MK-6194 in Adult Participants with Systemic Lupus Erythematosus

JRCT ID: jRCT2041230137

Registered date:22/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 21/02/2024
• Target sample size: 270
• Countries of recruitment: US,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Guatemala,Japan,Mexico,Japan,France,Japan,Italy,Japan,Poland,Japan,Spain,Japan,Turkiye,Japan,Malaysia,Japan,Phillipines,Japan,China,Japan
• Study type: Interventional

Intervention(s)

Base Study: One of two MK-6194 dose regimens or placebo regimen
Extension: Either of two MK-6194 dose regimens

Outcome(s)

Primary Outcome

- Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
- Percentage of Participants Experiencing Adverse Events (AEs)
- Percentage of Participants Discontinuing Study Treatment Due to an AE

Secondary Outcome

- Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28 and Week 52
- Percentage of Participants Achieving SRI-4 Response at Week 52
- Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28 and Week 52
- Change From Baseline of 28 Joint Count at Week 28 and Week 52
- Change From Baseline of Corticosteroid Dose at Week 28 and Week 52
- Cumulative Oral Corticosteroid Use Between Week 0 to Week 28 and Week 0 to Week 52
- Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28 and Week 52

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Has a diagnosis of systemic lupus erythematosus (SLE) >= 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.

Exclude 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).

Related Information

• Primary Sponsor: Iwamoto Taro
• Secondary ID(s): NCT06161116