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NCT07355218PHASE3Recruiting

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

EMD Serono Research & Development Institute, Inc.

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

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.

Interventions

DRUG

Enpatoran

DRUG

Placebo

DRUG

Standard of care (SoC)

Interested in This Trial?

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Conditions

Systematic Lupus ErythematosusCutaneous Lupus Erythematosus

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