Systemic Lupus ErythematosusPhase 2NCT06161116
Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
A Phase 2 study testing MK-6194 in people with Systemic Lupus Erythematosus, run by Merck Sharp & Dohme LLC at 127 sites in 17 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- MK-6194
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 127 sitesin 17 countries
- Study dates
- 27 Dec 2023to 30 Jul 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
127 sites in 17 countries.
127 sites in 17 countries
China20 sites
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Te ( Site 2006)
Baotou, Inner Mongolia, 014010
Beijing Peking Union Medical College Hospital-Department of Rheumatology and Immunology ( Site 2001)
Beijing, Beijing Municipality, 100730
The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 2019)
Bengbu, Anhui, 233000
Jilin Province People's Hospital ( Site 2033)
Changchun, Jilin, 130021
The First Affiliated Hospital Of Chengdu Medical College ( Site 2052)
Chengdu, Sichuan, 610500
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 2036)
Guangzhou, Guangdong, 510000
Southern Medical University Nanfang Hospital ( Site 2037)
Guangzhou, Guangdong, 510515
The Affiliated Hospital of Guizhou Medical University ( Site 2051)
Guiyang, Guizhou, 550004
Anhui Provincial Hospital ( Site 2043)
Hefei, Anhui, 230071
The First Affiliated Hospital of Nanhua University ( Site 2061)
Hengyang, Hunan, 421001
Gansu Provincial Hospital ( Site 2065)
Lanzhou, Gansu, 730000
The First Affiliated Hospital of Henan University of Science &Technology ( Site 2041)
Luoyang, Henan, 471003
Affiliated Hospital of Nantong University ( Site 2027)
Nantong, Jiangsu, 226001
Pingxiang People's Hospital ( Site 2005)
Pingxiang, Jiangxi, 337055
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 2053)
Shanghai, Shanghai Municipality, 200001
The Second Afilliated Hospital of Hebei Medical University-Immunology And Rheumatology ( Site 2064)
Shijiazhuang, Hebei, 050000
Shanxi Bethune Hospital ( Site 2029)
Taiyuan, Shanxi, 030032
Tianjin Medical University General Hospital-Rheumatism and Immunology ( Site 2011)
Tianjin, Tianjin Municipality, 300052
Tongji Hospital Tongji Medical,Science & Technology ( Site 2042)
Wuhan, Hubei, 430000
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2056)
Xi'an, Shaanxi, 710061
United States19 sites
Morehouse School of Medicine ( Site 0146)
Atlanta, Georgia, 30310
Accurate Clinical Management, LLC. ( Site 0134)
Baytown, Texas, 77521
Javara - Tryon Medical Partners ( Site 0121)
Charlotte, North Carolina, 28210
DJL Clinical Research, PLLC ( Site 0103)
Charlotte, North Carolina, 28211
Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)
Clearwater, Florida, 33765
Medvin Clinical Research - Metyas ( Site 0128)
Covina, California, 91722
Denver Arthritis Clinic ( Site 0102)
Denver, Colorado, 80230
Epic Medical Research ( Site 0113)
DeSoto, Texas, 75115
AA Medical Research Center ( Site 0136)
Grand Blanc, Michigan, 48439
Accurate Clinical Research, Inc. ( Site 0133)
Houston, Texas, 77089
UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
La Jolla, California, 92037
Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
La Palma, California, 90623
Accurate Clinical Research, Inc ( Site 0135)
Lake Charles, Louisiana, 70605
Shelby Research, LLC ( Site 0142)
Memphis, Tennessee, 38119
SouthWest Rheumatology Research, LLC ( Site 0115)
Mesquite, Texas, 75150
University of Oklahoma Health Science Center ( Site 0130)
Oklahoma City, Oklahoma, 73104
IRIS Research and Development, LLC-Research ( Site 0117)
Plantation, Florida, 33324
Clinical Research of West Florida, Inc ( Site 0124)
Tampa, Florida, 33606
Medvin Clinical Research - Tujunga ( Site 0127)
Tujunga, California, 91042
Japan12 sites
Chiba University Hospital ( Site 2120)
Chiba, 260-8677
NHO Chiba Medical Center Chibahigashi National Hospital ( Site 2112)
Chiba, 260-8712
Nihon University Itabashi Hospital ( Site 2105)
Itabashiku, Tokyo, 173-8610
Shimane University Hospital ( Site 2119)
Izumo, Shimane, 693-0021
St. Marianna University Hospital ( Site 2121)
Kawasaki, Kanagawa, 216-8511
Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)
Nagoya, Aichi-ken, 457-8510
Okayama University Hospital ( Site 2106)
Okayama, 700-8558
Osaka Keisatsu Hospital ( Site 2117)
Osaka, 543-8922
Tohoku University Hospital ( Site 2116)
Sendai, Miyagi, 980-8574
Dokkyo Medical University Hospital ( Site 2118)
Shimotsuga, Tochigi, 321-0293
Showa Medical University East Hospital ( Site 2123)
Shinagawa, Tokyo, 142-0054
Yuuai Medical Center ( Site 2122)
Tomigusuku, Okinawa, 901-0224
Mexico12 sites
ICARO Investigaciones en Medicina ( Site 0702)
Chihuahua City, 31000
Clinstile, S.A. de C.V. ( Site 0709)
Distrito Federal, 06700
Centro Integral en Reumatologia ( Site 0701)
Guadalajara, Jalisco, 44160
Centro de Atención en Enfermedades Inflamatorias CATEI ( Site 0707)
Guadalajara, Jalisco, 44638
Clinica de Investigacion en Reumatologia y Obesidad S. C. ( Site 0705)
Guadalajara, Jalisco, 44650
Centro de Estudios de Investigacion Basica y Clinica ( Site 0708)
Guadalajara, Jalisco, 44690
Morales Vargas Centro de Investigacion ( Site 0710)
León, Guanajuato, 37000
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 0712)
Mérida, Yucatán, 97130
RM Pharma Specialists ( Site 0711)
Mexico City, Mexico City, 03100
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0713)
Mexico City, Mexico City, 14080
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Rheumatology ( Site 0706)
Monterrey, Nuevo León, 64460
Centro Potosino de Investigación Médica ( Site 0703)
San Luis Potosí City, San Luis Potosí, 78250
Poland8 sites
Nova Reuma Społka Partnerska ( Site 1405)
Bialystok, Podlaskie Voivodeship, 15-707
MICS Centrum Medyczne Bydgoszcz ( Site 1410)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065
NZOZ BIF-MED ( Site 1409)
Bytom, Silesian Voivodeship, 41-902
Centrum Medyczne Plejady ( Site 1407)
Krakow, Lesser Poland Voivodeship, 30-363
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)
Lublin, Lublin Voivodeship, 20-607
Medyczne Centrum Hetmańska ( Site 1406)
Poznan, Greater Poland Voivodeship, 60-218
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)
Poznan, Greater Poland Voivodeship, 61-397
MICS Centrum Medyczne Warszawa ( Site 1411)
Warsaw, Masovian Voivodeship, 00-874
Colombia7 sites
Centro Integral de Reumatología del Caribe ( Site 0501)
Barranquilla, Atlántico, 080002
Clinica de la Costa S.A.S. ( Site 0502)
Barranquilla, Atlántico, 080020
Fundación Valle del Lili ( Site 0506)
Cali, Valle del Cauca Department, 760032
Centro de Estudios de Reumatología y Dermatología SAS ( Site 0512)
Cali, Valle del Cauca Department, 760042
Preventive Care ( Site 0507)
Chía, Cundinamarca, 250001
Salud SURA Industriales ( Site 0508)
Medellín, Antioquia, 50021
Healthy Medical Center S.A.S ( Site 0505)
Zipaquirá, Cundinamarca, 250252
Italy7 sites
AOU Careggi ( Site 1311)
Florence, 50141
Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UNITA'OPERATIVA DI REUMATOLOGIA, DIPAR ( Site 1305)
Naples, 80131
Azienda Ospedale - Università Padova-Department of Medicine-DIMED ( Site 1309)
Padova, Veneto, 35128
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -UOC Reumatologia ( Site 1304)
Roma, 00168
Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)
Rome, Roma, 00128
Istituto Clinico Humanitas Research Hospital ( Site 1310)
Rozzano, Milano, 20089
Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306)
Siena, Tuscany, 53100
Chile6 sites
IC La Serena Research ( Site 0414)
La Serena, Coquimbo Region, 1720430
Clinica Dermacross ( Site 0416)
Santiago, Region M. de Santiago, 7640881
Complejo Asistencial Dr. Sotero del Rio ( Site 0402)
Santiago, Region M. de Santiago, 8207257
CECIM ( Site 0405)
Santiago, Region M. de Santiago, 8320000
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)
Santiago, Region M. de Santiago, 8420383
James Lind Centro de Investigacion del Cancer ( Site 0407)
Temuco, Araucania, 4800827
France6 sites
Hopital Claude Huriez - CHU de Lille ( Site 1005)
Lille, Nord, 59037
Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)
Lyon, Auvergne-Rhône-Alpes, 69007
CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006)
Montpellier, Herault, 34295
CHU Bordeaux Haut-Leveque ( Site 1007)
Pessac, Aquitaine, 33600
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)
Saint Priest En Jarez, Pays de la Loire Region, 42270
CHU Rangueil ( Site 1008)
Toulouse, Haute-Garonne, 31400
Argentina5 sites
Centro de Investigaciones Médicas Mar del Plata ( Site 0210)
Mar del Plata, Buenos Aires, 7600
Instituto de Reumatología ( Site 0201)
Mendoza, M5500CPH
Sanatorio Parque ( Site 0205)
Rosario, Santa Fe Province, S2000DVC
Centro de Investigaciones Médicas Tucuman ( Site 0203)
SAN M. de Tucuman, Tucumán Province, T4000AXL
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0206)
Santa Fe, Santa Fe Province, S3000BPJ
Brazil5 sites
IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0313)
Cuiabá, Mato Grosso, 78020-500
Núcleo de Pesquisa Clínica do Rio Grande do Sul ( Site 0309)
Porto Alegre, Rio Grande do Sul, 90430-001
LMK Serviços Médicos S/S-Reumacenter ( Site 0303)
Porto Alegre, Rio Grande do Sul, 90480-000
Centro Multidisciplinar de Estudos Clinicos ( Site 0302)
São Bernardo do Campo, São Paulo, 09715-090
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
Spain5 sites
CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)
A Coruña, La Coruna, 15006
Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)
Barcelona, 08035
Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)
Seville, 41010
HOSPITAL CLINICO DE VALENCIA ( Site 1608)
Valencia, Valenciana, Comunitat, 46010
Hospital Universitario Rio Hortega ( Site 1606)
Valladolid, 47012
Malaysia4 sites
Hospital Canselor Tuanku Muhriz UKM ( Site 2225)
Cheras, Kuala Lumpur, 56000
Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224)
Kuantan, Pahang, 25100
University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 2222)
Lembah Pantai, Kuala Lumpur, 59100
Hospital Taiping ( Site 2221)
Taiping, Perak, 34000
Turkey (Türkiye)4 sites
ANKARA UNIVERSITY IBNI SINA HOSPITAL-Rheumatology Department ( Site 1703)
Ankara, 06230
Ankara Bilkent Şehir Hastanesi-Rheumatology ( Site 1702)
Ankara, 06800
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1709)
Kadıköy, Istanbul, 34722
Sakarya Training and Research Hospital-Rheumatology ( Site 1708)
Sakarya
Guatemala3 sites
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)
Guatemala City, 01009
CELAN,S.A ( Site 0603)
Guatemala City, 01010
Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)
Guatemala City, 01010
Philippines3 sites
Iloilo Doctors' Hospital ( Site 2301)
Iloilo City, 5000
Mary Mediatrix Medical Center ( Site 2303)
Lipa City, Batangas, 4217
ST. LUKE'S MEDICAL CENTER ( Site 2304)
Quezon City, National Capital Region, 1102
Canada1 site
Diex Recherche Sherbrooke ( Site 0003)
Sherbrooke, Quebec, J1L 0H8
About this study
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
The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with systemic lupus erythematosus.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- MK-6194, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6194Biological
SC Injection
PlaceboBiological
SC Injection
| Study group | Role | What they receive |
|---|---|---|
| MK-6194 3 mg Q2W | Experimental | Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w). Receives: Biological: MK-6194 |
| MK-6194 3 mg Q4W | Experimental | Participants receive SC MK-6194 3 mg every 4 weeks (q4w). Receives: Biological: MK-6194 |
| Placebo | Placebo comparator | Participants receive SC placebo q2w. Receives: Biological: Placebo |
| MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period) | Experimental | 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. Receives: Biological: MK-6194 |
| MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period) | Experimental | 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. Receives: Biological: MK-6194 |
| Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period) | Experimental | 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. Receives: Biological: MK-6194; Biological: Placebo |
| Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period) | Experimental | 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. Receives: Biological: MK-6194; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 16 months
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start27 Dec 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161116
- Sponsor's protocol ID
- 6194-006
- Other IDs
- MK-6194-006, 2023-505520-61-00, U1111-1291-8716, jRCT2041230137, 2023
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2023
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf