Enpatoran: Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
Placebo: Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
Standard of care (SoC): Participants will receive Investigator-recommended SoC.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | Recruiting |
| Omega Research Debary, LLC | DeBary | Florida | Recruiting |
| Centre for Rheumatology, Immunology and Arthritis | Fort Lauderdale | Florida | Recruiting |
| South Florida Rheumatology | Hollywood | Florida | Recruiting |
| GTL Medical And Research Group | Miami | Florida | Recruiting |
| Bolanos Clinical Research | Pembroke Pines | Florida | Recruiting |
| Vantage Clinical Trials | Tampa | Florida | Recruiting |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | Recruiting |
| Accurate Clinical Research Inc. - Lake Charles | Lake Charles | Louisiana | Recruiting |
| Oakland Hills Dermatology | Auburn Hills | Michigan | Recruiting |
| Arthritis and Osteoporosis Consultants of the Carolinas II, LLC | Charlotte | North Carolina | Recruiting |
| Superior Clinical Research, LLC | Smithfield | North Carolina | Recruiting |
| North Texas Center for Clinical Research | Frisco | Texas | Recruiting |
| Accurate Clinical Research | Humble | Texas | Recruiting |
| Monash Medical Centre Clayton | Clayton | Victoria | Recruiting |
| L2IP - Instituto de Pesquisas Clínicas Ltda. | Brasília | Federal District | Recruiting |
| A2Z Clinical Centro Avancado de Pesquisa Clinica | Campinas | São Paulo | Recruiting |
| Hospital Alemão Oswaldo Cruz | São Paulo | Brazil | Recruiting |
| RDSS Ricardo Diaz Scientific Solution | São Paulo | Brazil | Recruiting |
| DCC 1 Sevlievo EOOD | Sevlievo | Bulgaria | Recruiting |
| DCC "Alexandrovska", EOOD | Sofia | Bulgaria | Recruiting |
| The Medical Arts Health Research Group - 300128547 | Kelowna | British Columbia | Recruiting |
| Fujian Provincial Hospital | Fuzhou | Fujian | Recruiting |
| Nanfang Hospital of Southern Medical University - 300165627 | Guangzhou | Guangdong | Recruiting |
| The Second Hospital of Hebei Medical University - 300184836 | Shijiazhuang | Hebei | Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | Recruiting |
| The First Affiliated Hospital of Baotou Medical College | Baotou | Inner Mongolia | Recruiting |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | Recruiting |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Recruiting |
| The First Hospital of Jilin University | Changchun | Jilin | Recruiting |
| Qilu Hospital of Shandong University - 300163463 | Jinan | Shandong | Recruiting |
| West China Hospital, Sichuan University | Chengdu | Sichuan | Recruiting |
| Prof.MUDr.Petr Arenberger,DrSc.MBA | Prague | Czechia | Recruiting |
| MEDICAL PLUS s.r.o. | Uherské Hradiště | Czechia | Recruiting |
| Universitaetsklinikum Tuebingen - Hautklinik | Tübingen | Baden-Wurttemberg | Recruiting |
| Klinikum Oldenburg AoeR - Universitatsklinik f Dermatologie u. Allergologie | Oldenburg | Lower Saxony | Recruiting |
| Helios Klinikum Wuppertal - Klinik fuer Dermatologie, Venerologie | Wuppertal | North Rhine-Westphalia | Recruiting |
| Universitaetsklinikum Leipzig AoeR - Klinik u. Polikl. f.Dermatol.,Venerol. u. Allergol | Leipzig | Saxony | Recruiting |
| Tel Aviv Sourasky Medical Center-Derma - 150314762 | Tel Aviv | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center - Neurosurgery | Tel Aviv | Israel | Recruiting |
+ 17 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07355218 on ClinicalTrials.gov ↗ ← All trials in the UK