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NCT07355218RecruitingPhase 3

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

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-2)

Source: ClinicalTrials.gov · Last updated 6 Oct 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
12 Jan 2026
Start date
1 Apr 2026
Primary completion date
25 May 2029
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Diseases
Lupus (SLE)
NCT number
NCT07355218
EU CT number
2025-524855-30-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 202
  • From 1 Apr 2026 to the primary completion date, 25 May 2029
  • 82 sites in 20 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 (82)

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

SiteCityCountrySite status
Monash Medical Centre Clayton
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ClaytonAustraliaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Medical Center Rodopimed EOOD
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KirdzhaliBulgariaRecruiting
DCC 1 Sevlievo EOOD
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SevlievoBulgariaRecruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaRecruiting
L2IP - Instituto de Pesquisas Clínicas Ltda
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BrasíliaBrazilRecruiting
A2Z Clinical Centro Avancado de Pesquisa Clinica
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CampinasBrazilRecruiting
Hospital Alemão Oswaldo Cruz
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São PauloBrazilRecruiting
RDSS Ricardo Diaz Scientific Solution
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São PauloBrazilRecruiting
The Medical Arts Health Research Group - 300128547
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KelownaCanadaRecruiting
Dermatotomi AG
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WeinfeldenSwitzerlandRecruiting
IZZ Immunologie-Zentrum Zuerich - Innere Medizin, Allergologie, Immunologie
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ZurichSwitzerlandRecruiting
The First Affiliated Hospital of Baotou Medical College
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BaotouChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
Fujian Provincial Hospital
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FuzhouChinaRecruiting
Nanfang Hospital of Southern Medical University - 300165627
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GuangzhouChinaRecruiting
Qilu Hospital of Shandong University - 300163463
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JinanChinaRecruiting
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaRecruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
The Second Hospital of Hebei Medical University - 300184836
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ShijiazhuangChinaRecruiting
The Second Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaRecruiting
prof. MUDr. Petr Arenberger
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Praha 1CzechiaRecruiting
MEDICAL PLUS Research, s.r.o.
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Uherské HradištěCzechiaRecruiting
Universitaetsklinikum Aachen AöR
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AachenGermanyRecruiting
Klinikum Dortmund gGmbH
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DortmundGermanyRecruiting
Medizinische Hochschule Hannover
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HannoverGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Klinikum Oldenburg Aor
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OldenburgGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Helios Universitaetsklinikum Wuppertal
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WuppertalGermanyRecruiting
Hospital General Universitario De Castellon
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Castello De La PlanaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital de Mérida
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MéridaSpainRecruiting
Hospital Universitario Rio Hortega
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ValladolidSpainRecruiting
Centre Hospitalier Universitaire De Bordeaux
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Bordeaux CedexFranceNot yet recruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceNot yet recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceNot yet recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceNot yet recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceNot yet recruiting
Doncaster Royal Infirmary - Dept of Rheumatology
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DoncasterUnited KingdomRecruiting
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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AthensGreeceNot yet recruiting
Evangelismos S A
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AthensGreeceNot yet recruiting
University General Hospital of Heraklion
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HeraklionGreeceNot yet recruiting
Tel Aviv Sourasky Medical Center - Neurosurgery
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Tel AvivIsraelRecruiting
Tel Aviv Sourasky Medical Center-Derma - 150314762
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Tel AvivIsraelRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyRecruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyRecruiting
Chung-ang University Gwangmyeong Hospital
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Seongnam-siSouth KoreaRecruiting
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaRecruiting
Pratia S.A.
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CracowPolandRecruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ
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LodzPolandRecruiting
Pratia S.A.
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PoznanPolandRecruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandRecruiting
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.
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WroclawPolandRecruiting
Neurocity S.R.L.
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BucharestRomaniaNot yet recruiting
Policlinica CCBR S.R.L.
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BucharestRomaniaNot yet recruiting
Delta Health Care S.R.L
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BucharestRomaniaNot yet recruiting
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
Kaohsiung Veterans General Hospital - Internal Medicine
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Kaohsiung CityTaiwanRecruiting
Oakland Hills Dermatology
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Auburn HillsUnited StatesRecruiting
Arthritis and Osteoporosis Consultants of the Carolinas II, LLC
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CharlotteUnited StatesRecruiting
Omega Research Debary, LLC
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DeBaryUnited StatesRecruiting
Centre for Rheumatology, Immunology and Arthritis
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Fort LauderdaleUnited StatesRecruiting
North Texas Center for Clinical Research
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FriscoUnited StatesRecruiting
South Florida Rheumatology
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HollywoodUnited StatesRecruiting
Accurate Clinical Research
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HumbleUnited StatesRecruiting
Dawes Fretzin Clinical Research Group, LLC
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IndianapolisUnited StatesRecruiting
Accurate Clinical Research Inc. - Lake Charles
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Lake CharlesUnited StatesRecruiting
GTL Medical and Research Group
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MiamiUnited StatesRecruiting
Bolanos Clinical Research
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Pembroke PinesUnited StatesRecruiting
Superior Clinical Research, LLC
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SmithfieldUnited StatesRecruiting
Vantage Clinical Trials
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TampaUnited StatesRecruiting
Inland Rheumatology Clinical Trials Inc.
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UplandUnited StatesRecruiting

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