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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06161116
Other study ID # 6194-006
Secondary ID MK-6194-0062023-
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 27, 2023
Est. completion date July 9, 2027

Study information

Verified date June 2024
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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).

Study Design


Intervention

Biological:
MK-6194
SC Injection
Placebo
SC Injection

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Canada,  Chile,  China,  Colombia,  France,  Guatemala,  Italy,  Japan,  Malaysia,  Poland,  Spain, 

Outcome

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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