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Werkzaamheid en veiligheid van MK-6194 bij volwassen deelnemers met systemische lupus erythematosus (MK-6194-006)

16 juli 2026 bijgewerkt door: Merck Sharp & Dohme LLC

Een fase 2a, multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde studie om de werkzaamheid en veiligheid van MK-6194 te evalueren bij volwassen deelnemers met systemische lupus erythematosus

Het doel van deze studie is om de werkzaamheid en veiligheid van MK-6194 bij volwassen deelnemers met systemische lupus erythematosus te evalueren. De primaire hypothese is dat ten minste 1 van de MK-6194-armen superieur is aan placebo wat betreft het primaire eindpunt van het percentage deelnemers met een systemische lupus erythematosus-responderindex (SRI-4)-respons in week 28.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

149

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Mendoza, Argentinië, M5500CPH
        • Instituto de Reumatología ( Site 0201)
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentinië, 7600
        • Centro de Investigaciones Médicas Mar del Plata ( Site 0210)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentinië, S2000DVC
        • Sanatorio Parque ( Site 0205)
      • Santa Fe, Santa Fe Province, Argentinië, S3000BPJ
        • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
    • Tucumán Province
      • SAN M. de Tucuman, Tucumán Province, Argentinië, T4000AXL
        • Centro de Investigaciones Médicas Tucuman ( Site 0203)
  • Brazilië
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazilië, 78020-500
        • IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90480-000
        • LMK Serviços Médicos S/S-Reumacenter ( Site 0303)
    • São Paulo
      • São Bernardo do Campo, São Paulo, Brazilië, 09715-090
        • Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
      • São José do Rio Preto, São Paulo, Brazilië, 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)
  • Chili
    • Araucania
      • Temuco, Araucania, Chili, 4800827
        • James Lind Centro de Investigacion del Cancer ( Site 0407)
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chili, 1720430
        • IC La Serena Research ( Site 0414)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chili, 7640881
        • Clinica Dermacross ( Site 0416)
      • Santiago, Region M. de Santiago, Chili, 8207257
        • Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
      • Santiago, Region M. de Santiago, Chili, 8320000
        • CECIM ( Site 0405)
      • Santiago, Region M. de Santiago, Chili, 8420383
        • Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
      • Hefei, Anhui, China, 230071
        • Anhui Provincial Hospital ( Site 2043)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Peking Union Medical College Hospital-Department of Rheumatology and Immunology ( Site 2001)
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Gansu Provincial Hospital ( Site 2065)
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital ( Site 2037)
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • The Affiliated Hospital of Guizhou Medical University ( Site 2051)
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Afilliated Hospital of Hebei Medical University-Immunology And Rheumatology ( Site 2064)
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
    • Hunan
      • Hengyang, Hunan, China, 421001
        • The First Affiliated Hospital of Nanhua University ( Site 2061)
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Te ( Site 2006)
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
        • Affiliated Hospital of Nantong University ( Site 2027)
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337055
        • Pingxiang People's Hospital ( Site 2005)
    • Jilin
      • Changchun, Jilin, China, 130021
        • Jilin Province People's Hospital ( Site 2033)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2056)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Bethune Hospital ( Site 2029)
    • Sichuan
      • Chengdu, Sichuan, China, 610500
        • The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
  • 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)
  • Filippijnen
      • Iloilo City, Filippijnen, 5000
        • Iloilo Doctors' Hospital ( Site 2301)
    • Batangas
      • Lipa City, Batangas, Filippijnen, 4217
        • Mary Mediatrix Medical Center ( Site 2303)
    • National Capital Region
      • Quezon City, National Capital Region, Filippijnen, 1102
        • ST. LUKE'S MEDICAL CENTER ( Site 2304)
  • Frankrijk
    • Aquitaine
      • Pessac, Aquitaine, Frankrijk, 33600
        • CHU Bordeaux Haut-Leveque ( Site 1007)
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankrijk, 69007
        • Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Frankrijk, 31400
        • CHU Rangueil ( Site 1008)
    • Herault
      • Montpellier, Herault, Frankrijk, 34295
        • CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
    • Nord
      • Lille, Nord, Frankrijk, 59037
        • Hopital Claude Huriez - CHU de Lille ( Site 1005)
    • Pays de la Loire Region
      • Saint Priest En Jarez, Pays de la Loire Region, Frankrijk, 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)
  • Italië
      • Florence, Italië, 50141
        • AOU Careggi ( Site 1311)
      • Naples, Italië, 80131
        • Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
      • Roma, Italië, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
    • Milano
      • Rozzano, Milano, Italië, 20089
        • Istituto Clinico Humanitas Research Hospital ( Site 1310)
    • Roma
      • Rome, Roma, Italië, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
    • Tuscany
      • Siena, Tuscany, Italië, 53100
        • Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
    • Veneto
      • Padova, Veneto, Italië, 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)
  • Maleisië
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Maleisië, 56000
        • Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
      • Lembah Pantai, Kuala Lumpur, Maleisië, 59100
        • University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
    • Pahang
      • Kuantan, Pahang, Maleisië, 25100
        • Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
    • Perak
      • Taiping, Perak, Maleisië, 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)
  • Spanje
      • Barcelona, Spanje, 08035
        • Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
      • Seville, Spanje, 41010
        • Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
      • Valladolid, Spanje, 47012
        • Hospital Universitario Rio Hortega ( Site 1606)
    • La Coruna
      • A Coruña, La Coruna, Spanje, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spanje, 46010
        • HOSPITAL CLINICO DE VALENCIA ( Site 1608)
  • Turkije (Türkiye)
      • Ankara, Turkije (Türkiye), 06230
        • ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
      • Ankara, Turkije (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
      • Sakarya, Turkije (Türkiye)
        • Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
    • Istanbul
      • Kadıköy, Istanbul, Turkije (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
  • Verenigde Staten
    • California
      • Covina, California, Verenigde Staten, 91722
        • Medvin Clinical Research - Metyas ( Site 0128)
      • La Jolla, California, Verenigde Staten, 92037
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
      • La Palma, California, Verenigde Staten, 90623
        • Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
      • Tujunga, California, Verenigde Staten, 91042
        • Medvin Clinical Research - Tujunga ( Site 0127)
    • Colorado
      • Denver, Colorado, Verenigde Staten, 80230
        • Denver Arthritis Clinic ( Site 0102)
    • Florida
      • Clearwater, Florida, Verenigde Staten, 33765
        • Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
      • Plantation, Florida, Verenigde Staten, 33324
        • IRIS Research and Development, LLC-Research ( Site 0117)
      • Tampa, Florida, Verenigde Staten, 33606
        • Clinical Research of West Florida, Inc ( Site 0124)
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30310
        • Morehouse School of Medicine ( Site 0146)
    • Louisiana
      • Lake Charles, Louisiana, Verenigde Staten, 70605
        • Accurate Clinical Research, Inc ( Site 0135)
    • Michigan
      • Grand Blanc, Michigan, Verenigde Staten, 48439
        • AA Medical Research Center ( Site 0136)
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten, 28210
        • Javara - Tryon Medical Partners ( Site 0121)
      • Charlotte, North Carolina, Verenigde Staten, 28211
        • DJL Clinical Research, PLLC ( Site 0103)
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • University of Oklahoma Health Science Center ( Site 0130)
    • Tennessee
      • Memphis, Tennessee, Verenigde Staten, 38119
        • Shelby Research, LLC ( Site 0142)
    • Texas
      • Baytown, Texas, Verenigde Staten, 77521
        • Accurate Clinical Management, LLC. ( Site 0134)
      • DeSoto, Texas, Verenigde Staten, 75115
        • Epic Medical Research ( Site 0113)
      • Houston, Texas, Verenigde Staten, 77089
        • Accurate Clinical Research, Inc. ( Site 0133)
      • Mesquite, Texas, Verenigde Staten, 75150
        • SouthWest Rheumatology Research, LLC ( Site 0115)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  • Heeft een diagnose van systemische lupus erythematosus (SLE) ≥6 maanden vóór de screening.
  • Neemt minimaal 1 achtergrondtherapie (1 immunosuppressivum of dapson en/of 1 antimalariamiddel en/of orale corticosteroïden) voor SLE.
  • Heeft + antinucleair antilichaam (+ANA) (titer ≥1:80) of positief anti-dubbelstrengs deoxyribonucleïnezuur (dsDNA) antilichaam of positief anti-Sm-antilichaam, of positief anti-SSA/Ro-antilichaam.
  • Heeft de aanwezigheid van ten minste één van de volgende manifestaties van SLE: Actieve lupusuitslag met CLASI-A erytheem en schaal/hypertrofie gecombineerde score>2, of>2 gevoelige en gezwollen gewrichten in polsen, metacarpofalangeale (MCP's) of proximale interfalangeale gewrichten ( PIP's).
  • Heeft een hybride Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-totaalscore van ≥6 en een klinische hybride SLEDAI-score van ≥4.

Uitsluitingscriteria:

  • Heeft gelijktijdig een klinisch significante ziekte of klinisch relevante laboratoriumafwijkingen, of heeft een voorgeschiedenis van een ziekte of medische aandoening die, naar de mening van de onderzoeker, de resultaten van het onderzoek zou kunnen vertroebelen of een extra risico voor de deelnemer zou kunnen vormen door deelname aan het onderzoek. studie.
  • Heeft symptomatisch hartfalen (New York Heart Association klasse III of IV) of een hartinfarct of instabiele angina pectoris binnen 6 maanden voorafgaand aan de screening.
  • Heeft een ernstige chronische longziekte die zuurstoftherapie vereist.
  • Heeft een getransplanteerd orgaan waarvoor voortdurende immunosuppressie nodig is.
  • Heeft een bekende systemische overgevoeligheid voor IL-2, of gemodificeerd IL-2 inclusief MK-6194, of de inactieve ingrediënten ervan.
  • Heeft een bekende voorgeschiedenis van lymfoproliferatieve ziekte, waaronder lymfoom, of tekenen en symptomen die wijzen op een mogelijke lymfoproliferatieve ziekte, zoals lymfadenopathie en/of splenomegalie.
  • Heeft door geneesmiddelen geïnduceerde cutane lupus erythematosus (CLE) en/of door geneesmiddelen geïnduceerde SLE in de setting van voortgezette behandeling met een veroorzaker.
  • Heeft actieve of onstabiele neuropsychiatrische lupus, inclusief maar niet beperkt tot het volgende: toevallen, nieuw of verergerend verminderd bewustzijnsniveau, psychose, delirium of verwarde toestand, aseptische meningitis, craniale neuropathie, cerebrovasculair accident, opstijgende of transversale myelitis, chorea, cerebellaire ataxie, mononeuritis multiplex of demyeliniserende syndromen.
  • Heeft een diagnose van antifosfolipidensyndroom met een voorgeschiedenis van vasculaire trombose, catastrofale APS of zwangerschapsmorbiditeit binnen 6 maanden voorafgaand aan de screening.
  • Heeft een voorgeschiedenis van enige vorm van maligniteit, met uitzondering van succesvol behandelde niet-melanome huidkanker of gelokaliseerd carcinoom in situ van de baarmoederhals.
  • Heeft een actieve, klinisch significante infectie, of een infectie waarvoor ziekenhuisopname of behandeling met anti-infectieuze middelen vereist is.
  • Heeft aanwijzingen voor actieve tuberculose (tbc), latente tuberculose of onvoldoende behandelde tuberculose.
  • Heeft een bevestigde of vermoede besmetting met COVID-19.
  • Heeft binnen de 3 maanden voorafgaand aan de screening een grote operatie ondergaan of heeft tijdens het onderzoek een grote operatie gepland.
  • Neemt meer dan 1 immunosuppressivum.
  • Neemt meer dan 1 oraal NSAID (met uitzondering van een lage dosis aspirine [<350 mg/dag]) of gebruikt dagelijks een oraal niet-steroïde anti-inflammatoir geneesmiddel (NSAID) in een hogere dosis dan de maximaal aanbevolen dosering.
  • Krijgt momenteel een chronische systemische (orale of IV) anti-infectieuze therapie voor chronische infecties (zoals pneumocystis, cytomegalovirus, herpes zoster of atypische mycobacteriën).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
Biologisch: MK-6194
SC-injectie
Experimenteel: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
Biologisch: MK-6194
SC-injectie
Placebo-vergelijker: Placebo
Participants receive SC placebo q2w.
Biologisch: Placebo
SC-injectie
Experimenteel: 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.
Biologisch: MK-6194
SC-injectie
Experimenteel: 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.
Biologisch: MK-6194
SC-injectie
Experimenteel: 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.
Biologisch: MK-6194
SC-injectie
Biologisch: Placebo
SC-injectie
Experimenteel: 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.
Biologisch: MK-6194
SC-injectie
Biologisch: Placebo
SC-injectie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 december 2023

Primaire voltooiing (Werkelijk)

30 juli 2025

Studie voltooiing (Werkelijk)

30 juli 2025

Studieregistratiedata

Eerst ingediend

29 november 2023

Eerst ingediend dat voldeed aan de QC-criteria

29 november 2023

Eerst geplaatst (Werkelijk)

7 december 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 6194-006
  • MK-6194-006 (Andere identificatie: MSD)
  • U1111-1291-8716 (Register-ID: UTN)
  • jRCT2041230137 (Register-ID: jRCT)
  • 2023-505520-61-00 (Register-ID: EU CT)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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