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Systematic Lupus ErythematosusPhase 3NCT07355218

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

A Phase 3 study testing Enpatoran in people with Systematic Lupus Erythematosus and Cutaneous Lupus Erythematosus, run by EMD Serono Research & Development Institute, Inc. at 70 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Enpatoran
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
70 sitesin 20 countries
Study dates
1 Apr 2026to 25 May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

70 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

US Medical Information contact

888-275-7376

eMediUSA@emdserono.com

Communication Center contact

+49 6151 72 5200

service@emdgroup.com

70 sites in 20 countries

United States15 sites, 15 recruiting

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326

    Recruiting

  • Arthritis and Osteoporosis Consultants of the Carolinas II, LLC

    Charlotte, North Carolina, 28207

    Recruiting

  • Omega Research Debary, LLC

    DeBary, Florida, 32713

    Recruiting

  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33309

    Recruiting

  • North Texas Center for Clinical Research

    Frisco, Texas, 75034

    Recruiting

  • South Florida Rheumatology

    Hollywood, Florida, 33026

    Recruiting

  • Prolato Clinical Research Center

    Houston, Texas, 77054

    Recruiting

  • Accurate Clinical Research

    Humble, Texas, 77346

    Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

    Recruiting

  • Accurate Clinical Research Inc. - Lake Charles

    Lake Charles, Louisiana, 70605

    Recruiting

  • GTL Medical And Research Group

    Miami, Florida, 33173

    Recruiting

  • Bolanos Clinical Research

    Pembroke Pines, Florida, 33026

    Recruiting

  • Superior Clinical Research, LLC

    Smithfield, North Carolina, 27577

    Recruiting

  • Vantage Clinical Trials

    Tampa, Florida, 33603

    Recruiting

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

    Recruiting

Other trials in United States

China10 sites, 10 recruiting

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014010

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

    Recruiting

  • Nanfang Hospital of Southern Medical University - 300165627

    Guangzhou, Guangdong, 510515

    Recruiting

  • Qilu Hospital of Shandong University - 300163463

    Jinan, Shandong, 250012

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Recruiting

  • The Second Hospital of Hebei Medical University - 300184836

    Shijiazhuang, Hebei, 050000

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

    Recruiting

Other trials in China

Poland5 sites, 5 recruiting

  • Centrum Medyczne Plejady

    Kraków, 30-363

    Recruiting

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

    Szczecin, 71- 500

    Recruiting

  • Medycyna Kliniczna

    Warsaw, 00-660

    Recruiting

  • Pratia MCM Krakow

    Warsaw, 02-637

    Recruiting

  • Pratia Poznan

    Warsaw, 02-637

    Recruiting

Other trials in Poland

Spain5 sites, 5 recruiting

  • Hospital General de Castellon - Servicio de Reumatologia

    Castellón, Castellón, 12004

    Recruiting

  • Hospital Universitario Reina Sofia - Dermatology Dep

    Córdoba, 14004

    Recruiting

  • Hospital Universitario La Paz - Internal Medicine Department

    Madrid, 28046

    Recruiting

  • Hospital de Merida - Servicio de Reumatologia

    Mérida, Badajoz, 06800

    Recruiting

  • Hospital Universitario Rio Hortega - Servicio de Medicina Interna

    Valladolid, Cantabria, 47012

    Recruiting

Other trials in Spain

Brazil4 sites, 4 recruiting

  • L2IP - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

    Recruiting

  • A2Z Clinical Centro Avancado de Pesquisa Clinica

    Campinas, São Paulo, 13083-888

    Recruiting

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-903

    Recruiting

  • RDSS Ricardo Diaz Scientific Solution

    São Paulo, 04037-030

    Recruiting

Other trials in Brazil

Germany4 sites, 4 recruiting

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

    Leipzig, Saxony, 04103

    Recruiting

  • Klinikum Oldenburg AoeR - Universitatsklinik f Dermatologie u. Allergologie

    Oldenburg, Lower Saxony, 26133

    Recruiting

  • Universitaetsklinikum Tuebingen - Hautklinik

    Tübingen, Baden-Wurttemberg, 72076

    Recruiting

  • Helios Klinikum Wuppertal - Klinik fuer Dermatologie, Venerologie

    Wuppertal, North Rhine-Westphalia, 42283

    Recruiting

Other trials in Germany

Czechia3 sites, 3 recruiting

  • Fakultni nemocnice u sv. Anny v Brne - Dept of I. Dermatovenerologicka klinika

    Brno, 65691

    Recruiting

  • Prof.MUDr.Petr Arenberger,DrSc.MBA

    Prague, 100 34

    Recruiting

  • MEDICAL PLUS s.r.o.

    Uherské Hradiště, 686 01

    Recruiting

Other trials in Czechia

Italy3 sites, 3 recruiting

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata - U.O.C Servizio di Reumatologia

    Rome, 00133

    Recruiting

  • Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri - Parent

    Rome, 00144

    Recruiting

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

    Verona, 37126

    Recruiting

Other trials in Italy

South Korea3 sites, 3 recruiting

  • Chung-ang University Gwangmyeong Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul, Gangwon-do, 134-727

    Recruiting

  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

    Seoul, 03722

    Recruiting

Other trials in South Korea

United Kingdom3 sites, 3 recruiting

  • Doncaster Royal Infirmary - Dept of Rheumatology

    Doncaster, South Yorkshire, DN2 5LT

    Recruiting

  • Guy's Hospital - Louise Coote Lupus Unit

    London, Greater London, SE1 9RT

    Recruiting

  • Walsall Manor Hospital

    Walsall, West Midlands, WS2 9PS

    Recruiting

Other trials in United Kingdom

Bulgaria2 sites, 2 recruiting

  • DCC 1 Sevlievo EOOD

    Sevlievo, 5400

    Recruiting

  • DCC "Alexandrovska", EOOD

    Sofia, 1431

    Recruiting

Other trials in Bulgaria

Israel2 sites, 2 recruiting

  • Tel Aviv Sourasky Medical Center-Derma - 150314762

    Tel Aviv, 6423906

    Recruiting

  • Tel Aviv Sourasky Medical Center - Neurosurgery

    Tel Aviv, 64239

    Recruiting

Other trials in Israel

South Africa2 sites, 2 recruiting

  • Dr JM Engelbrecht Trial Site - 300229887

    Somerset West, Western Cape, 7130

    Recruiting

  • Clinical Trial Network (CTN) Helderberg

    Stellenbosch, Western Cape, 7600

    Recruiting

Other trials in South Africa

Switzerland2 sites, 2 recruiting

  • Dermatotomi AG

    Weinfelden, 8570

    Recruiting

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

    Zurich, 8006

    Recruiting

Other trials in Switzerland

Taiwan2 sites, 2 recruiting

  • Kaohsiung Veterans General Hospital - Internal Medicine

    Kaohsiung City, 81362

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

Other trials in Taiwan

Australia1 site, 1 recruiting

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3156

    Recruiting

Other trials in Australia

Belgium1 site, 1 recruiting

  • Universitair Ziekenhuis Gent - UZG

    Ghent, 9000

    Recruiting

Other trials in Belgium

Canada1 site, 1 recruiting

  • The Medical Arts Health Research Group - 300128547

    Kelowna, British Columbia, V1Y 4Z5

    Recruiting

Other trials in Canada

Romania1 site, 1 recruiting

  • S.C Neurocity S.R.L

    Bucharest, 040215

    Recruiting

Other trials in Romania

Thailand1 site, 1 recruiting

  • Siriraj Hospital

    Bangkok, 10700

    Recruiting

Other trials in Thailand

About this study

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)

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.

Being tested
Enpatoran, Placebo, Standard of care (SoC)
Keywords
Toll-like Receptor 7, Toll-like Receptor 8, Adults, SLE, CLE, Lupus, Discoid lupus erythematosus, Subacute cutaneous lupus erythematosus, M5049, Enpatoran, Cutaneous manifestations, Lupus erythematosus, Acute cutaneous lupus erythematosus, Systemic lupus erythematosus, Interferon gene signature
Medical subject headings
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnpatoranDrug

    Also called M5049

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

  • PlaceboDrug

    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)Drug

    Participants will receive Investigator-recommended SoC.

Study groups in NCT07355218
Study groupRoleWhat they receive
EnpatoranExperimentalNot described
Receives: Drug: Enpatoran; Drug: Standard of care (SoC)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Standard of care (SoC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At Week 24

Secondary outcomes (14)

  1. Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response

    A BICLA response is defined as British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) -improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to [<=] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; -no worsening in disease activity (no new BILAG 2004 A scores and <= 1 new B score); -no worsening of total Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score from Baseline; -no significant deterioration (less than [<] 10% worsening) in visual analog Physician's Global Assessment (PGA) and -no treatment failure i.e. protocol-prohibited medications as determined by Endpoint Adjudication Committee (EAC) or premature discontinuation from study treatment).

    Measured: At Week 24

  2. Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)

    Measured: From Day 1 to Week 24

  3. Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters

    Measured: From Day 1 to Week 24

  4. Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24

    CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.

    Measured: At Week 24

  5. Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline

    Measured: At Weeks 4 and 24

  6. Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction

    Clinically meaningful CS reduction, is defined as reduction of daily prednisone-equivalent dose from >= 10 milligrams (mg) at Day 1 to <= 5 mg by the Week 12 visit and sustained through Week 24.

    Measured: Day 1 up to Week 12 and thereafter upto Week 24

  7. Change from Baseline in Worst Itch Numeric Rating Scale (NRS) Score at Week 24

    The Worst Itch NRS is a self-rated single item scale designed for assessing worst itch in the past 7 days. The scale utilizes 11-point NRS, scored from of 0 (no itch) to 10 (worst imaginable itch).

    Measured: Baseline and at Week 24

  8. Change from Baseline in CLASI-A Erythema at Week 24

    CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.

    Measured: Baseline and at Week 24

  9. Change from Baseline in CLASI-A Scale/Hypertrophy at Week 24

    CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.

    Measured: Baseline and at Week 24

  10. Change from Baseline in CLASI-A Alopecia at Week 24

    CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.

    Measured: Baseline and at Week 24

  11. Percentage of Participants With a Cutaneous Lupus Activity Investigator's Global Assessment-Revised (CLA-IGA-R OMC) Score of 0 or 1 and at Least a 1-Point Reduction at Week 24

    The CLA-IGA-R is assessed by the investigator, who assigns rater to assign scores to 3 individual domains (e.g. erythema, other morphologic characteristics - OMC [scales, edema)/infiltration and secondary change (vesicles, erosion, crusting)] and follicular activity). Clinicians assess the severity of the first 2 domains of erythema and OMC from 0 (Clear) to 4 (Severe); they assess the severity of the third domain of follicular activity as "absent" or "present." Higher scores indicate more disease activity.

    Measured: At Week 24

  12. Percentage of Participants with BILAG Moderate to Severe Flares

    Measured: up to Week 24

  13. Time to First Moderate/Severe BILAG Flare

    Median time to first moderate or severe BILAG Flare will be calculated.

    Measured: Day 1 through Week 24

  14. Percentage of Participants with Corticosteroid (CS) reduction of Daily Prednisone Equivalent Dose

    CS reduction is defined as of daily prednisone-equivalent dose from >= 10 milligrams per day (mg/day) at Day 1 to <= 5 mg/day and sustained for 12 weeks

    Measured: Day 1 up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start1 Apr 2026
  3. Primary completion25 May 2029 (estimated)
  4. Study completion25 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
202 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07355218
Sponsor's protocol ID
MS504908_0008
Other IDs
2025-524855-30-00, 169831, CTR20261950, 2025
Status last verified
Oct 2026
First submitted
12 Jan 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD supporting publicly available results will be evaluated for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enpatoran in people with Systematic Lupus Erythematosus and Cutaneous Lupus Erythematosus, run by EMD Serono Research & Development Institute, Inc. at 70 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, China, Poland, Spain, Brazil and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US Medical Information (888-275-7376, eMediUSA@emdserono.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07355218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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