Clinical trial NCT06161116: Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
Official title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
timeFrame: Week 28
measure: Percentage of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 28 weeks
measure: Percentage of Participants Discontinuing Study Treatment Due to an AE
timeFrame: Up to approximately 28 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28
timeFrame: Week 28
measure: Percentage of Participants Achieving SRI-4 Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants Achieving BICLA at Week 52
timeFrame: Week 52
measure: Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28
timeFrame: Week 28
measure: Percentage of Participants with a CLASI-50 Response at Week 52
timeFrame: Week 52
measure: Change From Baseline of 28 Joint Count at Week 28
timeFrame: Baseline and Week 28
measure: Change From Baseline of 28 Joint Count at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline of Corticosteroid Dose at Week 28
timeFrame: Baseline and Week 28
measure: Change From Baseline of Corticosteroid Dose at Week 52
timeFrame: Baseline and Week 52
measure: Cumulative Oral Corticosteroid Use Between Week 0 to Week 28
timeFrame: Up to approximately 28 weeks
measure: Cumulative Oral Corticosteroid Use Between Week 0 to Week 52
timeFrame: Up to approximately 52 weeks
measure: Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28
timeFrame: Week 28
measure: Percentage of Participants Who Achieve LLDAS at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Covina
country: United States
facility: Medvin Clinical Research - Metyas ( Site 0128)
state: California
city: La Jolla
country: United States
facility: UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
state: California
city: La Palma
country: United States
facility: Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research - Tujunga ( Site 0127)
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic ( Site 0102)
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC-Research ( Site 0117)
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc ( Site 0124)
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine ( Site 0146)
state: Georgia
city: Lake Charles
country: United States
facility: Accurate Clinical Research, Inc ( Site 0135)
state: Louisiana
city: Grand Blanc
country: United States
facility: AA Medical Research Center ( Site 0136)
state: Michigan
city: Charlotte
country: United States
facility: Javara - Tryon Medical Partners ( Site 0121)
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC ( Site 0103)
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center ( Site 0130)
state: Oklahoma
city: Memphis
country: United States
facility: Shelby Research, LLC ( Site 0142)
state: Tennessee
city: Baytown
country: United States
facility: Accurate Clinical Management, LLC. ( Site 0134)
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research ( Site 0113)
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc. ( Site 0133)
state: Texas
city: Mesquite
country: United States
facility: SouthWest Rheumatology Research, LLC ( Site 0115)
state: Texas
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Médicas Mar del Plata ( Site 0210)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0205)
state: Santa Fe
city: Santa Fe.
country: Argentina
facility: Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
state: Santa Fe
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman ( Site 0203)
state: Tucuman
city: Mendoza
country: Argentina
facility: Instituto de Reumatología ( Site 0201)
city: Cuiaba
country: Brazil
facility: IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)
state: Mato Grosso
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: LMK Serviços Médicos S/S-Reumacenter ( Site 0303)
state: Rio Grande Do Sul
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)
state: Sao Paulo
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke ( Site 0003)
state: Quebec
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer ( Site 0407)
state: Araucania
city: La Serena.
country: Chile
facility: IC La Serena Research ( Site 0414)
state: Coquimbo
city: Santiago.
country: Chile
facility: Clinica Dermacross ( Site 0416)
state: Region M. De Santiago
city: Santiago.
