Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

NCT06161116 | Terminated Phase 2 DMC FDA Drug

• 5 other identifiers: 6194-006MK-6194-0062023-505520-61-00U1111-1291-8716jRCT2041230137
• Study Type: interventional
• Target: 149
• Locations: 17 countries
• Sites: 127

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at 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.

  Week 28

• Percentage of Participants Experiencing Adverse Events (AEs)

  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.

  Up to approximately 28 weeks

• Percentage of Participants Discontinuing Study Treatment Due to an AE

  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.

  Up to approximately 28 weeks

Secondary Outcomes (13)

• Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28

  Week 28

• Percentage of Participants Achieving SRI-4 Response at Week 52

  Week 52

• Percentage of Participants Achieving BICLA at Week 52

  Week 52

• Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28

  Week 28

• Percentage of Participants with a CLASI-50 Response at Week 52

  Week 52

Study Arms (5)

Base Study: Dose 1

EXPERIMENTAL

Participants receive subcutaneous (SC) MK-6194 dose regimen 1.

Biological: MK-6194

Base Study: Dose 2

EXPERIMENTAL

Participants receive SC MK-6194 dose regimen 2.

Biological: MK-6194

Base Study: Placebo

PLACEBO COMPARATOR

Participants receive an SC placebo regimen.

Biological: Placebo

Extension: Dose 1

EXPERIMENTAL

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.

Biological: MK-6194; Biological: Placebo

Extension: Dose 2

EXPERIMENTAL

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.

Biological: MK-6194; Biological: Placebo

Interventions

MK-6194 BIOLOGICAL

SC Injection

Base Study: Dose 1; Base Study: Dose 2; Extension: Dose 1; Extension: Dose 2

Placebo BIOLOGICAL

SC Injection

Base Study: Placebo; Extension: Dose 1; Extension: Dose 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (127)

Medvin Clinical Research - Metyas ( Site 0128)

Covina, California, 91722, United States

Location

UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)

La Jolla, California, 92037, United States

Location

Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)

La Palma, California, 90623, United States

Location

Medvin Clinical Research - Tujunga ( Site 0127)

Tujunga, California, 91042, United States

Location

Denver Arthritis Clinic ( Site 0102)

Denver, Colorado, 80230, United States

Location

Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)

Clearwater, Florida, 33765, United States

Location

IRIS Research and Development, LLC-Research ( Site 0117)

Plantation, Florida, 33324, United States

Location

Clinical Research of West Florida, Inc ( Site 0124)

Tampa, Florida, 33606, United States

Location

Morehouse School of Medicine ( Site 0146)

Atlanta, Georgia, 30310, United States

Location

Accurate Clinical Research, Inc ( Site 0135)

Lake Charles, Louisiana, 70605, United States

Location

AA Medical Research Center ( Site 0136)

Grand Blanc, Michigan, 48439, United States

Location

Javara - Tryon Medical Partners ( Site 0121)

Charlotte, North Carolina, 28210, United States

Location

DJL Clinical Research, PLLC ( Site 0103)

Charlotte, North Carolina, 28211, United States

Location

University of Oklahoma Health Science Center ( Site 0130)

Oklahoma City, Oklahoma, 73104, United States

Location

Shelby Research, LLC ( Site 0142)

Memphis, Tennessee, 38119, United States

Location

Accurate Clinical Management, LLC. ( Site 0134)

Baytown, Texas, 77521, United States

Location

Epic Medical Research ( Site 0113)

DeSoto, Texas, 75115, United States

Location

Accurate Clinical Research, Inc. ( Site 0133)

Houston, Texas, 77089, United States

Location

SouthWest Rheumatology Research, LLC ( Site 0115)

Mesquite, Texas, 75150, United States

Location

Centro de Investigaciones Médicas Mar del Plata ( Site 0210)

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Sanatorio Parque ( Site 0205)

Rosario, Santa Fe Province, S2000DVC, Argentina

Location

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)

Santa Fe, Santa Fe Province, S3000BPJ, Argentina

Location

Centro de Investigaciones Médicas Tucuman ( Site 0203)

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina

Location

Instituto de Reumatología ( Site 0201)

Mendoza, M5500CPH, Argentina

Location

IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)

Cuiabá, Mato Grosso, 78020-500, Brazil

Location

Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

Location

LMK Serviços Médicos S/S-Reumacenter ( Site 0303)

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Centro Multidisciplinar de Estudos Clinicos ( Site 0302)

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas ( Site 0311)

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Diex Recherche Sherbrooke ( Site 0003)

Sherbrooke, Quebec, J1L 0H8, Canada

Location

IC La Serena Research ( Site 0414)

La Serena, Coquimbo Region, 1720430, Chile

Location

Clinica Dermacross ( Site 0416)

Santiago, Region M. de Santiago, 7640881, Chile

Location

Complejo Asistencial Dr. Sotero del Rio ( Site 0402)

Santiago, Region M. de Santiago, 8207257, Chile

Location

CECIM ( Site 0405)

Santiago, Region M. de Santiago, 8320000, Chile

Location

Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)

Santiago, Region M. de Santiago, 8420383, Chile

Location

James Lind Centro de Investigacion del Cancer ( Site 0407)

Temuco, Región de la Araucanía, 4800827, Chile

Location

The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)

Bengbu, Anhui, 233000, China

Location

Anhui Provincial Hospital ( Site 2043)

Hefei, Anhui, 230071, China

Location

Beijing Peking Union Medical College Hospital-Department of Rheumatology and Immunology ( Site 2001)

Beijing, Beijing Municipality, 100730, China

Location

Gansu Provincial Hospital ( Site 2065)

Lanzhou, Gansu, 730000, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)

Guangzhou, Guangdong, 510000, China

Location

Southern Medical University Nanfang Hospital ( Site 2037)

Guangzhou, Guangdong, 510515, China

Location

The Affiliated Hospital of Guizhou Medical University ( Site 2051)

Guiyang, Guizhou, 550004, China

Location

The Second Afilliated Hospital of Hebei Medical University-Immunology And Rheumatology ( Site 2064)

Shijiazhuang, Hebei, 050000, China

Location

The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)

Luoyang, Henan, 471003, China

Location

Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)

Wuhan, Hubei, 430000, China

Location

The First Affiliated Hospital of Nanhua University ( Site 2061)

Hengyang, Hunan, 421001, China

Location

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Te ( Site 2006)

Baotou, Inner Mongolia, 014010, China

Location

Affiliated Hospital of Nantong University ( Site 2027)

Nantong, Jiangsu, 226001, China

Location

Pingxiang People's Hospital ( Site 2005)

Pingxiang, Jiangxi, 337055, China

Location

Jilin Province People's Hospital ( Site 2033)

Changchun, Jilin, 130021, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2056)

Xi'an, Shaanxi, 710061, China

Location

Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)

Shanghai, Shanghai Municipality, 200001, China

Location

Shanxi Bethune Hospital ( Site 2029)

Taiyuan, Shanxi, 030032, China

Location

The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)

Chengdu, Sichuan, 610500, China

Location

Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)

Tianjin, Tianjin Municipality, 300052, China

Location

Salud SURA Industriales ( Site 0508)

Medellín, Antioquia, 50021, Colombia

Location

Centro Integral de Reumatología del Caribe ( Site 0501)

Barranquilla, Atlántico, 080002, Colombia

Location

Clinica de la Costa S.A.S. ( Site 0502)

Barranquilla, Atlántico, 080020, Colombia

Location

Preventive Care ( Site 0507)

Chía, Cundinamarca, 250001, Colombia

Location

Healthy Medical Center S.A.S ( Site 0505)

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Fundación Valle del Lili ( Site 0506)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)

Cali, Valle del Cauca Department, 760042, Colombia

Location

CHU Bordeaux Haut-Leveque ( Site 1007)

Pessac, Aquitaine, 33600, France

Location

Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)

Lyon, Auvergne-Rhône-Alpes, 69007, France

Location

CHU Rangueil ( Site 1008)

Toulouse, Haute-Garonne, 31400, France

Location

CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)

Montpellier, Herault, 34295, France

Location

Hopital Claude Huriez - CHU de Lille ( Site 1005)

Lille, Nord, 59037, France

Location

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)

Saint Priest En Jarez, Pays de la Loire Region, 42270, France

Location

Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)

Guatemala City, 01009, Guatemala

Location

CELAN,S.A ( Site 0603)

Guatemala City, 01010, Guatemala

Location

Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)

Guatemala City, 01010, Guatemala

Location

Istituto Clinico Humanitas Research Hospital ( Site 1310)

Rozzano, Milano, 20089, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)

Rome, Roma, 00128, Italy

Location

Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)

Siena, Tuscany, 53100, Italy

Location

Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)

Padua, Veneto, 35128, Italy

Location

AOU Careggi ( Site 1311)

Florence, 50141, Italy

Location

Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)

Napoli, 80131, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)

Roma, 00168, Italy

Location

Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)

Nagoya, Aichi-ken, 457-8510, Japan

Location

St. Marianna University Hospital ( Site 2121)

Kawasaki, Kanagawa, 216-8511, Japan

Location

Tohoku University Hospital ( Site 2116)

Sendai, Miyagi, 980-8574, Japan

Location

Yuuai Medical Center ( Site 2122)

Tomigusuku, Okinawa, 901-0224, Japan

Location

Shimane University Hospital ( Site 2119)

Izumo, Shimane, 693-0021, Japan

Location

Dokkyo Medical University Hospital ( Site 2118)

Shimotsuga, Tochigi, 321-0293, Japan

Location

Nihon University Itabashi Hospital ( Site 2105)

Itabashiku, Tokyo, 173-8610, Japan

Location

Showa Medical University East Hospital ( Site 2123)

Shinagawa, Tokyo, 142-0054, Japan

Location

Chiba University Hospital ( Site 2120)

Chiba, 260-8677, Japan

Location

NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)

Chiba, 260-8712, Japan

Location

Okayama University Hospital ( Site 2106)

Okayama, 700-8558, Japan

Location

Osaka Keisatsu Hospital ( Site 2117)

Osaka, 543-8922, Japan

Location

Hospital Canselor Tuanku Muhriz UKM ( Site 2225)

Cheras, Kuala Lumpur, 56000, Malaysia

Location

University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Taiping ( Site 2221)

Taiping, Perak, 34000, Malaysia

Location

Morales Vargas Centro de Investigacion ( Site 0710)

León, Guanajuato, 37000, Mexico

Location

Centro Integral en Reumatologia ( Site 0701)

Guadalajara, Jalisco, 44160, Mexico

Location

Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)

Guadalajara, Jalisco, 44638, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)

Guadalajara, Jalisco, 44650, Mexico

Location

Centro de Estudios de Investigacion Basica y Clinica ( Site 0708)

Guadalajara, Jalisco, 44690, Mexico

Location

RM Pharma Specialists ( Site 0711)

Mexico City, Mexico City, 03100, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)

Mexico City, Mexico City, 14080, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)

Monterrey, Nuevo León, 64460, Mexico

Location

Centro Potosino de Investigación Médica ( Site 0703)

San Luis Potosí City, San Luis Potosí, 78250, Mexico

Location

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)

Mérida, Yucatán, 97130, Mexico

Location

ICARO Investigaciones en Medicina ( Site 0702)

Chihuahua City, 31000, Mexico

Location

Clinstile, S.A. de C.V. ( Site 0709)

Distrito Federal, 06700, Mexico

Location

Mary Mediatrix Medical Center ( Site 2303)

Lipa City, Batangas, 4217, Philippines

Location

ST. LUKE'S MEDICAL CENTER ( Site 2304)

Quezon City, National Capital Region, 1102, Philippines

Location

Iloilo Doctors' Hospital ( Site 2301)

Iloilo City, 5000, Philippines

Location

Medyczne Centrum Hetmańska ( Site 1406)

Poznan, Greater Poland Voivodeship, 60-218, Poland

Location

Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)

Poznan, Greater Poland Voivodeship, 61-397, Poland

Location

MICS Centrum Medyczne Bydgoszcz ( Site 1410)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065, Poland

Location

Centrum Medyczne Plejady ( Site 1407)

Krakow, Lesser Poland Voivodeship, 30-363, Poland

Location

Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)

Lublin, Lublin Voivodeship, 20-607, Poland

Location

MICS Centrum Medyczne Warszawa ( Site 1411)

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Nova Reuma Społka Partnerska ( Site 1405)

Bialystok, Podlaskie Voivodeship, 15-707, Poland

Location

NZOZ BIF-MED ( Site 1409)

Bytom, Silesian Voivodeship, 41-902, Poland

Location

CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)

A Coruña, La Coruna, 15006, Spain

Location

HOSPITAL CLINICO DE VALENCIA ( Site 1608)

Valencia, Valenciana, Comunitat, 46010, Spain

Location

Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)

Barcelona, 08035, Spain

Location

Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)

Seville, 41010, Spain

Location

Hospital Universitario Rio Hortega ( Site 1606)

Valladolid, 47012, Spain

Location

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)

Kadıköy, Istanbul, 34722, Turkey (Türkiye)

Location

ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)

Ankara, 06800, Turkey (Türkiye)

Location

Sakarya Training and Research Hospital-Rheumatology ( Site 1708)

Sakarya, Turkey (Türkiye)

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 27, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

PH (3); CO (7); AR (5); CA (1); ES (5); TU (4); BR (5); FR (6); MY (4); CL (6); PL (8); CN (20); US (19); IT (7); ME (12); GU (3); JP (12)