Efficacité et innocuité du MK-6194 chez les participants adultes atteints de lupus érythémateux systémique (MK-6194-006)
16 juillet 2026 mis à jour par: Merck Sharp & Dohme LLC
Une étude de phase 2a, multicentrique, randomisée, en double aveugle, contrôlée par placebo, pour évaluer l'efficacité et l'innocuité du MK-6194 chez des participants adultes atteints de lupus érythémateux systémique
Le but de cette étude est d'évaluer l'efficacité et l'innocuité du MK-6194 chez les participants adultes atteints de lupus érythémateux systémique.
L'hypothèse principale est qu'au moins 1 des bras MK-6194 est supérieur au placebo dans le critère d'évaluation principal du pourcentage de participants présentant une réponse à l'indice de réponse au lupus érythémateux disséminé (SRI-4) à la semaine 28.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
149
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Mendoza, Argentine, M5500CPH
- Instituto de Reumatología ( Site 0201)
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentine, 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, Argentine, S2000DVC
- Sanatorio Parque ( Site 0205)
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Santa Fe, Santa Fe Province, Argentine, 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, Argentine, T4000AXL
- Centro de Investigaciones Médicas Tucuman ( Site 0203)
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Mato Grosso
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Cuiabá, Mato Grosso, Brésil, 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, Brésil, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
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Porto Alegre, Rio Grande do Sul, Brésil, 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, Brésil, 09715-090
- Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
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São José do Rio Preto, São Paulo, Brésil, 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, Chili, 4800827
- James Lind Centro de Investigacion del Cancer ( Site 0407)
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Coquimbo Region
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La Serena, Coquimbo Region, Chili, 1720430
- IC La Serena Research ( Site 0414)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chili, 7640881
- Clinica Dermacross ( Site 0416)
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Santiago, Region M. de Santiago, Chili, 8207257
- Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
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Santiago, Region M. de Santiago, Chili, 8320000
- CECIM ( Site 0405)
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Santiago, Region M. de Santiago, Chili, 8420383
- Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
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Anhui
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Bengbu, Anhui, Chine, 233000
- The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
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Hefei, Anhui, Chine, 230071
- Anhui Provincial Hospital ( Site 2043)
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 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, Chine, 730000
- Gansu Provincial Hospital ( Site 2065)
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Guangdong
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Guangzhou, Guangdong, Chine, 510000
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
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Guangzhou, Guangdong, Chine, 510515
- Southern Medical University Nanfang Hospital ( Site 2037)
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Guizhou
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Guiyang, Guizhou, Chine, 550004
- The Affiliated Hospital of Guizhou Medical University ( Site 2051)
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Hebei
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Shijiazhuang, Hebei, Chine, 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, Chine, 471003
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
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Hubei
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Wuhan, Hubei, Chine, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
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Hunan
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Hengyang, Hunan, Chine, 421001
- The First Affiliated Hospital of Nanhua University ( Site 2061)
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Inner Mongolia
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Baotou, Inner Mongolia, Chine, 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, Chine, 226001
- Affiliated Hospital of Nantong University ( Site 2027)
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Jiangxi
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Pingxiang, Jiangxi, Chine, 337055
- Pingxiang People's Hospital ( Site 2005)
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Jilin
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Changchun, Jilin, Chine, 130021
- Jilin Province People's Hospital ( Site 2033)
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Shaanxi
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Xi'an, Shaanxi, Chine, 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, Chine, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
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Shanxi
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Taiyuan, Shanxi, Chine, 030032
- Shanxi Bethune Hospital ( Site 2029)
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Sichuan
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Chengdu, Sichuan, Chine, 610500
- The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chine, 300052
- Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
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Antioquia
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Medellín, Antioquia, Colombie, 50021
- Salud SURA Industriales ( Site 0508)
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Atlántico
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Barranquilla, Atlántico, Colombie, 080020
- Clinica de la Costa S.A.S. ( Site 0502)
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Barranquilla, Atlántico, Colombie, 080002
- Centro Integral de Reumatología del Caribe ( Site 0501)
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Cundinamarca
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Chía, Cundinamarca, Colombie, 250001
- Preventive Care ( Site 0507)
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Zipaquirá, Cundinamarca, Colombie, 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, Colombie, 760032
- Fundación Valle del Lili ( Site 0506)
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Cali, Valle del Cauca Department, Colombie, 760042
- Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
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Barcelona, Espagne, 08035
- Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
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Seville, Espagne, 41010
- Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
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Valladolid, Espagne, 47012
- Hospital Universitario Rio Hortega ( Site 1606)
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La Coruna
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A Coruña, La Coruna, Espagne, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Espagne, 46010
- HOSPITAL CLINICO DE VALENCIA ( Site 1608)
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Aquitaine
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Pessac, Aquitaine, France, 33600
- CHU Bordeaux Haut-Leveque ( Site 1007)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, France, 69007
- Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
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Haute-Garonne
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Toulouse, Haute-Garonne, France, 31400
- CHU Rangueil ( Site 1008)
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Herault
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Montpellier, Herault, France, 34295
- CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
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Nord
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Lille, Nord, France, 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, France, 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, Italie, 50141
- AOU Careggi ( Site 1311)
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Naples, Italie, 80131
- Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
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Roma, Italie, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
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Milano
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Rozzano, Milano, Italie, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 1310)
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Roma
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Rome, Roma, Italie, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
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Tuscany
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Siena, Tuscany, Italie, 53100
- Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
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Veneto
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Padova, Veneto, Italie, 35128
- Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
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Chiba, Japon, 260-8677
- Chiba University Hospital ( Site 2120)
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Chiba, Japon, 260-8712
- NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
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Okayama, Japon, 700-8558
- Okayama University Hospital ( Site 2106)
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Osaka, Japon, 543-8922
- Osaka Keisatsu Hospital ( Site 2117)
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Aichi-ken
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Nagoya, Aichi-ken, Japon, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
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Kanagawa
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Kawasaki, Kanagawa, Japon, 216-8511
- St. Marianna University Hospital ( Site 2121)
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Miyagi
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Sendai, Miyagi, Japon, 980-8574
- Tohoku University Hospital ( Site 2116)
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Okinawa
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Tomigusuku, Okinawa, Japon, 901-0224
- Yuuai Medical Center ( Site 2122)
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Shimane
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Izumo, Shimane, Japon, 693-0021
- Shimane University Hospital ( Site 2119)
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Tochigi
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Shimotsuga, Tochigi, Japon, 321-0293
- Dokkyo Medical University Hospital ( Site 2118)
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Tokyo
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Itabashiku, Tokyo, Japon, 173-8610
- Nihon University Itabashi Hospital ( Site 2105)
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Shinagawa, Tokyo, Japon, 142-0054
- Showa Medical University East Hospital ( Site 2123)
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malaisie, 56000
- Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
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Lembah Pantai, Kuala Lumpur, Malaisie, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
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Pahang
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Kuantan, Pahang, Malaisie, 25100
- Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
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Perak
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Taiping, Perak, Malaisie, 34000
- Hospital Taiping ( Site 2221)
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Chihuahua City, Mexique, 31000
- ICARO Investigaciones en Medicina ( Site 0702)
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Distrito Federal, Mexique, 06700
- Clinstile, S.A. de C.V. ( Site 0709)
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Guanajuato
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León, Guanajuato, Mexique, 37000
- Morales Vargas Centro de Investigacion ( Site 0710)
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Jalisco
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Guadalajara, Jalisco, Mexique, 44160
- Centro Integral en Reumatologia ( Site 0701)
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Guadalajara, Jalisco, Mexique, 44638
- Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
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Guadalajara, Jalisco, Mexique, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
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Guadalajara, Jalisco, Mexique, 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, Mexique, 03100
- RM Pharma Specialists ( Site 0711)
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Mexico City, Mexico City, Mexique, 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, Mexique, 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, Mexique, 78250
- Centro Potosino de Investigación Médica ( Site 0703)
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Yucatán
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Mérida, Yucatán, Mexique, 97130
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
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Iloilo City, Philippines, 5000
- Iloilo Doctors' Hospital ( Site 2301)
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Batangas
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Lipa City, Batangas, Philippines, 4217
- Mary Mediatrix Medical Center ( Site 2303)
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National Capital Region
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Quezon City, National Capital Region, Philippines, 1102
- ST. LUKE'S MEDICAL CENTER ( Site 2304)
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Pologne, 60-218
- Medyczne Centrum Hetmańska ( Site 1406)
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Poznan, Greater Poland Voivodeship, Pologne, 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, Pologne, 85-065
- MICS Centrum Medyczne Bydgoszcz ( Site 1410)
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Pologne, 30-363
- Centrum Medyczne Plejady ( Site 1407)
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Pologne, 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, Pologne, 00-874
- MICS Centrum Medyczne Warszawa ( Site 1411)
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Pologne, 15-707
- Nova Reuma Społka Partnerska ( Site 1405)
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Silesian Voivodeship
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Bytom, Silesian Voivodeship, Pologne, 41-902
- NZOZ BIF-MED ( Site 1409)
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Ankara, Turquie (Türkiye), 06230
- ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
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Ankara, Turquie (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
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Sakarya, Turquie (Türkiye)
- Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
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Istanbul
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Kadıköy, Istanbul, Turquie (Türkiye), 34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
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California
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Covina, California, États-Unis, 91722
- Medvin Clinical Research - Metyas ( Site 0128)
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La Jolla, California, États-Unis, 92037
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
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La Palma, California, États-Unis, 90623
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
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Tujunga, California, États-Unis, 91042
- Medvin Clinical Research - Tujunga ( Site 0127)
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Colorado
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Denver, Colorado, États-Unis, 80230
- Denver Arthritis Clinic ( Site 0102)
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Florida
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Clearwater, Florida, États-Unis, 33765
- Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
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Plantation, Florida, États-Unis, 33324
- IRIS Research and Development, LLC-Research ( Site 0117)
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Tampa, Florida, États-Unis, 33606
- Clinical Research of West Florida, Inc ( Site 0124)
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Georgia
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Atlanta, Georgia, États-Unis, 30310
- Morehouse School of Medicine ( Site 0146)
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Louisiana
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Lake Charles, Louisiana, États-Unis, 70605
- Accurate Clinical Research, Inc ( Site 0135)
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Michigan
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Grand Blanc, Michigan, États-Unis, 48439
- AA Medical Research Center ( Site 0136)
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North Carolina
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Charlotte, North Carolina, États-Unis, 28210
- Javara - Tryon Medical Partners ( Site 0121)
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Charlotte, North Carolina, États-Unis, 28211
- DJL Clinical Research, PLLC ( Site 0103)
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- University of Oklahoma Health Science Center ( Site 0130)
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Tennessee
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Memphis, Tennessee, États-Unis, 38119
- Shelby Research, LLC ( Site 0142)
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Texas
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Baytown, Texas, États-Unis, 77521
- Accurate Clinical Management, LLC. ( Site 0134)
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DeSoto, Texas, États-Unis, 75115
- Epic Medical Research ( Site 0113)
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Houston, Texas, États-Unis, 77089
- Accurate Clinical Research, Inc. ( Site 0133)
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Mesquite, Texas, États-Unis, 75150
- SouthWest Rheumatology Research, LLC ( Site 0115)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- A un diagnostic de lupus érythémateux systémique (LED) ≥6 mois avant le dépistage.
- Prend au moins 1 traitement de fond (1 immunosuppresseur ou dapsone et/ou 1 antipaludique et/ou corticostéroïdes oraux) pour le LED.
- Possède + anticorps antinucléaire (+ANA) (titre ≥1:80) ou anticorps anti-acide désoxyribonucléique double brin (ADNdb) positif ou anticorps anti-Sm positif, ou anticorps anti-SSA/Ro positif.
- Présente la présence d'au moins une des manifestations suivantes du LED : éruption cutanée lupique active avec érythème CLASI-A et score combiné squame/hypertrophie > 2, ou > 2 articulations sensibles et enflées des poignets, des métacarpophalangiennes (MCP) ou des interphalangiennes proximales ( PIP).
- A un score total hybride de l'indice d'activité de la maladie du lupus érythémateux systémique (SLEDAI) ≥6 et un score SLEDAI hybride clinique de ≥4.
Critère d'exclusion:
- Présente simultanément une maladie cliniquement significative ou des anomalies de laboratoire cliniquement pertinentes, ou des antécédents de maladie ou de condition médicale qui, de l'avis de l'investigateur, pourraient fausser les résultats de l'étude ou présenter un risque supplémentaire pour le participant en raison de sa participation à l'étude. étude.
- Présente une insuffisance cardiaque symptomatique (classe III ou IV de la New York Heart Association) ou un infarctus du myocarde ou une angine de poitrine instable dans les 6 mois précédant le dépistage.
- A une maladie pulmonaire chronique grave nécessitant une oxygénothérapie.
- A un organe transplanté qui nécessite une immunosuppression continue.
- Présente une hypersensibilité systémique connue à l'IL-2 ou à l'IL-2 modifiée, y compris le MK-6194, ou à ses ingrédients inactifs.
- A des antécédents connus de maladie lymphoproliférative, y compris un lymphome, ou des signes et symptômes évocateurs d'une éventuelle maladie lymphoproliférative, comme une lymphadénopathie et/ou une splénomégalie.
- Présente un lupus érythémateux cutané d'origine médicamenteuse (CLE) et/ou un LED d'origine médicamenteuse dans le cadre d'un traitement continu avec un agent causal.
- Souffre d'un lupus neuropsychiatrique actif ou instable, y compris, sans toutefois s'y limiter : convulsions, altération du niveau de conscience, nouvelle ou aggravation, psychose, délire ou état de confusion, méningite aseptique, neuropathie crânienne, accident vasculaire cérébral, myélite ascendante ou transverse, chorée, ataxie cérébelleuse, mononévrite multiplex ou syndromes démyélinisants.
- A un diagnostic de syndrome des antiphospholipides avec des antécédents de thrombose vasculaire, de SAPL catastrophique ou de morbidité liée à la grossesse dans les 6 mois précédant le dépistage.
- A des antécédents de tumeur maligne, à l'exception d'un cancer de la peau autre que le mélanome traité avec succès ou d'un carcinome localisé in situ du col de l'utérus.
- Présente une infection active cliniquement significative ou toute infection nécessitant une hospitalisation ou un traitement avec des anti-infectieux.
- Présente des signes de tuberculose (TB) active, de tuberculose latente ou de tuberculose insuffisamment traitée.
- A une infection confirmée ou suspectée au COVID-19.
- A subi une intervention chirurgicale majeure dans les 3 mois précédant le dépistage ou a une intervention chirurgicale majeure prévue au cours de l'étude.
- Prend plus d’un immunosuppresseur.
- Prend plus d'un AINS oral (à l'exclusion de l'aspirine à faible dose [<350 mg/jour]) ou prend quotidiennement un anti-inflammatoire non stéroïdien (AINS) oral à une dose supérieure à la dose maximale recommandée.
- Est actuellement sous traitement anti-infectieux systémique chronique (oral ou IV) pour une infection chronique (telle que pneumocystis, cytomégalovirus, herpès zoster ou mycobactéries atypiques).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
|
Injection SC
|
|
Expérimental: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
|
Injection SC
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Comparateur placebo: Placebo
Participants receive SC placebo q2w.
|
Injection SC
|
|
Expérimental: 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.
|
Injection SC
|
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Expérimental: 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.
|
Injection SC
|
|
Expérimental: 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.
|
Injection SC
Injection SC
|
|
Expérimental: 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.
|
Injection SC
Injection SC
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Délai: 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
|
|
Number of Participants Who Experienced an Adverse Event (AE)
Délai: 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.
|
Up to approximately 16 months
|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
Délai: 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.
|
Up to approximately 16 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
|
Change From Baseline in Swollen Joint Count at Week 28
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Merck Sharp & Dohme LLC
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 décembre 2023
Achèvement primaire (Réel)
30 juillet 2025
Achèvement de l'étude (Réel)
30 juillet 2025
Dates d'inscription aux études
Première soumission
29 novembre 2023
Première soumission répondant aux critères de contrôle qualité
29 novembre 2023
Première publication (Réel)
7 décembre 2023
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6194-006
- MK-6194-006 (Autre identifiant: MSD)
- U1111-1291-8716 (Identificateur de registre: UTN)
- jRCT2041230137 (Identificateur de registre: jRCT)
- 2023-505520-61-00 (Identificateur de registre: EU CT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .