Eficacia y seguridad de MK-6194 en participantes adultos con lupus eritematoso sistémico (MK-6194-006)
16 de julio de 2026 actualizado por: Merck Sharp & Dohme LLC
Un estudio de fase 2a, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de MK-6194 en participantes adultos con lupus eritematoso sistémico
El propósito de este estudio es evaluar la eficacia y seguridad de MK-6194 en participantes adultos con lupus eritematoso sistémico.
La hipótesis principal es que al menos 1 de los brazos de MK-6194 es superior al placebo en el criterio de valoración principal del porcentaje de participantes con respuesta del índice de respuesta al lupus eritematoso sistémico (SRI-4) en la semana 28.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
149
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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, Brasil, 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, Brasil, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
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Porto Alegre, Rio Grande do Sul, Brasil, 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, Brasil, 09715-090
- Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
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São José do Rio Preto, São Paulo, Brasil, 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, Canadá, J1L 0H8
- Diex Recherche Sherbrooke ( Site 0003)
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Araucania
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Temuco, Araucania, Chile, 4800827
- James Lind Centro de Investigacion del Cancer ( Site 0407)
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Coquimbo Region
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La Serena, Coquimbo Region, Chile, 1720430
- IC La Serena Research ( Site 0414)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7640881
- Clinica Dermacross ( Site 0416)
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Santiago, Region M. de Santiago, Chile, 8207257
- Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
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Santiago, Region M. de Santiago, Chile, 8320000
- CECIM ( Site 0405)
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Santiago, Region M. de Santiago, Chile, 8420383
- Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
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Antioquia
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Medellín, Antioquia, Colombia, 50021
- Salud SURA Industriales ( Site 0508)
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Atlántico
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Barranquilla, Atlántico, Colombia, 080020
- Clinica de la Costa S.A.S. ( Site 0502)
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Barranquilla, Atlántico, Colombia, 080002
- Centro Integral de Reumatología del Caribe ( Site 0501)
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Cundinamarca
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Chía, Cundinamarca, Colombia, 250001
- Preventive Care ( Site 0507)
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Zipaquirá, Cundinamarca, Colombia, 250252
- Healthy Medical Center S.A.S ( Site 0505)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 0506)
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Cali, Valle del Cauca Department, Colombia, 760042
- Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
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Barcelona, España, 08035
- Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
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Seville, España, 41010
- Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
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Valladolid, España, 47012
- Hospital Universitario Rio Hortega ( Site 1606)
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La Coruna
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A Coruña, La Coruna, España, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, España, 46010
- HOSPITAL CLINICO DE VALENCIA ( Site 1608)
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California
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Covina, California, Estados Unidos, 91722
- Medvin Clinical Research - Metyas ( Site 0128)
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La Jolla, California, Estados Unidos, 92037
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
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La Palma, California, Estados Unidos, 90623
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
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Tujunga, California, Estados Unidos, 91042
- Medvin Clinical Research - Tujunga ( Site 0127)
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Colorado
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Denver, Colorado, Estados Unidos, 80230
- Denver Arthritis Clinic ( Site 0102)
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Florida
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Clearwater, Florida, Estados Unidos, 33765
- Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
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Plantation, Florida, Estados Unidos, 33324
- IRIS Research and Development, LLC-Research ( Site 0117)
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Tampa, Florida, Estados Unidos, 33606
- Clinical Research of West Florida, Inc ( Site 0124)
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Georgia
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Atlanta, Georgia, Estados Unidos, 30310
- Morehouse School of Medicine ( Site 0146)
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Louisiana
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Lake Charles, Louisiana, Estados Unidos, 70605
- Accurate Clinical Research, Inc ( Site 0135)
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Michigan
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Grand Blanc, Michigan, Estados Unidos, 48439
- AA Medical Research Center ( Site 0136)
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28210
- Javara - Tryon Medical Partners ( Site 0121)
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Charlotte, North Carolina, Estados Unidos, 28211
- DJL Clinical Research, PLLC ( Site 0103)
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Science Center ( Site 0130)
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38119
- Shelby Research, LLC ( Site 0142)
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Texas
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Baytown, Texas, Estados Unidos, 77521
- Accurate Clinical Management, LLC. ( Site 0134)
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DeSoto, Texas, Estados Unidos, 75115
- Epic Medical Research ( Site 0113)
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Houston, Texas, Estados Unidos, 77089
- Accurate Clinical Research, Inc. ( Site 0133)
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Mesquite, Texas, Estados Unidos, 75150
- SouthWest Rheumatology Research, LLC ( Site 0115)
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Iloilo City, Filipinas, 5000
- Iloilo Doctors' Hospital ( Site 2301)
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Batangas
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Lipa City, Batangas, Filipinas, 4217
- Mary Mediatrix Medical Center ( Site 2303)
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National Capital Region
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Quezon City, National Capital Region, Filipinas, 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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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, Japón, 260-8677
- Chiba University Hospital ( Site 2120)
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Chiba, Japón, 260-8712
- NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
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Okayama, Japón, 700-8558
- Okayama University Hospital ( Site 2106)
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Osaka, Japón, 543-8922
- Osaka Keisatsu Hospital ( Site 2117)
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Aichi-ken
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Nagoya, Aichi-ken, Japón, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
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Kanagawa
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Kawasaki, Kanagawa, Japón, 216-8511
- St. Marianna University Hospital ( Site 2121)
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Miyagi
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Sendai, Miyagi, Japón, 980-8574
- Tohoku University Hospital ( Site 2116)
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Okinawa
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Tomigusuku, Okinawa, Japón, 901-0224
- Yuuai Medical Center ( Site 2122)
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Shimane
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Izumo, Shimane, Japón, 693-0021
- Shimane University Hospital ( Site 2119)
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Tochigi
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Shimotsuga, Tochigi, Japón, 321-0293
- Dokkyo Medical University Hospital ( Site 2118)
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Tokyo
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Itabashiku, Tokyo, Japón, 173-8610
- Nihon University Itabashi Hospital ( Site 2105)
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Shinagawa, Tokyo, Japón, 142-0054
- Showa Medical University East Hospital ( Site 2123)
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malasia, 56000
- Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
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Lembah Pantai, Kuala Lumpur, Malasia, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
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Pahang
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Kuantan, Pahang, Malasia, 25100
- Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
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Perak
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Taiping, Perak, Malasia, 34000
- Hospital Taiping ( Site 2221)
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Chihuahua City, México, 31000
- ICARO Investigaciones en Medicina ( Site 0702)
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Distrito Federal, México, 06700
- Clinstile, S.A. de C.V. ( Site 0709)
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Guanajuato
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León, Guanajuato, México, 37000
- Morales Vargas Centro de Investigacion ( Site 0710)
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Jalisco
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Guadalajara, Jalisco, México, 44160
- Centro Integral en Reumatologia ( Site 0701)
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Guadalajara, Jalisco, México, 44638
- Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
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Guadalajara, Jalisco, México, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
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Guadalajara, Jalisco, México, 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, México, 03100
- RM Pharma Specialists ( Site 0711)
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Mexico City, Mexico City, México, 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, México, 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, México, 78250
- Centro Potosino de Investigación Médica ( Site 0703)
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Yucatán
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Mérida, Yucatán, México, 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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Anhui
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Bengbu, Anhui, Porcelana, 233000
- The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
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Hefei, Anhui, Porcelana, 230071
- Anhui Provincial Hospital ( Site 2043)
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 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, Porcelana, 730000
- Gansu Provincial Hospital ( Site 2065)
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510000
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
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Guangzhou, Guangdong, Porcelana, 510515
- Southern Medical University Nanfang Hospital ( Site 2037)
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Guizhou
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Guiyang, Guizhou, Porcelana, 550004
- The Affiliated Hospital of Guizhou Medical University ( Site 2051)
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Hebei
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Shijiazhuang, Hebei, Porcelana, 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, Porcelana, 471003
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
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Hubei
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Wuhan, Hubei, Porcelana, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
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Hunan
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Hengyang, Hunan, Porcelana, 421001
- The First Affiliated Hospital of Nanhua University ( Site 2061)
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Inner Mongolia
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Baotou, Inner Mongolia, Porcelana, 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, Porcelana, 226001
- Affiliated Hospital of Nantong University ( Site 2027)
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Jiangxi
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Pingxiang, Jiangxi, Porcelana, 337055
- Pingxiang People's Hospital ( Site 2005)
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Jilin
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Changchun, Jilin, Porcelana, 130021
- Jilin Province People's Hospital ( Site 2033)
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 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, Porcelana, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
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Shanxi
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Taiyuan, Shanxi, Porcelana, 030032
- Shanxi Bethune Hospital ( Site 2029)
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Sichuan
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Chengdu, Sichuan, Porcelana, 610500
- The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300052
- Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
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Ankara, Turquía (Türkiye), 06230
- ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
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Ankara, Turquía (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
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Sakarya, Turquía (Türkiye)
- Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
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Istanbul
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Kadıköy, Istanbul, Turquía (Türkiye), 34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Tiene un diagnóstico de lupus eritematoso sistémico (LES) ≥6 meses antes de la selección.
- Está tomando al menos 1 tratamiento de base (1 inmunosupresor o dapsona y/o 1 antipalúdico y/o corticosteroides orales) para el LES.
- Tiene + anticuerpo antinuclear (+ANA) (título ≥1:80) o anticuerpo anti-ácido desoxirribonucleico de doble hebra (ADNds) positivo o anticuerpo anti-Sm positivo, o anticuerpo anti-SSA/Ro positivo.
- Tiene la presencia de al menos una de las siguientes manifestaciones de LES: erupción lúpica activa con eritema CLASI-A y puntuación combinada de escala/hipertrofia >2, o >2 articulaciones sensibles e inflamadas en muñecas, metacarpofalángicas (MCP) o interfalángicas proximales ( PIP).
- Tiene una puntuación total híbrida del índice de actividad de la enfermedad del lupus eritematoso sistémico (SLEDAI) de ≥6 y una puntuación SLEDAI híbrida clínica de ≥4.
Criterio de exclusión:
- Tiene una enfermedad clínicamente significativa concurrente o anomalías de laboratorio clínicamente relevantes, o antecedentes de cualquier enfermedad o condición médica que, en opinión del investigador, pueda confundir los resultados del estudio o represente un riesgo adicional para el participante por su participación en el estudiar.
- Tiene insuficiencia cardíaca sintomática (clase III o IV de la New York Heart Association) o infarto de miocardio o angina de pecho inestable dentro de los 6 meses anteriores a la selección.
- Tiene una enfermedad pulmonar crónica grave que requiere oxigenoterapia.
- Tiene un órgano trasplantado que requiere inmunosupresión continua.
- Tiene una hipersensibilidad sistémica conocida a la IL-2, o a la IL-2 modificada, incluido MK-6194, o sus ingredientes inactivos.
- Tiene antecedentes conocidos de enfermedad linfoproliferativa, incluido linfoma, o signos y síntomas que sugieren una posible enfermedad linfoproliferativa, como linfadenopatía y/o esplenomegalia.
- Tiene lupus eritematoso cutáneo (LEC) inducido por fármacos y/o LES inducido por fármacos en el contexto de un tratamiento continuo con un agente causal.
- Tiene lupus neuropsiquiátrico activo o inestable que incluye, entre otros, los siguientes: convulsiones, deterioro del nivel de conciencia nuevo o que empeora, psicosis, delirio o estado de confusión, meningitis aséptica, neuropatía craneal, accidente cerebrovascular, mielitis ascendente o transversa, corea, ataxia cerebelosa, mononeuritis múltiple o síndromes desmielinizantes.
- Tiene un diagnóstico de síndrome antifosfolípido con antecedentes de trombosis vascular, SAF catastrófico o morbilidad durante el embarazo dentro de los 6 meses anteriores a la selección.
- Tiene antecedentes de cualquier tumor maligno, excepto cáncer de piel no melanoma tratado con éxito o carcinoma localizado in situ del cuello uterino.
- Tiene una infección activa clínicamente significativa, o cualquier infección que requiera hospitalización o tratamiento con antiinfecciosos.
- Tiene evidencia de tuberculosis (TB) activa, tuberculosis latente o tuberculosis tratada inadecuadamente.
- Tiene infección por COVID-19 confirmada o sospechada.
- Ha tenido una cirugía mayor dentro de los 3 meses anteriores a la selección o tiene una cirugía mayor planificada durante el estudio.
- Está tomando más de 1 inmunosupresor.
- Está tomando más de 1 AINE oral (excluyendo aspirina en dosis bajas [<350 mg/día]) o está tomando un medicamento antiinflamatorio no esteroideo (AINE) oral diario en una dosis mayor que la máxima recomendada.
- Está actualmente en alguna terapia antiinfecciosa sistémica crónica (oral o intravenosa) para infecciones crónicas (como pneumocystis, citomegalovirus, herpes zóster o micobacterias atípicas).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
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Inyección SC
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Experimental: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
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Inyección SC
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Comparador de placebos: Placebo
Participants receive SC placebo q2w.
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Inyección SC
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Experimental: 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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Inyección SC
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Experimental: 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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Inyección SC
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Experimental: 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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Inyección SC
Inyección SC
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Experimental: 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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Inyección SC
Inyección SC
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Week 52
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The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of tenderness.
The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations was reported.
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Baseline and Week 52
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Change From Baseline in Swollen and Tender Joint Count at Week 28
Periodo de tiempo: 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.
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Baseline and Week 28
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Change From Baseline in Swollen and Tender Joint Count at Week 52
Periodo de tiempo: 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 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Week 52
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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 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de diciembre de 2023
Finalización primaria (Actual)
30 de julio de 2025
Finalización del estudio (Actual)
30 de julio de 2025
Fechas de registro del estudio
Enviado por primera vez
29 de noviembre de 2023
Primero enviado que cumplió con los criterios de control de calidad
29 de noviembre de 2023
Publicado por primera vez (Actual)
7 de diciembre de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6194-006
- MK-6194-006 (Otro identificador: MSD)
- U1111-1291-8716 (Identificador de registro: UTN)
- jRCT2041230137 (Identificador de registro: jRCT)
- 2023-505520-61-00 (Identificador de registro: EU CT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .