NCT01965145终止3 期
A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Time to first acute ocular exacerbation
研究概览
简要总结
The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations
详细描述
A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.
- •History of Behçet's disease uveitis with ocular involvement of the posterior segment.
- •Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.
- •Male or female, age ≥18 (or legal age of majority in the country) at selection
- •For subjects with reproductive potential, a willingness to use highly effective contraceptive measures
排除标准
- •Infectious uveitis, uveitis due to causes other than Behçet's disease.
- •Monocular vision
- •Presence of severe cataract or severe posterior capsular opacification.
- •Contraindication to mydriasis or presence of posterior synechiae.
- •Active TB disease.
- •History of severe allergic or anaphylactic reactions to monoclonal antibodies
- •History of malignancy within 5 years prior to Selection.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Gevokizumab
Experimental
Solution for subcutaneous injection, Dose 1
干预措施: Gevokizumab (Drug)
Placebo
Placebo Comparator
Solution for subcutaneous injection, placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first acute ocular exacerbation
时间窗: up to 3 years
number of days
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne VulgarisAcne VulgarisNCT01498874XOMA (US) LLC127
终止
3 期
Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic TreatmentUveitisNCT01747538XOMA (US) LLC281
终止
3 期
Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious UveitisUveitisNCT01684345XOMA (US) LLC200
终止
3 期
A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical ResectionCrohn's DiseaseNCT05784129Janssen Research & Development, LLC4
已完成
3 期
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for CyclosporineDermatitis, AtopicEczemaNCT05149313Almirall, S.A.331