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

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 1antimalarial and/or oral corticosteroids) for SLE.

• Has + antinuclear antibody (+ANA) (titer ≥1:80) or positive anti-double-stranddeoxyribonucleic acid (dsDNA) antibody or positive anti-Sm antibody, or positiveanti-SSA/Ro antibody.

• Has the presence of at least one of the following manifestations of SLE: Activelupus rash with CLASI-A erythema and scale/hypertrophy combined score >2, or >2tender and swollen joints in wrists, metacarpophalangeals (MCPs), or proximalinterphalangeals (PIPs).

• Has a hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) totalscore of ≥6 and clinical hybrid SLEDAI score of ≥4.

Exclusion Criteria:

• Has a concurrent clinically significant disease or clinically relevant laboratoryabnormalities, or a history of any illness or medical condition that, in the opinionof the investigator, might confound the results of the study or poses an additionalrisk to the participant by their participation in the study.

• Has symptomatic heart failure (New York Heart Association class III or IV) ormyocardial infarction or unstable angina pectoris within 6 months prior toScreening.

• 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 andsymptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathyand/or splenomegaly.

• Has drug-induced cutaneous lupus erythematosus (CLE) and/or drug-induced SLE in thesetting of continued treatment with a causative agent.

• Has active or unstable neuropsychiatric lupus including but not limited to thefollowing: seizure, new or worsening impaired level of consciousness, psychosis,delirium or confused state, aseptic meningitis, cranial neuropathy, cerebrovascularaccident, ascending or transverse myelitis, chorea, cerebellar ataxia, mononeuritismultiplex, 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 skincancer or localized carcinoma in situ of the cervix.

• Has an active or clinically significant infection requiring hospitalization ortreatment 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 surgeryplanned during the study.

• Is taking more than 1 immunosuppressant.

• Is taking more than 1 oral NSAID (excluding low-dose aspirin [<350 mg/day]) or istaking daily oral nonsteroidal anti-inflammatory drug (NSAID) at greater than themaximum recommended dosage.

• Is currently on any chronic systemic (oral or IV) anti-infective therapy for chronicactive infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypicalmycobacteria).