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Wirksamkeit und Sicherheit von MK-6194 bei erwachsenen Teilnehmern mit systemischem Lupus erythematodes (MK-6194-006)

16. Juli 2026 aktualisiert von: Merck Sharp & Dohme LLC

Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Phase-2a-Studie zur Bewertung der Wirksamkeit und Sicherheit von MK-6194 bei erwachsenen Teilnehmern mit systemischem Lupus erythematodes

Der Zweck dieser Studie besteht darin, die Wirksamkeit und Sicherheit von MK-6194 bei erwachsenen Teilnehmern mit systemischem Lupus erythematodes zu bewerten. Die primäre Hypothese ist, dass mindestens einer der MK-6194-Arme dem Placebo im primären Endpunkt des Prozentsatzes der Teilnehmer mit Ansprechen auf den systemischen Lupus erythematodes Responder Index (SRI-4) in Woche 28 überlegen ist.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

149

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Mendoza, Argentinien, M5500CPH
        • Instituto de Reumatología ( Site 0201)
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentinien, 7600
        • Centro de Investigaciones Médicas Mar del Plata ( Site 0210)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentinien, S2000DVC
        • Sanatorio Parque ( Site 0205)
      • Santa Fe, Santa Fe Province, Argentinien, S3000BPJ
        • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
    • Tucumán Province
      • SAN M. de Tucuman, Tucumán Province, Argentinien, T4000AXL
        • Centro de Investigaciones Médicas Tucuman ( Site 0203)
  • Brasilien
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brasilien, 78020-500
        • IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90480-000
        • LMK Serviços Médicos S/S-Reumacenter ( Site 0303)
    • São Paulo
      • São Bernardo do Campo, São Paulo, Brasilien, 09715-090
        • Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
      • São José do Rio Preto, São Paulo, Brasilien, 15090-000
        • Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
  • 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)
  • 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)
  • Frankreich
    • Aquitaine
      • Pessac, Aquitaine, Frankreich, 33600
        • CHU Bordeaux Haut-Leveque ( Site 1007)
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankreich, 69007
        • Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Frankreich, 31400
        • CHU Rangueil ( Site 1008)
    • Herault
      • Montpellier, Herault, Frankreich, 34295
        • CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
    • Nord
      • Lille, Nord, Frankreich, 59037
        • Hopital Claude Huriez - CHU de Lille ( Site 1005)
    • Pays de la Loire Region
      • Saint Priest En Jarez, Pays de la Loire Region, Frankreich, 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)
  • Italien
      • Florence, Italien, 50141
        • AOU Careggi ( Site 1311)
      • Naples, Italien, 80131
        • Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
      • Roma, Italien, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
    • Milano
      • Rozzano, Milano, Italien, 20089
        • Istituto Clinico Humanitas Research Hospital ( Site 1310)
    • Roma
      • Rome, Roma, Italien, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
    • Tuscany
      • Siena, Tuscany, Italien, 53100
        • Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
    • Veneto
      • Padova, Veneto, Italien, 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)
  • Kanada
    • Quebec
      • Sherbrooke, Quebec, Kanada, J1L 0H8
        • Diex Recherche Sherbrooke ( Site 0003)
  • Kolumbien
    • Antioquia
      • Medellín, Antioquia, Kolumbien, 50021
        • Salud SURA Industriales ( Site 0508)
    • Atlántico
      • Barranquilla, Atlántico, Kolumbien, 080020
        • Clinica de la Costa S.A.S. ( Site 0502)
      • Barranquilla, Atlántico, Kolumbien, 080002
        • Centro Integral de Reumatología del Caribe ( Site 0501)
    • Cundinamarca
      • Chía, Cundinamarca, Kolumbien, 250001
        • Preventive Care ( Site 0507)
      • Zipaquirá, Cundinamarca, Kolumbien, 250252
        • Healthy Medical Center S.A.S ( Site 0505)
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Kolumbien, 760032
        • Fundación Valle del Lili ( Site 0506)
      • Cali, Valle del Cauca Department, Kolumbien, 760042
        • Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
  • 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)
  • Mexiko
      • Chihuahua City, Mexiko, 31000
        • ICARO Investigaciones en Medicina ( Site 0702)
      • Distrito Federal, Mexiko, 06700
        • Clinstile, S.A. de C.V. ( Site 0709)
    • Guanajuato
      • León, Guanajuato, Mexiko, 37000
        • Morales Vargas Centro de Investigacion ( Site 0710)
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 44160
        • Centro Integral en Reumatologia ( Site 0701)
      • Guadalajara, Jalisco, Mexiko, 44638
        • Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
      • Guadalajara, Jalisco, Mexiko, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
      • Guadalajara, Jalisco, Mexiko, 44690
        • Centro de Estudios de Investigacion Basica y Clinica ( Site 0708)
    • Mexico City
      • Mexico City, Mexico City, Mexiko, 03100
        • RM Pharma Specialists ( Site 0711)
      • Mexico City, Mexico City, Mexiko, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)
    • Nuevo León
      • Monterrey, Nuevo León, Mexiko, 64460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexiko, 78250
        • Centro Potosino de Investigación Médica ( Site 0703)
    • Yucatán
      • Mérida, Yucatán, Mexiko, 97130
        • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
  • Philippinen
      • Iloilo City, Philippinen, 5000
        • Iloilo Doctors' Hospital ( Site 2301)
    • Batangas
      • Lipa City, Batangas, Philippinen, 4217
        • Mary Mediatrix Medical Center ( Site 2303)
    • National Capital Region
      • Quezon City, National Capital Region, Philippinen, 1102
        • ST. LUKE'S MEDICAL CENTER ( Site 2304)
  • 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)
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
      • Seville, Spanien, 41010
        • Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
      • Valladolid, Spanien, 47012
        • Hospital Universitario Rio Hortega ( Site 1606)
    • La Coruna
      • A Coruña, La Coruna, Spanien, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spanien, 46010
        • HOSPITAL CLINICO DE VALENCIA ( Site 1608)
  • Türkei (türkiye)
      • Ankara, Türkei (türkiye), 06230
        • ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
      • Ankara, Türkei (türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
      • Sakarya, Türkei (türkiye)
        • Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
    • Istanbul
      • Kadıköy, Istanbul, Türkei (türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
  • Vereinigte Staaten
    • California
      • Covina, California, Vereinigte Staaten, 91722
        • Medvin Clinical Research - Metyas ( Site 0128)
      • La Jolla, California, Vereinigte Staaten, 92037
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
      • La Palma, California, Vereinigte Staaten, 90623
        • Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
      • Tujunga, California, Vereinigte Staaten, 91042
        • Medvin Clinical Research - Tujunga ( Site 0127)
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80230
        • Denver Arthritis Clinic ( Site 0102)
    • Florida
      • Clearwater, Florida, Vereinigte Staaten, 33765
        • Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
      • Plantation, Florida, Vereinigte Staaten, 33324
        • IRIS Research and Development, LLC-Research ( Site 0117)
      • Tampa, Florida, Vereinigte Staaten, 33606
        • Clinical Research of West Florida, Inc ( Site 0124)
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30310
        • Morehouse School of Medicine ( Site 0146)
    • Louisiana
      • Lake Charles, Louisiana, Vereinigte Staaten, 70605
        • Accurate Clinical Research, Inc ( Site 0135)
    • Michigan
      • Grand Blanc, Michigan, Vereinigte Staaten, 48439
        • AA Medical Research Center ( Site 0136)
    • North Carolina
      • Charlotte, North Carolina, Vereinigte Staaten, 28210
        • Javara - Tryon Medical Partners ( Site 0121)
      • Charlotte, North Carolina, Vereinigte Staaten, 28211
        • DJL Clinical Research, PLLC ( Site 0103)
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
        • University of Oklahoma Health Science Center ( Site 0130)
    • Tennessee
      • Memphis, Tennessee, Vereinigte Staaten, 38119
        • Shelby Research, LLC ( Site 0142)
    • Texas
      • Baytown, Texas, Vereinigte Staaten, 77521
        • Accurate Clinical Management, LLC. ( Site 0134)
      • DeSoto, Texas, Vereinigte Staaten, 75115
        • Epic Medical Research ( Site 0113)
      • Houston, Texas, Vereinigte Staaten, 77089
        • Accurate Clinical Research, Inc. ( Site 0133)
      • Mesquite, Texas, Vereinigte Staaten, 75150
        • SouthWest Rheumatology Research, LLC ( Site 0115)

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Hat eine Diagnose von systemischem Lupus erythematodes (SLE) ≥6 Monate vor dem Screening.
  • Nimmt mindestens eine Hintergrundtherapie (1 Immunsuppressivum oder Dapson und/oder 1 Antimalariamittel und/oder orale Kortikosteroide) gegen SLE ein.
  • Hat + antinukleäre Antikörper (+ANA) (Titer ≥1:80) oder positive Anti-Doppelstrang-Desoxyribonukleinsäure (dsDNA)-Antikörper oder positive Anti-Sm-Antikörper oder positive Anti-SSA/Ro-Antikörper.
  • Liegt mindestens eine der folgenden Manifestationen von SLE vor: Aktiver Lupusausschlag mit CLASI-A-Erythem und einem kombinierten Skalen-/Hypertrophie-Score von >2 oder >2 empfindlichen und geschwollenen Gelenken in den Handgelenken, den Metakarpophalangealen (MCPs) oder den proximalen Interphalangealen ( PIPs).
  • Hat einen hybriden Systemic Lupus Erythematodes Disease Activity Index (SLEDAI)-Gesamtscore von ≥6 und einen klinischen Hybrid-SLEDAI-Score von ≥4.

Ausschlusskriterien:

  • Hat gleichzeitig eine klinisch bedeutsame Krankheit oder klinisch relevante Laboranomalien oder eine Vorgeschichte einer Krankheit oder eines medizinischen Zustands, der nach Ansicht des Prüfers die Ergebnisse der Studie verfälschen könnte oder durch seine Teilnahme an der Studie ein zusätzliches Risiko für den Teilnehmer darstellt Studie.
  • Hat innerhalb von 6 Monaten vor dem Screening eine symptomatische Herzinsuffizienz (Klasse III oder IV der New York Heart Association) oder einen Myokardinfarkt oder eine instabile Angina pectoris.
  • Hat eine schwere chronische Lungenerkrankung, die eine Sauerstofftherapie erfordert.
  • Hat ein transplantiertes Organ, das eine fortgesetzte Immunsuppression erfordert.
  • Hat eine bekannte systemische Überempfindlichkeit gegen IL-2 oder modifiziertes IL-2, einschließlich MK-6194, oder seine inaktiven Inhaltsstoffe.
  • Hat eine bekannte Vorgeschichte von lymphoproliferativen Erkrankungen, einschließlich Lymphomen, oder Anzeichen und Symptome, die auf eine mögliche lymphoproliferative Erkrankung hinweisen, wie z. B. Lymphadenopathie und/oder Splenomegalie.
  • Hat einen medikamenteninduzierten kutanen Lupus erythematodes (CLE) und/oder einen medikamenteninduzierten SLE im Rahmen einer fortgesetzten Behandlung mit einem Erreger.
  • Hat aktiven oder instabilen neuropsychiatrischen Lupus, einschließlich, aber nicht beschränkt auf: Krampfanfall, neue oder sich verschlimmernde Bewusstseinsstörungen, Psychose, Delirium oder Verwirrtheitszustand, aseptische Meningitis, kraniale Neuropathie, zerebrovaskulärer Unfall, aufsteigende oder transversale Myelitis, Chorea, Kleinhirnataxie, Mononeuritis multiplex oder demyelinisierende Syndrome.
  • Hat eine Diagnose eines Antiphospholipid-Syndroms mit einer Vorgeschichte von Gefäßthrombosen, katastrophalem APS oder Schwangerschaftsmorbidität innerhalb von 6 Monaten vor dem Screening.
  • Hat eine Vorgeschichte von bösartigen Erkrankungen, mit Ausnahme von erfolgreich behandeltem Nicht-Melanom-Hautkrebs oder lokalisiertem Carcinoma in situ des Gebärmutterhalses.
  • Hat eine aktive, klinisch bedeutsame Infektion oder eine Infektion, die einen Krankenhausaufenthalt oder eine Behandlung mit Antiinfektiva erfordert.
  • Hat Hinweise auf aktive Tuberkulose (TB), latente Tuberkulose oder unzureichend behandelte Tuberkulose.
  • Hat eine bestätigte oder vermutete COVID-19-Infektion.
  • Hat sich innerhalb von 3 Monaten vor dem Screening einer größeren Operation unterzogen oder während der Studie ist eine größere Operation geplant.
  • Nimmt mehr als ein Immunsuppressivum.
  • Nimmt mehr als ein orales NSAID (ausgenommen niedrig dosiertes Aspirin [<350 mg/Tag]) oder nimmt täglich ein orales nichtsteroidales entzündungshemmendes Arzneimittel (NSAID) in einer höheren als der empfohlenen Höchstdosis ein.
  • Befindet sich derzeit in einer chronischen systemischen (oralen oder intravenösen) antiinfektiösen Therapie gegen chronische Infektionen (z. B. Pneumocystis, Cytomegalovirus, Herpes Zoster oder atypische Mykobakterien).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
Biologisch: MK-6194
SC-Injektion
Experimental: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
Biologisch: MK-6194
SC-Injektion
Placebo-Komparator: Placebo
Participants receive SC placebo q2w.
Biologisch: Placebo
SC-Injektion
Experimental: MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continue to receive SC MK-6194 3 mg q2w in the extension period.
Biologisch: MK-6194
SC-Injektion
Experimental: MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continue to receive SC MK-6194 3 mg q4w in the extension period.
Biologisch: MK-6194
SC-Injektion
Experimental: Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
Biologisch: MK-6194
SC-Injektion
Biologisch: Placebo
SC-Injektion
Experimental: Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
Biologisch: MK-6194
SC-Injektion
Biologisch: Placebo
SC-Injektion

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Merck Sharp & Dohme LLC

Ermittler

  • Studienleiter: Medical Director, Merck Sharp & Dohme LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Dezember 2023

Primärer Abschluss (Tatsächlich)

30. Juli 2025

Studienabschluss (Tatsächlich)

30. Juli 2025

Studienanmeldedaten

Zuerst eingereicht

29. November 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. November 2023

Zuerst gepostet (Tatsächlich)

7. Dezember 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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