NCT03957681已完成3 期
A Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin Thickening
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change in modified Rodnan skin score (mRSS) from baseline at Week 24
研究概览
简要总结
To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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)
- •Myocartial 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 (%FVC < 60% and %DLco < 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calcluated 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)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in modified Rodnan skin score (mRSS) from baseline at Week 24
时间窗: at least 2 weeks up to 24 weeks
mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51
次要结局
- Change in modified Rodnan skin score (mRSS) from baseline at Week 52(at least 2 weeks up to 52 weeks)
研究者
研究点 (6)
Loading locations...
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