Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Biological: Placebo
- Registration Number
- NCT06161116
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythematosus responder index (SRI-4) response at Week 28.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
- Has a diagnosis of systemic lupus erythematosus (SLE) ≥6 months prior to Screening.
- 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.
- Has a concurrent clinically significant disease or clinically relevant laboratory abnormalities, or a history of any illness or medical condition that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Base Study: Dose 1 MK-6194 Participants receive subcutaneous (SC) MK-6194 dose regimen 1. Base Study: Dose 2 MK-6194 Participants receive SC MK-6194 dose regimen 2. Base Study: Placebo Placebo Participants receive an SC placebo regimen. Extension: Dose 1 MK-6194 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. Extension: Dose 1 Placebo 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. Extension: Dose 2 MK-6194 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. Extension: Dose 2 Placebo 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28 Week 28 The SRI is a composite index used to assess clinical improvement in participants with Systemic Lupus Erythematosus (SLE). The SRI-4 response evaluates global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the patient's overall condition. SRI-4 response is binary and is either achieved or not achieved by the participant, thus there is no associated score.
Percentage of Participants Experiencing Adverse Events (AEs) Up to approximately 28 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to approximately 28 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28 Week 28 The BICLA response is a composite global measure of SLE disease activity. It distinguishes between partial and complete improvement in all body systems. BICLA response is binary and is either achieved or not achieved by the participant, thus there is no associated score.
Percentage of Participants Achieving SRI-4 Response at Week 52 Week 52 The SRI is a composite index used to assess clinical improvement in patients with Systemic Lupus Erythematosus (SLE). The SRI-4 response evaluates global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the patient's overall condition. SRI-4 response is binary and is either achieved or not achieved by the participant, thus there is no associated score.
Percentage of Participants Achieving BICLA at Week 52 Week 52 The BICLA response is a composite global measure of SLE disease activity. It distinguishes between partial and complete improvement in all body systems. BICLA response is binary and is either achieved or not achieved by the participant, thus there is no associated score.
Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28 Week 28 The CLASI-A score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in the CLASI-A score.
Percentage of Participants with a CLASI-50 Response at Week 52 Week 52 The CLASI-A score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in the CLASI-A score.
Change From Baseline of 28 Joint Count at Week 28 Baseline and Week 28 The joint count score is an evaluation of 28 joints in which joints are assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints may range from 0 to 28; with higher values corresponding to higher disease activity and lower values to better.
Change From Baseline of 28 Joint Count at Week 52 Baseline and Week 52 The joint count score is an evaluation of 28 joints in which joints are assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints may range from 0 to 28; with higher values corresponding to higher disease activity and lower values to better.
Change From Baseline of Corticosteroid Dose at Week 28 Baseline and Week 28 Participants are assessed for corticosteroid dose change.
Change From Baseline of Corticosteroid Dose at Week 52 Baseline and Week 52 Participants are assessed for corticosteroid dose change.
Cumulative Oral Corticosteroid Use Between Week 0 to Week 28 Up to approximately 28 weeks Participants are assessed for total corticosteroid use.
Cumulative Oral Corticosteroid Use Between Week 0 to Week 52 Up to approximately 52 weeks Participants are assessed for total corticosteroid use.
Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28 Week 28 LLDAS is a low disease activity state associated with significant protection against flares and organ damage accrual. It includes both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response is binary and is either achieved or not achieved by the participant, thus there is no associated score.
Percentage of Participants Who Achieve LLDAS at Week 52 Week 52 LLDAS is a low disease activity state associated with significant protection against flares and organ damage accrual. It includes both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response is binary and is either achieved or not achieved by the participant, thus there is no associated score.
Trial Locations
- Locations (124)
Medvin Clinical Research - Metyas ( Site 0128)
🇺🇸Covina, California, 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
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
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, Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
🇦🇷Santa Fe., Santa Fe, Argentina
Centro de Investigaciones Médicas Tucuman ( Site 0203)
🇦🇷SAN M. DE Tucuman, Tucuman, Argentina
Instituto de Reumatología ( Site 0201)
🇦🇷Mendoza, Argentina
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)
🇧🇷Sao Bernardo do Campo, Sao Paulo, Brazil
Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
🇧🇷São José do Rio Preto, Sao Paulo, Brazil
Diex Recherche Sherbrooke ( Site 0003)
🇨🇦Sherbrooke, Quebec, Canada
James Lind Centro de Investigacion del Cancer ( Site 0407)
🇨🇱Temuco, Araucania, Chile
IC La Serena Research ( Site 0414)
🇨🇱La Serena., Coquimbo, Chile
Clinica Dermacross ( Site 0416)
🇨🇱Santiago., Region M. De Santiago, Chile
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
🇨🇱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
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, 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)
🇨🇳Chang chun, 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, 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, China
Salud SURA Industriales ( Site 0508)
🇨🇴Medellín, Antioquia, Colombia
Centro Integral de Reumatología del Caribe ( Site 0501)
🇨🇴Barranquilla, Atlantico, Colombia
Clinica de la Costa S.A.S. ( Site 0502)
🇨🇴Barranquilla, Atlantico, Colombia
Preventive Care ( Site 0507)
🇨🇴Chía, Cundinamarca, Colombia
Healthy Medical Center S.A.S ( Site 0505)
🇨🇴Zipaquira, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0506)
🇨🇴Cali, Valle Del Cauca, Colombia
Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
🇨🇴Cali, Valle Del Cauca, Colombia
CHU Bordeaux Haut-Leveque ( Site 1007)
🇫🇷Pessac, Aquitaine, France
CHU Rangueil ( Site 1008)
🇫🇷Toulouse, Haute-Garonne, France
CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
🇫🇷Montpellier, Herault, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
🇫🇷Saint Priest En Jarez, Loire, France
Hopital Claude Huriez - CHU de Lille ( Site 1005)
🇫🇷Lille, Nord, France
Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
🇫🇷Lyon, Rhone-Alpes, France
Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)
🇬🇹Ciudad de Guatemala, Guatemala
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)
🇬🇹Guatemala, Guatemala
CELAN,S.A ( Site 0603)
🇬🇹Guatemala, 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, Toscana, Italy
AOU Careggi ( Site 1311)
🇮🇹Firenze, 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, Japan
St. Marianna University Hospital ( Site 2121)
🇯🇵Kawasaki, Kanagawa, Japan
Tohoku University Hospital ( Site 2116)
🇯🇵Sendai-shi, 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
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
RM Pharma Specialists ( Site 0711)
🇲🇽Mexico City, Distrito Federal, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)
🇲🇽Mexico City, Distrito Federal, Mexico
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
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)
🇲🇽Monterrey, Nuevo Leon, Mexico
Centro Potosino de Investigación Médica ( Site 0703)
🇲🇽San Luis Potosí, San Luis Potosi, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
🇲🇽Merida, Yucatan, Mexico
ICARO Investigaciones en Medicina ( Site 0702)
🇲🇽Chihuahua, 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, Philippines
MICS Centrum Medyczne Bydgoszcz ( Site 1410)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)
🇵🇱Lublin, Lubelskie, Poland
Centrum Medyczne Plejady ( Site 1407)
🇵🇱Krakow, Malopolskie, Poland
MICS Centrum Medyczne Warszawa ( Site 1411)
🇵🇱Warszawa, Mazowieckie, Poland
Nova Reuma Społka Partnerska ( Site 1405)
🇵🇱Bialystok, Podlaskie, Poland
NZOZ BIF-MED ( Site 1409)
🇵🇱Bytom, Slaskie, Poland
Medyczne Centrum Hetmańska ( Site 1406)
🇵🇱Poznan, Wielkopolskie, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)
🇵🇱Poznan, Wielkopolskie, 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)
🇪🇸Sevilla, Spain
Hospital Universitario Rio Hortega ( Site 1606)
🇪🇸Valladolid, Spain
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
🇹🇷Kadikoy, Istanbul, Turkey
ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
🇹🇷Ankara, Turkey
Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
🇹🇷Ankara, Turkey
Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
🇹🇷Sakarya, Turkey