Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 176
- 主要终点
- Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12
研究概览
简要总结
A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.
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
- •Adult men and women > 18 years
- •Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
- •Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %
- •Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
排除标准
- •Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
- •A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);
- •White blood cell counts less than 4000/mm^3 or more than 20000/mm^3
- •Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- •Systemic Lupus
- •Non respect of adequate wash out periods for treatments that might have an impact on the disease
- •Any associated disease that could be impacted by the study treatment intake
- •Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
研究组 & 干预措施
Placebo
Subcutaneous injections of Placebo every 2 weeks
干预措施: Placebo (Other)
Certolizumab Pegol 200 mg
Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
干预措施: Certolizumab Pegol (Drug)
Certolizumab Pegol 400 mg
Subcutaneous injections of 400 mg every 2 weeks
干预措施: Certolizumab Pegol (Drug)
结局指标
主要结局
Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12
时间窗: Week 12
The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12
时间窗: Week 12
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI75 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %.
次要结局
- Time to Psoriasis Activity and Severity Index 50 (PASI50)(During the 12-weeks Treatment Period)
- Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12(Week 12)
- Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis(During the 12-week Treatment Period)
- Time to Psoriasis Activity and Severity Index 75 (PASI75)(During the 12-weeks Treatment Period)
- Experience of a Rebound Effect Within 2 Months After Stopping Therapy(Within 2 months of stopping therapy)
- Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12(Week 12)
- Time to Relapse(During the 12-weeks Treatment Period)
- Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12(Baseline up to Week 12)
- Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12(Week 12)