Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

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

The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with systemic lupus erythematosus.

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: MK-6194; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• 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 positive antinuclear antibody (+ANA; titer ≥1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Smith (anti-Sm) antibody, or positive anti-Sjögren's Syndrome A (SSA)/Ro antibody.
• Has the presence of at least 1 of the following manifestations of SLE: active lupus rash with Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (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:

The main exclusion criteria include but are not limited to the following:

• Has a concurrent clinically significant disease or clinically relevant laboratory abnormalities, or a history of any illness or medical condition that 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 interleukin-2 (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 (APS) 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 coronavirus disease of 2019 (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 nonsteroidal anti-inflammatory drug (NSAID), excluding low-dose aspirin (<350 mg/day), or is taking daily oral NSAID at greater than the maximum recommended dosage.
• Is currently on any chronic systemic (oral or intravenous [IV]) anti-infective therapy for chronic active infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-6194 3 mg Q2W; Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).	Biological: MK-6194; SC Injection
Experimental: MK-6194 3 mg Q4W; Participants receive SC MK-6194 3 mg every 4 weeks (q4w).	Biological: MK-6194; SC Injection
Placebo Comparator: Placebo; Participants receive SC placebo q2w.	Biological: Placebo; SC Injection
Experimental: 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.	Biological: MK-6194; SC Injection
Experimental: 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.	Biological: MK-6194; SC Injection
Experimental: 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.	Biological: MK-6194; SC Injection; Biological: Placebo; SC Injection
Experimental: 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.	Biological: MK-6194; SC Injection; Biological: Placebo; SC Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at 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)	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at 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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 6194-006; MK-6194-006 (Other Identifier: MSD); U1111-1291-8716 (Registry Identifier: UTN); jRCT2041230137 (Registry Identifier: jRCT); 2023-505520-61-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No