthritis
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AllenUnited StatesRecruiting
Emory University School of Medicine
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AtlantaUnited StatesRecruiting
GNP Research at Mark Jaffe, MD
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Cooper CityUnited StatesRecruiting
Arthritis Care of Texas
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Corpus ChristiUnited StatesRecruiting
Dermatology Research Associates - 300204025
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Los AngelesUnited StatesRecruiting
Advance Medical Research Center
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MiamiUnited StatesRecruiting
Diverse Clinical Research LLC
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MiamiUnited StatesRecruiting
D&H National Research Centers, Inc.
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TamaracUnited StatesRecruiting
Clinical Research of West Florida Inc
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TampaUnited StatesRecruiting
Cohen Medical Centers
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Thousand OaksUnited StatesRecruiting
Revival Research Institute, LLC
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TroyUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.