NCT02612857已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis
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
- 30
- 试验地点
- 20
- 主要终点
- To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
研究概览
简要总结
The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.
详细描述
This study will evaluate the safety and efficacy of IMO-8400 in adults with active dermatomyositis (DM).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has definite or probable DM based on the criteria of Bohan and Peter
- •Has a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)-Activity score ≥15
- •Patients with muscle weakness are eligible; however having muscle weakness is not mandatory.
- •Study participants must have a diagnostic evaluation for cancer if the diagnosis of DM was within 2 years prior to the Screening Visit
排除标准
- •Has ongoing severe dysphagia (e.g., requires a feeding tube) for the 3 months prior to Screening
- •Has known hypersensitivity to any oligodeoxynucleotide
- •Has a history of drug or alcohol abuse within one year of screening, or evidence of drug abuse by urine drug screening
- •Has body weight >140 kg
- •Has a diagnosis of Juvenile DM, IBM, drug-induced toxic myopathy, metabolic myopathy, dystrophy, cancer-associated DM, or connective tissue disease-associated DM (e.g., overlap syndrome)
- •Has received one or more of following prohibited treatments within the interval noted prior to Screening (Visit 1):
- •Rituximab within 24 weeks (Note: patients who received rituximab are only eligible for inclusion if B-cell counts are confirmed to be within normal limits)
- •Intravenous corticosteroids within 12 weeks
- •Antimalarials (e.g., hydroxychloroquine) within 36 weeks
- •Topical corticosteroids (excluding scalp) within 2 weeks
- •Has evidence of or has required treatment for cancer (except for treated, non-invasive carcinoma of the skin or cured cervical carcinoma-in-situ) within 5 years
- •Has interstitial lung disease requiring the use of supplemental oxygen
研究组 & 干预措施
Placebo
Placebo Comparator
normal saline subcutaneous injections once a week for 24 weeks.
干预措施: Placebo (Drug)
IMO-8400 Dose Group 1
Experimental
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
干预措施: IMO-8400 Dose Group 1 (Drug)
IMO-8400 Dose Group 2
Experimental
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
干预措施: IMO-8400 Dose Group 2 (Drug)
结局指标
主要结局
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
时间窗: 28 weeks (24 weeks treatment + 4 weeks follow up)
Number of participants with different types of Treatment Emergent Adverse Events
次要结局
- Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score(28 weeks (24 weeks treatment + 4 weeks follow up))
研究者
研究点 (20)
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