Účinnost a bezpečnost MK-6194 u dospělých účastníků se systémovým lupus erythematodes (MK-6194-006)
16. července 2026 aktualizováno: Merck Sharp & Dohme LLC
Fáze 2a, multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie k vyhodnocení účinnosti a bezpečnosti MK-6194 u dospělých účastníků se systémovým lupus erythematodes
Účelem této studie je vyhodnotit účinnost a bezpečnost MK-6194 u dospělých účastníků se systémovým lupus erythematodes.
Primární hypotéza je, že alespoň 1 z ramen MK-6194 je lepší než placebo v primárním koncovém bodě procenta účastníků s odpovědí indexu systémového lupus erythematodes responder (SRI-4) v týdnu 28.
Přehled studie
Postavení
Postavení
Ukončeno
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Aktuální)
Zápis
149
Fáze
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
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Studijní místa
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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, Brazílie, 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, Brazílie, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
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Porto Alegre, Rio Grande do Sul, Brazílie, 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, Brazílie, 09715-090
- Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
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São José do Rio Preto, São Paulo, Brazílie, 15090-000
- Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
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Araucania
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Temuco, Araucania, Chile, 4800827
- James Lind Centro de Investigacion del Cancer ( Site 0407)
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Coquimbo Region
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La Serena, Coquimbo Region, Chile, 1720430
- IC La Serena Research ( Site 0414)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7640881
- Clinica Dermacross ( Site 0416)
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Santiago, Region M. de Santiago, Chile, 8207257
- Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
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Santiago, Region M. de Santiago, Chile, 8320000
- CECIM ( Site 0405)
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Santiago, Region M. de Santiago, Chile, 8420383
- Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
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Iloilo City, Filipíny, 5000
- Iloilo Doctors' Hospital ( Site 2301)
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Batangas
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Lipa City, Batangas, Filipíny, 4217
- Mary Mediatrix Medical Center ( Site 2303)
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National Capital Region
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Quezon City, National Capital Region, Filipíny, 1102
- ST. LUKE'S MEDICAL CENTER ( Site 2304)
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Aquitaine
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Pessac, Aquitaine, Francie, 33600
- CHU Bordeaux Haut-Leveque ( Site 1007)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, Francie, 69007
- Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
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Haute-Garonne
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Toulouse, Haute-Garonne, Francie, 31400
- CHU Rangueil ( Site 1008)
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Herault
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Montpellier, Herault, Francie, 34295
- CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
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Nord
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Lille, Nord, Francie, 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, Francie, 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, Itálie, 50141
- AOU Careggi ( Site 1311)
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Naples, Itálie, 80131
- Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
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Roma, Itálie, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
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Milano
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Rozzano, Milano, Itálie, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 1310)
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Roma
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Rome, Roma, Itálie, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
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Tuscany
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Siena, Tuscany, Itálie, 53100
- Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
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Veneto
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Padova, Veneto, Itálie, 35128
- Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
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Chiba, Japonsko, 260-8677
- Chiba University Hospital ( Site 2120)
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Chiba, Japonsko, 260-8712
- NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
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Okayama, Japonsko, 700-8558
- Okayama University Hospital ( Site 2106)
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Osaka, Japonsko, 543-8922
- Osaka Keisatsu Hospital ( Site 2117)
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Aichi-ken
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Nagoya, Aichi-ken, Japonsko, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
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Kanagawa
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Kawasaki, Kanagawa, Japonsko, 216-8511
- St. Marianna University Hospital ( Site 2121)
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Miyagi
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Sendai, Miyagi, Japonsko, 980-8574
- Tohoku University Hospital ( Site 2116)
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Okinawa
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Tomigusuku, Okinawa, Japonsko, 901-0224
- Yuuai Medical Center ( Site 2122)
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Shimane
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Izumo, Shimane, Japonsko, 693-0021
- Shimane University Hospital ( Site 2119)
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Tochigi
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Shimotsuga, Tochigi, Japonsko, 321-0293
- Dokkyo Medical University Hospital ( Site 2118)
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Tokyo
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Itabashiku, Tokyo, Japonsko, 173-8610
- Nihon University Itabashi Hospital ( Site 2105)
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Shinagawa, Tokyo, Japonsko, 142-0054
- Showa Medical University East Hospital ( Site 2123)
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Quebec
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Sherbrooke, Quebec, Kanada, J1L 0H8
- Diex Recherche Sherbrooke ( Site 0003)
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Antioquia
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Medellín, Antioquia, Kolumbie, 50021
- Salud SURA Industriales ( Site 0508)
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Atlántico
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Barranquilla, Atlántico, Kolumbie, 080020
- Clinica de la Costa S.A.S. ( Site 0502)
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Barranquilla, Atlántico, Kolumbie, 080002
- Centro Integral de Reumatología del Caribe ( Site 0501)
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Cundinamarca
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Chía, Cundinamarca, Kolumbie, 250001
- Preventive Care ( Site 0507)
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Zipaquirá, Cundinamarca, Kolumbie, 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, Kolumbie, 760032
- Fundación Valle del Lili ( Site 0506)
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Cali, Valle del Cauca Department, Kolumbie, 760042
- Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malajsie, 56000
- Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
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Lembah Pantai, Kuala Lumpur, Malajsie, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
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Pahang
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Kuantan, Pahang, Malajsie, 25100
- Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
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Perak
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Taiping, Perak, Malajsie, 34000
- Hospital Taiping ( Site 2221)
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Chihuahua City, Mexiko, 31000
- ICARO Investigaciones en Medicina ( Site 0702)
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Distrito Federal, Mexiko, 06700
- Clinstile, S.A. de C.V. ( Site 0709)
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Guanajuato
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León, Guanajuato, Mexiko, 37000
- Morales Vargas Centro de Investigacion ( Site 0710)
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Jalisco
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Guadalajara, Jalisco, Mexiko, 44160
- Centro Integral en Reumatologia ( Site 0701)
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Guadalajara, Jalisco, Mexiko, 44638
- Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
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Guadalajara, Jalisco, Mexiko, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
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Guadalajara, Jalisco, Mexiko, 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, Mexiko, 03100
- RM Pharma Specialists ( Site 0711)
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Mexico City, Mexico City, Mexiko, 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, Mexiko, 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, Mexiko, 78250
- Centro Potosino de Investigación Médica ( Site 0703)
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Yucatán
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Mérida, Yucatán, Mexiko, 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, Polsko, 60-218
- Medyczne Centrum Hetmańska ( Site 1406)
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Poznan, Greater Poland Voivodeship, Polsko, 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, Polsko, 85-065
- MICS Centrum Medyczne Bydgoszcz ( Site 1410)
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polsko, 30-363
- Centrum Medyczne Plejady ( Site 1407)
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polsko, 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, Polsko, 00-874
- MICS Centrum Medyczne Warszawa ( Site 1411)
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polsko, 15-707
- Nova Reuma Społka Partnerska ( Site 1405)
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Silesian Voivodeship
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Bytom, Silesian Voivodeship, Polsko, 41-902
- NZOZ BIF-MED ( Site 1409)
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California
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Covina, California, Spojené státy, 91722
- Medvin Clinical Research - Metyas ( Site 0128)
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La Jolla, California, Spojené státy, 92037
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
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La Palma, California, Spojené státy, 90623
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
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Tujunga, California, Spojené státy, 91042
- Medvin Clinical Research - Tujunga ( Site 0127)
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Colorado
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Denver, Colorado, Spojené státy, 80230
- Denver Arthritis Clinic ( Site 0102)
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Florida
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Clearwater, Florida, Spojené státy, 33765
- Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
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Plantation, Florida, Spojené státy, 33324
- IRIS Research and Development, LLC-Research ( Site 0117)
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Tampa, Florida, Spojené státy, 33606
- Clinical Research of West Florida, Inc ( Site 0124)
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Georgia
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Atlanta, Georgia, Spojené státy, 30310
- Morehouse School of Medicine ( Site 0146)
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Louisiana
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Lake Charles, Louisiana, Spojené státy, 70605
- Accurate Clinical Research, Inc ( Site 0135)
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Michigan
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Grand Blanc, Michigan, Spojené státy, 48439
- AA Medical Research Center ( Site 0136)
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28210
- Javara - Tryon Medical Partners ( Site 0121)
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Charlotte, North Carolina, Spojené státy, 28211
- DJL Clinical Research, PLLC ( Site 0103)
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- University of Oklahoma Health Science Center ( Site 0130)
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Tennessee
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Memphis, Tennessee, Spojené státy, 38119
- Shelby Research, LLC ( Site 0142)
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Texas
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Baytown, Texas, Spojené státy, 77521
- Accurate Clinical Management, LLC. ( Site 0134)
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DeSoto, Texas, Spojené státy, 75115
- Epic Medical Research ( Site 0113)
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Houston, Texas, Spojené státy, 77089
- Accurate Clinical Research, Inc. ( Site 0133)
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Mesquite, Texas, Spojené státy, 75150
- SouthWest Rheumatology Research, LLC ( Site 0115)
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Ankara, Turecko (Türkiye), 06230
- ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
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Ankara, Turecko (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
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Sakarya, Turecko (Türkiye)
- Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
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Istanbul
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Kadıköy, Istanbul, Turecko (Türkiye), 34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
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Anhui
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Bengbu, Anhui, Čína, 233000
- The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
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Hefei, Anhui, Čína, 230071
- Anhui Provincial Hospital ( Site 2043)
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 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, Čína, 730000
- Gansu Provincial Hospital ( Site 2065)
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Guangdong
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Guangzhou, Guangdong, Čína, 510000
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
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Guangzhou, Guangdong, Čína, 510515
- Southern Medical University Nanfang Hospital ( Site 2037)
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Guizhou
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Guiyang, Guizhou, Čína, 550004
- The Affiliated Hospital of Guizhou Medical University ( Site 2051)
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Hebei
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Shijiazhuang, Hebei, Čína, 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, Čína, 471003
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
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Hubei
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Wuhan, Hubei, Čína, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
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Hunan
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Hengyang, Hunan, Čína, 421001
- The First Affiliated Hospital of Nanhua University ( Site 2061)
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Inner Mongolia
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Baotou, Inner Mongolia, Čína, 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, Čína, 226001
- Affiliated Hospital of Nantong University ( Site 2027)
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Jiangxi
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Pingxiang, Jiangxi, Čína, 337055
- Pingxiang People's Hospital ( Site 2005)
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Jilin
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Changchun, Jilin, Čína, 130021
- Jilin Province People's Hospital ( Site 2033)
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Shaanxi
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Xi'an, Shaanxi, Čína, 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, Čína, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
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Shanxi
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Taiyuan, Shanxi, Čína, 030032
- Shanxi Bethune Hospital ( Site 2029)
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Sichuan
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Chengdu, Sichuan, Čína, 610500
- The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Čína, 300052
- Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
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Barcelona, Španělsko, 08035
- Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
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Seville, Španělsko, 41010
- Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
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Valladolid, Španělsko, 47012
- Hospital Universitario Rio Hortega ( Site 1606)
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La Coruna
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A Coruña, La Coruna, Španělsko, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Španělsko, 46010
- HOSPITAL CLINICO DE VALENCIA ( Site 1608)
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Má diagnózu systémového lupus erythematodes (SLE) ≥ 6 měsíců před screeningem.
- Užívá alespoň 1 základní terapii (1 imunosupresivum nebo dapson a/nebo 1 antimalarikum a/nebo perorální kortikosteroidy) pro SLE.
- Má + antinukleární protilátku (+ANA) (titr ≥1:80) nebo pozitivní protilátku proti dvouvláknové deoxyribonukleové kyselině (dsDNA) nebo pozitivní anti-Sm protilátku nebo pozitivní anti-SSA/Ro protilátku.
- Má přítomnost alespoň jednoho z následujících projevů SLE: Aktivní lupusová vyrážka s erytémem CLASI-A a kombinované skóre měřítka/hypertrofie >2 nebo >2 citlivé a oteklé klouby v zápěstích, metakarpofalangeách (MCP) nebo proximálních interfalangeách ( PIP).
- Má celkové skóre indexu aktivity hybridního systémového lupus erythematodes Disease Activity Index (SLEDAI) ≥6 a klinické hybridní skóre SLEDAI ≥4.
Kritéria vyloučení:
- Má souběžné klinicky významné onemocnění nebo klinicky relevantní laboratorní abnormality nebo má v anamnéze jakékoli onemocnění nebo zdravotní stav, který by podle názoru zkoušejícího mohl zmást výsledky studie nebo představovat další riziko pro účastníka tím, že se účastní studie.
- Má symptomatické srdeční selhání (třída III nebo IV New York Heart Association) nebo infarkt myokardu nebo nestabilní anginu pectoris během 6 měsíců před screeningem.
- Má závažné chronické plicní onemocnění vyžadující kyslíkovou terapii.
- Má transplantovaný orgán, který vyžaduje pokračující imunosupresi.
- Má známou systémovou přecitlivělost na IL-2 nebo modifikovaný IL-2 včetně MK-6194 nebo jeho neaktivní složky.
- Má známou anamnézu lymfoproliferativního onemocnění, včetně lymfomu, nebo známky a příznaky naznačující možné lymfoproliferativní onemocnění, jako je lymfadenopatie a/nebo splenomegalie.
- Má lékem indukovaný kožní lupus erythematodes (CLE) a/nebo lékem indukovaný SLE v podmínkách pokračující léčby kauzálním činidlem.
- Má aktivní nebo nestabilní neuropsychiatrický lupus včetně, ale bez omezení na následující: záchvat, nová nebo zhoršená porucha vědomí, psychóza, delirium nebo zmatený stav, aseptická meningitida, kraniální neuropatie, cerebrovaskulární příhoda, ascendentní nebo transverzální myelitida, chorea, cerebelární ataxie, mononeuritis multiplex nebo demyelinizační syndromy.
- Má diagnostikovaný antifosfolipidový syndrom s anamnézou vaskulární trombózy, katastrofální APS nebo těhotenskou morbiditou během 6 měsíců před screeningem.
- Má v anamnéze jakoukoli malignitu, kromě úspěšně léčené nemelanomové rakoviny kůže nebo lokalizovaného karcinomu in situ děložního čípku.
- Má aktivní klinicky významnou infekci nebo jakoukoli infekci vyžadující hospitalizaci nebo léčbu antiinfekčními látkami.
- Má známky aktivní tuberkulózy (TBC), latentní TBC nebo nedostatečně léčené TBC.
- Má potvrzenou infekci COVID-19 nebo podezření na ni.
- Prodělal větší chirurgický zákrok během 3 měsíců před screeningem nebo má během studie naplánovaný velký chirurgický zákrok.
- Užívá více než 1 imunosupresivum.
- Užívá více než 1 perorální NSAID (kromě nízké dávky aspirinu [<350 mg/den]) nebo užívá denně perorální nesteroidní protizánětlivé léčivo (NSAID) ve vyšší než maximální doporučené dávce.
- V současné době je na jakékoli chronické systémové (perorální nebo IV) antiinfekční léčbě chronické infekce (jako je pneumocystis, cytomegalovirus, herpes zoster nebo atypické mykobakterie).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Počet zbraní
7
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Experimentální: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
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SC injekce
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Experimentální: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
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SC injekce
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Komparátor placeba: Placebo
Participants receive SC placebo q2w.
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SC injekce
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Experimentální: MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continue to receive SC MK-6194 3 mg q2w in the extension period.
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SC injekce
|
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Experimentální: MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continue to receive SC MK-6194 3 mg q4w in the extension period.
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SC injekce
|
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Experimentální: Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
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SC injekce
SC injekce
|
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Experimentální: Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
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SC injekce
SC injekce
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Časové okno: Week 28
|
The SRI was a composite index used to assess clinical improvement in participants with SLE.
The SRI-4 response evaluated global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the participant's overall condition.
SRI-4 response was binary and either achieved or not achieved by the participant, thus there was no associated score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
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Week 28
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Number of Participants Who Experienced an Adverse Event (AE)
Časové okno: Up to approximately 16 months
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
AEs were reported based on study treatment received by the participant at time of event.
The number of participants who experienced one or more AEs was reported.
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Up to approximately 16 months
|
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Number of Participants Who Discontinued Study Treatment Due to an AE
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Časové okno: 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
|
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Number of Participants Achieving SRI-4 Response at Week 52
Časové okno: 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
|
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Number of Participants Achieving BICLA Response at Week 52
Časové okno: 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
|
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Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28
Časové okno: 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
|
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Number of Participants With a CLASI-50 Response at Week 52
Časové okno: Week 52
|
The CLASI-A score was used to evaluate lupus skin manifestations, with higher scores indicating increased disease severity and lower scores indicating less disease severity.
CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represented disease severity of mild, moderate, and severe, respectively.
CLASI-50 was 50% improvement from baseline in the CLASI-A score.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of counts calculated as percentages was reported.
|
Week 52
|
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Change From Baseline in Swollen Joint Count at Week 28
Časové okno: 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
|
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Change From Baseline in Swollen Joint Count at Week 52
Časové okno: 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
|
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Change From Baseline in Tender Joint Count at Week 28
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Change From Baseline in Oral Corticosteroid Dose at Week 28
Časové okno: 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
Časové okno: 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
|
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Cumulative Oral Corticosteroid Use Between Week 0 and Week 28
Časové okno: 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
Časové okno: Up to approximately 52 weeks
|
Participants were assessed for cumulative oral corticosteroid dose.
Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose.
The cumulative oral corticosteroid dose at Week 52, calculated from Week 0 (Day 1) to Week 52 was reported.
Due to insufficient sample size, no statistical analysis was performed.
Descriptive statistics in the form of means and standard deviations were reported.
|
Up to approximately 52 weeks
|
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Number of Participants Who Achieved Low Level of Disease Activity (LLDAS) at Week 28
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Medical Director, Merck Sharp & Dohme LLC
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
27. prosince 2023
Primární dokončení (Aktuální)
Primární dokončení
30. července 2025
Dokončení studie (Aktuální)
Dokončení studie
30. července 2025
Termíny zápisu do studia
První předloženo
První předloženo
29. listopadu 2023
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
29. listopadu 2023
První zveřejněno (Aktuální)
První zveřejněno
7. prosince 2023
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
10. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. července 2026
Naposledy ověřeno
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 6194-006
- MK-6194-006 (Jiný identifikátor: MSD)
- U1111-1291-8716 (Identifikátor registru: UTN)
- jRCT2041230137 (Identifikátor registru: jRCT)
- 2023-505520-61-00 (Identifikátor registru: EU CT)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .