Systemic Lupus Erythematosus Clinical Trial
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. 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.
Status | Recruiting |
Enrollment | 270 |
Est. completion date | July 9, 2027 |
Est. primary completion date | January 22, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Has a diagnosis of systemic lupus erythematosus (SLE) =6 months prior to Screening. - Is taking at least 1 background therapy (1 immunosuppressant or dapsone and/or 1 antimalarial and/or oral corticosteroids) for SLE. - Has + antinuclear antibody (+ANA) (titer =1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Sm antibody, or positive anti-SSA/Ro antibody. - Has the presence of at least one of the following manifestations of SLE: Active lupus rash with CLASI-A erythema and scale/hypertrophy combined score >2, or >2 tender and swollen joints in wrists, metacarpophalangeals (MCPs), or proximal interphalangeals (PIPs). - Has a hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score of =6 and clinical hybrid SLEDAI score of =4. Exclusion Criteria: - Has a concurrent clinically significant disease or clinically relevant laboratory abnormalities, or a history of any illness or medical condition that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. - Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening. - Has a severe chronic pulmonary disease requiring oxygen therapy. - Has a transplanted organ which requires continued immunosuppression. - Has a known systemic hypersensitivity to IL-2, or modified IL-2 including MK-6194, or its inactive ingredients. - Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly. - Has drug-induced cutaneous lupus erythematosus (CLE) and/or drug-induced SLE in the setting of continued treatment with a causative agent. - Has active or unstable neuropsychiatric lupus including but not limited to the following: seizure, new or worsening impaired level of consciousness, psychosis, delirium or confused state, aseptic meningitis, cranial neuropathy, cerebrovascular accident, ascending or transverse myelitis, chorea, cerebellar ataxia, mononeuritis multiplex, or demyelinating syndromes. - Has a diagnosis of Antiphospholipid Syndrome with history of vascular thrombosis, catastrophic APS, or pregnancy morbidity within 6 months prior to Screening. - Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix. - Has an active or clinically significant infection requiring hospitalization or treatment with anti-infectives. - Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB. - Has confirmed or suspected COVID-19 infection. - Has had major surgery within 3 months prior to Screening or has a major surgery planned during the study. - Is taking more than 1 immunosuppressant. - Is taking more than 1 oral NSAID (excluding low-dose aspirin [<350 mg/day]) or is taking daily oral nonsteroidal anti-inflammatory drug (NSAID) at greater than the maximum recommended dosage. - Is currently on any chronic systemic (oral or IV) anti-infective therapy for chronic active infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria). |
Country | Name | City | State |
---|---|---|---|
Canada | Diex Recherche sherbrooke Inc. ( Site 0003) | Sherbrooke | Quebec |
Chile | IC La Serena Research ( Site 0414) | La Serena | Coquimbo |
Chile | CECIM ( Site 0405) | Santiago | Region M. De Santiago |
Chile | Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410) | Santiago | Region M. De Santiago |
Chile | Complejo Asistencial Dr. Sotero del Rio ( Site 0402) | Santiago | Region M. De Santiago |
Chile | James Lind Centro de Investigación del Cáncer ( Site 0407) | Temuco | Araucania |
China | The Affiliated Hospital of Guizhou Medical University ( Site 2051) | Guiyang | Guizhou |
Colombia | Centro Integral de Reumatología del Caribe ( Site 0501) | Barranquilla | Atlantico |
Colombia | Clinica de la Costa S.A.S. ( Site 0502) | Barranquilla | Atlantico |
Colombia | Fundación Valle del Lili ( Site 0506) | Cali | Valle Del Cauca |
Colombia | Preventive Care ( Site 0507) | Chía | Cundinamarca |
Colombia | Healthy Medical Center S.A.S ( Site 0505) | Zipaquira | Cundinamarca |
France | Hopital Claude Huriez - CHU de Lille ( Site 1005) | Lille | Nord |
France | Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003) | Lyon | Rhone-Alpes |
France | CHU Montpellier Lapeyronie Hospital-Rhumatologie ( Site 1006) | Montpellier | Herault |
France | CHU Bordeaux Haut-Leveque ( Site 1007) | Pessac | Aquitaine |
France | Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009) | Saint Priest En Jarez | Loire |
France | CHU Rangueil ( Site 1008) | Toulouse | Haute-Garonne |
Guatemala | Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601) | Ciudad de Guatemala | |
Guatemala | CELAN,S.A ( Site 0603) | Guatemala | |
Guatemala | Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602) | Guatemala | |
Italy | Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307) | Rome | Roma |
Italy | Azienda Ospedaliero Universitaria Senese-Medicina Interna e Specialistica ( Site 1306) | Siena | Toscana |
Japan | Chiba University Hospital ( Site 2120) | Chiba | |
Japan | National Hospital Organization Chibahigashi National Hospital ( Site 2112) | Chiba | |
Japan | Nihon University Itabashi Hospital ( Site 2105) | Itabashiku | Tokyo |
Japan | Shimane University Hospital ( Site 2119) | Izumo | Shimane |
Japan | St. Marianna University Hospital ( Site 2121) | Kawasaki | Kanagawa |
Japan | Japan Community Healthcare Organization Chukyo Hospital ( Site 2107) | Nagoya | Aichi |
Japan | Okayama University Hospital ( Site 2106) | Okayama | |
Japan | Daini Osaka Keisatsu Hospital ( Site 2117) | Osaka | |
Japan | Tohoku University Hospital ( Site 2116) | Sendai-shi | Miyagi |
Japan | Dokkyo Medical University Hospital ( Site 2118) | Shimotsuga | Tochigi |
Malaysia | Hospital Tengku Ampuan Afzan-Medical Outpatient Department ( Site 2224) | Kuantan | Pahang |
Malaysia | Hospital Taiping ( Site 2221) | Taiping | Perak |
Poland | Nova Reuma Spolka Partnerska ( Site 1405) | Bialystok | Podlaskie |
Poland | MICS Centrum Medyczne Bydgoszcz ( Site 1410) | Bydgoszcz | Kujawsko-pomorskie |
Poland | NZOZ BIF-MED ( Site 1409) | Bytom | Slaskie |
Poland | Centrum Medyczne Plejady ( Site 1407) | Krakow | Malopolskie |
Poland | Zespól Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408) | Lublin | Lubelskie |
Poland | Medyczne Centrum Hetmanska ( Site 1406) | Poznan | Wielkopolskie |
Poland | Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402) | Poznan | Wielkopolskie |
Spain | CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604) | A Coruña | La Coruna |
Spain | Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601) | Barcelona | |
Spain | Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602) | Sevilla | |
Spain | HOSPITAL CLINICO DE VALENCIA ( Site 1608) | Valencia | Valenciana, Comunitat |
Spain | Hospital Universitario Rio Hortega ( Site 1606) | Valladolid | |
United States | DJL Clinical Research, PLLC ( Site 0103) | Charlotte | North Carolina |
United States | Javara - Tryon Medical Partners ( Site 0121) | Charlotte | North Carolina |
United States | Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111) | Clearwater | Florida |
United States | Denver Arthritis Clinic ( Site 0102) | Denver | Colorado |
United States | Epic Medical Research ( Site 0113) | DeSoto | Texas |
United States | Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108) | La Palma | California |
United States | IRIS Research and Development, LLC-Research ( Site 0117) | Plantation | Florida |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme LLC |
United States, Canada, Chile, China, Colombia, France, Guatemala, Italy, Japan, Malaysia, Poland, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28 | The BICLA response is a composite global measure of SLE disease activity. It distinguishes between partial and complete improvement in all body systems. BICLA response is binary and is either achieved or not achieved by the participant, thus there is no associated score. | Week 28 | |
Secondary | Percentage of Participants Achieving SRI-4 Response at Week 52 | The SRI is a composite index used to assess clinical improvement in patients 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 52 | |
Secondary | Percentage of Participants Achieving BICLA at Week 52 | The BICLA response is a composite global measure of SLE disease activity. It distinguishes between partial and complete improvement in all body systems. BICLA response is binary and is either achieved or not achieved by the participant, thus there is no associated score. | Week 52 | |
Secondary | Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28 | The CLASI-A score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in the CLASI-A score. | Week 28 | |
Secondary | Percentage of Participants with a CLASI-50 Response at Week 52 | The CLASI-A score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in the CLASI-A score. | Week 52 | |
Secondary | Change From Baseline of 28 Joint Count at Week 28 | The joint count score is an evaluation of 28 joints in which joints are assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints may range from 0 to 28; with higher values corresponding to higher disease activity and lower values to better. | Baseline and Week 28 | |
Secondary | Change From Baseline of 28 Joint Count at Week 52 | The joint count score is an evaluation of 28 joints in which joints are assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints may range from 0 to 28; with higher values corresponding to higher disease activity and lower values to better. | Baseline and Week 52 | |
Secondary | Change From Baseline of Corticosteroid Dose at Week 28 | Participants are assessed for corticosteroid dose change. | Baseline and Week 28 | |
Secondary | Change From Baseline of Corticosteroid Dose at Week 52 | Participants are assessed for corticosteroid dose change. | Baseline and Week 52 | |
Secondary | Cumulative Oral Corticosteroid Use Between Week 0 to Week 28 | Participants are assessed for total corticosteroid use. | Up to approximately 28 weeks | |
Secondary | Cumulative Oral Corticosteroid Use Between Week 0 to Week 52 | Participants are assessed for total corticosteroid use. | Up to approximately 52 weeks | |
Secondary | Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28 | LLDAS is a low disease activity state associated with significant protection against flares and organ damage accrual. It includes both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response is binary and is either achieved or not achieved by the participant, thus there is no associated score. | Week 28 | |
Secondary | Percentage of Participants Who Achieve LLDAS at Week 52 | LLDAS is a low disease activity state associated with significant protection against flares and organ damage accrual. It includes both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response is binary and is either achieved or not achieved by the participant, thus there is no associated score. | Week 52 |
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