전신홍반루푸스(MK-6194-006)가 있는 성인 참가자에서 MK-6194의 효능 및 안전성
2026년 7월 16일 업데이트: Merck Sharp & Dohme LLC
전신성 홍반성 루푸스를 앓고 있는 성인 참가자를 대상으로 MK-6194의 효능과 안전성을 평가하기 위한 2a상, 다기관, 무작위, 이중 맹검, 위약 대조 연구
이 연구의 목적은 전신홍반루푸스를 앓는 성인 참가자를 대상으로 MK-6194의 효능과 안전성을 평가하는 것입니다.
1차 가설은 28주차에 전신 홍반성 루푸스 반응 지수(SRI-4) 반응을 보이는 참가자의 비율 측면에서 MK-6194군 중 최소 1개가 위약보다 우수하다는 것입니다.
연구 개요
연구 유형
중재적
등록 (실제)
149
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Guatemala City, 과테말라, 01009
- Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)
-
Guatemala City, 과테말라, 01010
- CELAN,S.A ( Site 0603)
-
Guatemala City, 과테말라, 01010
- Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)
-
-
-
-
Kuala Lumpur
-
Cheras, Kuala Lumpur, 말레이시아, 56000
- Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
-
Lembah Pantai, Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
-
-
Pahang
-
Kuantan, Pahang, 말레이시아, 25100
- Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
-
-
Perak
-
Taiping, Perak, 말레이시아, 34000
- Hospital Taiping ( Site 2221)
-
-
-
-
-
Chihuahua City, 멕시코, 31000
- ICARO Investigaciones en Medicina ( Site 0702)
-
Distrito Federal, 멕시코, 06700
- Clinstile, S.A. de C.V. ( Site 0709)
-
-
Guanajuato
-
León, Guanajuato, 멕시코, 37000
- Morales Vargas Centro de Investigacion ( Site 0710)
-
-
Jalisco
-
Guadalajara, Jalisco, 멕시코, 44160
- Centro Integral en Reumatologia ( Site 0701)
-
Guadalajara, Jalisco, 멕시코, 44638
- Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
-
Guadalajara, Jalisco, 멕시코, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
-
Guadalajara, Jalisco, 멕시코, 44690
- Centro de Estudios de Investigacion Basica y Clinica ( Site 0708)
-
-
Mexico City
-
Mexico City, Mexico City, 멕시코, 03100
- RM Pharma Specialists ( Site 0711)
-
Mexico City, Mexico City, 멕시코, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)
-
-
Nuevo León
-
Monterrey, Nuevo León, 멕시코, 64460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)
-
-
San Luis Potosí
-
San Luis Potosí City, San Luis Potosí, 멕시코, 78250
- Centro Potosino de Investigación Médica ( Site 0703)
-
-
Yucatán
-
Mérida, Yucatán, 멕시코, 97130
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
-
-
-
-
California
-
Covina, California, 미국, 91722
- Medvin Clinical Research - Metyas ( Site 0128)
-
La Jolla, California, 미국, 92037
- UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
-
La Palma, California, 미국, 90623
- Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
-
Tujunga, California, 미국, 91042
- Medvin Clinical Research - Tujunga ( Site 0127)
-
-
Colorado
-
Denver, Colorado, 미국, 80230
- Denver Arthritis Clinic ( Site 0102)
-
-
Florida
-
Clearwater, Florida, 미국, 33765
- Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
-
Plantation, Florida, 미국, 33324
- IRIS Research and Development, LLC-Research ( Site 0117)
-
Tampa, Florida, 미국, 33606
- Clinical Research of West Florida, Inc ( Site 0124)
-
-
Georgia
-
Atlanta, Georgia, 미국, 30310
- Morehouse School of Medicine ( Site 0146)
-
-
Louisiana
-
Lake Charles, Louisiana, 미국, 70605
- Accurate Clinical Research, Inc ( Site 0135)
-
-
Michigan
-
Grand Blanc, Michigan, 미국, 48439
- AA Medical Research Center ( Site 0136)
-
-
North Carolina
-
Charlotte, North Carolina, 미국, 28210
- Javara - Tryon Medical Partners ( Site 0121)
-
Charlotte, North Carolina, 미국, 28211
- DJL Clinical Research, PLLC ( Site 0103)
-
-
Oklahoma
-
Oklahoma City, Oklahoma, 미국, 73104
- University of Oklahoma Health Science Center ( Site 0130)
-
-
Tennessee
-
Memphis, Tennessee, 미국, 38119
- Shelby Research, LLC ( Site 0142)
-
-
Texas
-
Baytown, Texas, 미국, 77521
- Accurate Clinical Management, LLC. ( Site 0134)
-
DeSoto, Texas, 미국, 75115
- Epic Medical Research ( Site 0113)
-
Houston, Texas, 미국, 77089
- Accurate Clinical Research, Inc. ( Site 0133)
-
Mesquite, Texas, 미국, 75150
- SouthWest Rheumatology Research, LLC ( Site 0115)
-
-
-
-
Mato Grosso
-
Cuiabá, Mato Grosso, 브라질, 78020-500
- IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, 브라질, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
-
Porto Alegre, Rio Grande do Sul, 브라질, 90480-000
- LMK Serviços Médicos S/S-Reumacenter ( Site 0303)
-
-
São Paulo
-
São Bernardo do Campo, São Paulo, 브라질, 09715-090
- Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
-
São José do Rio Preto, São Paulo, 브라질, 15090-000
- Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
-
-
-
-
-
Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
-
Seville, 스페인, 41010
- Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
-
Valladolid, 스페인, 47012
- Hospital Universitario Rio Hortega ( Site 1606)
-
-
La Coruna
-
A Coruña, La Coruna, 스페인, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, 스페인, 46010
- HOSPITAL CLINICO DE VALENCIA ( Site 1608)
-
-
-
-
-
Mendoza, 아르헨티나, M5500CPH
- Instituto de Reumatología ( Site 0201)
-
-
Buenos Aires
-
Mar del Plata, Buenos Aires, 아르헨티나, 7600
- Centro de Investigaciones Médicas Mar del Plata ( Site 0210)
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, 아르헨티나, S2000DVC
- Sanatorio Parque ( Site 0205)
-
Santa Fe, Santa Fe Province, 아르헨티나, S3000BPJ
- Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
-
-
Tucumán Province
-
SAN M. de Tucuman, Tucumán Province, 아르헨티나, T4000AXL
- Centro de Investigaciones Médicas Tucuman ( Site 0203)
-
-
-
-
-
Florence, 이탈리아, 50141
- AOU Careggi ( Site 1311)
-
Naples, 이탈리아, 80131
- Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
-
Roma, 이탈리아, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
-
-
Milano
-
Rozzano, Milano, 이탈리아, 20089
- Istituto Clinico Humanitas Research Hospital ( Site 1310)
-
-
Roma
-
Rome, Roma, 이탈리아, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
-
-
Tuscany
-
Siena, Tuscany, 이탈리아, 53100
- Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
-
-
Veneto
-
Padova, Veneto, 이탈리아, 35128
- Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
-
-
-
-
-
Chiba, 일본, 260-8677
- Chiba University Hospital ( Site 2120)
-
Chiba, 일본, 260-8712
- NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
-
Okayama, 일본, 700-8558
- Okayama University Hospital ( Site 2106)
-
Osaka, 일본, 543-8922
- Osaka Keisatsu Hospital ( Site 2117)
-
-
Aichi-ken
-
Nagoya, Aichi-ken, 일본, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
-
-
Kanagawa
-
Kawasaki, Kanagawa, 일본, 216-8511
- St. Marianna University Hospital ( Site 2121)
-
-
Miyagi
-
Sendai, Miyagi, 일본, 980-8574
- Tohoku University Hospital ( Site 2116)
-
-
Okinawa
-
Tomigusuku, Okinawa, 일본, 901-0224
- Yuuai Medical Center ( Site 2122)
-
-
Shimane
-
Izumo, Shimane, 일본, 693-0021
- Shimane University Hospital ( Site 2119)
-
-
Tochigi
-
Shimotsuga, Tochigi, 일본, 321-0293
- Dokkyo Medical University Hospital ( Site 2118)
-
-
Tokyo
-
Itabashiku, Tokyo, 일본, 173-8610
- Nihon University Itabashi Hospital ( Site 2105)
-
Shinagawa, Tokyo, 일본, 142-0054
- Showa Medical University East Hospital ( Site 2123)
-
-
-
-
Anhui
-
Bengbu, Anhui, 중국, 233000
- The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
-
Hefei, Anhui, 중국, 230071
- Anhui Provincial Hospital ( Site 2043)
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, 중국, 100730
- Beijing Peking Union Medical College Hospital-Department of Rheumatology and Immunology ( Site 2001)
-
-
Gansu
-
Lanzhou, Gansu, 중국, 730000
- Gansu Provincial Hospital ( Site 2065)
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510000
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
-
Guangzhou, Guangdong, 중국, 510515
- Southern Medical University Nanfang Hospital ( Site 2037)
-
-
Guizhou
-
Guiyang, Guizhou, 중국, 550004
- The Affiliated Hospital of Guizhou Medical University ( Site 2051)
-
-
Hebei
-
Shijiazhuang, Hebei, 중국, 050000
- The Second Afilliated Hospital of Hebei Medical University-Immunology And Rheumatology ( Site 2064)
-
-
Henan
-
Luoyang, Henan, 중국, 471003
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
-
-
Hubei
-
Wuhan, Hubei, 중국, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
-
-
Hunan
-
Hengyang, Hunan, 중국, 421001
- The First Affiliated Hospital of Nanhua University ( Site 2061)
-
-
Inner Mongolia
-
Baotou, Inner Mongolia, 중국, 014010
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Te ( Site 2006)
-
-
Jiangsu
-
Nantong, Jiangsu, 중국, 226001
- Affiliated Hospital of Nantong University ( Site 2027)
-
-
Jiangxi
-
Pingxiang, Jiangxi, 중국, 337055
- Pingxiang People's Hospital ( Site 2005)
-
-
Jilin
-
Changchun, Jilin, 중국, 130021
- Jilin Province People's Hospital ( Site 2033)
-
-
Shaanxi
-
Xi'an, Shaanxi, 중국, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2056)
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
-
-
Shanxi
-
Taiyuan, Shanxi, 중국, 030032
- Shanxi Bethune Hospital ( Site 2029)
-
-
Sichuan
-
Chengdu, Sichuan, 중국, 610500
- The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, 중국, 300052
- Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
-
-
-
-
Araucania
-
Temuco, Araucania, 칠레, 4800827
- James Lind Centro de Investigacion del Cancer ( Site 0407)
-
-
Coquimbo Region
-
La Serena, Coquimbo Region, 칠레, 1720430
- IC La Serena Research ( Site 0414)
-
-
Region M. de Santiago
-
Santiago, Region M. de Santiago, 칠레, 7640881
- Clinica Dermacross ( Site 0416)
-
Santiago, Region M. de Santiago, 칠레, 8207257
- Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
-
Santiago, Region M. de Santiago, 칠레, 8320000
- CECIM ( Site 0405)
-
Santiago, Region M. de Santiago, 칠레, 8420383
- Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
-
-
-
-
Quebec
-
Sherbrooke, Quebec, 캐나다, J1L 0H8
- Diex Recherche Sherbrooke ( Site 0003)
-
-
-
-
Antioquia
-
Medellín, Antioquia, 콜롬비아, 50021
- Salud SURA Industriales ( Site 0508)
-
-
Atlántico
-
Barranquilla, Atlántico, 콜롬비아, 080020
- Clinica de la Costa S.A.S. ( Site 0502)
-
Barranquilla, Atlántico, 콜롬비아, 080002
- Centro Integral de Reumatología del Caribe ( Site 0501)
-
-
Cundinamarca
-
Chía, Cundinamarca, 콜롬비아, 250001
- Preventive Care ( Site 0507)
-
Zipaquirá, Cundinamarca, 콜롬비아, 250252
- Healthy Medical Center S.A.S ( Site 0505)
-
-
Valle del Cauca Department
-
Cali, Valle del Cauca Department, 콜롬비아, 760032
- Fundación Valle del Lili ( Site 0506)
-
Cali, Valle del Cauca Department, 콜롬비아, 760042
- Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
-
-
-
-
-
Ankara, 터키 (Türkiye), 06230
- ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
-
Ankara, 터키 (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
-
Sakarya, 터키 (Türkiye)
- Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
-
-
Istanbul
-
Kadıköy, Istanbul, 터키 (Türkiye), 34722
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, 폴란드, 60-218
- Medyczne Centrum Hetmańska ( Site 1406)
-
Poznan, Greater Poland Voivodeship, 폴란드, 61-397
- Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 폴란드, 85-065
- MICS Centrum Medyczne Bydgoszcz ( Site 1410)
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, 폴란드, 30-363
- Centrum Medyczne Plejady ( Site 1407)
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, 폴란드, 20-607
- Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, 폴란드, 00-874
- MICS Centrum Medyczne Warszawa ( Site 1411)
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, 폴란드, 15-707
- Nova Reuma Społka Partnerska ( Site 1405)
-
-
Silesian Voivodeship
-
Bytom, Silesian Voivodeship, 폴란드, 41-902
- NZOZ BIF-MED ( Site 1409)
-
-
-
-
Aquitaine
-
Pessac, Aquitaine, 프랑스, 33600
- CHU Bordeaux Haut-Leveque ( Site 1007)
-
-
Auvergne-Rhône-Alpes
-
Lyon, Auvergne-Rhône-Alpes, 프랑스, 69007
- Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
-
-
Haute-Garonne
-
Toulouse, Haute-Garonne, 프랑스, 31400
- CHU Rangueil ( Site 1008)
-
-
Herault
-
Montpellier, Herault, 프랑스, 34295
- CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
-
-
Nord
-
Lille, Nord, 프랑스, 59037
- Hopital Claude Huriez - CHU de Lille ( Site 1005)
-
-
Pays de la Loire Region
-
Saint Priest En Jarez, Pays de la Loire Region, 프랑스, 42270
- Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
-
-
-
-
-
Iloilo City, 필리핀 제도, 5000
- Iloilo Doctors' Hospital ( Site 2301)
-
-
Batangas
-
Lipa City, Batangas, 필리핀 제도, 4217
- Mary Mediatrix Medical Center ( Site 2303)
-
-
National Capital Region
-
Quezon City, National Capital Region, 필리핀 제도, 1102
- ST. LUKE'S MEDICAL CENTER ( Site 2304)
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 스크리닝 ≥6개월 전에 전신홍반루푸스(SLE) 진단을 받은 경우.
- SLE에 대해 최소한 1가지 기본 요법(1가지 면역억제제 또는 답손 및/또는 1가지 항말라리아제 및/또는 경구 코르티코스테로이드)을 복용 중입니다.
- + 항핵 항체(+ANA)(역가 ≥1:80) 또는 양성 항이중 가닥 데옥시리보핵산(dsDNA) 항체 또는 양성 항-Sm 항체 또는 양성 항-SSA/Ro 항체가 있습니다.
- SLE의 다음 증상 중 적어도 하나가 존재합니다: CLASI-A 홍반 및 비늘/비대증 합산 점수 >2 또는 >2 손목, 중수지절(MCP) 또는 근위 지절간 관절의 압통 및 부어오름을 동반한 활동성 루푸스 발진( PIP).
- 하이브리드 전신 홍반성 루푸스 질병 활동 지수(SLEDAI) 총 점수가 ≥6이고 임상 하이브리드 SLEDAI 점수가 ≥4입니다.
제외 기준:
- 동시에 임상적으로 유의미한 질병 또는 임상적으로 관련된 실험실적 이상을 가지고 있거나, 연구자의 견해로 연구 결과를 혼동시킬 수 있거나 참가자의 참여로 인해 참가자에게 추가적인 위험을 초래할 수 있는 질병 또는 의학적 상태의 병력이 있는 경우 공부하다.
- 스크리닝 전 6개월 이내에 증상이 있는 심부전(뉴욕 심장 협회 클래스 III 또는 IV), 심근경색 또는 불안정 협심증이 있는 경우.
- 산소 요법이 필요한 심각한 만성 폐질환이 있습니다.
- 지속적인 면역억제를 필요로 하는 이식된 장기가 있습니다.
- IL-2, MK-6194를 포함한 변형된 IL-2 또는 그 비활성 성분에 대해 전신 과민증이 있는 것으로 알려져 있습니다.
- 림프종을 포함한 림프증식성 질환의 병력이 있거나 림프절병증 및/또는 비장종대와 같은 림프증식성 질환 가능성을 암시하는 징후 및 증상이 있는 경우.
- 원인 물질로 지속적인 치료를 받는 상황에서 약물 유발성 피부홍반루푸스(CLE) 및/또는 약물 유발성 SLE가 있는 경우.
- 다음을 포함하되 이에 국한되지 않는 활동성 또는 불안정성 신경정신병성 루푸스가 있음: 발작, 의식 수준의 새로운 또는 악화, 정신병, 섬망 또는 혼란 상태, 무균성 수막염, 뇌신경병증, 뇌혈관 사고, 상행 또는 횡단 척수염, 무도병, 소뇌 운동실조, 다발성 단신경염 또는 탈수초 증후군.
- 스크리닝 전 6개월 이내에 혈관 혈전증, 치명적인 APS 또는 임신 이환의 병력이 있는 항인지질 증후군으로 진단되었습니다.
- 성공적으로 치료된 비흑색종 피부암 또는 자궁경부의 국소 상피내암종을 제외하고 악성 종양의 병력이 있는 경우.
- 임상적으로 심각한 활성 감염이 있거나 입원이나 항감염제 치료가 필요한 감염이 있는 경우.
- 활동성 결핵(TB), 잠복성 결핵 또는 제대로 치료되지 않은 결핵의 증거가 있습니다.
- 코로나19 감염을 확인했거나 의심한 적이 있습니다.
- 스크리닝 전 3개월 이내에 대수술을 받았거나 연구 기간 동안 대수술이 계획되어 있습니다.
- 1가지 이상의 면역억제제를 복용하고 있습니다.
- 1가지 이상의 경구용 NSAID(저용량 아스피린(1일 350mg 미만) 제외)을 복용하고 있거나 매일 최대 권장 용량보다 많은 경구용 비스테로이드성 항염증제(NSAID)를 복용하고 있습니다.
- 현재 만성 감염(폐포자충, 거대세포바이러스, 대상포진 또는 비정형 마이코박테리아 등)에 대해 만성 전신(경구 또는 IV) 항감염 요법을 받고 있습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: MK-6194 3 mg Q2W
Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
|
SC주사
|
|
실험적: MK-6194 3 mg Q4W
Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
|
SC주사
|
|
위약 비교기: Placebo
Participants receive SC placebo q2w.
|
SC주사
|
|
실험적: 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.
|
SC주사
|
|
실험적: 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.
|
SC주사
|
|
실험적: 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.
|
SC주사
SC주사
|
|
실험적: 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.
|
SC주사
SC주사
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
기간: 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)
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 12월 27일
기본 완료 (실제)
2025년 7월 30일
연구 완료 (실제)
2025년 7월 30일
연구 등록 날짜
최초 제출
2023년 11월 29일
QC 기준을 충족하는 최초 제출
2023년 11월 29일
처음 게시됨 (실제)
2023년 12월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 16일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 6194-006
- MK-6194-006 (기타 식별자: MSD)
- U1111-1291-8716 (레지스트리 식별자: UTN)
- jRCT2041230137 (레지스트리 식별자: jRCT)
- 2023-505520-61-00 (레지스트리 식별자: EU CT)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .