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RECRUITING

NCT07355218

PHASE3

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

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-2)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2026-04-01

Completion Date

2029-05-25

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Systematic Lupus Erythematosus Cutaneous Lupus Erythematosus

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 (57)

Inland Rheumatology Clinical Trials, Inc.

Upland, California, United States

Omega Research Debary, LLC

DeBary, Florida, United States

Centre for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, United States

South Florida Rheumatology

Hollywood, Florida, United States

GTL Medical And Research Group

Miami, Florida, United States

Bolanos Clinical Research

Pembroke Pines, Florida, United States

Vantage Clinical Trials

Tampa, Florida, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Accurate Clinical Research Inc. - Lake Charles

Lake Charles, Louisiana, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

Arthritis and Osteoporosis Consultants of the Carolinas II, LLC

Charlotte, North Carolina, United States

Superior Clinical Research, LLC

Smithfield, North Carolina, United States

North Texas Center for Clinical Research

Frisco, Texas, United States

Accurate Clinical Research

Humble, Texas, United States

Monash Medical Centre Clayton

Clayton, Victoria, Australia

L2IP - Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, Brazil

A2Z Clinical Centro Avancado de Pesquisa Clinica

Campinas, São Paulo, Brazil

Hospital Alemão Oswaldo Cruz

São Paulo, Brazil

RDSS Ricardo Diaz Scientific Solution

São Paulo, Brazil

DCC 1 Sevlievo EOOD

Sevlievo, Bulgaria

DCC "Alexandrovska", EOOD

Sofia, Bulgaria

The Medical Arts Health Research Group - 300128547

Kelowna, British Columbia, Canada

Fujian Provincial Hospital

Fuzhou, Fujian, China

Nanfang Hospital of Southern Medical University - 300165627

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University - 300184836

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Qilu Hospital of Shandong University - 300163463

Jinan, Shandong, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Prof.MUDr.Petr Arenberger,DrSc.MBA

Prague, Czechia

MEDICAL PLUS s.r.o.

Uherské Hradiště, Czechia

Universitaetsklinikum Tuebingen - Hautklinik

Tübingen, Baden-Wurttemberg, Germany

Klinikum Oldenburg AoeR - Universitatsklinik f Dermatologie u. Allergologie

Oldenburg, Lower Saxony, Germany

Helios Klinikum Wuppertal - Klinik fuer Dermatologie, Venerologie

Wuppertal, North Rhine-Westphalia, Germany

Universitaetsklinikum Leipzig AoeR - Klinik u. Polikl. f.Dermatol.,Venerol. u. Allergol

Leipzig, Saxony, Germany

Tel Aviv Sourasky Medical Center-Derma - 150314762

Tel Aviv, Israel

Tel Aviv Sourasky Medical Center - Neurosurgery

Tel Aviv, Israel

Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri - Parent

Rome, Italy

Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - Dip. Medicina - U.O.C. Reumatologia

Verona, Italy

Centrum Medyczne Plejady

KrakÃ³w, Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

Szczecin, Poland

Pratia Poznan

Warsaw, Poland

S.C Neurocity S.R.L

Bucharest, Romania

Kyung Hee University Hospital at Gangdong

Seoul, Gangwon-do, South Korea

Chung-ang University Gwangmyeong Hospital

Seongnam-si, Gyeonggi-do, South Korea

Hospital Universitario Rio Hortega - Servicio de Medicina Interna

Valladolid, Cantabria, Spain

Hospital General de Castellon - Servicio de Reumatologia

CastellÃ³n, CastellÃ³n, Spain

Hospital Universitario Reina Sofia - Dermatology Dep

Córdoba, Spain

Hospital Universitario La Paz - Internal Medicine Department

Madrid, Spain

Dermatotomi AG

Weinfelden, Switzerland

IZZ Immunologie-Zentrum Zuerich - Innere Medizin, Allergologie, Immunologie

Zurich, Switzerland

Kaohsiung Veterans General Hospital - Internal Medicine

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Doncaster Royal Infirmary - Dept of Rheumatology

Doncaster, South Yorkshire, United Kingdom

Clinical Research Directory

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)