{
  "data": {
    "asOf": "2026-10-30T22:26:02.817Z",
    "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only",
    "byRegistry": {
      "clinicaltrials_gov": 1
    },
    "canonicalTrial": {
      "canonicalId": "NCT05648500",
      "title": "A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus",
      "scientificTitle": "A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy",
      "status": "active",
      "studyType": "interventional",
      "phase": [
        "PHASE3"
      ],
      "conditions": [
        "Lupus Erythematosus, Systemic"
      ],
      "interventions": [
        {
          "name": "Cenerimod",
          "type": "DRUG",
          "description": "Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg."
        },
        {
          "name": "Placebo",
          "type": "DRUG",
          "description": "Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod."
        }
      ],
      "sponsor": {
        "name": "Viatris Innovation GmbH",
        "type": "INDUSTRY"
      },
      "locations": [
        {
          "city": "Huntington Park",
          "country": "United States",
          "facility": "California Research Institute"
        },
        {
          "city": "Aurora",
          "country": "United States",
          "facility": "University of Colorado Denver"
        },
        {
          "city": "Clearwater",
          "country": "United States",
          "facility": "Clinical Research of West Florida, Inc."
        },
        {
          "city": "DeBary",
          "country": "United States",
          "facility": "Omega Research MetroWest, LLC"
        },
        {
          "city": "Kissimmee",
          "country": "United States",
          "facility": "Alloy Clinical Research, LLC"
        },
        {
          "city": "Miami",
          "country": "United States",
          "facility": "SouthCoast Research Center, Inc."
        },
        {
          "city": "Miami",
          "country": "United States",
          "facility": "Allied Biomedical Research Institute"
        },
        {
          "city": "Miami",
          "country": "United States",
          "facility": "Professional research Center INC"
        },
        {
          "city": "Plantation",
          "country": "United States",
          "facility": "IRIS Research and Development, LLC"
        },
        {
          "city": "Augusta",
          "country": "United States",
          "facility": "Augusta University"
        },
        {
          "city": "Orland Park",
          "country": "United States",
          "facility": "Advance Quality Medical Research"
        },
        {
          "city": "Lake Charles",
          "country": "United States",
          "facility": "Accurate Clinical Research Inc. - Lake Charles"
        },
        {
          "city": "New Orleans",
          "country": "United States",
          "facility": "Louisiana State University School of Medicine section of Rheumatology"
        },
        {
          "city": "Baltimore",
          "country": "United States",
          "facility": "Axon Clinical Research -Baltimore"
        },
        {
          "city": "The Bronx",
          "country": "United States",
          "facility": "Bronx Care Health and Wellness Center"
        },
        {
          "city": "Charlotte",
          "country": "United States",
          "facility": "DJL Clinical Research, PLLC"
        },
        {
          "city": "Oklahoma City",
          "country": "United States",
          "facility": "University of Oklahoma College of Medicine"
        },
        {
          "city": "Baytown",
          "country": "United States",
          "facility": "Accurate Clinical Research Inc."
        },
        {
          "city": "Bellaire",
          "country": "United States",
          "facility": "Rheumatology Care Center, PLLC"
        },
        {
          "city": "Houston",
          "country": "United States",
          "facility": "Houston MD Medspa and Wellness Clinic"
        },
        {
          "city": "Houston",
          "country": "United States",
          "facility": "Accurate Clinical Research Inc."
        },
        {
          "city": "San Antonio",
          "country": "United States",
          "facility": "Sun Research Institute"
        },
        {
          "city": "Buenos Aires",
          "country": "Argentina",
          "facility": "Fundación Respirar"
        },
        {
          "city": "Buenos Aires",
          "country": "Argentina",
          "facility": "Instituto Medico CER"
        },
        {
          "city": "Buenos Aires",
          "country": "Argentina",
          "facility": "Aprillus Asistencia e Investigacion"
        },
        {
          "city": "Buenos Aires",
          "country": "Argentina",
          "facility": "Arsema Clinica Adventista Belgrano"
        },
        {
          "city": "Mendoza",
          "country": "Argentina",
          "facility": "IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología"
        },
        {
          "city": "Rosario",
          "country": "Argentina",
          "facility": "Instituto CAICI SRL"
        },
        {
          "city": "San Miguel de Tucumán",
          "country": "Argentina",
          "facility": "Centro de investigaciones medicas Tucuman"
        },
        {
          "city": "San Miguel de Tucumán",
          "country": "Argentina",
          "facility": "Centro Integral de Reumatología"
        },
        {
          "city": "San Miguel de Tucumán",
          "country": "Argentina",
          "facility": "ICT (Investigaciones Clínicas Tucumán)"
        },
        {
          "city": "Belo Horizonte",
          "country": "Brazil",
          "facility": "Santa Casa de Belo Horizonte"
        },
        {
          "city": "Juiz de Fora",
          "country": "Brazil",
          "facility": "Centro Mineiro de Pesquisas"
        },
        {
          "city": "Passo Fundo",
          "country": "Brazil",
          "facility": "Instituto Méderi de Pesquisa e Saúde"
        },
        {
          "city": "Porto Alegre",
          "country": "Brazil",
          "facility": "Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre"
        },
        {
          "city": "Porto Alegre",
          "country": "Brazil",
          "facility": "LMK Servicos Medico S/S"
        },
        {
          "city": "Rio de Janeiro",
          "country": "Brazil",
          "facility": "IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas"
        },
        {
          "city": "Salvador",
          "country": "Brazil",
          "facility": "SER - Serviços Especializados em Reumatologia da Bahia"
        },
        {
          "city": "Santa Cecília",
          "country": "Brazil",
          "facility": "Hospital de Clínicas de Porto Alegre"
        },
        {
          "city": "São Bernardo do Campo",
          "country": "Brazil",
          "facility": "Centro Multidiciplinar de Estudos Clínicos- CEMEC"
        },
        {
          "city": "São José do Rio Preto",
          "country": "Brazil",
          "facility": "Fundação Faculdade Regional de Medicina de São José do Rio Preto"
        },
        {
          "city": "São Paulo",
          "country": "Brazil",
          "facility": "CPClin - Centro de Pesquisas Clínicas"
        },
        {
          "city": "Uberlândia",
          "country": "Brazil",
          "facility": "Ebserh Hospital de Clínicas da Universidade Federal de Uberlândia-HC-UFU"
        },
        {
          "city": "Plovdiv",
          "country": "Bulgaria",
          "facility": "University Multi-profile Hospital for Active Treatment - Plovdiv AD"
        },
        {
          "city": "Plovdiv",
          "country": "Bulgaria",
          "facility": "\"University Multiprofile Hospital for Active Treatment - Pulmed\" OOD"
        },
        {
          "city": "Plovdiv",
          "country": "Bulgaria",
          "facility": "Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd."
        },
        {
          "city": "Sevlievo",
          "country": "Bulgaria",
          "facility": "DCC-1-Sevlievo EOOD"
        },
        {
          "city": "Sofia",
          "country": "Bulgaria",
          "facility": "DCC \"Sveta Anna\" EOOD"
        },
        {
          "city": "Sofia",
          "country": "Bulgaria",
          "facility": "Acibadem City Clinic Diagnostic-Consultative Center\" EOOD, 127 Okolovrasten pat, Mladost"
        },
        {
          "city": "Varna",
          "country": "Bulgaria",
          "facility": "DCC Equita EOOD"
        },
        {
          "city": "Barranquilla",
          "country": "Colombia",
          "facility": "Clínica de la costa Ltda."
        },
        {
          "city": "Bogotá",
          "country": "Colombia",
          "facility": "Bluecare salud SAS"
        },
        {
          "city": "Bogotá",
          "country": "Colombia",
          "facility": "IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)"
        },
        {
          "city": "Bucaramanga",
          "country": "Colombia",
          "facility": "SERVIMED S.A.S Bucaramanga"
        },
        {
          "city": "Cali",
          "country": "Colombia",
          "facility": "Fundación Valle de Lili"
        },
        {
          "city": "Cali",
          "country": "Colombia",
          "facility": "Centro de Estudios de Reumatología y Dermatología"
        },
        {
          "city": "Chía",
          "country": "Colombia",
          "facility": "Preventive Care SAS"
        },
        {
          "city": "Medellín",
          "country": "Colombia",
          "facility": "Hospital Pablo Tobón Uribe"
        },
        {
          "city": "Zipaquirá",
          "country": "Colombia",
          "facility": "Healthy Medical Center SAS"
        },
        {
          "city": "Paris",
          "country": "France",
          "facility": "Hôpital Pitié-Salpêtrière"
        },
        {
          "city": "Saint-Denis",
          "country": "France",
          "facility": "CHU Félix Guyon Site Nord"
        },
        {
          "city": "Toulouse",
          "country": "France",
          "facility": "CHU de Purpan"
        },
        {
          "city": "Athens",
          "country": "Greece",
          "facility": "Naval Hospital of Athens"
        },
        {
          "city": "Athens",
          "country": "Greece",
          "facility": "General Hospital of Athens \"Hippokration\""
        },
        {
          "city": "Athens",
          "country": "Greece",
          "facility": "General Hospital of Athens \"Laiko\""
        },
        {
          "city": "Athens",
          "country": "Greece",
          "facility": "University General Hospital \"Attikon\""
        },
        {
          "city": "Larissa",
          "country": "Greece",
          "facility": "General University Hospital of Larissa"
        },
        {
          "city": "Pátrai",
          "country": "Greece",
          "facility": "General University Hospital of Patras"
        },
        {
          "city": "Thessaloniki",
          "country": "Greece",
          "facility": "Euromedica - Kyanos Stavros"
        },
        {
          "city": "Thessaloniki",
          "country": "Greece",
          "facility": "General Hospital of Thessaloniki \"Hippokration\""
        },
        {
          "city": "Thessaloniki",
          "country": "Greece",
          "facility": "424 General Military Hospital"
        },
        {
          "city": "Ahmedabad",
          "country": "India",
          "facility": "Sangini Hospital"
        },
        {
          "city": "Bangalore",
          "country": "India",
          "facility": "ChanRe Rheumatology and Immunology Centre and Research"
        },
        {
          "city": "Chennai",
          "country": "India",
          "facility": "Rajiv Gandhi Government General Hospital"
        },
        {
          "city": "Hyderabad",
          "country": "India",
          "facility": "Nizam's Institute of medical Sciences"
        },
        {
          "city": "Jaipur",
          "country": "India",
          "facility": "Maharaja Agrasen Superspeciality Hospital"
        },
        {
          "city": "Nagpur",
          "country": "India",
          "facility": "Radiance Hospital"
        },
        {
          "city": "Nagpur",
          "country": "India",
          "facility": "Shree Hospital and Critical Care Centre."
        },
        {
          "city": "Nashik",
          "country": "India",
          "facility": "Assured Care Plus Hospital"
        },
        {
          "city": "Pune",
          "country": "India",
          "facility": "Coherence Pain & Arthritis Clinics"
        },
        {
          "city": "Sadashivnagar",
          "country": "India",
          "facility": "Vijaya Ortho & Trauma Centre"
        },
        {
          "city": "Surat",
          "country": "India",
          "facility": "Unity Hospital and Trauma Centre"
        },
        {
          "city": "Amagasaki-shi",
          "country": "Japan",
          "facility": "Hyogo Prefectural Amagasaki General Medical Center"
        },
        {
          "city": "Bunkyō City",
          "country": "Japan",
          "facility": "The University of Tokyo Hospital"
        },
        {
          "city": "Chiba",
          "country": "Japan",
          "facility": "National Hospital Organization Chiba Medical Center Chibahigashi National Hospital"
        },
        {
          "city": "Chuo-shi",
          "country": "Japan",
          "facility": "University of Yamanashi Hospital"
        },
        {
          "city": "Chūōku",
          "country": "Japan",
          "facility": "St.Luke's International Hospital"
        },
        {
          "city": "Fukuoka",
          "country": "Japan",
          "facility": "National Hospital Organization Kyushu Medical Center"
        },
        {
          "city": "Hiroshima",
          "country": "Japan",
          "facility": "Hiroshima Prefectural Hospital"
        },
        {
          "city": "Hiroshima",
          "country": "Japan",
