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Can a new biologic tame lupus flares?

NCT ID NCT06161116

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial is testing whether an experimental biologic called MK-6194 can reduce disease activity in adults with systemic lupus erythematosus (SLE), an autoimmune condition that causes inflammation and organ damage. Participants receive either MK-6194 or a placebo as an injection under the skin, alongside their usual lupus medications. The study measures how many people achieve a meaningful improvement in lupus symptoms by week 28, as well as safety and tolerability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-6194, an experimental biologic given as an injection under the skin
What this could lead to
If successful, MK-6194 could become a new treatment option to help control lupus disease activity and reduce symptoms.
What could go wrong
This is an early-phase trial with a modest number of participants, so results may not confirm benefit. Possible side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

149 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • AA Medical Research Center ( Site 0136)

    Grand Blanc, Michigan, 48439, United States

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

    Ankara, 06230, Turkey (Türkiye)

  • AOU Careggi ( Site 1311)

    Florence, 50141, Italy

  • Accurate Clinical Management, LLC. ( Site 0134)

    Baytown, Texas, 77521, United States

  • Accurate Clinical Research, Inc ( Site 0135)

    Lake Charles, Louisiana, 70605, United States

  • Accurate Clinical Research, Inc. ( Site 0133)

    Houston, Texas, 77089, United States

  • Affiliated Hospital of Nantong University ( Site 2027)

    Nantong, Jiangsu, 226001, China

  • Anhui Provincial Hospital ( Site 2043)

    Hefei, Anhui, 230071, China

  • Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)

    Ankara, 06800, Turkey (Türkiye)

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

    La Palma, California, 90623, United States

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

    Padova, Veneto, 35128, Italy

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

    Naples, 80131, Italy

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

    Siena, Tuscany, 53100, Italy

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

    Beijing, Beijing Municipality, 100730, China

  • CECIM ( Site 0405)

    Santiago, Region M. de Santiago, 8320000, Chile

  • CELAN,S.A ( Site 0603)

    Guatemala City, 01010, Guatemala

  • CHU Bordeaux Haut-Leveque ( Site 1007)

    Pessac, Aquitaine, 33600, France

  • CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)

    Montpellier, Herault, 34295, France

  • CHU Rangueil ( Site 1008)

    Toulouse, Haute-Garonne, 31400, France

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

    A Coruña, La Coruna, 15006, Spain

  • Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)

    Lyon, Auvergne-Rhône-Alpes, 69007, France

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

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

  • Centro Integral de Reumatología del Caribe ( Site 0501)

    Barranquilla, Atlántico, 080002, Colombia

  • Centro Integral en Reumatologia ( Site 0701)

    Guadalajara, Jalisco, 44160, Mexico

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

    Santiago, Region M. de Santiago, 8420383, Chile

  • Centro Multidisciplinar de Estudos Clinicos ( Site 0302)

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

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

    Mérida, Yucatán, 97130, Mexico

  • Centro Potosino de Investigación Médica ( Site 0703)

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

  • Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)

    Guadalajara, Jalisco, 44638, Mexico

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

    Guadalajara, Jalisco, 44690, Mexico

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

    Cali, Valle del Cauca Department, 760042, Colombia

  • Centro de Investigaciones Médicas Mar del Plata ( Site 0210)

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Centro de Investigaciones Médicas Tucuman ( Site 0203)

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

  • Centrum Medyczne Plejady ( Site 1407)

    Krakow, Lesser Poland Voivodeship, 30-363, Poland

  • Chiba University Hospital ( Site 2120)

    Chiba, 260-8677, Japan

  • Clinica Dermacross ( Site 0416)

    Santiago, Region M. de Santiago, 7640881, Chile

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

    Guatemala City, 01010, Guatemala

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

    Guadalajara, Jalisco, 44650, Mexico

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

    Barranquilla, Atlántico, 080020, Colombia

  • Clinical Research of West Florida, Inc ( Site 0124)

    Tampa, Florida, 33606, United States

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

    Clearwater, Florida, 33765, United States

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

    Distrito Federal, 06700, Mexico

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

    Guatemala City, 01009, Guatemala

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

    Santa Fe, Santa Fe Province, S3000BPJ, Argentina

  • Complejo Asistencial Dr. Sotero del Rio ( Site 0402)

    Santiago, Region M. de Santiago, 8207257, Chile

  • DJL Clinical Research, PLLC ( Site 0103)

    Charlotte, North Carolina, 28211, United States

  • Denver Arthritis Clinic ( Site 0102)

    Denver, Colorado, 80230, United States

  • Diex Recherche Sherbrooke ( Site 0003)

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Dokkyo Medical University Hospital ( Site 2118)

    Shimotsuga, Tochigi, 321-0293, Japan

  • Epic Medical Research ( Site 0113)

    DeSoto, Texas, 75115, United States

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

    Roma, 00168, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)

    Rome, Roma, 00128, Italy

  • Fundación Valle del Lili ( Site 0506)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gansu Provincial Hospital ( Site 2065)

    Lanzhou, Gansu, 730000, China

  • HOSPITAL CLINICO DE VALENCIA ( Site 1608)

    Valencia, Valenciana, Comunitat, 46010, Spain

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

    Zipaquirá, Cundinamarca, 250252, Colombia

  • Hopital Claude Huriez - CHU de Lille ( Site 1005)

    Lille, Nord, 59037, France

  • Hospital Canselor Tuanku Muhriz UKM ( Site 2225)

    Cheras, Kuala Lumpur, 56000, Malaysia

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

    Seville, 41010, Spain

  • Hospital Taiping ( Site 2221)

    Taiping, Perak, 34000, Malaysia

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

    Kuantan, Pahang, 25100, Malaysia

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

    Barcelona, 08035, Spain

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

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario Rio Hortega ( Site 1606)

    Valladolid, 47012, Spain

  • 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

  • IC La Serena Research ( Site 0414)

    La Serena, Coquimbo Region, 1720430, Chile

  • ICARO Investigaciones en Medicina ( Site 0702)

    Chihuahua City, 31000, Mexico

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

    Cuiabá, Mato Grosso, 78020-500, Brazil

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

    Plantation, Florida, 33324, United States

  • Iloilo Doctors' Hospital ( Site 2301)

    Iloilo City, 5000, Philippines

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

    Mexico City, Mexico City, 14080, Mexico

  • Instituto de Reumatología ( Site 0201)

    Mendoza, M5500CPH, Argentina

  • Istituto Clinico Humanitas Research Hospital ( Site 1310)

    Rozzano, Milano, 20089, Italy

  • James Lind Centro de Investigacion del Cancer ( Site 0407)

    Temuco, Araucania, 4800827, Chile

  • Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)

    Nagoya, Aichi-ken, 457-8510, Japan

  • Javara - Tryon Medical Partners ( Site 0121)

    Charlotte, North Carolina, 28210, United States

  • Jilin Province People's Hospital ( Site 2033)

    Changchun, Jilin, 130021, China

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

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

  • MICS Centrum Medyczne Bydgoszcz ( Site 1410)

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

  • MICS Centrum Medyczne Warszawa ( Site 1411)

    Warsaw, Masovian Voivodeship, 00-874, Poland

  • Mary Mediatrix Medical Center ( Site 2303)

    Lipa City, Batangas, 4217, Philippines

  • Medvin Clinical Research - Metyas ( Site 0128)

    Covina, California, 91722, United States

  • Medvin Clinical Research - Tujunga ( Site 0127)

    Tujunga, California, 91042, United States

  • Medyczne Centrum Hetmańska ( Site 1406)

    Poznan, Greater Poland Voivodeship, 60-218, Poland

  • Morales Vargas Centro de Investigacion ( Site 0710)

    León, Guanajuato, 37000, Mexico

  • Morehouse School of Medicine ( Site 0146)

    Atlanta, Georgia, 30310, United States

  • NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)

    Chiba, 260-8712, Japan

  • NZOZ BIF-MED ( Site 1409)

    Bytom, Silesian Voivodeship, 41-902, Poland

  • Nihon University Itabashi Hospital ( Site 2105)

    Itabashiku, Tokyo, 173-8610, Japan

  • Nova Reuma Społka Partnerska ( Site 1405)

    Bialystok, Podlaskie Voivodeship, 15-707, Poland

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

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

  • Okayama University Hospital ( Site 2106)

    Okayama, 700-8558, Japan

  • Osaka Keisatsu Hospital ( Site 2117)

    Osaka, 543-8922, Japan

  • Pingxiang People's Hospital ( Site 2005)

    Pingxiang, Jiangxi, 337055, China

  • Preventive Care ( Site 0507)

    Chía, Cundinamarca, 250001, Colombia

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

    Poznan, Greater Poland Voivodeship, 61-397, Poland

  • RM Pharma Specialists ( Site 0711)

    Mexico City, Mexico City, 03100, Mexico

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

    Shanghai, Shanghai Municipality, 200001, China

  • ST. LUKE'S MEDICAL CENTER ( Site 2304)

    Quezon City, National Capital Region, 1102, Philippines

  • Sakarya Training and Research Hospital-Rheumatology ( Site 1708)

    Sakarya, Turkey (Türkiye)

  • Salud SURA Industriales ( Site 0508)

    Medellín, Antioquia, 50021, Colombia

  • Sanatorio Parque ( Site 0205)

    Rosario, Santa Fe Province, S2000DVC, Argentina

  • Shanxi Bethune Hospital ( Site 2029)

    Taiyuan, Shanxi, 030032, China

  • Shelby Research, LLC ( Site 0142)

    Memphis, Tennessee, 38119, United States

  • Shimane University Hospital ( Site 2119)

    Izumo, Shimane, 693-0021, Japan

  • Showa Medical University East Hospital ( Site 2123)

    Shinagawa, Tokyo, 142-0054, Japan

  • SouthWest Rheumatology Research, LLC ( Site 0115)

    Mesquite, Texas, 75150, United States

  • Southern Medical University Nanfang Hospital ( Site 2037)

    Guangzhou, Guangdong, 510515, China

  • St. Marianna University Hospital ( Site 2121)

    Kawasaki, Kanagawa, 216-8511, Japan

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

    Guangzhou, Guangdong, 510000, China

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

    Kadıköy, Istanbul, 34722, Turkey (Türkiye)

  • The Affiliated Hospital of Guizhou Medical University ( Site 2051)

    Guiyang, Guizhou, 550004, China

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

    Chengdu, Sichuan, 610500, China

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

    Baotou, Inner Mongolia, 014010, China

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

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Nanhua University ( Site 2061)

    Hengyang, Hunan, 421001, China

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

    Xi'an, Shaanxi, 710061, China

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

    Bengbu, Anhui, 233000, China

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

    Shijiazhuang, Hebei, 050000, China

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

    Tianjin, Tianjin Municipality, 300052, China

  • Tohoku University Hospital ( Site 2116)

    Sendai, Miyagi, 980-8574, Japan

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

    Wuhan, Hubei, 430000, China

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

    La Jolla, California, 92037, United States

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

    Lembah Pantai, Kuala Lumpur, 59100, Malaysia

  • University of Oklahoma Health Science Center ( Site 0130)

    Oklahoma City, Oklahoma, 73104, United States

  • Yuuai Medical Center ( Site 2122)

    Tomigusuku, Okinawa, 901-0224, Japan

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

    Lublin, Lublin Voivodeship, 20-607, Poland

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