Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 33
- 主要终点
- Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female, >= 20 years of age.
- •Institutional Review Board-approved written informed consent form is signed and dated by the subject.
- •Other protocol-defined inclusion criteria may apply.
- •For subjects with moderate to severe chronic plaque psoriasis (PSO)
- •Chronic plaque psoriasis for at least 6 months.
- •Baseline Psoriasis Activity and Severity Index (PASI) >=12 and Body Surface Area (BSA) affected by PSO >=10% and Physician's Global Assessment (PGA) score of 3 or higher.
- •Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy.
- •For subjects with generalized pustular PSO or erythrodermic PSO
- •Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening.
- •History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO.
- •Baseline BSA affected by PSO >=80% if subjects have a diagnosis of erythrodermic PSO.
排除标准
- •Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. Male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug.
- •Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded.
- •History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. Also, subjects with a high risk of infection in the Investigator's opinion.
- •History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
- •History of other malignancy or concurrent malignancy as described in the protocol.
- •Class III or IV congestive heart failure
- •History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).
- •Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study.
- •Concurrent medication restrictions as described in the protocol.
- •Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or with untreated latent tuberculosis infection (LTBI) or current or history of nontuberculous mycobacterial (NTMB) infection.
- •Subject has any protocol defined clinically significant laboratory abnormalities at the screening
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo subcutaneous (sc) injection every two weeks (Q2W)
干预措施: Placebo (Other)
CZP 200 mg
Certolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) with PBO administered to maintain the blind, starting at Week 6
干预措施: Placebo (Other)
CZP 200 mg
Certolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) with PBO administered to maintain the blind, starting at Week 6
干预措施: Certolizumab Pegol (Drug)
CZP 400 mg
Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).
干预措施: Certolizumab Pegol (Drug)
结局指标
主要结局
Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
时间窗: Week 16
The PASI75 response assessments were 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
- Percentage 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)
- Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16(Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Baseline and Week 16)
- Change From Baseline in Itch Numeric Rating Scale at Week 16(Baseline and Week 16)
- Plasma Concentration of Certolizumab Pegol (CZP)(Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60)
- Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma(Blood samples will be collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60)