A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind 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
- 227
- 试验地点
- 36
- 主要终点
- Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
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 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 Treatment Period from Week 48 to Week 144
- Safety Follow-Up Period from Week 144 to Week 152
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 3 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose
- •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
研究组 & 干预措施
Placebo
Placebo subcutaneous (sc) injection every two weeks (Q2W).
Treatment received from Week 16 - 48 is based on initial treatment and response to treatment:
- PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
- PASI75 responders at Week 16 continue to receive Placebo.
- PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
- PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.
Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.
干预措施: Placebo (Other)
CZP 200 mg
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.
Treatment received from Week 16-48 is based on initial treatment and response to treatment:
- PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
- PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
- PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.
Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.
干预措施: Certolizumab Pegol (Biological)
CZP 400 mg
CZP 400 mg every two weeks (Q2W) through Week 14.
Treatment received from Week 16 - 48 is based on initial treatment and response to treatment:
- PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
- PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
- PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.
Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.
Subjects who achieve a PASI75 response during the OLE Phase may switch to CZP 200 mg Q2W.
干预措施: Certolizumab Pegol (Biological)
结局指标
主要结局
Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
时间窗: Week 16
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.
Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16
时间窗: Week 16
The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
次要结局
- Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48(Week 48)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Week 16)
- Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16(Week 16)
- Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48(Week 48)