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
Sites (92)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumatology Research Unit Sunshine Coast Coordinator of this site? Confirm its status | Maroochydore | Australia | Recruiting |
| The Alfred Hospital - PARENT Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| John Hunter Hospital - PARENT Coordinator of this site? Confirm its status | New Lambton Heights | Australia | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| DCC 'Sveti Georgi' EOOD Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Recruiting |
| DCC V Plovdiv Sv. Archbishop Luka EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| ASMC IPSMC Skin And Venereal Diseases Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| Freire Pesquisa Clinica Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| IPC MT Instituto de Pesquisas Clinicas do Mato Grosso Coordinator of this site? Confirm its status | Cuiabá | Brazil | Recruiting |
| HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará Coordinator of this site? Confirm its status | Fortaleza | Brazil | Recruiting |
| Clínica SER da Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Universitaetsspital Basel - Klinik fuer Dermatologie Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Kantonsspital St. Gallen - Klinik f. Dermatologie, Venerologie u Allergologie Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Ganzhou People's Hospital - 300165192 Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Elbe Kliniken Stade-Buxtehude gGmbH Coordinator of this site? Confirm its status | Buxtehude | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| HELIOS St. Elisabeth Klinik Oberhausen GmbH Coordinator of this site? Confirm its status | Oberhausen | Germany | Recruiting |
| Hospital Quironsalud Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Hospital Edouard Herriot Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Hopital Tenon Coordinator of this site? Confirm its status | Paris Cedex 20 | France | Not yet recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Saint Etienne Coordinator of this site? Confirm its status | St Etienne Cedex 2 | France | Not yet recruiting |
| Whipps Cross University Hospital - Dept of Rheumatology Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Freeman Hospital - Dept of Rheumatology Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Not yet recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Not yet recruiting |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Not yet recruiting |
| Chaim Sheba Medical Center - pt Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Azienda USL Toscana Centro Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
| NHO Asahikawa Medical Center - Dept of Gastroenterology Coordinator of this site? Confirm its status | Asahikawa-shi | Japan | Recruiting |
| Institute of Science Tokyo Hospital - Dept of Dermatology Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| University of Yamanashi Hospital - Dept of Rheumatology/Immunology Coordinator of this site? Confirm its status | Chūō | Japan | Recruiting |
| St. Luke's International Hospital - Dept of Immunology/Allergy Coordinator of this site? Confirm its status | Chūōku | Japan | Recruiting |
| Fukushima Medical University Hospital - Dept of Rheumatology/Immunology Coordinator of this site? Confirm its status | Fukushima | Japan | Recruiting |
| Kanazawa University Hospital - Dept of Rheumatology/Immunology Coordinator of this site? Confirm its status | Kanazawa | Japan | Recruiting |
| Hospital of the University of Occupational and Environmental Health - Dept of Dermatology Coordinator of this site? Confirm its status | Kitakyushu-shi | Japan | Recruiting |
| Kobe University Hospital - Dept of Immunology/Rheumatology Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| JCHO Chukyo Hospital - Dept of Dermatology Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Okayama University Hospital - Dept of Rheumatology/Immunology Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Sapporo City General Hospital - Dept of Rheumatology/Immunology Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| The University of Osaka Hospital - Dept of Dermatology Coordinator of this site? Confirm its status | Suita-shi | Japan | Recruiting |
| Nihon University Itabashi Hospital - Dept of Hematology/Immunology Coordinator of this site? Confirm its status | tabashi City | Japan | Recruiting |
| Yokohama City University Hospital - Dept of Dermatology Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Korea University Ansan Hospital - 300133335 Coordinator of this site? Confirm its status | Ansan-si | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Hanyang University Seoul Hospital - 300186741 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| BIF-MED Coordinator of this site? Confirm its status | Bytom | Poland | Recruiting |
| Jagiellonskie Centrum Innowacji Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| ETG Lublin Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o Coordinator of this site? Confirm its status | Malbork | Poland | Recruiting |
| Somed Cr Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Rzeszow | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n.med. Jakub Trefler Coordinator of this site? Confirm its status | Warszawa | Poland | Recruiting |
| Velocity Nova Sp. z o.o. Coordinator of this site? Confirm its status | Zamość | Poland | Recruiting |
| Futuremeds S R L. Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Spitalul Clinic Dr. I. Cantacuzino Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| F D Roosevelt University General Hospital Of Banska Bystrica Coordinator of this site? Confirm its status | Banska Bystrica | Slovakia | Not yet recruiting |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Not yet recruiting |
| Artromac n.o. Coordinator of this site? Confirm its status | Košice | Slovakia | Not yet recruiting |
| Thammasat University Hospital Coordinator of this site? Confirm its status | Amphur Klongluang | Thailand | Recruiting |
| Ramathibodi Hospital - 300195177 Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| Chi Mei Medical Center - 300192662 Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Arthritis and Rheumatology Research Institute, PLLC Coordinator of this site? Confirm its status | Allen | United States | Recruiting |
| Allen Arthritis Coordinator of this site? Confirm its status | Allen | United States | Recruiting |
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| GNP Research at Mark Jaffe, MD Coordinator of this site? Confirm its status | Cooper City | United States | Recruiting |
| Arthritis Care of Texas Coordinator of this site? Confirm its status | Corpus Christi | United States | Recruiting |
| Dermatology Research Associates - 300204025 Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Advance Medical Research Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Diverse Clinical Research LLC Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| D&H National Research Centers, Inc. Coordinator of this site? Confirm its status | Tamarac | United States | Recruiting |
| Clinical Research of West Florida Inc Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Cohen Medical Centers Coordinator of this site? Confirm its status | Thousand Oaks | United States | Recruiting |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Troy | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.