country: Chile
facility: Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: CECIM ( Site 0405)
state: Region M. De Santiago
city: Bengbu
country: China
facility: The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 2043)
state: Anhui
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-Department of Rheumatology and Immunology ( Site 2001)
state: Beijing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital ( Site 2065)
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital ( Site 2037)
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University ( Site 2051)
state: Guizhou
city: Shijiazhuang
country: China
facility: The Second Afilliated Hospital of Hebei Medical University-Immunology And Rheumatology ( Site 2064)
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
state: Hubei
city: Hengyang
country: China
facility: The First Affiliated Hospital of Nanhua University ( Site 2061)
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Te ( Site 2006)
state: Inner Mongolia
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University ( Site 2027)
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital ( Site 2005)
state: Jiangxi
city: Chang chun
country: China
facility: Jilin Province People's Hospital ( Site 2033)
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2056)
state: Shaanxi
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital ( Site 2029)
state: Shanxi
city: Chengdu
country: China
facility: The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
state: Tianjin
city: Medellín
country: Colombia
facility: Salud SURA Industriales ( Site 0508)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatología del Caribe ( Site 0501)
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 0502)
state: Atlantico
city: Chía
country: Colombia
facility: Preventive Care ( Site 0507)
state: Cundinamarca
city: Zipaquira
country: Colombia
facility: Healthy Medical Center S.A.S ( Site 0505)
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0506)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
state: Valle Del Cauca
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque ( Site 1007)
state: Aquitaine
city: Toulouse
country: France
facility: CHU Rangueil ( Site 1008)
state: Haute-Garonne
city: Montpellier
country: France
facility: CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
state: Herault
city: Saint Priest En Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
state: Loire
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille ( Site 1005)
state: Nord
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
state: Rhone-Alpes
city: Ciudad de Guatemala
country: Guatemala
facility: Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)
city: Guatemala
country: Guatemala
facility: Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)
city: Guatemala
country: Guatemala
facility: CELAN,S.A ( Site 0603)
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Research Hospital ( Site 1310)
state: Milano
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
state: Roma
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
state: Veneto
city: Firenze
country: Italy
facility: AOU Careggi ( Site 1311)
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
city: Nagoya
country: Japan
facility: Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
state: Aichi
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 2121)
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital ( Site 2116)
state: Miyagi
city: Tomigusuku
country: Japan
facility: Yuuai Medical Center ( Site 2122)
state: Okinawa
city: Izumo
country: Japan
facility: Shimane University Hospital ( Site 2119)
state: Shimane
city: Shimotsuga
country: Japan
facility: Dokkyo Medical University Hospital ( Site 2118)
state: Tochigi
city: Itabashiku
country: Japan
facility: Nihon University Itabashi Hospital ( Site 2105)
state: Tokyo
city: Shinagawa
country: Japan
facility: Showa Medical University East Hospital ( Site 2123)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 2120)
city: Chiba
country: Japan
facility: NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 2106)
city: Osaka
country: Japan
facility: Osaka Keisatsu Hospital ( Site 2117)
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
state: Kuala Lumpur
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
state: Kuala Lumpur
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
state: Pahang
city: Taiping
country: Malaysia
facility: Hospital Taiping ( Site 2221)
state: Perak
city: Mexico City
country: Mexico
facility: RM Pharma Specialists ( Site 0711)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)
state: Distrito Federal
city: León
country: Mexico
facility: Morales Vargas Centro de Investigacion ( Site 0710)
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia ( Site 0701)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica ( Site 0708)
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)
state: Nuevo Leon
city: San Luis Potosí
country: Mexico
facility: Centro Potosino de Investigación Médica ( Site 0703)
state: San Luis Potosi
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
state: Yucatan
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina ( Site 0702)
city: Distrito Federal
country: Mexico
facility: Clinstile, S.A. de C.V. ( Site 0709)
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center ( Site 2303)
state: Batangas
city: Quezon City
country: Philippines
facility: ST. LUKE'S MEDICAL CENTER ( Site 2304)
state: National Capital Region
city: Iloilo
country: Philippines
facility: Iloilo Doctors' Hospital ( Site 2301)
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Bydgoszcz ( Site 1410)
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)
state: Lubelskie
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady ( Site 1407)
state: Malopolskie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa ( Site 1411)
state: Mazowieckie
city: Bialystok
country: Poland
facility: Nova Reuma Społka Partnerska ( Site 1405)
state: Podlaskie
city: Bytom
country: Poland
facility: NZOZ BIF-MED ( Site 1409)
state: Slaskie
city: Poznan
country: Poland
facility: Medyczne Centrum Hetmańska ( Site 1406)
state: Wielkopolskie
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)
state: Wielkopolskie
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
state: La Coruna
city: Valencia
country: Spain
facility: HOSPITAL CLINICO DE VALENCIA ( Site 1608)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega ( Site 1606)
city: Kadikoy
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
state: Istanbul
city: Ankara
country: Turkey
facility: ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
city: Sakarya
country: Turkey
facility: Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: