Systemic Lupus Erythematosus (SLE)Phase 3ELOWEN-1NCT07332481
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
A Phase 3 study testing Enpatoran in people with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), run by EMD Serono Research & Development Institute, Inc. at 60 sites in 16 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
- Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- 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
- 60 sitesin 16 countries
- Study dates
- 10 Mar 2026to 24 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
60 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
60 sites in 16 countries
Japan14 sites, 14 recruiting
- Recruiting
NHO Asahikawa Medical Center - Dept of Gastroenterology
Asahikawa-shi, Hokkaido, 070-8644
- Recruiting
Institute of Science Tokyo Hospital - Dept of Dermatology
Bunkyo-ku, Tokyo, 113-8519
- Recruiting
NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology
Chiba, Chiba, 260-8712
- Recruiting
St. Luke's International Hospital - Dept of Immunology/Allergy
Chūōku, Tokyo-To, 104-8560
- Recruiting
Fukushima Medical University Hospital - Dept of Rheumatology/Immunology
Fukushima, Fukushima, 960-1295
- Recruiting
Kanazawa University Hospital - Dept of Rheumatology/Immunology
Kanazawa, Ishikawa-ken, 920-8641
- Recruiting
Hospital of the University of Occupational and Environmental Health - Dept of Dermatology
Kitakyushu-shi, Fukuoka, 807-8556
- Recruiting
Kobe University Hospital - Dept of Immunology/Rheumatology
Kobe, Hyōgo, 650-0017
- Recruiting
JCHO Chukyo Hospital - Dept of Dermatology
Nagoya, Aichi-ken, 457-8510
- Recruiting
Okayama University Hospital - Dept of Rheumatology/Immunology
Okayama, Okayama-ken, 700-8558
- Recruiting
Sapporo City General Hospital - Dept of Rheumatology/Immunology
Sapporo, Hokkaido, 060-8604
- Recruiting
Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology
Sendai, Miyagi, 983-8512
- Recruiting
The University of Osaka Hospital - Dept of Dermatology
Suita-shi, Osaka, 565-0871
- Recruiting
Yokohama City University Hospital - Dept of Dermatology
Yokohama, Kanagawa, 236-0004
United States12 sites, 12 recruiting
- Recruiting
Allen Arthritis
Allen, Texas, 75013
- Recruiting
Arthritis and Rheumatology Research Institute PLLC
Allen, Texas, 75013
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30303
- Recruiting
GNP Research at Mark Jaffe, MD
Cooper City, Florida, 33024
- Recruiting
Arthritis Care of Texas
Corpus Christi, Texas, 78415
- Recruiting
Dermatology Research Associates - 300204025
Los Angeles, California, 90045
- Recruiting
Advance Medical Research Center
Miami, Florida, 33135
- Recruiting
Diverse Clinical Research LLC
Miami, Florida, 33175
- Recruiting
D&H National Research Centers, Inc.
Tamarac, Florida, 33321
- Recruiting
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606
- Recruiting
Cohen Medical Centers
Thousand Oaks, California, 91360
- Recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
Poland7 sites, 7 recruiting
- Recruiting
Centrum Badan Klinicznych JCI
Krakow, 30-348
- Recruiting
ETG Lublin - ETG NETWORK Sp. z o.o.
Lublin, 20-412
- Recruiting
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
Malbork, 82-200
- Recruiting
Uniwersytecki Szpital Kliniczny im Fryderyka Chopina w Rzeszowie - Klinika Dermatologii i Dermatologii Onkologicznej
Rzeszów, 35-055
- Recruiting
SOMED CR
Rzeszów, 35-309
- Recruiting
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
Warsaw, 04-305
- Recruiting
Velocity Zamosc
Zamość, 22-400
Brazil5 sites, 5 recruiting
- Recruiting
Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor de Barretos
Barretos, São Paulo, 14784400
- Recruiting
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais, 30150-221
- Recruiting
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Cuiabá, Mato Grosso, 78020-500
- Recruiting
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, 60430-370
- Recruiting
Clínica SER da Bahia
Salvador, Estado de Bahia, 40150-150
Germany3 sites, 3 recruiting
- Recruiting
Charité - Campus Charité Mitte - Klinik fuer Dermatol., Venerol., Allergologie
Berlin, 10117
- Recruiting
Elbekliniken Buxtehude GmbH - Dermatologie
Buxtehude, Lower Saxony, 21614
- Recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
South Korea3 sites, 3 recruiting
- Recruiting
Korea University Ansan Hospital - 300133335
Ansan-si, Gyeonggi-do, 15355
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Bulgaria2 sites, 2 recruiting
- Recruiting
DCC V Plovdiv Sv. Archbishop Luka EOOD
Plovdiv, 4023
- Recruiting
Ambulatory for Specialized Medical Help - skin and venereal diseases
Sofia, 1407
France2 sites, 2 recruiting
- Recruiting
Hopital Tenon - service dermatologie et centre d'allergie
Paris, 75020
- Recruiting
CHU Saint Etienne - Hôpital Nord - service de medecine interne
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055
Italy2 sites, 2 recruiting
- Recruiting
Azienda USL Toscana Centro - Ospedale Piero Palagi
Florence, Firenze, 50125
- Recruiting
Università Campus Bio-Medico di Roma - UOC Reumatologia
Roma, 00155
Spain2 sites, 2 recruiting
- Recruiting
Complejo Hospitalario Universitario de Santiago - Dermatology Unit
Santiago de Compostela, La Coruña, 15706
- Recruiting
Hospital General Universitario de Valencia - Rheumatology
Valencia, 46014
Switzerland2 sites, 2 recruiting
- Recruiting
Universitaetsspital Basel - Klinik fuer Dermatologie
Basel, 4031
- Recruiting
Kantonsspital St. Gallen - Klinik f. Dermatologie, Venerologie u Allergologie
Sankt Gallen, 9000
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404332
- Recruiting
Chi Mei Medical Center - 300192662
Tainan, 71004
Australia1 site, 1 recruiting
- Recruiting
Rheumatology Research Unit Sunshine Coast
Maroochydore, Queensland, 4558
Israel1 site, 1 recruiting
- Recruiting
Chaim Sheba Medical Center - pt
Ramat Gan, 5265601
Slovakia1 site, 1 recruiting
- Recruiting
Artromac n.o. - Reumatologicka ambulancia
Košice, 04011
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-1)
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 (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), M5049, Enpatoran, Cutaneous manifestations, Lupus erythematosus, Acute cutaneous lupus erythematosus (ACLE), Interferon gene signature
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
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-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline
Measured: At Weeks 4 and 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 BICLA Response and Clinically Meaningful Corticosteroid (CS) Reduction
BICLA Response and 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 up to 24 weeks
Percentage of Participants with Corticosteroid (CS) reduction of Daily Prednisone Equivalent Dose
CS reduction is defined as reduction of daily prednisone-equivalent dose from >= 10 milligrams per day (mg/day) at Day 1 to <= 5 mg/day by the Week 12 visit and sustained through Week 24.
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 posted12 Jan 2026
- Study start10 Mar 2026
- Primary completion24 May 2029 (estimated)
- Study completion24 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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
- NCT07332481
- Sponsor's protocol ID
- MS504908_0001
- Other IDs
- 169831, 2025-523871-44-00, jRCT2011250064, CTR20262380, 2025
- Acronym
- ELOWEN-1
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD supporting publicly available results will be evaluated for sharing.