NCT02951533已完成3 期
Multicenter, Randomized, Open-Label, Efficacy Assessor-Blinded, Active Comparator-Controlled Phase 3b Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters (Fumaderm Initial/ Fumaderm) for Adult Patients With Moderate to Severe Plaque Psoriasis Who Are Candidates for and Naive to Systemic Treatment
Janssen-Cilag G.m.b.H0 个研究点目标入组 119 人开始时间: 2016年12月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 主要终点
- Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
研究概览
简要总结
The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.
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
- None
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
- •Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug
- •Have a Psoriasis Area and Severity Index (PASI) greater than (>)10 or Body Surface Area (BSA) >10 at screening and at baseline
- •Have a Dermatology Life Quality Index (DLQI) >10 at screening and at baseline
- •Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug; for information on Bacille Calmette-Guérin (BCG) vaccination, agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug
- •No dipstick detection of proteins or glucose in urine. If there are signs of proteins and/or glucose on urine test strip, the urine sample must be analyzed centrally. Here, protein and glucose levels must not exceed trace levels, example, <=(+); one re-test (central urine analysis) is allowed
排除标准
- •Has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •Known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients
- •Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
研究组 & 干预措施
Group I: Guselkumab
Experimental
Participants will receive Guselkumab 100 milligram (mg) administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) by single-use prefilled syringe (PFS) at weeks 0, 4, 12 and 20.
干预措施: Guselkumab (Drug)
Group II: Fumaric Acid Esters (FAE)
Active Comparator
Participants will receive Fumaderm initial/Fumaderm tablets by self administration at week 0. The individual FAE dose representing the optimal efficacy/tolerability ratio needs to be determined for each participant according to local prescription information. To this aim, FAE doses will be slowly increased beginning with increasing doses of Fumderm initial (containing 30 mg dimethylfumarate) over the first 3 weeks. Thereafter, participants will be switched to Fumaderm tablets (containing 120 mg dimethylfumarate) starting with 1 tablet per day. Fumaderm dose may be increased to a maximum of 3*2 tablets per day. The decision to maintain, increase or decrease the FAE dose depends on efficacy, safety and tolerability.
干预措施: Fumaric Acid Esters (Drug)
结局指标
主要结局
Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
时间窗: At Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
次要结局
- Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24(At Week 24)
- Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24(Baseline and Week 24)
- Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24(At Week 24)
- Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24(At Week 24)
- Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24(Baseline and Week 24)
- Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24(Baseline and Week 24)
- Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at Week 56(Week 56)
- Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at Week 56(Week 56)
- Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24(At Week 24)
- Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24(At Week 24)
- Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24(Baseline and Week 24)
- Part I: Change From Baseline in DLQI Score at Week 24(Baseline and Week 24)
- Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24(At Week 24)
- Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32(Week 32)
- Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32(Week 32)
- Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100(Week 100)
- Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100(Week 100)
- Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56(Week 56)
- Part IIb: Percentage of Participants With a PASI 75 Response at Week 56(Week 56)
- Part IIb: Percentage of Participants With a PASI 90 Response at Week 56(Week 56)
- Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32(Week 32)
- Part IIb: Percentage of Participants With a PASI 100 Response at Week 56(Week 56)
- Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56(Week 56)
- Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32(Week 32)
- Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal(Week 100)
- Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100(Week 100)
- Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100(Week 100)
- Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100(Week 100)
- Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal(Week 100)
- Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100(Week 100)
- Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100(Week 100)
- Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100(Baseline (Week 56) and Week 100)
- Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100(Week 100)
- Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100(Baseline (Week 56) and Week 100)
- Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100(Baseline (Week 56) and Week 100)
- Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability(Week 64 to Week 100)
- Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100(Week 100)
- Part III: Change From Baseline in DLQI Score at Week 100(Baseline (Week 56) and Week 100)
- Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100(Week 100)
- Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0)(Week 100)
- Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0)(Week 100)
- Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability(Up to Week 32)
- Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability(Week 32 to Week 64)
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