A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients With Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 主要终点
- Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26
研究概览
简要总结
This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have body surface area (BSA) ≥ 10% and a target fingernail Modified Nail Psoriasis Severity Index (mNAPSI) ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail mNAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Week
- •Subject must have a Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain Numeric Rating Scale (NRS) score of >
- •Subjects must have a Physician's Global Assessment (PGA) of Fingernail Psoriasis and a PGA of Skin Psoriasis of at least moderate.
- •Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Week 0, ustekinumab must have been discontinued at least 12 weeks prior to Week
- •Target fingernail must have mNAPSI score of ≥
- •Adult subjects with clinical diagnosis of chronic plaque psoriasis (with disease duration of at least 6 months).
排除标准
- •Prior adalimumab therapy.
- •Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis.
- •Recent infection requiring treatment.
- •Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse.
- •Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
- •History of cancer, except successfully treated skin cancer.
结局指标
主要结局
Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26
时间窗: Week 26
Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.
For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26
时间窗: Week 26
The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of "clear" (0) or "minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.
次要结局
- Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26(Week 26)
- Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26(Baseline, Week 26)
- Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26(Week 26)
- Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26(Week 26)
- Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26(Week 26)
- Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26(Week 26)
- Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26(Week 26)
- Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26(Week 26)
- Change From Baseline in Target Fingernail NAPSI Score at Week 26(Baseline, Week 26)
- Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26(Baseline, Week 26)
- Change From Baseline in Target Fingernail mNAPSI Score at Week 26(Baseline, Week 26)
- Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26(Baseline, Week 26)
- Change From Baseline in Total Fingernail mNAPSI Score at Week 26(Baseline, Week 26)
- Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26(Week 26)
- Change From Baseline in Total Fingernail NAPSI Score at Week 26(Baseline, Week 26)
- Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26(Baseline, Week 26)
- Percent Change From Baseline in PASI Score at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26(Week 26)
- Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26(Week 26)
- Percentage of Participants Achieving PGA-S of "Clear" at Week 26(Week 26)
- Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26(Week 26)
- Change From Baseline in Total Body Surface Area (BSA) at Week 26(Baseline, Week 26)
- Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26(Baseline, Week 26)
- Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study(up to Week 26)
- Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26(Baseline, Week 26)
- Percent Change From Baseline in Total BSA at Week 26(Baseline, Week 26)
- Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26(Baseline, Week 26)
- Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26(Baseline, Week 26)
- Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26(Baseline, Week 26)
- Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26(Baseline, Week 26)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26(Week 26)
- Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26(Baseline, Week 26)
- Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26(Baseline, Week 26)
- Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26(Baseline, Week 26)