N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

Sponsor: EMD Serono Research & Development Institute, Inc. • ClinicalTrials.gov ID: NCT07332481

Registry updated: 2026-10-06
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Enpatoran (Drug)
    Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
  • Placebo (Drug)
    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.

Eligibility criteria

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.

Conditions

Systemic Lupus Erythematosus (SLE) Cutaneous Lupus Erythematosus (CLE)

Locations

  • Dermatology Research Associates - 300204025 — Los Angeles, California, United States
  • Cohen Medical Centers — Thousand Oaks, California, United States
  • GNP Research at Mark Jaffe, MD — Cooper City, Florida, United States
  • Advance Medical Research Center — Miami, Florida, United States
  • Diverse Clinical Research LLC — Miami, Florida, United States
  • D&H National Research Centers, Inc. — Tamarac, Florida, United States
  • Clinical Research of West Florida, Inc. — Tampa, Florida, United States
  • Emory University School of Medicine — Atlanta, Georgia, United States
  • Revival Research Institute, LLC — Troy, Michigan, United States
  • Allen Arthritis — Allen, Texas, United States
  • Arthritis and Rheumatology Research Institute PLLC — Allen, Texas, United States
  • Arthritis Care of Texas — Corpus Christi, Texas, United States
  • Rheumatology Research Unit Sunshine Coast — Maroochydore, Queensland, Australia
  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará — Fortaleza, Ceará, Brazil
  • Clínica SER da Bahia — Salvador, Estado de Bahia, Brazil
  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso — Cuiabá, Mato Grosso, Brazil
  • Freire Pesquisa Clinica — Belo Horizonte, Minas Gerais, Brazil
  • Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor de Barretos — Barretos, São Paulo, Brazil
  • DCC V Plovdiv Sv. Archbishop Luka EOOD — Plovdiv, Bulgaria
  • Ambulatory for Specialized Medical Help - skin and venereal diseases — Sofia, Bulgaria
  • CHU Saint Etienne - Hôpital Nord - service de medecine interne — Saint-Étienne-de-Montluc, Pays de la Loire Region, France
  • Hopital Tenon - service dermatologie et centre d'allergie — Paris, France
  • Elbekliniken Buxtehude GmbH - Dermatologie — Buxtehude, Lower Saxony, Germany
  • Charité - Campus Charité Mitte - Klinik fuer Dermatol., Venerol., Allergologie — Berlin, Germany
  • Universitaetsklinikum Carl Gustav Carus TU Dresden — Dresden, Germany
  • Chaim Sheba Medical Center - pt — Ramat Gan, Israel
  • Azienda USL Toscana Centro - Ospedale Piero Palagi — Florence, Firenze, Italy
  • Università Campus Bio-Medico di Roma - UOC Reumatologia — Roma, Italy
  • JCHO Chukyo Hospital - Dept of Dermatology — Nagoya, Aichi-ken, Japan
  • NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology — Chiba, Chiba, Japan
  • Hospital of the University of Occupational and Environmental Health - Dept of Dermatology — Kitakyushu-shi, Fukuoka, Japan
  • Fukushima Medical University Hospital - Dept of Rheumatology/Immunology — Fukushima, Fukushima, Japan
  • NHO Asahikawa Medical Center - Dept of Gastroenterology — Asahikawa-shi, Hokkaido, Japan
  • Sapporo City General Hospital - Dept of Rheumatology/Immunology — Sapporo, Hokkaido, Japan
  • Kobe University Hospital - Dept of Immunology/Rheumatology — Kobe, Hyōgo, Japan
  • Kanazawa University Hospital - Dept of Rheumatology/Immunology — Kanazawa, Ishikawa-ken, Japan
  • Yokohama City University Hospital - Dept of Dermatology — Yokohama, Kanagawa, Japan
  • Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology — Sendai, Miyagi, Japan
  • Okayama University Hospital - Dept of Rheumatology/Immunology — Okayama, Okayama-ken, Japan
  • The University of Osaka Hospital - Dept of Dermatology — Suita-shi, Osaka, Japan
  • Institute of Science Tokyo Hospital - Dept of Dermatology — Bunkyo-ku, Tokyo, Japan
  • St. Luke's International Hospital - Dept of Immunology/Allergy — Chūōku, Tokyo-To, Japan
  • Centrum Badan Klinicznych JCI — Krakow, Poland
  • ETG Lublin - ETG NETWORK Sp. z o.o. — Lublin, Poland
  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o. — Malbork, Poland
  • Uniwersytecki Szpital Kliniczny im Fryderyka Chopina w Rzeszowie - Klinika Dermatologii i Dermatologii Onkologicznej — Rzeszów, Poland
  • SOMED CR — Rzeszów, Poland
  • REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler — Warsaw, Poland
  • Velocity Zamosc — Zamość, Poland
  • Futuremeds S R L. — Brasov, Romania
  • Artromac n.o. - Reumatologicka ambulancia — Košice, Slovakia
  • Korea University Ansan Hospital - 300133335 — Ansan-si, Gyeonggi-do, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • Gachon University Gil Medical Center — Incheon, South Korea
  • Complejo Hospitalario Universitario de Santiago - Dermatology Unit — Santiago de Compostela, La Coruña, Spain
  • Hospital General Universitario de Valencia - Rheumatology — Valencia, Spain
  • Universitaetsspital Basel - Klinik fuer Dermatologie — Basel, Switzerland
  • Kantonsspital St. Gallen - Klinik f. Dermatologie, Venerologie u Allergologie — Sankt Gallen, Switzerland
  • China Medical University Hospital — Taichung, Taiwan
  • Chi Mei Medical Center - 300192662 — Tainan, Taiwan
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record