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

Launched by MERCK SHARP & DOHME LLC · Nov 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MK-6194 for adults with Systemic Lupus Erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissues. The main goal is to see if MK-6194 works better than a placebo (a fake treatment) in helping people with SLE feel better by the end of 28 weeks. To be eligible for the trial, participants must have been diagnosed with SLE for at least six months, be currently taking certain medications for their condition, and have specific symptoms related to SLE, such as a rash or swollen joints.

Participants in the trial will receive either MK-6194 or a placebo and will be monitored closely by healthcare professionals. It's important to note that some individuals may not qualify, especially those with serious heart or lung conditions, certain infections, or who are taking multiple immune-suppressing medications. This trial is currently recruiting participants, and those who are eligible can expect regular check-ins and assessments to track their progress and any side effects from the treatment.

Gender

ALL

Eligibility criteria

• 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).