A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Start Date
4/1/2026
Completion Date
5/25/2029
Summary
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Enpatoran
Placebo
Standard of care (SoC)
Conditions
Locations
Inland Rheumatology Clinical Trials, Inc.
Upland, California 91786
United States
Omega Research Debary, LLC
DeBary, Florida 32713
United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida 33309
United States
South Florida Rheumatology
Hollywood, Florida 33026
United States
GTL Medical And Research Group
Miami, Florida 33173
United States
Bolanos Clinical Research
Pembroke Pines, Florida 33026
United States
Vantage Clinical Trials
Tampa, Florida 33603
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United States
Accurate Clinical Research Inc. - Lake Charles
Lake Charles, Louisiana 70605
United States
Oakland Hills Dermatology
Auburn Hills, Michigan 48326
United States
Arthritis and Osteoporosis Consultants of the Carolinas II, LLC
Charlotte, North Carolina 28207
United States
Superior Clinical Research, LLC
Smithfield, North Carolina 27577
United States
North Texas Center for Clinical Research
Frisco, Texas 75034
United States
Accurate Clinical Research
Humble, Texas 77346
United States
Monash Medical Centre Clayton
Clayton, Victoria 3156
Australia
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District 70200-730
Brazil
A2Z Clinical Centro Avancado de Pesquisa Clinica
Campinas, São Paulo 13083-888
Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, 01323-903
Brazil
RDSS Ricardo Diaz Scientific Solution
São Paulo, 04037-030
Brazil
DCC 1 Sevlievo EOOD
Sevlievo, 5400
Bulgaria
DCC "Alexandrovska", EOOD
Sofia, 1431
Bulgaria
The Medical Arts Health Research Group - 300128547
Kelowna, British Columbia V1Y 4Z5
Canada
Fujian Provincial Hospital
Fuzhou, Fujian 350001
China
Nanfang Hospital of Southern Medical University - 300165627
Guangzhou, Guangdong 510515
China
The Second Hospital of Hebei Medical University - 300184836
Shijiazhuang, Hebei 050000
China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan 471000
China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia 014010
China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215004
China
The First Hospital of Jilin University
Changchun, Jilin 130021
China
Qilu Hospital of Shandong University - 300163463
Jinan, Shandong 250012
China
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
China
Prof.MUDr.Petr Arenberger,DrSc.MBA
Prague, 100 34
Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, 686 01
Czechia
Universitaetsklinikum Tuebingen - Hautklinik
Tübingen, Baden-Wurttemberg 72076
Germany
Klinikum Oldenburg AoeR - Universitatsklinik f Dermatologie u. Allergologie
Oldenburg, Lower Saxony 26133
Germany
Helios Klinikum Wuppertal - Klinik fuer Dermatologie, Venerologie
Wuppertal, North Rhine-Westphalia 42283
Germany
Universitaetsklinikum Leipzig AoeR - Klinik u. Polikl. f.Dermatol.,Venerol. u. Allergol
Leipzig, Saxony 04103
Germany
Tel Aviv Sourasky Medical Center-Derma - 150314762
Tel Aviv, 6423906
Israel
Tel Aviv Sourasky Medical Center - Neurosurgery
Tel Aviv, 64239
Israel
Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri - Parent
Rome, 00144
Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - Dip. Medicina - U.O.C. Reumatologia
Verona, 37126
Italy
Centrum Medyczne Plejady
Kraków, 30-363
Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
Szczecin, 71- 500
Poland
Pratia Poznan
Warsaw, 02-637
Poland
S.C Neurocity S.R.L
Bucharest, 040215
Romania
Kyung Hee University Hospital at Gangdong
Seoul, Gangwon-do 134-727
South Korea
Chung-ang University Gwangmyeong Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Hospital Universitario Rio Hortega - Servicio de Medicina Interna
Valladolid, Cantabria 47012
Spain
Hospital General de Castellon - Servicio de Reumatologia
Castellón, Castellón 12004
Spain
Hospital Universitario Reina Sofia - Dermatology Dep
Córdoba, 14004
Spain
Hospital Universitario La Paz - Internal Medicine Department
Madrid, 28046
Spain
Dermatotomi AG
Weinfelden, 8570
Switzerland
IZZ Immunologie-Zentrum Zuerich - Innere Medizin, Allergologie, Immunologie
Zurich, 8006
Switzerland
Kaohsiung Veterans General Hospital - Internal Medicine
Kaohsiung City, 81362
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Taiwan
Doncaster Royal Infirmary - Dept of Rheumatology
Doncaster, South Yorkshire DN2 5LT
United Kingdom