Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07332481

PHASE3

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2026-03-10

Completion Date

2029-05-24

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus (SLE)Cutaneous Lupus Erythematosus (CLE)

Interventions

DRUG

Enpatoran

Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.

DRUG

Placebo

Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.

DRUG

Standard of care (SoC)

Participants will receive Investigator-recommended SoC.

Inclusion Criteria * 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. Exclusion Criteria * 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 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). * 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. * 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. * Other protocol-defined exclusion criteria may apply.

Locations (60)

Dermatology Research Associates - 300204025

Los Angeles, California, United States

Cohen Medical Centers

Thousand Oaks, California, United States

GNP Research at Mark Jaffe, MD

Cooper City, Florida, United States

Advance Medical Research Center

Miami, Florida, United States

Diverse Clinical Research LLC

Miami, Florida, United States

D&H National Research Centers, Inc.

Tamarac, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Revival Research Institute, LLC

Troy, Michigan, United States

Allen Arthritis

Allen, Texas, United States

Arthritis and Rheumatology Research Institute PLLC

Allen, Texas, United States

Arthritis Care of Texas

Corpus Christi, Texas, United States

Rheumatology Research Unit Sunshine Coast

Maroochydore, Queensland, Australia

HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

Fortaleza, CearÃ¡, Brazil

Clínica SER da Bahia

Salvador, Estado de Bahia, Brazil

IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

CuiabÃ¡, Mato Grosso, Brazil

Freire Pesquisa Clinica

Belo Horizonte, Minas Gerais, Brazil

Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor de Barretos

Barretos, São Paulo, Brazil

DCC V Plovdiv Sv. Archbishop Luka EOOD

Plovdiv, Bulgaria

Ambulatory for Specialized Medical Help - skin and venereal diseases

Sofia, Bulgaria

CHU Saint Etienne - Hôpital Nord - service de medecine interne

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

Hopital Tenon - service dermatologie et centre d'allergie

Paris, France

Elbekliniken Buxtehude GmbH - Dermatologie

Buxtehude, Lower Saxony, Germany

Charité - Campus Charité Mitte - Klinik fuer Dermatol., Venerol., Allergologie

Berlin, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Germany

Chaim Sheba Medical Center - pt

Ramat Gan, Israel

Azienda USL Toscana Centro - Ospedale Piero Palagi

Florence, Firenze, Italy

Università Campus Bio-Medico di Roma - UOC Reumatologia

Roma, Italy

JCHO Chukyo Hospital - Dept of Dermatology

Nagoya, Aichi-ken, Japan

NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology

Chiba, Chiba, Japan

Hospital of the University of Occupational and Environmental Health - Dept of Dermatology

Kitakyushu-shi, Fukuoka, Japan

Fukushima Medical University Hospital - Dept of Rheumatology/Immunology

Fukushima, Fukushima, Japan

NHO Asahikawa Medical Center - Dept of Gastroenterology

Asahikawa-shi, Hokkaido, Japan

Sapporo City General Hospital - Dept of Rheumatology/Immunology

Sapporo, Hokkaido, Japan

Kobe University Hospital - Dept of Immunology/Rheumatology

Kobe, Hyōgo, Japan

Kanazawa University Hospital - Dept of Rheumatology/Immunology

Kanazawa, Ishikawa-ken, Japan

Yokohama City University Hospital - Dept of Dermatology

Yokohama, Kanagawa, Japan

Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology

Sendai, Miyagi, Japan

Okayama University Hospital - Dept of Rheumatology/Immunology

Okayama, Okayama-ken, Japan

The University of Osaka Hospital - Dept of Dermatology

Suita-shi, Osaka, Japan

Institute of Science Tokyo Hospital - Dept of Dermatology

Bunkyo-ku, Tokyo, Japan

St. Luke's International Hospital - Dept of Immunology/Allergy

Chūōku, Tokyo-To, Japan

Centrum Badan Klinicznych JCI

Krakow, Poland

ETG Lublin - ETG NETWORK Sp. z o.o.

Lublin, Poland

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

Malbork, Poland

Uniwersytecki Szpital Kliniczny im Fryderyka Chopina w Rzeszowie - Klinika Dermatologii i Dermatologii Onkologicznej

Rzeszów, Poland

SOMED CR

Rzeszów, Poland

REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler

Warsaw, Poland

Velocity Zamosc

Zamość, Poland

Futuremeds S R L.

Brasov, Romania

Artromac n.o. - Reumatologicka ambulancia

Košice, Slovakia

Korea University Ansan Hospital - 300133335

Ansan-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Complejo Hospitalario Universitario de Santiago - Dermatology Unit

Santiago de Compostela, La CoruÃ±a, Spain

Hospital General Universitario de Valencia - Rheumatology

Valencia, Spain

Universitaetsspital Basel - Klinik fuer Dermatologie

Basel, Switzerland

Kantonsspital St. Gallen - Klinik f. Dermatologie, Venerologie u Allergologie

Sankt Gallen, Switzerland

China Medical University Hospital

Taichung, Taiwan

Chi Mei Medical Center - 300192662

Tainan, Taiwan

Clinical Research Directory

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (60)