          "facility": "Hiroshima University Hospital"
        },
        {
          "city": "Hitachi-Naka",
          "country": "Japan",
          "facility": "Hitachi, Ltd. Hitachinaka General Hospital"
        },
        {
          "city": "Ichikawa-shi",
          "country": "Japan",
          "facility": "National Kohnodai Medical Center, Japan Institute for Health Security"
        },
        {
          "city": "Isehara-shi",
          "country": "Japan",
          "facility": "Tokai University Hospital"
        },
        {
          "city": "Kakogawa-shi",
          "country": "Japan",
          "facility": "Kakogawa Central City Hospital"
        },
        {
          "city": "Kitakyushu-shi",
          "country": "Japan",
          "facility": "Shin-Kokura Hospital"
        },
        {
          "city": "Kobe",
          "country": "Japan",
          "facility": "Kobe University Hospital"
        },
        {
          "city": "Kobe",
          "country": "Japan",
          "facility": "Kobe City Medical Center General Hospital"
        },
        {
          "city": "Kuwana-shi",
          "country": "Japan",
          "facility": "Kuwana City Medical Center"
        },
        {
          "city": "Meguro-ku",
          "country": "Japan",
          "facility": "National Hospital Organization Tokyo Medical Center"
        },
        {
          "city": "Meguro-ku",
          "country": "Japan",
          "facility": "Toho University - Ohashi Medical Center"
        },
        {
          "city": "Miyazaki",
          "country": "Japan",
          "facility": "University of Miyazaki Hospital"
        },
        {
          "city": "Nagasaki",
          "country": "Japan",
          "facility": "Nagasaki University Hospital"
        },
        {
          "city": "Nagoya",
          "country": "Japan",
          "facility": "Chubu Rosai Hospital"
        },
        {
          "city": "Nagoya",
          "country": "Japan",
          "facility": "Chukyo Hospital"
        },
        {
          "city": "Nagoya",
          "country": "Japan",
          "facility": "Nagoya City University Hospital"
        },
        {
          "city": "Narita-shi",
          "country": "Japan",
          "facility": "IUHW Narita Hospital"
        },
        {
          "city": "Niigata",
          "country": "Japan",
          "facility": "Niigata University Medical and Dental Hospital"
        },
        {
          "city": "Okayama",
          "country": "Japan",
          "facility": "Okayama City General Medical Center Okayama City Hospital"
        },
        {
          "city": "Ome-shi",
          "country": "Japan",
          "facility": "Ome Medical Center"
        },
        {
          "city": "Osaka",
          "country": "Japan",
          "facility": "Osaka Saiseikai Nakatsu Hospital"
        },
        {
          "city": "Ōta-ku",
          "country": "Japan",
          "facility": "Toho University Omori Medical Center"
        },
        {
          "city": "Saga",
          "country": "Japan",
          "facility": "Saga University Hospital"
        },
        {
          "city": "Saitama-shi",
          "country": "Japan",
          "facility": "Japanese Red Cross Saitama Hospital"
        },
        {
          "city": "Saitama-shi",
          "country": "Japan",
          "facility": "Sainokuni Higashiomiya Medical Center"
        },
        {
          "city": "Sakura-shi",
          "country": "Japan",
          "facility": "Toho University Sakura Medical Center"
        },
        {
          "city": "Sapporo",
          "country": "Japan",
          "facility": "Hokkaido University Hospital"
        },
        {
          "city": "Sapporo",
          "country": "Japan",
          "facility": "National Hospital Organization Hokkaido Medical Center"
        },
        {
          "city": "Sendai",
          "country": "Japan",
          "facility": "Tohoku Medical and Pharmaceutical University Hospital"
        },
        {
          "city": "Shinagawa-ku",
          "country": "Japan",
          "facility": "Showa Medical University East Hospital"
        },
        {
          "city": "Shinjuku",
          "country": "Japan",
          "facility": "Keio University Hospital"
        },
        {
          "city": "Shinjuku-ku",
          "country": "Japan",
          "facility": "Tokyo Women's Medical University Hospital"
        },
        {
          "city": "Tomakomai-shi",
          "country": "Japan",
          "facility": "Tomakomai City Hospital"
        },
        {
          "city": "Toyama",
          "country": "Japan",
          "facility": "Toyama University Hospital"
        },
        {
          "city": "Urayasu-shi",
          "country": "Japan",
          "facility": "Juntendo University Urayasu Hospital"
        },
        {
          "city": "Yokohama",
          "country": "Japan",
          "facility": "Yokohama City Minato Red Cross Hospital"
        },
        {
          "city": "Yoshida-gun",
          "country": "Japan",
          "facility": "University of Fukui Hospital"
        },
        {
          "city": "Guadalajara",
          "country": "Mexico",
          "facility": "Consultorio Privado de Especialidad"
        },
        {
          "city": "Guadalajara",
          "country": "Mexico",
          "facility": "Centro de Estudios de Investigación Básica y Clínica, S.C."
