A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 24
- 主要终点
- Proportion of subjects with clinical response relative to Baseline PASI score
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- •Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
排除标准
- •Subject had previously received systemic or biologic anti-IL-12 therapy
- •Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
- •Subject is taking or requires oral or injectable corticosteroids
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant
研究组 & 干预措施
1
Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks
干预措施: Anti IL-12 monoclonal antibody/ABT-874 (Drug)
2
Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks
干预措施: Anti IL-12 monoclonal antibody/ABT-874 (Drug)
3
Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks
干预措施: Anti IL-12 monoclonal antibody/ABT-874 (Drug)
4
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks
干预措施: Anti IL-12 monoclonal antibody/ABT-874 (Drug)
5
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks
干预措施: Anti IL-12 monoclonal antibody/ABT-874 (Drug)
6
placebo, 12 doses
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of subjects with clinical response relative to Baseline PASI score
时间窗: Week 12, Week 40 and Week 60
次要结局
- Quality of Life Surveys(Week 12, Week 48 and Week 60)
- Clinical response indicators(Week 12, Week 48 and Week 60)
- Safety parameters(Monthly through duration of study)
- PGA Assessment(Week 12, Week 40 and Week 60)