Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: MK-6194; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06161116

6194-006

2023-505520-61-00 (Registry Identifier)

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• 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 positive antinuclear antibody (+ANA; titer ≥1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Smith (anti-Sm) antibody, or positive anti-Sjögren's Syndrome A (SSA)/Ro antibody.
• Has the presence of at least 1 of the following manifestations of SLE: active lupus rash with Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (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

The main exclusion criteria include but are not limited to the following:

• Has a concurrent clinically significant disease or clinically relevant laboratory abnormalities, or a history of any illness or medical condition that 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 interleukin-2 (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 (APS) 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 coronavirus disease of 2019 (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 nonsteroidal anti-inflammatory drug (NSAID), excluding low-dose aspirin (<350 mg/day), or is taking daily oral NSAID at greater than the maximum recommended dosage.
• Is currently on any chronic systemic (oral or intravenous [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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149 participants in 7 patient groups, including a placebo group

MK-6194 3 mg Q2W

Experimental group

Description:

Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).

Treatment:

Biological: MK-6194

MK-6194 3 mg Q4W

Experimental group

Description:

Participants receive SC MK-6194 3 mg every 4 weeks (q4w).

Treatment:

Biological: MK-6194

Placebo

Placebo Comparator group

Description:

Participants receive SC placebo q2w.

Treatment:

Biological: Placebo

MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)

Experimental group

Description:

After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continue to receive SC MK-6194 3 mg q2w in the extension period.

Treatment:

Biological: MK-6194

MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)

Experimental group

Description:

After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continue to receive SC MK-6194 3 mg q4w in the extension period.

Treatment:

Biological: MK-6194

Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)

Experimental group

Description:

After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q2w in the extension period.

Treatment:

Biological: Placebo

Biological: MK-6194

Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)

Experimental group

Description:

After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q4w in the extension period.

Treatment:

Biological: Placebo

Biological: MK-6194