NCT05214794已完成2 期
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24
研究概览
简要总结
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
- •Systemic Sclerosis patients with moderate to sever skin sclerosis
排除标准
- •Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease
- •Patients with a diseases that could interfere with assessment of Systemic Sclerosis
- •Patients with body weight less than 30.0kg
- •Pregnant or lactating women.
研究组 & 干预措施
nemolizumab
Experimental
干预措施: nemolizumab (Drug)
结局指标
主要结局
Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24
时间窗: Baseline and week 24
Compare pre- and post-treatment total mRSS at Week 24. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 site
次要结局
- Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52(From baseline up to Week 52)
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24(From baseline up to Week 24)
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52(From baseline up to Week 52)
- Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24(From baseline up to Week 24)
- Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52(From baseline up to Week 52)
- Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24(From baseline up to Week 24)
- Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52(From baseline up to Week 52)
- Change From Baseline in Physician's Global Assessment at Week 24(From baseline up to Week 24)
- Change From Baseline in Physician's Global Assessment at Week 52(From baseline up to Week 52)
- Change From Baseline in Patient's Global Assessment at Week 24(From baseline up to Week 24)
- Change From Baseline in Patient's Global Assessment at Week 52(From baseline up to Week 52)
研究者
研究点 (1)
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