A 24-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients With Moderate-to-Severe Plaque Psoriasis Who Are Naive to Systemic Treatment With an Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.
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
- Single (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
- •Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline.
- •Participants who are candidates for systemic therapy and who are naive to systemic treatment for psoriasis.
- •Have a (PASI score >10 or BSA >10) and DLQI >10 at screening and at baseline.
排除标准
- •Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
- •Have received systemic nonbiologic psoriasis therapy.
- •Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy.
- •Have any condition or contraindication as addressed in the local labeling for MTX or FAE.
- •Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening.
- •Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer.
- •Have had a serious infection or are immunocompromised.
- •At screening, participants with significant, present, or early liver disease, e.g., explained by alcohol consumption or hepatic insufficiency.
研究组 & 干预措施
Ixekizumab
160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.
Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks.
干预措施: Ixekizumab (Drug)
Fumaric Acid Esters
Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.
Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.
干预措施: Fumaric Acid Esters (Drug)
Fumaric Acid Esters
Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.
Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.
干预措施: Ixekizumab (Drug)
Methotrexate
7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.
Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.
干预措施: Methotrexate (Drug)
Methotrexate
7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.
Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24
时间窗: Week 24
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
次要结局
- Change From Baseline in PASI Total Score(Baseline, Week 24)
- Change From Baseline on Dermatology Life Quality Index (DLQI) Total Score(Baseline, Week 24)
- Change From Baseline on Itch Numeric Rating Scale (NRS) Score(Baseline, Week 24)
- Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline(Week 24)
- Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score(Baseline, Week 24)
- Patient Benefit Index (PBI) Overall Benefit Score(Week 24)
- Change From Baseline on the Skin Pain Visual Analog Scale (VAS)(Baseline, Week 24)
- Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) From Baseline(Week 24)
- Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis(Baseline, Week 24)
- Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score(Baseline, Week 24)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS)(Baseline, Week 24)
- Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) and ≥2 Point Improvement From Baseline Among Those With sPGA Score ≥3 at Baseline(Week 24)
- Percentage of Participants Achieving DLQI (0,1)(Week 24)
- Change From Baseline on Patient's Global Assessment (PatGA) of Disease Severity(Baseline, Week 24)
- Change From Baseline on the Psoriasis Skin Appearance Bothersomeness (PSAB) Total Score(Baseline, Week 24)
- Change From Baseline on Quick Inventory of Depressive Symptomatology-Self Report (16 Items) (QIDS-SR16)(Baseline, Week 24)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Scores(Baseline, Week 24)
- Change From Baseline on the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA-CLIN) Total Score(Baseline, Week 24)
- Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" - Psoriasis (PSO) Index Score(Baseline, Week 24)
- Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D) + Bolt On UK Population-based Index Score(Baseline, Week 24)
- Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" - Visual Analog Scale Score(Baseline, Week 24)
- Percentage of Participants With Positive Responses to Neck/Face Psoriasis Question(Week 24)
- Percentage of Participants Positive Responses to Genital Psoriasis Question(Week 24)
- Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Absenteeism Score(Baseline, Week 24)
- Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Presenteeism Score(Baseline, Week 24)
- Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Impairment in Activities Performed Outside of Work(Baseline, Week 24)
- Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Overall Work Impairment Score(Baseline, Week 24)
- Mean Adherence on Medication and Satisfaction With Therapy (STAQ)(Week 24)