Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 97
- 试验地点
- 44
- 主要终点
- Change From Baseline in Modified Rodnan Skin Score to Week 24
研究概览
简要总结
Primary Objective:
To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc).
Secondary Objectives:
- To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc.
- To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc.
- To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc.
- To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc.
- To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.
详细描述
The total study duration per participant was 39 weeks; consisting of a 4-week screening, a 24-week of study treatment period, and an 11-week follow-up with no study drug treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24.
干预措施: Placebo (Drug)
SAR156597
SAR156597 200 milligram (mg), single SC injection QW up to Week 24.
干预措施: SAR156597 (Drug)
结局指标
主要结局
Change From Baseline in Modified Rodnan Skin Score to Week 24
时间窗: Baseline, Week 24
mRSS, an accepted clinical measure of the skin thickness (fibrosis). Investigator physicians or qualified medical personnel assessed the thickening of skin in 17 skin sites including fingers, hands, forearms, arms, feet, legs and thighs, face, chest and abdomen. Each skin site was rated on a 0-3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness and 3 = severe thickness. Total mRSS ranged from 0 (no thickening) to 51 (severe thickening in all 17 areas), where higher score indicated more severity of skin thickening/worst outcome.
次要结局
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24(Baseline, Week 24)
- Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24(Baseline, Week 24)
- Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24(Baseline, Week 24)