NCT02044848终止2 期
A Randomized, Double-blind, Multiple Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Efficacy of Secukinumab in Adult and Pediatric Patients With New-onset Type 1 Diabetes Mellitus(T1D)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test
研究概览
简要总结
This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.
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
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-35 years initially (subjects aged 8-17 may be included at a later stage, starting with age 12-17 years, followed by age 8-11 years).
- •Body weight between 40-120 kg initially (subjects weighing 21-39 kg may be included at a later stage).
- •Recent onset type 1 diabetes mellitus, diagnosed with 100 days of first dose. Peak stimulated C-peptide levels >/= 0.2 pmol/L following mixed meal tolerance test
排除标准
- •Any form of diabetes other than auto-immune type 1 (eg, type 2 diabetes, maturity onset diabetes of the young, latent autoimmune diabetes of the adult).
- •Diabetic ketoacidosis within 2 weeks of screening. Pregnancy or lactation. Recent (within 2 weeks of screening), ongoing, chronic or recurrent infectious disease.
- •Active infection with hepatitis B or C, Epstein-Barr virus, cytomegalovirus, or HIV.
- •Tuberculosis infection. Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Secukinumab
Experimental
Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
干预措施: Secukinumab (Drug)
Placebo
Placebo Comparator
Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
干预措施: Placebo (Drug)
结局指标
主要结局
Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test
时间窗: Week 52
Study was terminated and no data were collected for the Outcome Measure.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 YearModerate to Severe Plaque-type PsoriasisNCT01365455Novartis Pharmaceuticals738
已完成
2 期
A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell ArteritisGiant Cell ArteritisNCT03765788Novartis Pharmaceuticals52
已完成
3 期
Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp PsoriasisChronic Scalp PsoriasisNCT02267135Novartis Pharmaceuticals102
已完成
3 期
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type PsoriasisChronic Plaque PsoriasisNCT01358578Novartis Pharmaceuticals1,306
已完成
3 期
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type PsoriasisPlaque PsoriasisNCT03066609Novartis Pharmaceuticals543