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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: MK-6194; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06161116

2023-505520-61 (Registry Identifier)

6194-006

U1111-1291-8716 (Other Identifier)

MK-6194-006 (Other Identifier)

jRCT2041230137 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 5 patient groups, including a placebo group

Base Study: Dose 1

Experimental group

Description:

Participants receive subcutaneous (SC) MK-6194 dose regimen 1.

Treatment:

Biological: MK-6194

Base Study: Dose 2

Experimental group

Description:

Participants receive SC MK-6194 dose regimen 2.

Treatment:

Biological: MK-6194

Base Study: Placebo

Placebo Comparator group

Description:

Participants receive an SC placebo regimen.

Treatment:

Biological: Placebo

Extension: Dose 1

Experimental group

Description:

Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.

Treatment:

Biological: Placebo

Biological: MK-6194

Extension: Dose 2

Experimental group

Description:

Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.

Treatment:

Biological: Placebo

Biological: MK-6194