NCT01635127Unknown2 期
A Phase II Randomized Double-Blind Placebo Controlled Single Center Study of Canakinumab Treatment of Adult Patients With Moderate to Severe Chronic Idiopathic Urticaria
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete clinical remission
研究概览
简要总结
Evaluation whether canakinumab leads to improvement of urticaria
详细描述
Single center prospective placebo-controlled cross-over phase II study.
- To assess if canakinumab can induce clinical improvement and/or complete clinical remission of chronic idiopathic urticaria at week 4 as compared to placebo
- To compare canakinumab and placebo treated patients in the percentage who achieve complete clinical remission at week 1, 2, 4, and 8.
- To compare the percentage with clinical improvement as measured by UAS7 score at week 1, 2, 4, and 8 in canakinumab and placebo treated patients
- To compare the percentage of canakinumab and placebo treated patients with 75% and 100% improvement of their baseline (Run-in-period) UAS7 score at week 1,2,4,and 8
- To compare the daily wheal score for Days 1 to 7 in canakinumab and placebo treated patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 70 Years（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 Comparator
Constituent, inactive
干预措施: Placebo (Drug)
Canakinumab
Experimental
Monoclonal antibody inhibiting interleukin 1 beta
干预措施: Canakinumab (Drug)
结局指标
主要结局
Complete clinical remission
时间窗: 4 weeks
Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7
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
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic FeversHereditary Periodic FeversNCT02059291Novartis Pharmaceuticals203
已完成
3 期
Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic Arthritis With Active FlareNCT00889863Novartis Pharmaceuticals177
招募中
2 期
A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic LeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent Myelodysplastic SyndromeRefractory Chronic Myelomonocytic LeukemiaRefractory Myelodysplastic SyndromeMyelodysplastic SyndromeChronic Myelomonocytic LeukemiaNCT04239157M.D. Anderson Cancer Center76
已完成
4 期
Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis PatientsPlaque PsoriasisNCT03055494Novartis Pharmaceuticals102
终止
3 期
Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)Systemic Juvenile Idiopathic ArthritisNCT00886769Novartis Pharmaceuticals84