Effekt og sikkerhed af MK-6194 hos voksne deltagere med systemisk lupus erythematosus (MK-6194-006)
16. juli 2026 opdateret af: Merck Sharp & Dohme LLC
En fase 2a, multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at evaluere effektiviteten og sikkerheden af MK-6194 hos voksne deltagere med systemisk lupus erythematosus
Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af MK-6194 hos voksne deltagere med systemisk lupus erythematosus.
Den primære hypotese er, at mindst 1 af MK-6194 armene er bedre end placebo i det primære endepunkt for procentdel af deltagere med systemisk lupus erythematosus responder index (SRI-4) respons i uge 28.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
149
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Mendoza, Argentina, M5500CPH
- Instituto de Reumatología ( Site 0201)
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentina, 7600
- Centro de Investigaciones Médicas Mar del Plata ( Site 0210)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DVC
- Sanatorio Parque ( Site 0205)
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Santa Fe, Santa Fe Province, Argentina, S3000BPJ
- Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
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Tucumán Province
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SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman ( Site 0203)
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Mato Grosso
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Cuiabá, Mato Grosso, Brasilien, 78020-500
- IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
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Porto Alegre, Rio Grande do Sul, Brasilien, 90480-000
- LMK Serviços Médicos S/S-Reumacenter ( Site 0303)
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São Paulo
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São Bernardo do Campo, São Paulo, Brasilien, 09715-090
- Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
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São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
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Quebec
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Sherbrooke, Quebec, Canada, J1L 0H8
- Diex Recherche Sherbrooke ( Site 0003)
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Araucania
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Temuco, Araucania, Chile, 4800827
- James Lind Centro de Investigacion del Cancer ( Site 0407)
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Coquimbo Region
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La Serena, Coquimbo Region, Chile, 1720430
- IC La Serena Research ( Site 0414)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7640881
- Clinica Dermacross ( Site 0416)
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Santiago, Region M. de Santiago, Chile, 8207257
- Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
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Santiago, Region M. de Santiago, Chile, 8320000
- CECIM ( Site 0405)
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Santiago, Region M. de Santiago, Chile, 8420383
- Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
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Antioquia
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Medellín, Antioquia, Colombia, 50021
- Salud SURA Industriales ( Site 0508)
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Atlántico
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Barranquilla, Atlántico, Colombia, 080020
- Clinica de la Costa S.A.S. ( Site 0502)
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Barranquilla, Atlántico, Colombia, 080002
- Centro Integral de Reumatología del Caribe ( Site 0501)
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Cundinamarca
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Chía, Cundinamarca, Colombia, 250001
- Preventive Care ( Site 0507)
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Zipaquirá, Cundinamarca, Colombia, 250252
- Healthy Medical Center S.A.S ( Site 0505)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 0506)
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Cali, Valle del Cauca Department, Colombia, 760042
- Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
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Iloilo City, Filippinerne, 5000
- Iloilo Doctors' Hospital ( Site 2301)
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Batangas
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Lipa City, Batangas, Filippinerne, 4217
- Mary Mediatrix Medical Center ( Site 2303)
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National Capital Region
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Quezon City, National Capital Region, Filippinerne, 1102
- ST. LUKE'S MEDICAL CENTER ( Site 2304)
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California
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Covina, California, Forenede Stater, 91722
- Medvin Clinical Research - Metyas ( Site 0128)
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La Jolla, California, Forenede Stater, 92037
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
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La Palma, California, Forenede Stater, 90623
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
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Tujunga, California, Forenede Stater, 91042
- Medvin Clinical Research - Tujunga ( Site 0127)
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Colorado
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Denver, Colorado, Forenede Stater, 80230
- Denver Arthritis Clinic ( Site 0102)
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Florida
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Clearwater, Florida, Forenede Stater, 33765
- Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
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Plantation, Florida, Forenede Stater, 33324
- IRIS Research and Development, LLC-Research ( Site 0117)
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Tampa, Florida, Forenede Stater, 33606
- Clinical Research of West Florida, Inc ( Site 0124)
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Georgia
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Atlanta, Georgia, Forenede Stater, 30310
- Morehouse School of Medicine ( Site 0146)
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Louisiana
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Lake Charles, Louisiana, Forenede Stater, 70605
- Accurate Clinical Research, Inc ( Site 0135)
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Michigan
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Grand Blanc, Michigan, Forenede Stater, 48439
- AA Medical Research Center ( Site 0136)
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28210
- Javara - Tryon Medical Partners ( Site 0121)
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Charlotte, North Carolina, Forenede Stater, 28211
- DJL Clinical Research, PLLC ( Site 0103)
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Science Center ( Site 0130)
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38119
- Shelby Research, LLC ( Site 0142)
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Texas
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Baytown, Texas, Forenede Stater, 77521
- Accurate Clinical Management, LLC. ( Site 0134)
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DeSoto, Texas, Forenede Stater, 75115
- Epic Medical Research ( Site 0113)
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Houston, Texas, Forenede Stater, 77089
- Accurate Clinical Research, Inc. ( Site 0133)
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Mesquite, Texas, Forenede Stater, 75150
- SouthWest Rheumatology Research, LLC ( Site 0115)
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Aquitaine
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Pessac, Aquitaine, Frankrig, 33600
- CHU Bordeaux Haut-Leveque ( Site 1007)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, Frankrig, 69007
- Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrig, 31400
- CHU Rangueil ( Site 1008)
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Herault
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Montpellier, Herault, Frankrig, 34295
- CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
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Nord
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Lille, Nord, Frankrig, 59037
- Hopital Claude Huriez - CHU de Lille ( Site 1005)
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Pays de la Loire Region
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Saint Priest En Jarez, Pays de la Loire Region, Frankrig, 42270
- Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
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Guatemala City, Guatemala, 01009
- Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)
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Guatemala City, Guatemala, 01010
- CELAN,S.A ( Site 0603)
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Guatemala City, Guatemala, 01010
- Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)
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Florence, Italien, 50141
- AOU Careggi ( Site 1311)
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Naples, Italien, 80131
- Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
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Roma, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
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Milano
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Rozzano, Milano, Italien, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 1310)
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Roma
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Rome, Roma, Italien, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
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Tuscany
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Siena, Tuscany, Italien, 53100
- Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
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Veneto
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Padova, Veneto, Italien, 35128
- Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
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Chiba, Japan, 260-8677
- Chiba University Hospital ( Site 2120)
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Chiba, Japan, 260-8712
- NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
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Okayama, Japan, 700-8558
- Okayama University Hospital ( Site 2106)
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Osaka, Japan, 543-8922
- Osaka Keisatsu Hospital ( Site 2117)
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
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Kanagawa
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Kawasaki, Kanagawa, Japan, 216-8511
- St. Marianna University Hospital ( Site 2121)
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
- Tohoku University Hospital ( Site 2116)
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Okinawa
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Tomigusuku, Okinawa, Japan, 901-0224
- Yuuai Medical Center ( Site 2122)
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Shimane
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Izumo, Shimane, Japan, 693-0021
- Shimane University Hospital ( Site 2119)
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Tochigi
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Shimotsuga, Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital ( Site 2118)
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Tokyo
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Itabashiku, Tokyo, Japan, 173-8610
- Nihon University Itabashi Hospital ( Site 2105)
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Shinagawa, Tokyo, Japan, 142-0054
- Showa Medical University East Hospital ( Site 2123)
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Anhui
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Bengbu, Anhui, Kina, 233000
- The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
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Hefei, Anhui, Kina, 230071
- Anhui Provincial Hospital ( Site 2043)
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100730
- Beijing Peking Union Medical College Hospital-Department of Rheumatology and Immunology ( Site 2001)
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Gansu
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Lanzhou, Gansu, Kina, 730000
- Gansu Provincial Hospital ( Site 2065)
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Guangdong
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Guangzhou, Guangdong, Kina, 510000
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
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Guangzhou, Guangdong, Kina, 510515
- Southern Medical University Nanfang Hospital ( Site 2037)
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Guizhou
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Guiyang, Guizhou, Kina, 550004
- The Affiliated Hospital of Guizhou Medical University ( Site 2051)
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Hebei
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Shijiazhuang, Hebei, Kina, 050000
- The Second Afilliated Hospital of Hebei Medical University-Immunology And Rheumatology ( Site 2064)
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Henan
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Luoyang, Henan, Kina, 471003
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
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Hubei
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Wuhan, Hubei, Kina, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
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Hunan
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Hengyang, Hunan, Kina, 421001
- The First Affiliated Hospital of Nanhua University ( Site 2061)
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Inner Mongolia
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Baotou, Inner Mongolia, Kina, 014010
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Te ( Site 2006)
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Jiangsu
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Nantong, Jiangsu, Kina, 226001
- Affiliated Hospital of Nantong University ( Site 2027)
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Jiangxi
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Pingxiang, Jiangxi, Kina, 337055
- Pingxiang People's Hospital ( Site 2005)
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Jilin
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Changchun, Jilin, Kina, 130021
- Jilin Province People's Hospital ( Site 2033)
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Shaanxi
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Xi'an, Shaanxi, Kina, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2056)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
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Shanxi
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Taiyuan, Shanxi, Kina, 030032
- Shanxi Bethune Hospital ( Site 2029)
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Sichuan
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Chengdu, Sichuan, Kina, 610500
- The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300052
- Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malaysia, 56000
- Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
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Lembah Pantai, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
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Pahang
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Kuantan, Pahang, Malaysia, 25100
- Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
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Perak
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Taiping, Perak, Malaysia, 34000
- Hospital Taiping ( Site 2221)
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Chihuahua City, Mexico, 31000
- ICARO Investigaciones en Medicina ( Site 0702)
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Distrito Federal, Mexico, 06700
- Clinstile, S.A. de C.V. ( Site 0709)
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Guanajuato
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León, Guanajuato, Mexico, 37000
- Morales Vargas Centro de Investigacion ( Site 0710)
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Jalisco
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Guadalajara, Jalisco, Mexico, 44160
- Centro Integral en Reumatologia ( Site 0701)
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Guadalajara, Jalisco, Mexico, 44638
- Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
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Guadalajara, Jalisco, Mexico, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
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Guadalajara, Jalisco, Mexico, 44690
- Centro de Estudios de Investigacion Basica y Clinica ( Site 0708)
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Mexico City
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Mexico City, Mexico City, Mexico, 03100
- RM Pharma Specialists ( Site 0711)
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Mexico City, Mexico City, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)
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San Luis Potosí
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San Luis Potosí City, San Luis Potosí, Mexico, 78250
- Centro Potosino de Investigación Médica ( Site 0703)
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Yucatán
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Mérida, Yucatán, Mexico, 97130
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 60-218
- Medyczne Centrum Hetmańska ( Site 1406)
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Poznan, Greater Poland Voivodeship, Polen, 61-397
- Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-065
- MICS Centrum Medyczne Bydgoszcz ( Site 1410)
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 30-363
- Centrum Medyczne Plejady ( Site 1407)
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-607
- Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 00-874
- MICS Centrum Medyczne Warszawa ( Site 1411)
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polen, 15-707
- Nova Reuma Społka Partnerska ( Site 1405)
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Silesian Voivodeship
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Bytom, Silesian Voivodeship, Polen, 41-902
- NZOZ BIF-MED ( Site 1409)
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
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Seville, Spanien, 41010
- Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
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Valladolid, Spanien, 47012
- Hospital Universitario Rio Hortega ( Site 1606)
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La Coruna
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A Coruña, La Coruna, Spanien, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Spanien, 46010
- HOSPITAL CLINICO DE VALENCIA ( Site 1608)
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Ankara, Tyrkiet (Türkiye), 06230
- ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
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Sakarya, Tyrkiet (Türkiye)
- Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
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Istanbul
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Kadıköy, Istanbul, Tyrkiet (Türkiye), 34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Har en diagnose af systemisk lupus erythematosus (SLE) ≥6 måneder før screening.
- Tager mindst 1 baggrundsbehandling (1 immunsuppressiv eller dapson og/eller 1 antimalariamiddel og/eller orale kortikosteroider) mod SLE.
- Har + antinukleært antistof (+ANA) (titer ≥1:80) eller positivt anti-dobbeltstrenget deoxyribonukleinsyre (dsDNA) antistof eller positivt anti-Sm antistof eller positivt anti-SSA/Ro antistof.
- Har tilstedeværelsen af mindst én af følgende manifestationer af SLE: Aktivt lupus udslæt med CLASI-A erytem og skala/hypertrofi kombineret score >2 eller >2 ømme og hævede led i håndled, metacarpophalangeals (MCP'er) eller proksimale interphalangeals ( PIP'er).
- Har en hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) totalscore på ≥6 og klinisk hybrid SLEDAI-score på ≥4.
Ekskluderingskriterier:
- Har en samtidig klinisk signifikant sygdom eller klinisk relevante laboratorieabnormiteter eller en historie med enhver sygdom eller medicinsk tilstand, der efter investigatorens mening kan forvirre resultaterne af undersøgelsen eller udgøre en yderligere risiko for deltageren ved deres deltagelse i undersøgelse.
- Har symptomatisk hjertesvigt (New York Heart Association klasse III eller IV) eller myokardieinfarkt eller ustabil angina pectoris inden for 6 måneder før screening.
- Har en alvorlig kronisk lungesygdom, der kræver iltbehandling.
- Har et transplanteret organ, som kræver fortsat immunsuppression.
- Har en kendt systemisk overfølsomhed over for IL-2 eller modificeret IL-2 inklusive MK-6194 eller dets inaktive ingredienser.
- Har en kendt historie med lymfoproliferativ sygdom, herunder lymfom, eller tegn og symptomer, der tyder på mulig lymfoproliferativ sygdom, såsom lymfadenopati og/eller splenomegali.
- Har lægemiddelinduceret kutan lupus erythematosus (CLE) og/eller lægemiddelinduceret SLE i forbindelse med fortsat behandling med et forårsagende middel.
- Har aktiv eller ustabil neuropsykiatrisk lupus, herunder men ikke begrænset til følgende: krampeanfald, nyt eller forværret nedsat bevidsthedsniveau, psykose, delirium eller forvirret tilstand, aseptisk meningitis, kraniel neuropati, cerebrovaskulær ulykke, ascendens eller tværgående myelitis, chorea, cerebellar ataksi, mononeuritis multiplex eller demyeliniserende syndromer.
- Har en diagnose af antifosfolipidsyndrom med en historie med vaskulær trombose, katastrofal APS eller graviditetssygelighed inden for 6 måneder før screening.
- Har en historie med en hvilken som helst malignitet, bortset fra vellykket behandlet ikke-melanom hudkræft eller lokaliseret carcinom in situ af livmoderhalsen.
- Har en aktiv klinisk signifikant infektion eller enhver infektion, der kræver hospitalsindlæggelse eller behandling med anti-infektionsmidler.
- Har tegn på aktiv tuberkulose (TB), latent TB eller utilstrækkeligt behandlet TB.
- Har bekræftet eller mistænkt COVID-19-infektion.
- Har haft en større operation inden for 3 måneder før screening eller har planlagt en større operation i løbet af undersøgelsen.
- Tager mere end 1 immunsuppressiv medicin.
- Tager mere end 1 oralt NSAID (undtagen lavdosis aspirin [<350 mg/dag]) eller tager dagligt oralt ikke-steroidt antiinflammatorisk lægemiddel (NSAID) i en højere dosis end den maksimalt anbefalede dosis.
- Er i øjeblikket på en hvilken som helst kronisk systemisk (oral eller IV) anti-infektionsbehandling for kronisk infektion (såsom pneumocystis, cytomegalovirus, herpes zoster eller atypiske mykobakterier).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
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SC indsprøjtning
|
|
Eksperimentel: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
|
SC indsprøjtning
|
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Placebo komparator: Placebo
Participants receive SC placebo q2w.
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SC indsprøjtning
|
|
Eksperimentel: MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continue to receive SC MK-6194 3 mg q2w in the extension period.
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SC indsprøjtning
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Eksperimentel: MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continue to receive SC MK-6194 3 mg q4w in the extension period.
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SC indsprøjtning
|
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Eksperimentel: Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
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SC indsprøjtning
SC indsprøjtning
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Eksperimentel: Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
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SC indsprøjtning
SC indsprøjtning
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Tidsramme: Week 28
|
The SRI was a composite index used to assess clinical improvement in participants with SLE.
The SRI-4 response evaluated global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the participant's overall condition.
SRI-4 response was binary and either achieved or not achieved by the participant, thus there was no associated score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
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Week 28
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Number of Participants Who Experienced an Adverse Event (AE)
Tidsramme: Up to approximately 16 months
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
AEs were reported based on study treatment received by the participant at time of event.
The number of participants who experienced one or more AEs was reported.
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Up to approximately 16 months
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Number of Participants Who Discontinued Study Treatment Due to an AE
Tidsramme: Up to approximately 16 months
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An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
AEs were reported based on study treatment received by the participant at time of event.
The number of participants who discontinued study treatment due to an AE was reported.
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Up to approximately 16 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Tidsramme: Week 28
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The BICLA response was a composite global measure of SLE disease activity.
It distinguished between partial and complete improvement in all body systems.
BICLA response was binary and either achieved or not achieved by the participant, thus there was no associated score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
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Week 28
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Number of Participants Achieving SRI-4 Response at Week 52
Tidsramme: Week 52
|
The SRI was a composite index used to assess clinical improvement in participants with SLE.
The SRI-4 response evaluated global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the participant's overall condition.
SRI-4 response was binary and either achieved or not achieved by the participant, thus there was no associated score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
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Week 52
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Number of Participants Achieving BICLA Response at Week 52
Tidsramme: Week 52
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The BICLA response was a composite global measure of SLE disease activity.
It distinguished between partial and complete improvement in all body systems.
BICLA response was binary and either achieved or not achieved by the participant, thus there was no associated score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
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Week 52
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Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28
Tidsramme: Week 28
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The CLASI-A score was used to evaluate lupus skin manifestations, with higher scores indicating increased disease severity and lower scores indicating less disease severity.
CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represented disease severity of mild, moderate, and severe, respectively.
CLASI-50 was 50% improvement from baseline in the CLASI-A score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
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Week 28
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Number of Participants With a CLASI-50 Response at Week 52
Tidsramme: Week 52
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The CLASI-A score was used to evaluate lupus skin manifestations, with higher scores indicating increased disease severity and lower scores indicating less disease severity.
CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represented disease severity of mild, moderate, and severe, respectively.
CLASI-50 was 50% improvement from baseline in the CLASI-A score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
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Week 52
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Change From Baseline in Swollen Joint Count at Week 28
Tidsramme: Baseline and Week 28
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The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling.
The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations was reported.
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Baseline and Week 28
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Change From Baseline in Swollen Joint Count at Week 52
Tidsramme: Baseline and Week 52
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The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling.
The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations was reported.
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Baseline and Week 52
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Change From Baseline in Tender Joint Count at Week 28
Tidsramme: Baseline and Week 28
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The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of tenderness.
The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations was reported.
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Baseline and Week 28
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Change From Baseline in Tender Joint Count at Week 52
Tidsramme: Baseline and Week 52
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The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of tenderness.
The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations was reported.
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Baseline and Week 52
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Change From Baseline in Swollen and Tender Joint Count at Week 28
Tidsramme: Baseline and Week 28
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The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling and presence or absence of tenderness.
The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations was reported.
|
Baseline and Week 28
|
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Change From Baseline in Swollen and Tender Joint Count at Week 52
Tidsramme: Baseline and Week 52
|
The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling and presence or absence of tenderness.
The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations was reported.
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Baseline and Week 52
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Change From Baseline in Oral Corticosteroid Dose at Week 28
Tidsramme: Baseline and Week 28
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Participants were assessed for corticosteroid dose change.
Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose.
The oral corticosteroid dose at Week 28 was determined by the visit window of Week 28 (±7 days).
Missing Week 28 dose was imputed with 0 if the participant completed Week 28 efficacy assessments.
Oral corticosteroid doses as the weighted average of all doses taken at Week 28, weighted by the number of days each oral corticosteroid dose was administered was reported.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations were reported.
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Baseline and Week 28
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Change From Baseline in Oral Corticosteroid Dose at Week 52
Tidsramme: Baseline and Week 52
|
Participants were assessed for corticosteroid dose change.
Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose.
The oral corticosteroid dose at Week 52 was determined by the visit window of Week 52 (±7 days).
Missing Week 52 dose was imputed with 0 if the participant completed Week 52 efficacy assessments.
Oral corticosteroid doses as the weighted average of all doses taken at Week 52, weighted by the number of days each oral corticosteroid dose was administered was reported.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations were reported.
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Baseline and Week 52
|
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Cumulative Oral Corticosteroid Use Between Week 0 and Week 28
Tidsramme: Up to approximately 28 weeks
|
Participants were assessed for cumulative oral corticosteroid dose.
Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose.
The cumulative oral corticosteroid dose at Week 28, calculated from Week 0 (Day 1) to Week 28 was reported.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations were reported.
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Up to approximately 28 weeks
|
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Cumulative Oral Corticosteroid Use Between Week 0 and Week 52
Tidsramme: Up to approximately 52 weeks
|
Participants were assessed for cumulative oral corticosteroid dose.
Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose.
The cumulative oral corticosteroid dose at Week 52, calculated from Week 0 (Day 1) to Week 52 was reported.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations were reported.
|
Up to approximately 52 weeks
|
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Number of Participants Who Achieved Low Level of Disease Activity (LLDAS) at Week 28
Tidsramme: Week 28
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LLDAS was a low disease activity state associated with significant protection against flares and organ damage accrual.
It included both the measurement of disease activity and maintenance of immunosuppressive medications.
LLDAS response was defined as hybrid SLEDAI ≤4 (with no activity in major organ systems), no new features of SLE activity compared with previous assessment, physician's global assessment (PGA) ≤1.0, current prednisone (or equivalent) dose ≤7.5 mg daily, and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs.
LLDAS response was binary and was either achieved or not achieved by the participant, thus there was no associated score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
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Week 28
|
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Number of Participants Who Achieved LLDAS at Week 52
Tidsramme: Week 52
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LLDAS was a low disease activity state associated with significant protection against flares and organ damage accrual.
It included both the measurement of disease activity and maintenance of immunosuppressive medications.
LLDAS response was defined as hybrid SLEDAI ≤4 (with no activity in major organ systems), no new features of SLE activity compared with previous assessment, physician's global assessment (PGA) ≤1.0, current prednisone (or equivalent) dose ≤7.5 mg daily, and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs.
LLDAS response was binary and was either achieved or not achieved by the participant, thus there was no associated score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
|
Week 52
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. december 2023
Primær færdiggørelse (Faktiske)
30. juli 2025
Studieafslutning (Faktiske)
30. juli 2025
Datoer for studieregistrering
Først indsendt
29. november 2023
Først indsendt, der opfyldte QC-kriterier
29. november 2023
Først opslået (Faktiske)
7. december 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6194-006
- MK-6194-006 (Anden identifikator: MSD)
- U1111-1291-8716 (Registry Identifier: UTN)
- jRCT2041230137 (Registry Identifier: jRCT)
- 2023-505520-61-00 (Registry Identifier: EU CT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .