A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 559
- 试验地点
- 89
- 主要终点
- Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.
详细描述
This study consists of the following Periods:
- Initial Treatment Period from Week 0 to Week 16
- Maintenance Treatment Period from Week 16 to Week 48
- Open-label Extension Treatment Period (96 weeks)
- Safety Follow-Up (10 weeks)
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
- •Provided informed consent
- •Adult men or women >= 18 years
- •Chronic plaque psoriasis for at least 6 months
- •Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and Physician's Global Assessments score >= 3
- •Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Erythrodermic, guttate, generalized pustular form of psoriasis
- •History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
- •Congestive heart failure
- •History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
- •Concurrent malignancy or a history of malignancy as described in the protocol
- •History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)
- •Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug in the UK, Czech Republic, Germany, and France, and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 5 months following the last dose in France and within 10 weeks in all other countries
- •Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12
时间窗: Week 12
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
次要结局
- Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12(Week 12)
- Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16(Week 16)
- Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16(Week 16)
- Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12(Week 12)
- Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16(Week 16)
- Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16(Week 48)