NCT01090063已完成不适用
An Investigator-Initiated, Open-label Study Evaluating the Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.
研究概览
简要总结
The purpose of this study is to determine the short and long term safety and effectiveness of ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 85 years of age with palmar plantar psoriasis with well defined psoriatic plaques on the palms and/or soles with a Physician Global Assessment (PGA) of 3 or higher who are unresponsive to topical management. Pustules, fissures and psoriatic arthritis may be present but are not required.
- •Adults in general good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination.
- •Females of reproductive potential are eligible to participate in the study if they have a negative urine pregnancy test at screening and baseline and who are using 2 forms of effective birth control.
- •Palmar/Plantar PGA of 3 or more
排除标准
- •Psoriasis patients without palm and/or sole psoriasis or a palmar/plantar PGA score of less than 3
- •Patients younger than 18 and older than 85 years old.
- •Evidence of skin conditions at the time of the screening visit (e.g. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
- •Receipt of any investigational drugs within 4 weeks of study drug initiation
- •Psoralens + UltraViolet A (PUVA) or oral systemic treatments within 4 weeks of study drug initiation.
- •Biologics within 3 months of study initiation
- •Ultraviolet B (UVB) therapy or topical steroids within 2 weeks of study drug initiation
- •A prior history of tuberculosis, and/or a positive Purified Protein Derivative (PPD) skin test/Chest X-Ray (CXR) at screening without appropriate treatment. Treatment of latent Tuberculosis (TB) infections (for those with positive PPD tests) must be initiated prior to therapy.
- •Receipt of live vaccines 1 month prior to or while in study
- •Chronic hepatitis B or hepatitis C infection
- •History of alcohol or drug abuse one year before and during the study.
- •Known Human Immunodeficiency Virus (HIV)-positive status or any other immune-suppressing disease.
- •Any grade 3 or 4 adverse event, or laboratory toxicity, at the time of the screening visit or at any time during the study
- •Presence of a grade 3 or 4 infection <30 days prior to the screening visit, between the screening visit and the first day of treatment on study, or any time during the study that in the opinion of the Investigator would preclude participation in the study.
- •Any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)
结局指标
主要结局
Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.
时间窗: 16 weeks
次要结局
- PGA Score Over Time From Baseline to Week 24(Baseline, 24 weeks)
- Pustule Count (if Present at Baseline) From Baseline to Week 24(Baseline, 24 weeks)
- Fissure Count (if Present at Baseline) From Baseline to Week 24(Baseline, 24 weeks)
- Pruritus Visual Analog Scale From Baseline to Week 24(Baseline, 24 weeks)
- Pain Visual Analog Scale From Baseline to Week 24(Baseline, 24 weeks)
- Safety Outcome Measures(24 weeks)
研究者
研究点 (2)
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