Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effekt og sikkerhet av MK-6194 hos voksne deltakere med systemisk lupus erythematosus (MK-6194-006)

16. juli 2026 oppdatert av: Merck Sharp & Dohme LLC

En fase 2a, multisenter, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til MK-6194 hos voksne deltakere med systemisk lupus erythematosus

Formålet med denne studien er å evaluere effekten og sikkerheten til MK-6194 hos voksne deltakere med systemisk lupus erythematosus. Den primære hypotesen er at minst 1 av MK-6194-armene er overlegen placebo i det primære endepunktet for prosentandelen av deltakerne med systemisk lupus erythematosus-responsindeks (SRI-4)-respons ved uke 28.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

149

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Mendoza, Argentina, M5500CPH
        • Instituto de Reumatología ( Site 0201)
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Centro de Investigaciones Médicas Mar del Plata ( Site 0210)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DVC
        • Sanatorio Parque ( Site 0205)
      • Santa Fe, Santa Fe Province, Argentina, S3000BPJ
        • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
    • Tucumán Province
      • SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman ( Site 0203)
  • Brasil
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brasil, 78020-500
        • IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
      • Porto Alegre, Rio Grande do Sul, Brasil, 90480-000
        • LMK Serviços Médicos S/S-Reumacenter ( Site 0303)
    • São Paulo
      • São Bernardo do Campo, São Paulo, Brasil, 09715-090
        • Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
      • São José do Rio Preto, São Paulo, Brasil, 15090-000
        • Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Diex Recherche Sherbrooke ( Site 0003)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • James Lind Centro de Investigacion del Cancer ( Site 0407)
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • IC La Serena Research ( Site 0414)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7640881
        • Clinica Dermacross ( Site 0416)
      • Santiago, Region M. de Santiago, Chile, 8207257
        • Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
      • Santiago, Region M. de Santiago, Chile, 8320000
        • CECIM ( Site 0405)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 50021
        • Salud SURA Industriales ( Site 0508)
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Clinica de la Costa S.A.S. ( Site 0502)
      • Barranquilla, Atlántico, Colombia, 080002
        • Centro Integral de Reumatología del Caribe ( Site 0501)
    • Cundinamarca
      • Chía, Cundinamarca, Colombia, 250001
        • Preventive Care ( Site 0507)
      • Zipaquirá, Cundinamarca, Colombia, 250252
        • Healthy Medical Center S.A.S ( Site 0505)
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Fundación Valle del Lili ( Site 0506)
      • Cali, Valle del Cauca Department, Colombia, 760042
        • Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
  • Filippinene
      • Iloilo City, Filippinene, 5000
        • Iloilo Doctors' Hospital ( Site 2301)
    • Batangas
      • Lipa City, Batangas, Filippinene, 4217
        • Mary Mediatrix Medical Center ( Site 2303)
    • National Capital Region
      • Quezon City, National Capital Region, Filippinene, 1102
        • ST. LUKE'S MEDICAL CENTER ( Site 2304)
  • Forente stater
    • California
      • Covina, California, Forente stater, 91722
        • Medvin Clinical Research - Metyas ( Site 0128)
      • La Jolla, California, Forente stater, 92037
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
      • La Palma, California, Forente stater, 90623
        • Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
      • Tujunga, California, Forente stater, 91042
        • Medvin Clinical Research - Tujunga ( Site 0127)
    • Colorado
      • Denver, Colorado, Forente stater, 80230
        • Denver Arthritis Clinic ( Site 0102)
    • Florida
      • Clearwater, Florida, Forente stater, 33765
        • Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
      • Plantation, Florida, Forente stater, 33324
        • IRIS Research and Development, LLC-Research ( Site 0117)
      • Tampa, Florida, Forente stater, 33606
        • Clinical Research of West Florida, Inc ( Site 0124)
    • Georgia
      • Atlanta, Georgia, Forente stater, 30310
        • Morehouse School of Medicine ( Site 0146)
    • Louisiana
      • Lake Charles, Louisiana, Forente stater, 70605
        • Accurate Clinical Research, Inc ( Site 0135)
    • Michigan
      • Grand Blanc, Michigan, Forente stater, 48439
        • AA Medical Research Center ( Site 0136)
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28210
        • Javara - Tryon Medical Partners ( Site 0121)
      • Charlotte, North Carolina, Forente stater, 28211
        • DJL Clinical Research, PLLC ( Site 0103)
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Science Center ( Site 0130)
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38119
        • Shelby Research, LLC ( Site 0142)
    • Texas
      • Baytown, Texas, Forente stater, 77521
        • Accurate Clinical Management, LLC. ( Site 0134)
      • DeSoto, Texas, Forente stater, 75115
        • Epic Medical Research ( Site 0113)
      • Houston, Texas, Forente stater, 77089
        • Accurate Clinical Research, Inc. ( Site 0133)
      • Mesquite, Texas, Forente stater, 75150
        • SouthWest Rheumatology Research, LLC ( Site 0115)
  • Frankrike
    • Aquitaine
      • Pessac, Aquitaine, Frankrike, 33600
        • CHU Bordeaux Haut-Leveque ( Site 1007)
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankrike, 69007
        • Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Frankrike, 31400
        • CHU Rangueil ( Site 1008)
    • Herault
      • Montpellier, Herault, Frankrike, 34295
        • CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
    • Nord
      • Lille, Nord, Frankrike, 59037
        • Hopital Claude Huriez - CHU de Lille ( Site 1005)
    • Pays de la Loire Region
      • Saint Priest En Jarez, Pays de la Loire Region, Frankrike, 42270
        • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
  • Guatemala
      • Guatemala City, Guatemala, 01009
        • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)
      • Guatemala City, Guatemala, 01010
        • CELAN,S.A ( Site 0603)
      • Guatemala City, Guatemala, 01010
        • Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)
  • Italia
      • Florence, Italia, 50141
        • AOU Careggi ( Site 1311)
      • Naples, Italia, 80131
        • Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
      • Roma, Italia, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
    • Milano
      • Rozzano, Milano, Italia, 20089
        • Istituto Clinico Humanitas Research Hospital ( Site 1310)
    • Roma
      • Rome, Roma, Italia, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
    • Tuscany
      • Siena, Tuscany, Italia, 53100
        • Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
    • Veneto
      • Padova, Veneto, Italia, 35128
        • Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital ( Site 2120)
      • Chiba, Japan, 260-8712
        • NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 2106)
      • Osaka, Japan, 543-8922
        • Osaka Keisatsu Hospital ( Site 2117)
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8510
        • Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University Hospital ( Site 2121)
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital ( Site 2116)
    • Okinawa
      • Tomigusuku, Okinawa, Japan, 901-0224
        • Yuuai Medical Center ( Site 2122)
    • Shimane
      • Izumo, Shimane, Japan, 693-0021
        • Shimane University Hospital ( Site 2119)
    • Tochigi
      • Shimotsuga, Tochigi, Japan, 321-0293
        • Dokkyo Medical University Hospital ( Site 2118)
    • Tokyo
      • Itabashiku, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital ( Site 2105)
      • Shinagawa, Tokyo, Japan, 142-0054
        • Showa Medical University East Hospital ( Site 2123)
  • Kina
    • Anhui
      • Bengbu, Anhui, Kina, 233000
        • The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
      • Hefei, Anhui, Kina, 230071
        • Anhui Provincial Hospital ( Site 2043)
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100730
        • Beijing Peking Union Medical College Hospital-Department of Rheumatology and Immunology ( Site 2001)
    • Gansu
      • Lanzhou, Gansu, Kina, 730000
        • Gansu Provincial Hospital ( Site 2065)
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
      • Guangzhou, Guangdong, Kina, 510515
        • Southern Medical University Nanfang Hospital ( Site 2037)
    • Guizhou
      • Guiyang, Guizhou, Kina, 550004
        • The Affiliated Hospital of Guizhou Medical University ( Site 2051)
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050000
        • The Second Afilliated Hospital of Hebei Medical University-Immunology And Rheumatology ( Site 2064)
    • Henan
      • Luoyang, Henan, Kina, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
    • Hubei
      • Wuhan, Hubei, Kina, 430000
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
    • Hunan
      • Hengyang, Hunan, Kina, 421001
        • The First Affiliated Hospital of Nanhua University ( Site 2061)
    • Inner Mongolia
      • Baotou, Inner Mongolia, Kina, 014010
        • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Te ( Site 2006)
    • Jiangsu
      • Nantong, Jiangsu, Kina, 226001
        • Affiliated Hospital of Nantong University ( Site 2027)
    • Jiangxi
      • Pingxiang, Jiangxi, Kina, 337055
        • Pingxiang People's Hospital ( Site 2005)
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • Jilin Province People's Hospital ( Site 2033)
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2056)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200001
        • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
    • Shanxi
      • Taiyuan, Shanxi, Kina, 030032
        • Shanxi Bethune Hospital ( Site 2029)
    • Sichuan
      • Chengdu, Sichuan, Kina, 610500
        • The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300052
        • Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
    • Perak
      • Taiping, Perak, Malaysia, 34000
        • Hospital Taiping ( Site 2221)
  • Mexico
      • Chihuahua City, Mexico, 31000
        • ICARO Investigaciones en Medicina ( Site 0702)
      • Distrito Federal, Mexico, 06700
        • Clinstile, S.A. de C.V. ( Site 0709)
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion ( Site 0710)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro Integral en Reumatologia ( Site 0701)
      • Guadalajara, Jalisco, Mexico, 44638
        • Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
      • Guadalajara, Jalisco, Mexico, 44690
        • Centro de Estudios de Investigacion Basica y Clinica ( Site 0708)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • RM Pharma Specialists ( Site 0711)
      • Mexico City, Mexico City, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78250
        • Centro Potosino de Investigación Médica ( Site 0703)
    • Yucatán
      • Mérida, Yucatán, Mexico, 97130
        • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
  • Polen
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 60-218
        • Medyczne Centrum Hetmańska ( Site 1406)
      • Poznan, Greater Poland Voivodeship, Polen, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-065
        • MICS Centrum Medyczne Bydgoszcz ( Site 1410)
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 30-363
        • Centrum Medyczne Plejady ( Site 1407)
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-607
        • Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 00-874
        • MICS Centrum Medyczne Warszawa ( Site 1411)
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-707
        • Nova Reuma Społka Partnerska ( Site 1405)
    • Silesian Voivodeship
      • Bytom, Silesian Voivodeship, Polen, 41-902
        • NZOZ BIF-MED ( Site 1409)
  • Spania
      • Barcelona, Spania, 08035
        • Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
      • Seville, Spania, 41010
        • Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
      • Valladolid, Spania, 47012
        • Hospital Universitario Rio Hortega ( Site 1606)
    • La Coruna
      • A Coruña, La Coruna, Spania, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spania, 46010
        • HOSPITAL CLINICO DE VALENCIA ( Site 1608)
  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye), 06230
        • ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
      • Ankara, Tyrkia (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
      • Sakarya, Tyrkia (Türkiye)
        • Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
    • Istanbul
      • Kadıköy, Istanbul, Tyrkia (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Har en diagnose av systemisk lupus erythematosus (SLE) ≥6 måneder før screening.
  • Tar minst 1 bakgrunnsbehandling (1 immunsuppressiv eller dapson og/eller 1 antimalariamiddel og/eller orale kortikosteroider) for SLE.
  • Har + antinukleært antistoff (+ANA) (titer ≥1:80) eller positivt anti-dobbeltstrenget deoksyribonukleinsyre (dsDNA) antistoff eller positivt anti-Sm antistoff, eller positivt anti-SSA/Ro antistoff.
  • Har tilstedeværelse av minst én av følgende manifestasjoner av SLE: Aktivt lupusutslett med CLASI-A erytem og skala/hypertrofi kombinert skår >2, eller >2 ømme og hovne ledd i håndledd, metakarpofalangealer (MCP) eller proksimale interfalangealer ( PIP-er).
  • Har en hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) totalskåre på ≥6 og klinisk hybrid SLEDAI-score på ≥4.

Ekskluderingskriterier:

  • Har en samtidig klinisk signifikant sykdom eller klinisk relevante laboratorieavvik, eller en historie med sykdom eller medisinsk tilstand som, etter etterforskerens oppfatning, kan forvirre resultatene av studien eller utgjøre en ytterligere risiko for deltakeren ved deres deltakelse i studere.
  • Har symptomatisk hjertesvikt (New York Heart Association klasse III eller IV) eller hjerteinfarkt eller ustabil angina pectoris innen 6 måneder før screening.
  • Har en alvorlig kronisk lungesykdom som krever oksygenbehandling.
  • Har et transplantert organ som krever fortsatt immunsuppresjon.
  • Har en kjent systemisk overfølsomhet overfor IL-2, eller modifisert IL-2 inkludert MK-6194, eller dets inaktive ingredienser.
  • Har en kjent historie med lymfoproliferativ sykdom, inkludert lymfom, eller tegn og symptomer som tyder på mulig lymfoproliferativ sykdom, som lymfadenopati og/eller splenomegali.
  • Har legemiddelindusert kutan lupus erythematosus (CLE) og/eller legemiddelindusert SLE i sammenheng med fortsatt behandling med et forårsakende middel.
  • Har aktiv eller ustabil nevropsykiatrisk lupus inkludert, men ikke begrenset til følgende: anfall, nytt eller forverret nedsatt bevissthetsnivå, psykose, delirium eller forvirret tilstand, aseptisk meningitt, kranial nevropati, cerebrovaskulær ulykke, ascenderende eller transversell myelitt, chorea, cerebellar ataksi, mononeuritt multipleks eller demyeliniserende syndromer.
  • Har en diagnose av antifosfolipidsyndrom med en historie med vaskulær trombose, katastrofal APS eller svangerskapssykdom innen 6 måneder før screening.
  • Har en historie med malignitet, bortsett fra vellykket behandlet ikke-melanom hudkreft eller lokalisert karsinom in situ i livmorhalsen.
  • Har en aktiv klinisk signifikant infeksjon, eller enhver infeksjon som krever sykehusinnleggelse eller behandling med anti-infeksjonsmidler.
  • Har tegn på aktiv tuberkulose (TB), latent tuberkulose eller utilstrekkelig behandlet tuberkulose.
  • Har bekreftet eller mistenkt COVID-19-infeksjon.
  • Har hatt en større operasjon innen 3 måneder før screening eller har planlagt en større operasjon i løpet av studien.
  • Tar mer enn 1 immundempende middel.
  • Tar mer enn 1 oralt NSAID (unntatt lavdose acetylsalisylsyre [<350 mg/dag]) eller tar daglig oralt ikke-steroid antiinflammatorisk legemiddel (NSAID) i høyere dose enn den maksimale anbefalte dosen.
  • Er for tiden på en hvilken som helst kronisk systemisk (oral eller IV) anti-infeksjonsbehandling for kronisk infeksjon (som pneumocystis, cytomegalovirus, herpes zoster eller atypiske mykobakterier).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
Biologisk: MK-6194
SC-injeksjon
Eksperimentell: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
Biologisk: MK-6194
SC-injeksjon
Placebo komparator: Placebo
Participants receive SC placebo q2w.
Biologisk: Placebo
SC-injeksjon
Eksperimentell: 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.
Biologisk: MK-6194
SC-injeksjon
Eksperimentell: 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.
Biologisk: MK-6194
SC-injeksjon
Eksperimentell: 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.
Biologisk: MK-6194
SC-injeksjon
Biologisk: Placebo
SC-injeksjon
Eksperimentell: 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.
Biologisk: MK-6194
SC-injeksjon
Biologisk: Placebo
SC-injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Merck Sharp & Dohme LLC

Etterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. desember 2023

Primær fullføring (Faktiske)

30. juli 2025

Studiet fullført (Faktiske)

30. juli 2025

Datoer for studieregistrering

Først innsendt

29. november 2023

Først innsendt som oppfylte QC-kriteriene

29. november 2023

Først lagt ut (Faktiske)

7. desember 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 6194-006
  • MK-6194-006 (Annen identifikator: MSD)
  • U1111-1291-8716 (Registeridentifikator: UTN)
  • jRCT2041230137 (Registeridentifikator: jRCT)
  • 2023-505520-61-00 (Registeridentifikator: EU CT)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere