Efficacia e sicurezza di MK-6194 nei partecipanti adulti con lupus eritematoso sistemico (MK-6194-006)
16 luglio 2026 aggiornato da: Merck Sharp & Dohme LLC
Uno studio di fase 2a, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di MK-6194 in partecipanti adulti con lupus eritematoso sistemico
Lo scopo di questo studio è valutare l'efficacia e la sicurezza di MK-6194 nei partecipanti adulti con lupus eritematoso sistemico.
L'ipotesi primaria è che almeno 1 dei bracci MK-6194 sia superiore al placebo nell'endpoint primario della percentuale di partecipanti con risposta dell'indice di risposta al lupus eritematoso sistemico (SRI-4) alla settimana 28.
Panoramica dello studio
Stato
Stato
Terminato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
149
Fase
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Toll Free Number
- Numero di telefono: 1-888-577-8839
- Email: Trialsites@msd.com
Luoghi di studio
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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, Brasile, 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, Brasile, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
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Porto Alegre, Rio Grande do Sul, Brasile, 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, Brasile, 09715-090
- Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
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São José do Rio Preto, São Paulo, Brasile, 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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Anhui
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Bengbu, Anhui, Cina, 233000
- The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
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Hefei, Anhui, Cina, 230071
- Anhui Provincial Hospital ( Site 2043)
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 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, Cina, 730000
- Gansu Provincial Hospital ( Site 2065)
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Guangdong
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Guangzhou, Guangdong, Cina, 510000
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
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Guangzhou, Guangdong, Cina, 510515
- Southern Medical University Nanfang Hospital ( Site 2037)
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Guizhou
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Guiyang, Guizhou, Cina, 550004
- The Affiliated Hospital of Guizhou Medical University ( Site 2051)
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Hebei
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Shijiazhuang, Hebei, Cina, 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, Cina, 471003
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
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Hubei
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Wuhan, Hubei, Cina, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
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Hunan
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Hengyang, Hunan, Cina, 421001
- The First Affiliated Hospital of Nanhua University ( Site 2061)
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Inner Mongolia
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Baotou, Inner Mongolia, Cina, 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, Cina, 226001
- Affiliated Hospital of Nantong University ( Site 2027)
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Jiangxi
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Pingxiang, Jiangxi, Cina, 337055
- Pingxiang People's Hospital ( Site 2005)
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Jilin
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Changchun, Jilin, Cina, 130021
- Jilin Province People's Hospital ( Site 2033)
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Shaanxi
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Xi'an, Shaanxi, Cina, 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, Cina, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
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Shanxi
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Taiyuan, Shanxi, Cina, 030032
- Shanxi Bethune Hospital ( Site 2029)
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Sichuan
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Chengdu, Sichuan, Cina, 610500
- The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Cina, 300052
- Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
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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, Filippine, 5000
- Iloilo Doctors' Hospital ( Site 2301)
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Batangas
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Lipa City, Batangas, Filippine, 4217
- Mary Mediatrix Medical Center ( Site 2303)
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National Capital Region
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Quezon City, National Capital Region, Filippine, 1102
- ST. LUKE'S MEDICAL CENTER ( Site 2304)
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Aquitaine
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Pessac, Aquitaine, Francia, 33600
- CHU Bordeaux Haut-Leveque ( Site 1007)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, Francia, 69007
- Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
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Haute-Garonne
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Toulouse, Haute-Garonne, Francia, 31400
- CHU Rangueil ( Site 1008)
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Herault
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Montpellier, Herault, Francia, 34295
- CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
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Nord
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Lille, Nord, Francia, 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, Francia, 42270
- Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
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Chiba, Giappone, 260-8677
- Chiba University Hospital ( Site 2120)
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Chiba, Giappone, 260-8712
- NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
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Okayama, Giappone, 700-8558
- Okayama University Hospital ( Site 2106)
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Osaka, Giappone, 543-8922
- Osaka Keisatsu Hospital ( Site 2117)
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Aichi-ken
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Nagoya, Aichi-ken, Giappone, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
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Kanagawa
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Kawasaki, Kanagawa, Giappone, 216-8511
- St. Marianna University Hospital ( Site 2121)
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Miyagi
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Sendai, Miyagi, Giappone, 980-8574
- Tohoku University Hospital ( Site 2116)
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Okinawa
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Tomigusuku, Okinawa, Giappone, 901-0224
- Yuuai Medical Center ( Site 2122)
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Shimane
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Izumo, Shimane, Giappone, 693-0021
- Shimane University Hospital ( Site 2119)
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Tochigi
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Shimotsuga, Tochigi, Giappone, 321-0293
- Dokkyo Medical University Hospital ( Site 2118)
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Tokyo
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Itabashiku, Tokyo, Giappone, 173-8610
- Nihon University Itabashi Hospital ( Site 2105)
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Shinagawa, Tokyo, Giappone, 142-0054
- Showa Medical University East Hospital ( Site 2123)
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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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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, Messico, 31000
- ICARO Investigaciones en Medicina ( Site 0702)
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Distrito Federal, Messico, 06700
- Clinstile, S.A. de C.V. ( Site 0709)
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Guanajuato
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León, Guanajuato, Messico, 37000
- Morales Vargas Centro de Investigacion ( Site 0710)
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Jalisco
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Guadalajara, Jalisco, Messico, 44160
- Centro Integral en Reumatologia ( Site 0701)
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Guadalajara, Jalisco, Messico, 44638
- Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
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Guadalajara, Jalisco, Messico, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
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Guadalajara, Jalisco, Messico, 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, Messico, 03100
- RM Pharma Specialists ( Site 0711)
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Mexico City, Mexico City, Messico, 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, Messico, 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, Messico, 78250
- Centro Potosino de Investigación Médica ( Site 0703)
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Yucatán
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Mérida, Yucatán, Messico, 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, Polonia, 60-218
- Medyczne Centrum Hetmańska ( Site 1406)
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Poznan, Greater Poland Voivodeship, Polonia, 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, Polonia, 85-065
- MICS Centrum Medyczne Bydgoszcz ( Site 1410)
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-363
- Centrum Medyczne Plejady ( Site 1407)
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polonia, 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, Polonia, 00-874
- MICS Centrum Medyczne Warszawa ( Site 1411)
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polonia, 15-707
- Nova Reuma Społka Partnerska ( Site 1405)
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Silesian Voivodeship
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Bytom, Silesian Voivodeship, Polonia, 41-902
- NZOZ BIF-MED ( Site 1409)
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Barcelona, Spagna, 08035
- Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
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Seville, Spagna, 41010
- Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
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Valladolid, Spagna, 47012
- Hospital Universitario Rio Hortega ( Site 1606)
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La Coruna
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A Coruña, La Coruna, Spagna, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Spagna, 46010
- HOSPITAL CLINICO DE VALENCIA ( Site 1608)
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California
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Covina, California, Stati Uniti, 91722
- Medvin Clinical Research - Metyas ( Site 0128)
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La Jolla, California, Stati Uniti, 92037
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
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La Palma, California, Stati Uniti, 90623
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
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Tujunga, California, Stati Uniti, 91042
- Medvin Clinical Research - Tujunga ( Site 0127)
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Colorado
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Denver, Colorado, Stati Uniti, 80230
- Denver Arthritis Clinic ( Site 0102)
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Florida
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Clearwater, Florida, Stati Uniti, 33765
- Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
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Plantation, Florida, Stati Uniti, 33324
- IRIS Research and Development, LLC-Research ( Site 0117)
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Tampa, Florida, Stati Uniti, 33606
- Clinical Research of West Florida, Inc ( Site 0124)
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Georgia
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Atlanta, Georgia, Stati Uniti, 30310
- Morehouse School of Medicine ( Site 0146)
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Louisiana
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Lake Charles, Louisiana, Stati Uniti, 70605
- Accurate Clinical Research, Inc ( Site 0135)
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Michigan
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Grand Blanc, Michigan, Stati Uniti, 48439
- AA Medical Research Center ( Site 0136)
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28210
- Javara - Tryon Medical Partners ( Site 0121)
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Charlotte, North Carolina, Stati Uniti, 28211
- DJL Clinical Research, PLLC ( Site 0103)
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- University of Oklahoma Health Science Center ( Site 0130)
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38119
- Shelby Research, LLC ( Site 0142)
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Texas
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Baytown, Texas, Stati Uniti, 77521
- Accurate Clinical Management, LLC. ( Site 0134)
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DeSoto, Texas, Stati Uniti, 75115
- Epic Medical Research ( Site 0113)
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Houston, Texas, Stati Uniti, 77089
- Accurate Clinical Research, Inc. ( Site 0133)
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Mesquite, Texas, Stati Uniti, 75150
- SouthWest Rheumatology Research, LLC ( Site 0115)
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Ankara, Turchia (Türkiye), 06230
- ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
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Ankara, Turchia (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
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Sakarya, Turchia (Türkiye)
- Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
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Istanbul
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Kadıköy, Istanbul, Turchia (Türkiye), 34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- Ha una diagnosi di lupus eritematoso sistemico (LES) ≥ 6 mesi prima dello screening.
- Sta assumendo almeno 1 terapia di base (1 immunosoppressore o dapsone e/o 1 antimalarico e/o corticosteroidi orali) per il LES.
- Contiene + anticorpo antinucleare (+ANA) (titolo ≥ 1:80) o anticorpo anti-acido desossiribonucleico a doppio filamento (dsDNA) positivo o anticorpo anti-Sm positivo o anticorpo anti-SSA/Ro positivo.
- Presenza di almeno una delle seguenti manifestazioni di LES: rash lupus attivo con eritema CLASI-A e punteggio combinato squame/ipertrofia >2, o >2 articolazioni dolenti e tumefatte dei polsi, metacarpofalangee (MCP) o interfalangee prossimali ( PIP).
- Ha un punteggio totale SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) ibrido pari a ≥6 e un punteggio SLEDAI ibrido clinico pari a ≥4.
Criteri di esclusione:
- Ha una malattia clinicamente significativa concomitante o anomalie di laboratorio clinicamente rilevanti, o una storia di qualsiasi malattia o condizione medica che, a giudizio dello sperimentatore, potrebbe confondere i risultati dello studio o comportare un rischio aggiuntivo per il partecipante a causa della sua partecipazione allo studio studio.
- Presenta insufficienza cardiaca sintomatica (classe III o IV della New York Heart Association) o infarto del miocardio o angina pectoris instabile nei 6 mesi precedenti lo screening.
- Ha una grave malattia polmonare cronica che richiede ossigenoterapia.
- Ha un organo trapiantato che richiede un'immunosoppressione continua.
- Presenta una nota ipersensibilità sistemica all'IL-2, o all'IL-2 modificata incluso MK-6194, o ai suoi ingredienti inattivi.
- Ha una storia nota di malattia linfoproliferativa, incluso linfoma, o segni e sintomi suggestivi di una possibile malattia linfoproliferativa, come linfoadenopatia e/o splenomegalia.
- Presenta lupus eritematoso cutaneo (CLE) indotto da farmaci e/o LES indotto da farmaci nel contesto di un trattamento continuato con un agente causale.
- Ha lupus neuropsichiatrico attivo o instabile incluso ma non limitato a quanto segue: convulsioni, nuovo o peggioramento del livello di coscienza, psicosi, delirio o stato confusionale, meningite asettica, neuropatia cranica, accidente cerebrovascolare, mielite ascendente o trasversa, corea, atassia cerebellare, mononeurite multipla o sindromi demielinizzanti.
- - Ha una diagnosi di sindrome antifosfolipidica con storia di trombosi vascolare, APS catastrofica o morbilità in gravidanza nei 6 mesi precedenti lo screening.
- Ha una storia di qualsiasi tumore maligno, ad eccezione del cancro della pelle non melanoma trattato con successo o del carcinoma localizzato in situ della cervice.
- Presenta un'infezione attiva clinicamente significativa o qualsiasi infezione che richieda il ricovero ospedaliero o il trattamento con antinfettivi.
- Presenta evidenza di tubercolosi attiva (TBC), tubercolosi latente o tubercolosi trattata in modo inadeguato.
- Ha confermato o sospettato un'infezione da COVID-19.
- Ha subito un intervento chirurgico importante nei 3 mesi precedenti lo screening o ha pianificato un intervento chirurgico importante durante lo studio.
- Sta assumendo più di 1 immunosoppressore.
- Sta assumendo più di 1 FANS orale (esclusa l'aspirina a basso dosaggio [<350 mg/giorno]) o sta assumendo quotidianamente un farmaco antinfiammatorio non steroideo orale (FANS) a una dose superiore alla dose massima raccomandata.
- È attualmente in terapia antinfettiva sistemica cronica (orale o endovenosa) per infezioni croniche (come pneumocisti, citomegalovirus, herpes zoster o micobatteri atipici).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Numero di armi
7
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
|
Iniezione SC
|
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Sperimentale: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
|
Iniezione SC
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Comparatore placebo: Placebo
Participants receive SC placebo q2w.
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Iniezione SC
|
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Sperimentale: 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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Iniezione SC
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Sperimentale: 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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Iniezione SC
|
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Sperimentale: 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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Iniezione SC
Iniezione SC
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Sperimentale: 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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Iniezione SC
Iniezione SC
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Lasso di tempo: 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.
|
Week 28
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Number of Participants Who Experienced an Adverse Event (AE)
Lasso di tempo: 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
|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
Lasso di tempo: 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 discontinued study treatment due to an AE was reported.
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Up to approximately 16 months
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Lasso di tempo: Week 28
|
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.
|
Week 28
|
|
Number of Participants Achieving SRI-4 Response at Week 52
Lasso di tempo: 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.
|
Week 52
|
|
Number of Participants Achieving BICLA Response at Week 52
Lasso di tempo: Week 52
|
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.
|
Week 52
|
|
Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28
Lasso di tempo: Week 28
|
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.
|
Week 28
|
|
Number of Participants With a CLASI-50 Response at Week 52
Lasso di tempo: Week 52
|
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.
|
Week 52
|
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Change From Baseline in Swollen Joint Count at Week 28
Lasso di tempo: Baseline and Week 28
|
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.
|
Baseline and Week 28
|
|
Change From Baseline in Swollen Joint Count at Week 52
Lasso di tempo: 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.
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 52
|
|
Change From Baseline in Tender Joint Count at Week 28
Lasso di tempo: Baseline and Week 28
|
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.
|
Baseline and Week 28
|
|
Change From Baseline in Tender Joint Count at Week 52
Lasso di tempo: 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.
|
Baseline and Week 52
|
|
Change From Baseline in Swollen and Tender Joint Count at Week 28
Lasso di tempo: Baseline and Week 28
|
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
Lasso di tempo: 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.
|
Baseline and Week 52
|
|
Change From Baseline in Oral Corticosteroid Dose at Week 28
Lasso di tempo: Baseline and Week 28
|
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.
|
Baseline and Week 28
|
|
Change From Baseline in Oral Corticosteroid Dose at Week 52
Lasso di tempo: 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.
|
Baseline and Week 52
|
|
Cumulative Oral Corticosteroid Use Between Week 0 and Week 28
Lasso di tempo: 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.
|
Up to approximately 28 weeks
|
|
Cumulative Oral Corticosteroid Use Between Week 0 and Week 52
Lasso di tempo: 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
|
|
Number of Participants Who Achieved Low Level of Disease Activity (LLDAS) at Week 28
Lasso di tempo: Week 28
|
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 28
|
|
Number of Participants Who Achieved LLDAS at Week 52
Lasso di tempo: Week 52
|
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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
27 dicembre 2023
Completamento primario (Effettivo)
Completamento primario
30 luglio 2025
Completamento dello studio (Effettivo)
Completamento dello studio
30 luglio 2025
Date di iscrizione allo studio
Primo inviato
Primo inviato
29 novembre 2023
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
29 novembre 2023
Primo Inserito (Effettivo)
Primo Inserito
7 dicembre 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
10 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 luglio 2026
Ultimo verificato
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 6194-006
- MK-6194-006 (Altro identificatore: MSD)
- U1111-1291-8716 (Identificatore di registro: UTN)
- jRCT2041230137 (Identificatore di registro: jRCT)
- 2023-505520-61-00 (Identificatore di registro: EU CT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .