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全身性エリテマトーデス(MK-6194-006)の成人参加者におけるMK-6194の有効性と安全性

2026年7月16日 更新者：Merck Sharp & Dohme LLC

全身性エリテマトーデスの成人参加者におけるMK-6194の有効性と安全性を評価するためのフェーズ2a、多施設共同、無作為化、二重盲検、プラセボ対照試験

この研究の目的は、全身性エリテマトーデスの成人参加者における MK-6194 の有効性と安全性を評価することです。 主な仮説は、28週目に全身性エリテマトーデスレスポンダーインデックス（SRI-4）反応を示した参加者の割合という主要評価項目において、MK-6194群の少なくとも1つがプラセボよりも優れているというものです。

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

149

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • スクリーニングの6か月以上前に全身性エリテマトーデス（SLE）と診断されている。
  • SLEに対して少なくとも1つの背景療法（1つの免疫抑制剤またはダプソンおよび/または1つの抗マラリア薬および/または経口コルチコステロイド）を服用している。
  • + 抗核抗体 (+ANA) (力価 ≥1:80) または陽性の抗二本鎖デオキシリボ核酸 (dsDNA) 抗体または陽性の抗 Sm 抗体、または陽性の抗 SSA/Ro 抗体を有する。
  • 以下の SLE 症状の少なくとも 1 つが存在する: CLASI-A 紅斑および鱗屑/肥大の複合スコアを伴う活動性狼瘡発疹 2 つ以上、または 2 つ以上の手首、中手指節 (MCP)、または近位指節間関節の圧痛と腫れ ( PIP）。
  • ハイブリッド全身性エリテマトーデス疾患活動性指数（SLEDAI）合計スコアが6以上、臨床ハイブリッドSLEDAIスコアが4以上である。

除外基準:

  • 臨床的に重大な疾患を併発している、臨床的に関連する臨床検査異常がある、あるいは研究者の意見で、研究の結果を混乱させる可能性がある、あるいは研究への参加により参加者にさらなるリスクをもたらす可能性がある病気や病状の病歴がある。勉強。
  • -スクリーニング前の6か月以内に症候性心不全（ニューヨーク心臓協会クラスIIIまたはIV）または心筋梗塞または不安定狭心症を患っている。
  • 酸素療法を必要とする重度の慢性肺疾患を患っている。
  • 臓器を移植されており、継続的な免疫抑制が必要です。
  • IL-2、またはMK-6194を含む改変型IL-2、またはその不活性成分に対する既知の全身性過敏症を有する。
  • リンパ腫を含むリンパ増殖性疾患、またはリンパ節腫脹および/または脾腫などのリンパ増殖性疾患の可能性を示唆する兆候および症状の既知の既往歴がある。
  • 原因物質による治療を継続している薬剤性皮膚エリテマトーデス（CLE）および/または薬剤性SLEを患っている。
  • 以下を含むがこれらに限定されない活動性または不安定な精神神経性狼瘡を患っている：発作、新たなまたは悪化する意識レベルの障害、精神病、せん妄または錯乱状態、無菌性髄膜炎、脳神経障害、脳血管障害、上行性または横行性脊髄炎、舞踏病、小脳性運動失調、多発性単神経炎、または脱髄症候群。
  • -スクリーニング前の6か月以内に血管血栓症、壊滅的APS、または妊娠の罹患歴を伴う抗リン脂質症候群の診断を受けている。
  • 治療に成功した非黒色腫皮膚がんまたは限局性子宮頸部上皮がんを除き、悪性腫瘍の既往歴がある。
  • 活動性の臨床的に重大な感染症、または入院または抗感染症薬による治療を必要とする感染症を患っている。
  • 活動性結核（TB）、潜在性結核、または不適切な治療を受けた結核の証拠がある。
  • 新型コロナウイルス感染症（COVID-19）感染が確認された、または感染の疑いがある。
  • -スクリーニング前の3か月以内に大手術を受けたか、研究中に大手術が計画されている。
  • 複数の免疫抑制剤を服用している。
  • 1 つ以上の経口 NSAID (低用量アスピリン [<350 mg/日] を除く) を服用しているか、最大推奨用量を超える経口非ステロイド性抗炎症薬 (NSAID) を毎日服用している。
  • 現在、慢性感染症（ニューモシスチス、サイトメガロウイルス、帯状疱疹、非定型マイコバクテリアなど）に対する慢性全身性（経口または点滴）抗感染症治療を受けている。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
生物学的：MK-6194
皮下注射
実験的：MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
生物学的：MK-6194
皮下注射
プラセボコンパレーター：Placebo
Participants receive SC placebo q2w.
生物学的：プラセボ
皮下注射
実験的：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.
生物学的：MK-6194
皮下注射
実験的：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.
生物学的：MK-6194
皮下注射
実験的：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.
生物学的：MK-6194
皮下注射
生物学的：プラセボ
皮下注射
実験的：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.
生物学的：MK-6194
皮下注射
生物学的：プラセボ
皮下注射

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
時間枠：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)
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Merck Sharp & Dohme LLC

捜査官

  • スタディディレクター：Medical Director、Merck Sharp & Dohme LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年12月27日

一次修了 (実際)

2025年7月30日

研究の完了 (実際)

2025年7月30日

試験登録日

最初に提出

2023年11月29日

QC基準を満たした最初の提出物

2023年11月29日

最初の投稿 (実際)

2023年12月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月10日

QC基準を満たした最後の更新が送信されました

2026年7月16日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 6194-006
  • MK-6194-006 (その他の識別子：MSD)
  • U1111-1291-8716 (レジストリ識別子：UTN)
  • jRCT2041230137 (レジストリ識別子：jRCT)
  • 2023-505520-61-00 (レジストリ識別子：EU CT)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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