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 57 sites in 17 countries.
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
- Conditions the study is for
- Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
- 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
- 57 sitesin 17 countries
- Study dates
- 1 Apr 2026to 25 May 2029
- Phase
- Phase 3
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.
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- 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
57 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
57 sites in 17 countries
United States14 sites, 14 recruiting
- 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
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
China10 sites, 10 recruiting
- 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
Brazil4 sites, 4 recruiting
- 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
Germany4 sites, 4 recruiting
- 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
Spain4 sites, 4 recruiting
- 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 Universitario Rio Hortega - Servicio de Medicina Interna
Valladolid, Cantabria, 47012
Poland3 sites, 3 recruiting
- Recruiting
Centrum Medyczne Plejady
Kraków, 30-363
- Recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
Szczecin, 71- 500
- Recruiting
Pratia Poznan
Warsaw, 02-637
Bulgaria2 sites, 2 recruiting
- Recruiting
DCC 1 Sevlievo EOOD
Sevlievo, 5400
- Recruiting
DCC "Alexandrovska", EOOD
Sofia, 1431
Czechia2 sites, 2 recruiting
- Recruiting
Prof.MUDr.Petr Arenberger,DrSc.MBA
Prague, 100 34
- Recruiting
MEDICAL PLUS s.r.o.
Uherské Hradiště, 686 01
Israel2 sites, 2 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center-Derma - 150314762
Tel Aviv, 6423906
- Recruiting
Tel Aviv Sourasky Medical Center - Neurosurgery
Tel Aviv, 64239
Italy2 sites, 2 recruiting
- 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
South Korea2 sites, 2 recruiting
- Recruiting
Chung-ang University Gwangmyeong Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, Gangwon-do, 134-727
Switzerland2 sites, 2 recruiting
- Recruiting
Dermatotomi AG
Weinfelden, 8570
- Recruiting
IZZ Immunologie-Zentrum Zuerich - Innere Medizin, Allergologie, Immunologie
Zurich, 8006
Taiwan2 sites, 2 recruiting
- Recruiting
Kaohsiung Veterans General Hospital - Internal Medicine
Kaohsiung City, 81362
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Australia1 site, 1 recruiting
- Recruiting
Monash Medical Centre Clayton
Clayton, Victoria, 3156
Canada1 site, 1 recruiting
- Recruiting
The Medical Arts Health Research Group - 300128547
Kelowna, British Columbia, V1Y 4Z5
United Kingdom1 site, 1 recruiting
- Recruiting
Doncaster Royal Infirmary - Dept of Rheumatology
Doncaster, South Yorkshire, DN2 5LT
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 group | Role | What they receive |
|---|---|---|
| Enpatoran | Experimental | Not described Receives: Drug: Enpatoran; Drug: Standard of care (SoC) |
| Placebo | Placebo comparator | Not 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.
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)
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
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
Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters
Measured: From Day 1 to Week 24
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
Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline
Measured: At Weeks 4 and 24
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
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
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
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
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
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
Percentage of Participants with BILAG Moderate to Severe Flares
Measured: up to Week 24
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
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.
- First posted21 Jan 2026
- Study start1 Apr 2026
- Primary completion25 May 2029 (estimated)
- Study completion25 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systematic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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
- Sep 2026
- First submitted
- 12 Jan 2026
- Last updated
- 6 Oct 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.