        },
        {
          "city": "León",
          "country": "Mexico",
          "facility": "Consultorio Médico de Reumatología - Hospital Aranda de la Parra"
        },
        {
          "city": "Mexico City",
          "country": "Mexico",
          "facility": "Biológicos Especializados S.A. de C.V."
        },
        {
          "city": "Mexico City",
          "country": "Mexico",
          "facility": "CITER, Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V."
        },
        {
          "city": "Mérida",
          "country": "Mexico",
          "facility": "Unidad de Atención Médica e Investigación en Salud"
        },
        {
          "city": "Morelia",
          "country": "Mexico",
          "facility": "Centro de Investigación Clínica Chapultepec S. A. de C. V."
        },
        {
          "city": "Querétaro",
          "country": "Mexico",
          "facility": "SMIQ, S. de R.L. de C.V."
        },
        {
          "city": "San Luis Potosí City",
          "country": "Mexico",
          "facility": "Centro de Atención e Investigación Cardiovascular del Potosí, S.C."
        },
        {
          "city": "San Luis Potosí City",
          "country": "Mexico",
          "facility": "Unidad de Investigaciones Reumatológicas A.C"
        },
        {
          "city": "Zapopan",
          "country": "Mexico",
          "facility": "Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V."
        },
        {
          "city": "Cebu City",
          "country": "Philippines",
          "facility": "Chong-Hua Hospital"
        },
        {
          "city": "Davao City",
          "country": "Philippines",
          "facility": "Davao Doctors Hospital"
        },
        {
          "city": "Lipa",
          "country": "Philippines",
          "facility": "Mary Mediatrix Medical Center"
        },
        {
          "city": "Makati",
          "country": "Philippines",
          "facility": "Makati Medical Center"
        },
        {
          "city": "Manila",
          "country": "Philippines",
          "facility": "UP-PGH"
        },
        {
          "city": "Quezon City",
          "country": "Philippines",
          "facility": "Far Eastern University - Nicanor Reyes Medical Foundation"
        },
        {
          "city": "Santa Cruz",
          "country": "Philippines",
          "facility": "Jose R. Reyes Memorial Medical Center"
        },
        {
          "city": "Bialystok",
          "country": "Poland",
          "facility": "INTER CLINIC Piotr Adrian Klimiuk"
        },
        {
          "city": "Częstochowa",
          "country": "Poland",
          "facility": "Centrum Medyczne Pratia Częstochowa"
        },
        {
          "city": "Katowice",
          "country": "Poland",
          "facility": "Centrum Medyczne Angelius Provita"
        },
        {
          "city": "Katowice",
          "country": "Poland",
          "facility": "Vita Longa Sp. z o.o."
        },
        {
          "city": "Krakow",
          "country": "Poland",
          "facility": "Małopolskie Badania Kliniczne"
        },
        {
          "city": "Krakow",
          "country": "Poland",
          "facility": "Centrum Medyczne Plejady"
        },
        {
          "city": "Lublin",
          "country": "Poland",
          "facility": "Velocity Nova Sp. z o. o."
        },
        {
          "city": "Lublin",
          "country": "Poland",
          "facility": "Zespół Poradni Specjalistycznych REUMED"
        },
        {
          "city": "Wroclaw",
          "country": "Poland",
          "facility": "Malwa-Med Iwona Chlebicka"
        },
        {
          "city": "Brasov",
          "country": "Romania",
          "facility": "Neomed Brasov"
        },
        {
          "city": "Bucharest",
          "country": "Romania",
          "facility": "Delta Health Care SRL"
        },
        {
          "city": "Craiova",
          "country": "Romania",
          "facility": "Spitalul Clinic Judetean de Urgentã Craiova"
        },
        {
          "city": "Râmnicu Vâlcea",
          "country": "Romania",
          "facility": "SC Medaudio-Optica SRL"
        },
        {
          "city": "Busan",
          "country": "South Korea",
          "facility": "Pusan National University Hospital"
        },
        {
          "city": "Daegu",
          "country": "South Korea",
          "facility": "Catholic University of Daegu (Daegu Catholic University Medical Center)"
        },
        {
          "city": "Junggu",
          "country": "South Korea",
          "facility": "Seoul National University Hospital"
        },
        {
          "city": "Seoul",
          "country": "South Korea",
          "facility": "Hanyang University Hospital, Seongdong-gu"
        },
        {
          "city": "Seoul",
          "country": "South Korea",
          "facility": "Ewha University Mokdong Hospital, Yangcheon-gu"
        },
        {
          "city": "Seoul",
          "country": "South Korea",
          "facility": "KonKuk University Medical Center, Gwangjin-gu"
        },
        {
          "city": "Seoul",
          "country": "South Korea",
          "facility": "Seoul Saint Mary's Hospital of the Catholic University of Korea, Seocho-gu"
        },
        {
          "city": "Kaohsiung City",
          "country": "Taiwan",
          "facility": "Kaohsiung Medical University Hospital"
        },
        {
          "city": "New Taipei City",
          "country": "Taiwan",
          "facility": "Far Eastern Memorial Hospital"
        },
        {
          "city": "Taichung",
          "country": "Taiwan",
          "facility": "China Medical University Hospital"
        },
        {
          "city": "Tainan",
          "country": "Taiwan",
          "facility": "Chi Mei Medical Center"
        },
        {
          "city": "Taipei",
          "country": "Taiwan",
          "facility": "National Taiwan University Hospital"
        },
        {
          "city": "Taipei",
          "country": "Taiwan",
          "facility": "Taipei Medical University Hospital"
        },
        {
          "city": "Taipei",
          "country": "Taiwan",
          "facility": "Taipei Veterans General Hospital"
        },
        {
          "city": "Taipei",
          "country": "Taiwan",
          "facility": "Cheng Hsin General Hospital"
        },
        {
          "city": "Taipei",
          "country": "Taiwan",
          "facility": "TRI-Service General Hospital"
        },
        {
          "city": "Taoyuan City",
          "country": "Taiwan",
          "facility": "Linkou Chang Gung Memorial Hospital"
        },
        {
          "city": "Bangkok",
          "country": "Thailand",
          "facility": "Vajira Hospital"
        },
        {
          "city": "Bangkok",
          "country": "Thailand",
          "facility": "King Chulalongkorn Memorial Hospital"
        },
        {
          "city": "Bangkok",
          "country": "Thailand",
          "facility": "Phramongkutklao Hospital (PMK)"
        },
        {
          "city": "Bangkok",
          "country": "Thailand",
          "facility": "Rajavithi Hospital"
        },
        {
          "city": "Bangkok",
          "country": "Thailand",
          "facility": "Ramathibodi Hospital"
        },
        {
          "city": "Chiang Mai",
          "country": "Thailand",
          "facility": "Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology"
        },
        {
          "city": "Khon Kaen",
          "country": "Thailand",
          "facility": "Srinagarind Hospital, Khon Kaen University"
        },
        {
          "city": "Songkhla",
          "country": "Thailand",
          "facility": "Songklanagarind Hospital"
        },
        {
          "city": "Ubon Ratchathani",
          "country": "Thailand",
          "facility": "Fort Sunpasithiprasong Hospital"
        },
        {
          "city": "Cherkasy",
          "country": "Ukraine",
          "facility": "Communal Non-Commercial Enterprise \"Cherkasy Regional Hospital of Cherkasy Regional Council\""
        },
        {
          "city": "Khmelnytskyi",
          "country": "Ukraine",
          "facility": "Communal Non-Commercial Enterprise \"Khmelnytsky Regional Hospital\" of Khmelnytsky Regional Council"
        },
        {
          "city": "Kyiv",
          "country": "Ukraine",
          "facility": "Clinic of Modern Rheumatology"
        },
        {
          "city": "Kyiv",
          "country": "Ukraine",
          "facility": "Kyiv City Clinical Hospital #3"
        },
        {
          "city": "Kyiv",
          "country": "Ukraine",
          "facility": "Kyiv Railway Clinical Hospital #2 of Branch \"Health Center\" of Joint-Stock Company \"Ukrainian Railway\""
        },
        {
          "city": "Kyiv",
          "country": "Ukraine",
          "facility": "State Ins Nat Scie Cen M.D.Strazhesko Ins of Cardio Clin"
        },
        {
          "city": "Kyiv",
          "country": "Ukraine",
          "facility": "Communal Non-Commercial Enterprise of Kyiv Regional Council Kyiv Clinical Regional Hospital, Consultation and Diagnostic Center"
        },
        {
          "city": "Lutsk",
          "country": "Ukraine",
          "facility": "Volyn Regional Clinical Hospital"
        },
        {
          "city": "Lviv",
          "country": "Ukraine",
          "facility": "Com Non-Com Entr of Lviv Reg Coun \"Lviv Reg Clin Hos, Rheu Dprt, Danylo Halytsky Lviv Nat Med Uni"
        },
        {
          "city": "Lviv",
          "country": "Ukraine",
          "facility": "Medical Center of Limited Liability Company \"Kalyna. Center of Modern Medicine"
        },
        {
          "city": "Lviv",
          "country": "Ukraine",
          "facility": "Medical Centre \"Academical Medical Group\" LLC"
        },
        {
          "city": "Uzhhorod",
          "country": "Ukraine",
          "facility": "Uzhhorod City Multidisciplinary Clinical Hospital"
        },
        {
          "city": "Vinnytsia",
          "country": "Ukraine",
          "facility": "Private Small-Scale Enterprise Medical Centre \"Pulse\", Therapeutical Department"
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      ],
      "outcomes": {
        "other": [],
        "primary": [
          "Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline"
        ],
        "secondary": [
          "Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline",
          "Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response",
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        "criteria": "Inclusion Criteria:\n\nInclusion criteria at screening:\n\n* Signed Informed Consent Form (ICF) prior to any study-mandated procedure.\n* Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism / American College of Rheumatology Criteria.\n* A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score ≥ 6 and clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not include \"leukopenia\".\n* British Isles Lupus Assessment Group-2004 (BILAG) Grade B in ≥ 2 organ systems or a BILAG Grade A in ≥ 1 organ system.\n* Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale.\n* Currently treated with one or more of the following SLE background medications:\n\n  * Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine).\n  * Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤1.44 g/day).\n  * Azathioprine (≤ 2 mg/kg/day).\n  * Methotrexate (≤ 25 mg/week).\n  * Oral Corticosteroids (OCS):\n\n    * if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.\n    * if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.\n  * Belimumab (≤10 mg/kg every 4 weeks intravenously \\[i.v.\\], or 200 mg/week subcutaneously \\[s.c.\\]).\n\nTreatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening. Treatment with OCS must have been started at least 30 days prior to Screening.\n\n• For women of childbearing potential (WoCBP):\n\n* Negative serum pregnancy test at Screening.\n* Agreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation.\n* Agreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation.\n\nInclusion criteria at randomization:\n\n* A clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).\n* BILAG Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system.\n* PGA score ≥ 1.0 on a 0 to 3 visual analog scale.\n* Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory):\n\n  * Anti-dsDNA antibodies elevated above normal,\n  * Antinuclear antibodies with a titer of at least 1:160,\n  * Anti-Smith antibody elevated above normal.\n* Currently treated with one or more of the following SLE background medications that must be stable for at least 30 days prior to Randomization (except OCS, which must be stable for at least 15 days prior to Randomization):\n\n  * Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine);\n  * Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44g/day);\n  * Azathioprine (≤ 2 mg/kg/day);\n  * Methotrexate (≤ 25 mg/week);\n  * OCS:\n\n    * if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.\n    * if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.\n  * Belimumab (≤ 10 mg/kg every 4 weeks i.v. or ≤ 200 mg/week s.c.).\n* WoCBP must have a negative urine pregnancy test at Randomization.\n\nMain Exclusion Criteria:\n\n* Pregnant, planning to be become pregnant up to Final Study Visit, or lactating women.\n* Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; or mononeuritis multiplex:\n\n  * That would make the subject unable to fully understand the ICF; OR\n  * Where, in the opinion of the investigator/delegate, protocol-specified standard of care is insufficient and the use of a more aggressive therapeutic approach, such as adding i.v. cyclophosphamide and/or high dose i.v. pulse corticosteroid (CS) therapy or other treatments not permitted in the protocol is indicated.\n* A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease.\n* History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders.\n* Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within 6 months prior to Screening.\n* Resting heart rate \\< 50 bpm as measured by the 12-lead ECG at Screening or at Randomization.\n* An elevated QT interval corrected according to Fridericia's formula (QTcF) interval of \\> 470 ms (females) / \\> 450 ms (males) at Screening or at Randomization.\n* History or presence of severe respiratory disease or pulmonary fibrosis, based on medical history, lung function, and chest X-ray (or CT scan as per local guidelines), performed at Screening or within 6 months prior to Screening.\n* History of clinically relevant bronchial asthma or chronic obstructive pulmonary disease that has required treatment with oral or parenteral CS for more than a total of 2 weeks within the last 6 months prior to Screening.\n* History or presence of malignancy (except for surgically excised and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma), lymphoproliferative disease, or history of total lymphoid irradiation within 10 years prior to Screening.\n* Presence of any of the following abnormalities detected during the ophthalmological evaluation and/or by optical coherence tomography (OCT) during screening:\n\n  * Macular edema of any cause: diabetic, cystoid, tractional.\n  * Foveal degeneration, macular hole, macular pseudohole, hereditary or degenerative maculopathies.\n  * Active uveitis, papilledema.\n  * Retinal neovascularization of any cause and in any location.\n* History of chronic liver or biliary disease (other than Gilbert's Syndrome) or subjects with alanine aminotransferase or aspartate aminotransferase \\> 3 × Upper Limit of Normal (ULN) or total bilirubin \\> 1.5 × ULN (unless in the context of known Gilbert's Syndrome).\n* Significant hematology abnormality at screening assessment:\n\n  * lymphocyte count \\< 500 /μL (0.5 × 10\\^9/L);\n  * hemoglobin \\< 7 g/dL;\n  * white blood cell count \\< 2000/μL (2.0 × 10\\^9/L); or\n  * platelets \\< 25000/μL (25 × 10\\^9/L).\n* Estimated glomerular filtration rate \\< 15 mL/min/1.73 m\\^2.\n* Treatment with the following medications within 15 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:\n\n  * β-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other anti-arrhythmic or heart-rate -lowering systemic therapy.\n  * QT-prolonging drugs with known risk of torsade de pointes irrespective of indication.\n* Treatment with the following medications within 30 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:\n\n  * Cyclophosphamide, cyclosporine, voclosporin, tacrolimus, sirolimus, etc.\n  * Pulse methylprednisolone.\n  * Vaccination with live vaccines (including live vaccines for COVID-19).\n* Intra-articular, intramuscular or i.v. CS within 6 weeks prior to Randomization.\n* Treatment with the following medications within 90 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:\n\n  * Leflunomide.\n  * i.v. immunoglobulins.\n* Treatment with any investigational agent within 90 days or 5 half-lives of the drug (whichever is longer) prior to Randomization.\n* Treatment with B cell-depleting biological agents (e.g., rituximab or ocrelizumab) or biological immunosuppressive agents (e.g., anti-tumor necrosis factor \\[TNF\\], anti-interleukin \\[IL\\]-1, anti-IL6 therapies), within 12 months prior to Randomization.\n* Treatment with anifrolumab within 6 months prior to Randomization.\n* Treatment with any of the following medications any time prior to Screening:\n\n  * Alemtuzumab,\n  * Sphingosine-1-phosphate receptor modulators (e.g., fingolimod),\n  * Subjects previously randomized to cenerimod or placebo in any trial involving cenerimod.",
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