NCT00941031已完成2 期
A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.
研究概览
简要总结
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 18 years of age at time of consent
- •Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
- •At time of randomization, moderate to severe psoriasis as defined by:
- •PASI score of 12 or greater and
- •IGA score of 3 or greater and
- •Body Surface Area (BSA) affected by plaque-type psoriasis of 10 % or greater
- •At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:
- •topical treatment and/or
- •phototherapy and/or
- •previous systemic therapy
排除标准
- •Patients meeting any of the following criteria will be excluded from entry into the study:
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
- •Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
- •Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
- •Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
- •Known immunosuppression (e.g., AIDS) at screening and / or randomization
- •History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
- •Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
- •At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- •History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
- •History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
- •Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
Induction Single Dose
Experimental
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
干预措施: AIN457 (Drug)
Induction Monthly Dose
Experimental
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
干预措施: AIN457A (Drug)
Induction Early Loading Dose
Experimental
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
干预措施: AIN457A (Drug)
Placebo Dose
Placebo Comparator
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
干预措施: Placebo (Drug)
结局指标
主要结局
The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.
时间窗: 13 weeks
Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
次要结局
- The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29(week 21 to 29)
- The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo(13 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type PsoriasisChronic Plaque-type PsoriasisNCT01071252Novartis Pharmaceuticals125
已完成
2 期
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis PatientsPsoriasis, Plaque-type PsoriasisNCT01537432Novartis Pharmaceuticals36
已完成
不适用
Bioelectrical Impedance Analysis of Not-celiac Wheat Sensitivity PatientsNot-celiac Gluten (Wheat) SensitivityNCT01762566University of Palermo30
已完成
3 期
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)Rhinitis, Allergic, PerennialNCT00092118Organon and Co1,992
已完成
1 期
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With PsoriasisPsoriasisNCT01510951Amgen9