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
Sites (82)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Medical Centre Clayton Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Medical Center Rodopimed EOOD Coordinator of this site? Confirm its status | Kirdzhali | Bulgaria | Recruiting |
| DCC 1 Sevlievo EOOD Coordinator of this site? Confirm its status | Sevlievo | Bulgaria | Recruiting |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| L2IP - Instituto de Pesquisas Clínicas Ltda Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| A2Z Clinical Centro Avancado de Pesquisa Clinica Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Hospital Alemão Oswaldo Cruz Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| RDSS Ricardo Diaz Scientific Solution Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| The Medical Arts Health Research Group - 300128547 Coordinator of this site? Confirm its status | Kelowna | Canada | Recruiting |
| Dermatotomi AG Coordinator of this site? Confirm its status | Weinfelden | Switzerland | Recruiting |
| IZZ Immunologie-Zentrum Zuerich - Innere Medizin, Allergologie, Immunologie Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| The First Affiliated Hospital of Baotou Medical College Coordinator of this site? Confirm its status | Baotou | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Fujian Provincial Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Nanfang Hospital of Southern Medical University - 300165627 Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Qilu Hospital of Shandong University - 300163463 Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The Second Hospital of Hebei Medical University - 300184836 Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Recruiting |
| prof. MUDr. Petr Arenberger Coordinator of this site? Confirm its status | Praha 1 | Czechia | Recruiting |
| MEDICAL PLUS Research, s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Recruiting |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
| Klinikum Dortmund gGmbH Coordinator of this site? Confirm its status | Dortmund | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hannover | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Klinikum Oldenburg Aor Coordinator of this site? Confirm its status | Oldenburg | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Helios Universitaetsklinikum Wuppertal Coordinator of this site? Confirm its status | Wuppertal | Germany | Recruiting |
| Hospital General Universitario De Castellon Coordinator of this site? Confirm its status | Castello De La Plana | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital de Mérida Coordinator of this site? Confirm its status | Mérida | Spain | Recruiting |
| Hospital Universitario Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Not yet recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| Doncaster Royal Infirmary - Dept of Rheumatology Coordinator of this site? Confirm its status | Doncaster | United Kingdom | Recruiting |
| Andreas Syngros Hospital Of Venereal And Dermatological Diseases Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Not yet recruiting |
| Tel Aviv Sourasky Medical Center - Neurosurgery Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center-Derma - 150314762 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Chung-ang University Gwangmyeong Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Neurocity S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Not yet recruiting |
| Policlinica CCBR S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Not yet recruiting |
| Delta Health Care S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Not yet recruiting |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Kaohsiung Veterans General Hospital - Internal Medicine Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Oakland Hills Dermatology Coordinator of this site? Confirm its status | Auburn Hills | United States | Recruiting |
| Arthritis and Osteoporosis Consultants of the Carolinas II, LLC Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Omega Research Debary, LLC Coordinator of this site? Confirm its status | DeBary | United States | Recruiting |
| Centre for Rheumatology, Immunology and Arthritis Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Recruiting |
| North Texas Center for Clinical Research Coordinator of this site? Confirm its status | Frisco | United States | Recruiting |
| South Florida Rheumatology Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Accurate Clinical Research Coordinator of this site? Confirm its status | Humble | United States | Recruiting |
| Dawes Fretzin Clinical Research Group, LLC Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Accurate Clinical Research Inc. - Lake Charles Coordinator of this site? Confirm its status | Lake Charles | United States | Recruiting |
| GTL Medical and Research Group Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Bolanos Clinical Research Coordinator of this site? Confirm its status | Pembroke Pines | United States | Recruiting |
| Superior Clinical Research, LLC Coordinator of this site? Confirm its status | Smithfield | United States | Recruiting |
| Vantage Clinical Trials Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Inland Rheumatology Clinical Trials Inc. Coordinator of this site? Confirm its status | Upland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.