A randomized, double-blind, parallel group, placebo-controlled multicenter study to evaluate efficacy, safety and tolerability of ianalumab in participants with diffuse cutaneous systemic sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Do participants that receive ianalumab have less dcSSc disease activity than those who receive placebo?
研究概览
简要总结
The goal of this study is to find out if a new medicine called VAY736 (ianalumab) is safe and works well for adults with a condition called diffuse cutaneous systemic sclerosis (dcSSc). dcSSc is a disease in which the immune system mistakenly attacks different parts of a person’s own body causing swelling and harm to important organs including kidneys, digestive system, lungs, and heart. This disease gets worse over time and causes the skin to become thicker. Ianalumab is a monoclonal antibody. This medicine sticks to a protein found on our B cells which is involved in the development and progression of dcSSc. By attaching to these B cells, ianalumab might be able to make the dcSSc condition better by reducing their activity and number.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults diagnosed with dcSSc are allowed to participate in the study.
排除标准
- •Participants must not have any chronic infections including hepatitis, tuberculosis, or HIV.
- •To take part in the study, participants cannot be pregnant or breastfeeding.
结局指标
主要结局
Do participants that receive ianalumab have less dcSSc disease activity than those who receive placebo?
时间窗: The number of participants who can get better in 3 out of 5 dcSSc disease activity measures at Week 52 without worsening.
次要结局
- • Do participants who receive ianalumab show improvement in lung function, assessment of skin thickness and difficulty in performing daily activities compared to placebo at Week 52?(By measuring the FVC%, mRSS and HAQ-DI at Week 52)
- Is it safe to use ianalumab as a treatment for a long time?(every 4 week)
- Are any antibodies produced against ianalumab?(every 12 week)
- How much ianalumab can be measured over time in the participant’s blood?(week 4,8,12 week 36)
研究者
Murugananthan K
Novartis Healthcare Private Limited