Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
NCT ID: NCT06161116
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
149 participants
INTERVENTIONAL
2023-12-27
2025-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Base Study: Dose 1
Participants receive subcutaneous (SC) MK-6194 dose regimen 1.
MK-6194
SC Injection
Base Study: Dose 2
Participants receive SC MK-6194 dose regimen 2.
MK-6194
SC Injection
Base Study: Placebo
Participants receive an SC placebo regimen.
Placebo
SC Injection
Extension: Dose 1
Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
MK-6194
SC Injection
Placebo
SC Injection
Extension: Dose 2
Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
MK-6194
SC Injection
Placebo
SC Injection
Interventions
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MK-6194
SC Injection
Placebo
SC Injection
Eligibility Criteria
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Inclusion Criteria
* Is taking at least 1 background therapy (1 immunosuppressant or dapsone and/or 1 antimalarial and/or oral corticosteroids) for SLE.
* Has + antinuclear antibody (+ANA) (titer ≥1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Sm antibody, or positive anti-SSA/Ro antibody.
* Has the presence of at least one of the following manifestations of SLE: Active lupus rash with CLASI-A erythema and scale/hypertrophy combined score \>2, or \>2 tender and swollen joints in wrists, metacarpophalangeals (MCPs), or proximal interphalangeals (PIPs).
* Has a hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score of ≥6 and clinical hybrid SLEDAI score of ≥4.
Exclusion Criteria
* Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening.
* Has a severe chronic pulmonary disease requiring oxygen therapy.
* Has a transplanted organ which requires continued immunosuppression.
* Has a known systemic hypersensitivity to IL-2, or modified IL-2 including MK-6194, or its inactive ingredients.
* Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
* Has drug-induced cutaneous lupus erythematosus (CLE) and/or drug-induced SLE in the setting of continued treatment with a causative agent.
* Has active or unstable neuropsychiatric lupus including but not limited to the following: seizure, new or worsening impaired level of consciousness, psychosis, delirium or confused state, aseptic meningitis, cranial neuropathy, cerebrovascular accident, ascending or transverse myelitis, chorea, cerebellar ataxia, mononeuritis multiplex, or demyelinating syndromes.
* Has a diagnosis of Antiphospholipid Syndrome with history of vascular thrombosis, catastrophic APS, or pregnancy morbidity within 6 months prior to Screening.
* Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
* Has an active or clinically significant infection requiring hospitalization or treatment with anti-infectives.
* Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB.
* Has confirmed or suspected COVID-19 infection.
* Has had major surgery within 3 months prior to Screening or has a major surgery planned during the study.
* Is taking more than 1 immunosuppressant.
* Is taking more than 1 oral NSAID (excluding low-dose aspirin \[\<350 mg/day\]) or is taking daily oral nonsteroidal anti-inflammatory drug (NSAID) at greater than the maximum recommended dosage.
* Is currently on any chronic systemic (oral or IV) anti-infective therapy for chronic active infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
18 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Medvin Clinical Research - Metyas ( Site 0128)
Covina, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
La Jolla, California, United States
Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
La Palma, California, United States
Medvin Clinical Research - Tujunga ( Site 0127)
Tujunga, California, United States
Denver Arthritis Clinic ( Site 0102)
Denver, Colorado, United States
Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
Clearwater, Florida, United States
IRIS Research and Development, LLC-Research ( Site 0117)
Plantation, Florida, United States
Clinical Research of West Florida, Inc ( Site 0124)
Tampa, Florida, United States
Morehouse School of Medicine ( Site 0146)
Atlanta, Georgia, United States
Accurate Clinical Research, Inc ( Site 0135)
Lake Charles, Louisiana, United States
AA Medical Research Center ( Site 0136)
Grand Blanc, Michigan, United States
Javara - Tryon Medical Partners ( Site 0121)
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC ( Site 0103)
Charlotte, North Carolina, United States
University of Oklahoma Health Science Center ( Site 0130)
Oklahoma City, Oklahoma, United States
Shelby Research, LLC ( Site 0142)
Memphis, Tennessee, United States
Accurate Clinical Management, LLC. ( Site 0134)
Baytown, Texas, United States
Epic Medical Research ( Site 0113)
DeSoto, Texas, United States
Accurate Clinical Research, Inc. ( Site 0133)
Houston, Texas, United States
SouthWest Rheumatology Research, LLC ( Site 0115)
Mesquite, Texas, United States
Centro de Investigaciones Médicas Mar del Plata ( Site 0210)
Mar del Plata, Buenos Aires, Argentina
Sanatorio Parque ( Site 0205)
Rosario, Santa Fe Province, Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
Santa Fe, Santa Fe Province, Argentina
Centro de Investigaciones Médicas Tucuman ( Site 0203)
SAN M. de Tucuman, Tucumán Province, Argentina
Instituto de Reumatología ( Site 0201)
Mendoza, , Argentina
IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)
Cuiabá, Mato Grosso, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
Porto Alegre, Rio Grande do Sul, Brazil
LMK Serviços Médicos S/S-Reumacenter ( Site 0303)
Porto Alegre, Rio Grande do Sul, Brazil
Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
São Bernardo do Campo, São Paulo, Brazil
Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
São José do Rio Preto, São Paulo, Brazil
Diex Recherche Sherbrooke ( Site 0003)
Sherbrooke, Quebec, Canada
IC La Serena Research ( Site 0414)
La Serena, Coquimbo Region, Chile
Clinica Dermacross ( Site 0416)
Santiago, Region M. de Santiago, Chile
Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
Santiago, Region M. de Santiago, Chile
CECIM ( Site 0405)
Santiago, Region M. de Santiago, Chile
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigacion del Cancer ( Site 0407)
Temuco, Región de la Araucanía, Chile
The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
Bengbu, Anhui, China
Anhui Provincial Hospital ( Site 2043)
Hefei, Anhui, China
Beijing Peking Union Medical College Hospital-Department of Rheumatology and Immunology ( Site 2001)
Beijing, Beijing Municipality, China
Gansu Provincial Hospital ( Site 2065)
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 2037)
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University ( Site 2051)
Guiyang, Guizhou, China
The Second Afilliated Hospital of Hebei Medical University-Immunology And Rheumatology ( Site 2064)
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
Luoyang, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
Wuhan, Hubei, China
The First Affiliated Hospital of Nanhua University ( Site 2061)
Hengyang, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Te ( Site 2006)
Baotou, Inner Mongolia, China
Affiliated Hospital of Nantong University ( Site 2027)
Nantong, Jiangsu, China
Pingxiang People's Hospital ( Site 2005)
Pingxiang, Jiangxi, China
Jilin Province People's Hospital ( Site 2033)
Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2056)
Xi'an, Shaanxi, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital ( Site 2029)
Taiyuan, Shanxi, China
The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
Chengdu, Sichuan, China
Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
Tianjin, Tianjin Municipality, China
Salud SURA Industriales ( Site 0508)
Medellín, Antioquia, Colombia
Centro Integral de Reumatología del Caribe ( Site 0501)
Barranquilla, Atlántico, Colombia
Clinica de la Costa S.A.S. ( Site 0502)
Barranquilla, Atlántico, Colombia
Preventive Care ( Site 0507)
Chía, Cundinamarca, Colombia
Healthy Medical Center S.A.S ( Site 0505)
Zipaquirá, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0506)
Cali, Valle del Cauca Department, Colombia
Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
Cali, Valle del Cauca Department, Colombia
CHU Bordeaux Haut-Leveque ( Site 1007)
Pessac, Aquitaine, France
Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
Lyon, Auvergne-Rhône-Alpes, France
CHU Rangueil ( Site 1008)
Toulouse, Haute-Garonne, France
CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
Montpellier, Herault, France
Hopital Claude Huriez - CHU de Lille ( Site 1005)
Lille, Nord, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
Saint Priest En Jarez, Pays de la Loire Region, France
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)
Guatemala City, , Guatemala
CELAN,S.A ( Site 0603)
Guatemala City, , Guatemala
Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)
Guatemala City, , Guatemala
Istituto Clinico Humanitas Research Hospital ( Site 1310)
Rozzano, Milano, Italy
Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
Rome, Roma, Italy
Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
Siena, Tuscany, Italy
Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
Padua, Veneto, Italy
AOU Careggi ( Site 1311)
Florence, , Italy
Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
Roma, , Italy
Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
Nagoya, Aichi-ken, Japan
St. Marianna University Hospital ( Site 2121)
Kawasaki, Kanagawa, Japan
Tohoku University Hospital ( Site 2116)
Sendai, Miyagi, Japan
Yuuai Medical Center ( Site 2122)
Tomigusuku, Okinawa, Japan
Shimane University Hospital ( Site 2119)
Izumo, Shimane, Japan
Dokkyo Medical University Hospital ( Site 2118)
Shimotsuga, Tochigi, Japan
Nihon University Itabashi Hospital ( Site 2105)
Itabashiku, Tokyo, Japan
Showa Medical University East Hospital ( Site 2123)
Shinagawa, Tokyo, Japan
Chiba University Hospital ( Site 2120)
Chiba, , Japan
NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
Chiba, , Japan
Okayama University Hospital ( Site 2106)
Okayama, , Japan
Osaka Keisatsu Hospital ( Site 2117)
Osaka, , Japan
Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
Cheras, Kuala Lumpur, Malaysia
University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
Kuantan, Pahang, Malaysia
Hospital Taiping ( Site 2221)
Taiping, Perak, Malaysia
Morales Vargas Centro de Investigacion ( Site 0710)
León, Guanajuato, Mexico
Centro Integral en Reumatologia ( Site 0701)
Guadalajara, Jalisco, Mexico
Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
Guadalajara, Jalisco, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigacion Basica y Clinica ( Site 0708)
Guadalajara, Jalisco, Mexico
RM Pharma Specialists ( Site 0711)
Mexico City, Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)
Monterrey, Nuevo León, Mexico
Centro Potosino de Investigación Médica ( Site 0703)
San Luis Potosí City, San Luis Potosí, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
Mérida, Yucatán, Mexico
ICARO Investigaciones en Medicina ( Site 0702)
Chihuahua City, , Mexico
Clinstile, S.A. de C.V. ( Site 0709)
Distrito Federal, , Mexico
Mary Mediatrix Medical Center ( Site 2303)
Lipa City, Batangas, Philippines
ST. LUKE'S MEDICAL CENTER ( Site 2304)
Quezon City, National Capital Region, Philippines
Iloilo Doctors' Hospital ( Site 2301)
Iloilo City, , Philippines
Medyczne Centrum Hetmańska ( Site 1406)
Poznan, Greater Poland Voivodeship, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)
Poznan, Greater Poland Voivodeship, Poland
MICS Centrum Medyczne Bydgoszcz ( Site 1410)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Plejady ( Site 1407)
Krakow, Lesser Poland Voivodeship, Poland
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)
Lublin, Lublin Voivodeship, Poland
MICS Centrum Medyczne Warszawa ( Site 1411)
Warsaw, Masovian Voivodeship, Poland
Nova Reuma Społka Partnerska ( Site 1405)
Bialystok, Podlaskie Voivodeship, Poland
NZOZ BIF-MED ( Site 1409)
Bytom, Silesian Voivodeship, Poland
CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
A Coruña, La Coruna, Spain
HOSPITAL CLINICO DE VALENCIA ( Site 1608)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
Barcelona, , Spain
Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
Seville, , Spain
Hospital Universitario Rio Hortega ( Site 1606)
Valladolid, , Spain
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
Kadıköy, Istanbul, Turkey (Türkiye)
ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
Ankara, , Turkey (Türkiye)
Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
Sakarya, , Turkey (Türkiye)
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-6194-006
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505520-61-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1291-8716
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2041230137
Identifier Type: REGISTRY
Identifier Source: secondary_id
6194-006
Identifier Type: -
Identifier Source: org_study_id
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