A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Biocad
- 入组人数
- 152
- 试验地点
- 6
- 主要终点
- Change in the modified Rodnan Skin Score (mRSS) from baseline
研究概览
简要总结
The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the ACR/EULAR 2013 criteria with a modified Rodnan skin score (mRSS) of 10 to 20. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value.
The study will include patients of either sex aged ≥16 years with systemic scleroderma according to the ACR/EULAR 2013 criteria, with a modified Rodnan skin score (mRSS) ≥10 and ≤20 , as well as patients of either sex aged ≥14 and <16 years with systemic scleroderma according to the PRES/ACR/EULAR 2007 criteria. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects aged ≥18 years will be randomized to divozilimab or placebo group. Subjects aged <18 years (not less than 16) will receive divozilimab.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For subjects aged ≥16 years: a diagnosis of systemic scleroderma according to the ACR/EULAR 2013 criteria; a modified Rodnan skin score (mRSS) ≥10 and ≤20
- •For subjects aged ≥14 and <16 years: a diagnosis of systemic scleroderma according to the PRES/ACR/EULAR 2007 criteria.
- •FVC ≥ 40 % of the due value.
排除标准
- •Induced scleroderma.
- •Silicone implants/protheses.
- •Digital ulcers with signs of infection or indications for any amputation.
- •Blood biochemistry or hematological abnormalities at screening.
- •FEV1/FVC < 0.7 and FEV1< 50 % at screening.
- •History of threatment with anti-CD20 monoclonal antibodies.
研究组 & 干预措施
Divozilimab
干预措施: Divozilimab (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the modified Rodnan Skin Score (mRSS) from baseline
时间窗: week 24
The modified Rodnan Skin Score (mRSS) describes the thickness of skin in 17 anatomic areas rated from 0 to 3, where 3 indicates the most severe thickening.
次要结局
- Change in the modified Rodnan Skin Score (mRSS) from baseline(week 48)
- Change in the FVC (forced vital capacity) from baseline(week 48)
- Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline(week 48)