NCT02980198撤回2 期
A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNα-Kinoid (IFN-K) in Adult Subjects With Dermatomyositis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Neovacs
- 试验地点
- 10
- 主要终点
- Change from baseline in the expression of IFN-induced genes at Week 48
研究概览
简要总结
This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient newly diagnosed or relapsing with "definite" or "probable" dermatomyositis based on ENMC criteria (2004)
- •Patient requiring corticosteroids (CS) at a dose of 1 mg/Kg and ≤ 70 mg of prednisone equivalent/day or currently receiving CS at a dose of 1 mg/Kg and ≤ 70 mg of prednisone equivalent/day
- •Is a male or female, aged between 18 and 65 years, inclusive, at the time of the screening visit
- •study patient and his/her partner of child bearing potential has to use effective method of contraception
排除标准
- •Is high-risk human papilloma virus (HPV) positive by (RT-PCR) on a cervical swab
- •Has cytological abnormalities ≥ HSIL on a cervical swab
- •Is positive for autoantibodies anti-NXP2, TIF1ɤ, MDA5 associated with severe pulmonary disease or anti-synthetase antibodies
- •Is positive for any malignancy or has a history of any malignancy
- •Has received IV pulse dose CS (≥ 250 mg prednisone equivalent/day)
- •Has received intravenous immunoglobulin (IVIg)
- •Has received potent immunosuppressive drugs such as cyclophosphamide, methotrexate, azathioprine, mycophenolate, cyclosporine A, oral tacrolimus
- •Has received abatacept, anifrolumab, belimumab, TNF antagonists or another registered or investigational biological therapy
- •Has received anti-B-cell therapy (e.g. rituximab, epratuzumab)
- •Has received any live vaccine
- •Has used any investigational or non-registered product , or any investigational or non-registered vaccine
- •Has inflammatory joint or skin disease other than dermatomyositis that may interfere with study assessments
- •Has frequent recurrences of oral or genital herpes simplex lesions
- •Is at high risk of significant infection and/or has any current signs or symptoms of infection at entry or has received intravenous antibiotics
结局指标
主要结局
Change from baseline in the expression of IFN-induced genes at Week 48
时间窗: Week 48
次要结局
- Number of subjects with treatment related adverse events(Week 48)
- Total improvement score from IMAC Core Set Measures (CSM) following Aggarwal et al (2017) recommendations(Week 0, Week 12, Week 24, Week 36, Week 48)
- Others tools: Cutaneous Disease Area and Severity Index (CDASI)(Week 0, Week 12, Week 24, Week 36, Week 48)
- Others tools: Manual Muscle Testing (MMT5)(Week 0, Week 12, Week 24, Week 36, Week 48)
- Others tools: Accelerometer(Week 0, Week 12, Week 24, Week 36, Week 48)
- Others tools:Dermatology Life Quality Index (DLQI score)(Week 0, Week 12, Week 24, Week 36, Week 48)
- Immune response induced by IFN-K as measured by antibodies production(Week 48)
研究者
研究点 (10)
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