NCT04368403已完成1 期
A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- serum KHK4827 concentration
研究概览
简要总结
Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject meets the criteria for diagnosis of the Diagnostic Criteria, Severity Classification, and Clinical Practice Guidelines for Systemic Sclerosis （Japanese Dermatological Association 2016） at the pre-examination
- •Subject presented the first symptoms of sclerosis other than Raynaud's phenomenon within 60 months before enrollment
- •Subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mRSS of 10 to <30 at the pre-examination and who has progressing skin thickening
排除标准
- •Any of the following significant concomitant diseases:
- •Type 1 diabetes
- •Poorly controlled type 2 diabetes (HbA1c > 8.5%)
- •Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification)
- •Myocardial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product
- •Poorly controlled hypertension (systolic pressure > 150 mm Hg or diastolic pressure > 90 mg Hg at screening)
- •Severe chronic lung disease (%Forced Vital Capacity (FVC) < 60% and %Diffusing capacity of lung for carbon monoxide (DLco) < 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calculated with the LMS Method and Compared with Previous Values [Japanese Respiratory Society])
- •Major chronic inflammatory diseases or connective tissue diseases other than scleroderma
- •Patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •Patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
- •Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment
研究组 & 干预措施
KHK4827
Experimental
干预措施: KHK4827 (Drug)
结局指标
主要结局
serum KHK4827 concentration
时间窗: Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2025.
次要结局
- Change in modified Rodnan skin score (mRSS) from baseline(Pre-dose, Week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and every 8 weeks through study completion until 2025.)
研究者
研究点 (1)
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