MK-6194:n tehokkuus ja turvallisuus aikuisilla potilailla, joilla on systeeminen lupus erythematosus (MK-6194-006)
torstai 16. heinäkuuta 2026 päivittänyt: Merck Sharp & Dohme LLC
Vaihe 2a, monikeskus, satunnaistettu, kaksoissokkoutettu, lumekontrolloitu tutkimus MK-6194:n tehon ja turvallisuuden arvioimiseksi aikuisilla potilailla, joilla on systeeminen lupus erythematosus
Tämän tutkimuksen tarkoituksena on arvioida MK-6194:n tehoa ja turvallisuutta aikuisilla potilailla, joilla on systeeminen lupus erythematosus.
Ensisijainen hypoteesi on, että vähintään yksi MK-6194-haaroista on parempi kuin lumelääke ensisijaisessa päätetapahtumassa, joka on niiden osallistujien prosenttiosuus, joilla on systeeminen lupus erythematosus -vasteindeksi (SRI-4) -vaste viikolla 28.
Tutkimuksen yleiskatsaus
Tila
Lopetettu
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
149
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Mendoza, Argentiina, M5500CPH
- Instituto de Reumatología ( Site 0201)
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentiina, 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, Argentiina, S2000DVC
- Sanatorio Parque ( Site 0205)
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Santa Fe, Santa Fe Province, Argentiina, 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, Argentiina, T4000AXL
- Centro de Investigaciones Médicas Tucuman ( Site 0203)
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Mato Grosso
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Cuiabá, Mato Grosso, Brasilia, 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, Brasilia, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
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Porto Alegre, Rio Grande do Sul, Brasilia, 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, Brasilia, 09715-090
- Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
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São José do Rio Preto, São Paulo, Brasilia, 15090-000
- Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
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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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Barcelona, Espanja, 08035
- Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
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Seville, Espanja, 41010
- Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
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Valladolid, Espanja, 47012
- Hospital Universitario Rio Hortega ( Site 1606)
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La Coruna
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A Coruña, La Coruna, Espanja, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Espanja, 46010
- HOSPITAL CLINICO DE VALENCIA ( Site 1608)
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Iloilo City, Filippiinit, 5000
- Iloilo Doctors' Hospital ( Site 2301)
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Batangas
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Lipa City, Batangas, Filippiinit, 4217
- Mary Mediatrix Medical Center ( Site 2303)
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National Capital Region
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Quezon City, National Capital Region, Filippiinit, 1102
- ST. LUKE'S MEDICAL CENTER ( Site 2304)
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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, Italia, 50141
- AOU Careggi ( Site 1311)
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Naples, Italia, 80131
- Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
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Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
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Milano
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Rozzano, Milano, Italia, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 1310)
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Roma
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Rome, Roma, Italia, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
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Tuscany
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Siena, Tuscany, Italia, 53100
- Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
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Veneto
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Padova, Veneto, Italia, 35128
- Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
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Chiba, Japani, 260-8677
- Chiba University Hospital ( Site 2120)
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Chiba, Japani, 260-8712
- NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
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Okayama, Japani, 700-8558
- Okayama University Hospital ( Site 2106)
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Osaka, Japani, 543-8922
- Osaka Keisatsu Hospital ( Site 2117)
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Aichi-ken
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Nagoya, Aichi-ken, Japani, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
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Kanagawa
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Kawasaki, Kanagawa, Japani, 216-8511
- St. Marianna University Hospital ( Site 2121)
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Miyagi
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Sendai, Miyagi, Japani, 980-8574
- Tohoku University Hospital ( Site 2116)
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Okinawa
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Tomigusuku, Okinawa, Japani, 901-0224
- Yuuai Medical Center ( Site 2122)
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Shimane
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Izumo, Shimane, Japani, 693-0021
- Shimane University Hospital ( Site 2119)
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Tochigi
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Shimotsuga, Tochigi, Japani, 321-0293
- Dokkyo Medical University Hospital ( Site 2118)
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Tokyo
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Itabashiku, Tokyo, Japani, 173-8610
- Nihon University Itabashi Hospital ( Site 2105)
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Shinagawa, Tokyo, Japani, 142-0054
- Showa Medical University East Hospital ( Site 2123)
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Quebec
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Sherbrooke, Quebec, Kanada, J1L 0H8
- Diex Recherche Sherbrooke ( Site 0003)
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Anhui
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Bengbu, Anhui, Kiina, 233000
- The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
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Hefei, Anhui, Kiina, 230071
- Anhui Provincial Hospital ( Site 2043)
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 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, Kiina, 730000
- Gansu Provincial Hospital ( Site 2065)
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Guangdong
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Guangzhou, Guangdong, Kiina, 510000
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
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Guangzhou, Guangdong, Kiina, 510515
- Southern Medical University Nanfang Hospital ( Site 2037)
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Guizhou
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Guiyang, Guizhou, Kiina, 550004
- The Affiliated Hospital of Guizhou Medical University ( Site 2051)
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Hebei
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Shijiazhuang, Hebei, Kiina, 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, Kiina, 471003
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
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Hubei
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Wuhan, Hubei, Kiina, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
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Hunan
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Hengyang, Hunan, Kiina, 421001
- The First Affiliated Hospital of Nanhua University ( Site 2061)
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Inner Mongolia
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Baotou, Inner Mongolia, Kiina, 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, Kiina, 226001
- Affiliated Hospital of Nantong University ( Site 2027)
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Jiangxi
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Pingxiang, Jiangxi, Kiina, 337055
- Pingxiang People's Hospital ( Site 2005)
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Jilin
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Changchun, Jilin, Kiina, 130021
- Jilin Province People's Hospital ( Site 2033)
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Shaanxi
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Xi'an, Shaanxi, Kiina, 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, Kiina, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
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Shanxi
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Taiyuan, Shanxi, Kiina, 030032
- Shanxi Bethune Hospital ( Site 2029)
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Sichuan
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Chengdu, Sichuan, Kiina, 610500
- The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kiina, 300052
- Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
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Antioquia
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Medellín, Antioquia, Kolumbia, 50021
- Salud SURA Industriales ( Site 0508)
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Atlántico
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Barranquilla, Atlántico, Kolumbia, 080020
- Clinica de la Costa S.A.S. ( Site 0502)
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Barranquilla, Atlántico, Kolumbia, 080002
- Centro Integral de Reumatología del Caribe ( Site 0501)
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Cundinamarca
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Chía, Cundinamarca, Kolumbia, 250001
- Preventive Care ( Site 0507)
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Zipaquirá, Cundinamarca, Kolumbia, 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, Kolumbia, 760032
- Fundación Valle del Lili ( Site 0506)
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Cali, Valle del Cauca Department, Kolumbia, 760042
- Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malesia, 56000
- Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
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Lembah Pantai, Kuala Lumpur, Malesia, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
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Pahang
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Kuantan, Pahang, Malesia, 25100
- Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
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Perak
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Taiping, Perak, Malesia, 34000
- Hospital Taiping ( Site 2221)
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Chihuahua City, Meksiko, 31000
- ICARO Investigaciones en Medicina ( Site 0702)
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Distrito Federal, Meksiko, 06700
- Clinstile, S.A. de C.V. ( Site 0709)
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Guanajuato
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León, Guanajuato, Meksiko, 37000
- Morales Vargas Centro de Investigacion ( Site 0710)
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Jalisco
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Guadalajara, Jalisco, Meksiko, 44160
- Centro Integral en Reumatologia ( Site 0701)
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Guadalajara, Jalisco, Meksiko, 44638
- Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
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Guadalajara, Jalisco, Meksiko, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
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Guadalajara, Jalisco, Meksiko, 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, Meksiko, 03100
- RM Pharma Specialists ( Site 0711)
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Mexico City, Mexico City, Meksiko, 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, Meksiko, 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, Meksiko, 78250
- Centro Potosino de Investigación Médica ( Site 0703)
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Yucatán
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Mérida, Yucatán, Meksiko, 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, Puola, 60-218
- Medyczne Centrum Hetmańska ( Site 1406)
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Poznan, Greater Poland Voivodeship, Puola, 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, Puola, 85-065
- MICS Centrum Medyczne Bydgoszcz ( Site 1410)
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Puola, 30-363
- Centrum Medyczne Plejady ( Site 1407)
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Puola, 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, Puola, 00-874
- MICS Centrum Medyczne Warszawa ( Site 1411)
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Puola, 15-707
- Nova Reuma Społka Partnerska ( Site 1405)
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Silesian Voivodeship
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Bytom, Silesian Voivodeship, Puola, 41-902
- NZOZ BIF-MED ( Site 1409)
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Aquitaine
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Pessac, Aquitaine, Ranska, 33600
- CHU Bordeaux Haut-Leveque ( Site 1007)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, Ranska, 69007
- Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
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Haute-Garonne
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Toulouse, Haute-Garonne, Ranska, 31400
- CHU Rangueil ( Site 1008)
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Herault
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Montpellier, Herault, Ranska, 34295
- CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
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Nord
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Lille, Nord, Ranska, 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, Ranska, 42270
- Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
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Ankara, Turkki (Türkiye), 06230
- ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
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Ankara, Turkki (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
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Sakarya, Turkki (Türkiye)
- Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
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Istanbul
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Kadıköy, Istanbul, Turkki (Türkiye), 34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
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California
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Covina, California, Yhdysvallat, 91722
- Medvin Clinical Research - Metyas ( Site 0128)
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La Jolla, California, Yhdysvallat, 92037
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
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La Palma, California, Yhdysvallat, 90623
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
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Tujunga, California, Yhdysvallat, 91042
- Medvin Clinical Research - Tujunga ( Site 0127)
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Colorado
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Denver, Colorado, Yhdysvallat, 80230
- Denver Arthritis Clinic ( Site 0102)
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Florida
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Clearwater, Florida, Yhdysvallat, 33765
- Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
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Plantation, Florida, Yhdysvallat, 33324
- IRIS Research and Development, LLC-Research ( Site 0117)
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Tampa, Florida, Yhdysvallat, 33606
- Clinical Research of West Florida, Inc ( Site 0124)
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30310
- Morehouse School of Medicine ( Site 0146)
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Louisiana
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Lake Charles, Louisiana, Yhdysvallat, 70605
- Accurate Clinical Research, Inc ( Site 0135)
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Michigan
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Grand Blanc, Michigan, Yhdysvallat, 48439
- AA Medical Research Center ( Site 0136)
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North Carolina
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Charlotte, North Carolina, Yhdysvallat, 28210
- Javara - Tryon Medical Partners ( Site 0121)
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Charlotte, North Carolina, Yhdysvallat, 28211
- DJL Clinical Research, PLLC ( Site 0103)
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73104
- University of Oklahoma Health Science Center ( Site 0130)
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Tennessee
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Memphis, Tennessee, Yhdysvallat, 38119
- Shelby Research, LLC ( Site 0142)
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Texas
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Baytown, Texas, Yhdysvallat, 77521
- Accurate Clinical Management, LLC. ( Site 0134)
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DeSoto, Texas, Yhdysvallat, 75115
- Epic Medical Research ( Site 0113)
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Houston, Texas, Yhdysvallat, 77089
- Accurate Clinical Research, Inc. ( Site 0133)
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Mesquite, Texas, Yhdysvallat, 75150
- SouthWest Rheumatology Research, LLC ( Site 0115)
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Sisällyttämiskriteerit:
- Hänellä on diagnosoitu systeeminen lupus erythematosus (SLE) ≥6 kuukautta ennen seulontatutkimusta.
- Käyttää vähintään yhtä SLE:n taustahoitoa (1 immunosuppressantti tai dapsoni ja/tai 1 malarialääke ja/tai oraalinen kortikosteroidi).
- Sisältää + antinukleaarista vasta-ainetta (+ANA) (tiitteri ≥1:80) tai positiivista anti-kaksoisjuosteista deoksiribonukleiinihappoa (dsDNA) tai positiivista anti-Sm-vasta-ainetta tai positiivista anti-SSA/Ro-vasta-ainetta.
- Hänellä on vähintään yksi seuraavista SLE:n ilmenemismuodoista: Aktiivinen lupus-ihottuma, johon liittyy CLASI-A-eryteema ja asteikko/hypertrofia yhdistetty pistemäärä >2 tai >2 arat ja turvonneet nivelet ranteissa, kämpäleissä (MCP) tai proksimaalisissa interfalangeaaleissa ( PIP-kuvat).
- SLEDAI:n (Systemic Lupus Erythematosus Disease Activity Index) -kokonaispistemäärä on ≥6 ja kliinisen hybridi-SLEDAI-pistemäärä ≥4.
Poissulkemiskriteerit:
- Hänellä on samanaikainen kliinisesti merkittävä sairaus tai kliinisesti merkittäviä laboratorioarvojen poikkeavuuksia tai hänellä on ollut jokin sairaus tai lääketieteellinen tila, joka tutkijan mielestä saattaa sekoittaa tutkimuksen tuloksia tai aiheuttaa lisäriskin osallistujalle hänen osallistuessaan opiskella.
- Hänellä on oireinen sydämen vajaatoiminta (New York Heart Associationin luokka III tai IV) tai sydäninfarkti tai epästabiili angina pectoris 6 kuukauden sisällä ennen seulontatutkimusta.
- Hänellä on vakava krooninen keuhkosairaus, joka vaatii happihoitoa.
- Hänellä on elinsiirto, joka vaatii jatkuvaa immunosuppressiota.
- Hänellä on tunnettu systeeminen yliherkkyys IL-2:lle tai modifioidulle IL-2:lle, mukaan lukien MK-6194, tai sen inaktiivisille aineosille.
- Hänellä on tunnettu lymfoproliferatiivinen sairaus, mukaan lukien lymfooma, tai merkkejä ja oireita, jotka viittaavat mahdolliseen lymfoproliferatiiviseen sairauteen, kuten lymfadenopatia ja/tai splenomegalia.
- Hänellä on lääkkeiden aiheuttama ihon lupus erythematosus (CLE) ja/tai lääkkeiden aiheuttama SLE jatkuvan taudinaiheuttajahoidon aikana.
- Hänellä on aktiivinen tai epästabiili neuropsykiatrinen lupus, mukaan lukien, mutta ei rajoittuen, kouristukset, tajunnan heikkeneminen tai paheneminen, psykoosi, delirium tai sekavuus, aseptinen aivokalvontulehdus, kallon neuropatia, aivoverenkiertohäiriö, nouseva tai poikittaismyeliitti, korea, pikkuaivojen ataksia, mononeuritis multiplex tai demyelinoiva oireyhtymä.
- Hänellä on diagnosoitu antifosfolipidisyndrooma ja hänellä on ollut verisuonitukos, katastrofaalinen APS tai raskaussairaus 6 kuukauden sisällä ennen seulontatutkimusta.
- Hänellä on anamneesissa mikä tahansa pahanlaatuinen kasvain, paitsi onnistuneesti hoidettu ei-melanooma-ihosyöpä tai paikallinen kohdunkaulan karsinooma in situ.
- Hänellä on aktiivinen kliinisesti merkittävä infektio tai mikä tahansa infektio, joka vaatii sairaalahoitoa tai hoitoa infektiolääkkeillä.
- Hänellä on merkkejä aktiivisesta tuberkuloosista (TB), piilevasta tuberkuloosista tai puutteellisesti hoidetusta tuberkuloosista.
- On vahvistanut tai epäillyt COVID-19-tartuntaa.
- Hänelle on tehty suuri leikkaus 3 kuukauden sisällä ennen seulontatutkimusta tai hänellä on suunnitteilla suuri leikkaus tutkimuksen aikana.
- Käyttää enemmän kuin 1 immunosuppressanttia.
- ottaa enemmän kuin yhden suun kautta otettavan tulehduskipulääkkeen (pois lukien pieniannoksinen aspiriini [<350 mg/vrk]) tai ottaa päivittäin suun kautta otettavaa ei-steroidista tulehduskipulääkettä (NSAID) suositeltua enimmäisannostusta suuremmalla annoksella.
- Hänellä on tällä hetkellä jokin krooninen systeeminen (suun kautta tai IV) anti-infektiivinen hoito kroonisten infektioiden (kuten pneumokystis, sytomegalovirus, herpes zoster tai epätyypilliset mykobakteerit) hoitoon.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
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SC-injektio
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Kokeellinen: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
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SC-injektio
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Placebo Comparator: Placebo
Participants receive SC placebo q2w.
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SC-injektio
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Kokeellinen: 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-injektio
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Kokeellinen: 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-injektio
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Kokeellinen: 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-injektio
SC-injektio
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Kokeellinen: 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-injektio
SC-injektio
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Aikaikkuna: Week 28
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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)
Aikaikkuna: 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 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Aikaikkuna: 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
Aikaikkuna: Week 52
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline and Week 52
|
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
Aikaikkuna: 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
|
|
Change From Baseline in Swollen and Tender Joint Count at Week 52
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Up to approximately 28 weeks
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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
Aikaikkuna: Up to approximately 52 weeks
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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.
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Up to approximately 52 weeks
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Number of Participants Who Achieved Low Level of Disease Activity (LLDAS) at Week 28
Aikaikkuna: 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
Aikaikkuna: 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.
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Week 52
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Medical Director, Merck Sharp & Dohme LLC
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Keskiviikko 27. joulukuuta 2023
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 30. heinäkuuta 2025
Opintojen valmistuminen (Todellinen)
Keskiviikko 30. heinäkuuta 2025
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 29. marraskuuta 2023
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 29. marraskuuta 2023
Ensimmäinen Lähetetty (Todellinen)
Torstai 7. joulukuuta 2023
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 10. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 16. heinäkuuta 2026
Viimeksi vahvistettu
Keskiviikko 1. heinäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 6194-006
- MK-6194-006 (Muu tunniste: MSD)
- U1111-1291-8716 (Rekisterin tunniste: UTN)
- jRCT2041230137 (Rekisterin tunniste: jRCT)
- 2023-505520-61-00 (Rekisterin tunniste: EU CT)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .