2023-505520-61-00
招募中
2/3 期
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus
概览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 24
- 主要终点
- Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
概览
简要总结
- To evaluate the efficacy of MK-6194 compared to placebo as assessed by the proportion of participants with SRI-4 response at Week 28.
- To evaluate the safety and tolerability of MK-6194.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 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).
- •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.
结局指标
主要结局
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
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 Experiencing Adverse Events (AEs)
Percentage of Participants Discontinuing Study Treatment Due to an AE
Percentage of Participants Discontinuing Study Treatment Due to an AE
次要结局
- Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28
- Percentage of Participants Achieving SRI-4 Response at Week 52
- Percentage of Participants Achieving BICLA at Week 52
- Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28
- Percentage of Participants with a CLASI-50 Response at Week 52
- Change From Baseline of 28 Joint Count at Week 28
- Change From Baseline of 28 Joint Count at Week 52
- Change From Baseline of Corticosteroid Dose at Week 28
- Change From Baseline of Corticosteroid Dose at Week 52
- Cumulative Oral Corticosteroid Use Between Week 0 to Week 28
- Cumulative Oral Corticosteroid Use Between Week 0 to Week 52
- Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28
- Percentage of Participants Who Achieve LLDAS at Week 52
研究者
Nancy Kim
Scientific
Merck Sharp & Dohme LLC
研究点 (24)
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