A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline — At Week 24
Trial sites (60)
| Facility | City | Region | Status |
|---|---|---|---|
| Dermatology Research Associates - 300204025 | Los Angeles | California | Recruiting |
| Cohen Medical Centers | Thousand Oaks | California | Recruiting |
| GNP Research at Mark Jaffe, MD | Cooper City | Florida | Recruiting |
| Advance Medical Research Center | Miami | Florida | Recruiting |
| Diverse Clinical Research LLC | Miami | Florida | Recruiting |
| D&H National Research Centers, Inc. | Tamarac | Florida | Recruiting |
| Clinical Research of West Florida, Inc. | Tampa | Florida | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | Recruiting |
| Revival Research Institute, LLC | Troy | Michigan | Recruiting |
| Allen Arthritis | Allen | Texas | Recruiting |
| Arthritis and Rheumatology Research Institute PLLC | Allen | Texas | Recruiting |
| Arthritis Care of Texas | Corpus Christi | Texas | Recruiting |
| Rheumatology Research Unit Sunshine Coast | Maroochydore | Queensland | Recruiting |
| HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Fortaleza | Ceará | Recruiting |
| Clínica SER da Bahia | Salvador | Estado de Bahia | Recruiting |
| IPC MT Instituto de Pesquisas Clinicas do Mato Grosso | Cuiabá | Mato Grosso | Recruiting |
| Freire Pesquisa Clinica | Belo Horizonte | Minas Gerais | Recruiting |
| Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor de Barretos | Barretos | São Paulo | Recruiting |
| DCC V Plovdiv Sv. Archbishop Luka EOOD | Plovdiv | Bulgaria | Recruiting |
| Ambulatory for Specialized Medical Help - skin and venereal diseases | Sofia | Bulgaria | Recruiting |
| CHU Saint Etienne - Hôpital Nord - service de medecine interne | Saint-Étienne-de-Montluc | Pays de la Loire Region | Recruiting |
| Hopital Tenon - service dermatologie et centre d'allergie | Paris | France | Recruiting |
| Elbekliniken Buxtehude GmbH - Dermatologie | Buxtehude | Lower Saxony | Recruiting |
| Charité - Campus Charité Mitte - Klinik fuer Dermatol., Venerol., Allergologie | Berlin | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | Germany | Recruiting |
| Chaim Sheba Medical Center - pt | Ramat Gan | Israel | Recruiting |
| Azienda USL Toscana Centro - Ospedale Piero Palagi | Florence | Firenze | Recruiting |
| Università Campus Bio-Medico di Roma - UOC Reumatologia | Roma | Italy | Recruiting |
| JCHO Chukyo Hospital - Dept of Dermatology | Nagoya | Aichi-ken | Recruiting |
| NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology | Chiba | Chiba | Recruiting |
| Hospital of the University of Occupational and Environmental Health - Dept of Dermatology | Kitakyushu-shi | Fukuoka | Recruiting |
| Fukushima Medical University Hospital - Dept of Rheumatology/Immunology | Fukushima | Fukushima | Recruiting |
| NHO Asahikawa Medical Center - Dept of Gastroenterology | Asahikawa-shi | Hokkaido | Recruiting |
| Sapporo City General Hospital - Dept of Rheumatology/Immunology | Sapporo | Hokkaido | Recruiting |
| Kobe University Hospital - Dept of Immunology/Rheumatology | Kobe | Hyōgo | Recruiting |
| Kanazawa University Hospital - Dept of Rheumatology/Immunology | Kanazawa | Ishikawa-ken | Recruiting |
| Yokohama City University Hospital - Dept of Dermatology | Yokohama | Kanagawa | Recruiting |
| Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology | Sendai | Miyagi | Recruiting |
| Okayama University Hospital - Dept of Rheumatology/Immunology | Okayama | Okayama-ken | Recruiting |
| The University of Osaka Hospital - Dept of Dermatology | Suita-shi | Osaka | Recruiting |
+ 20 more sites — see the full list on the official registry below.
More EMD Serono Research & Development Institute, Inc. trials in Italy
Other trials for the same condition
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 NCT07332481 on ClinicalTrials.gov ↗ ← All trials in Italy